Clinical Review & Education

Review

Effect of Physical Therapy on Wound Healing and Quality of Life in Patients With Venous Leg Ulcers A Systematic Review Elizabeth Yim, MPH; Robert S. Kirsner, MD, PhD; Robert S. Gailey, PhD, PT; David W. Mandel, PhD, PT; Suephy C. Chen, MD, MS; Marjana Tomic-Canic, PhD

Invited Commentary page 327 IMPORTANCE Patients with venous leg ulcers (VLUs) have calf muscle pump dysfunction,

which is associated with reduced ankle range of motion (ROM). Physical therapy or exercise that targets ankle joint mobility may lead to improvement in calf muscle pump function and subsequent healing. However, little is known regarding the effect of physical therapy or exercise on healing and quality of life (QOL), which is impaired in patients with VLUs. OBJECTIVES To systematically review the current literature on the effect of physical therapy on healing and QOL outcomes in patients with VLUs and to identify research gaps that warrant further investigation. EVIDENCE REVIEW PubMed (MEDLINE), CINAHL, and Cochrane databases were searched in

April 2014. FINDINGS We found 10 articles, consisting of randomized clinical trials and single-arm cohort studies with small sample sizes, that used physical therapy or exercise for patients with open or healed VLUs. Although there is evidence that exercise strengthens the calf muscle pump and improves ankle ROM, few studies have investigated the effect of these interventions on QOL and healing, and few involved the supervision of a physical therapist. CONCLUSIONS AND RELEVANCE The lack of evidence and randomized clinical trials suggests the need for further investigation on physical therapy–oriented exercise on wound healing and QOL. In addition, more studies are needed to investigate sustainability of the increased ankle ROM after physical therapy has ended or if VLU reoccurrences are prevented. JAMA Dermatol. 2015;151(3):320-327. doi:10.1001/jamadermatol.2014.3459 Published online December 17, 2014.

C

hronicvenousinsufficiency(CVI)isadysfunctionofthevenous system due to sustained ambulatory venous pressure in the lower limbs that occurs as a result of an impairment of the calf muscle pump, whose components include the veins and their valves, the leg and foot muscles, and ankle mobility. Venous leg ulcers (VLUs) are a severe consequence of CVI. They are the most common ulcers foundonthelegsandareoftenchronicandrecurrent.1 Onecomponent of the calf muscle pump, ankle range of motion (ROM), decreases with increasing severity of CVI, with patients with VLUs having the most impaired ankle ROM.2,3 Ankle mobility is needed for activation of the calf muscle pump in returning blood to the heart. Calf muscle contraction propelsbloodfromthesuperficialveinstothedeepvenoussystemsvia communicatingorperforatingveins.Severalfactorsmaylimitanklemobility, including but not limited to edema, pain, neuropathy, and muscle atrophy and weakness. Evidence suggests that decreased ankle ROM is associated with delayed healing. As an example, Barwell et al4 found that 13% of individuals with ankle ROM less than 35° of dorsiflexion and plantarflexioncomparedwith60%ofindividualswithtotalankleROM greater than 35° healed at 24 weeks. Patients with VLUs often have im320

Author Affiliations: Department of Dermatology and Cutaneous Surgery, University of Miami Miller School of Medicine, Miami, Florida (Yim, Kirsner, Tomic-Canic); Department of Physical Therapy, University of Miami Miller School of Medicine, Miami, Florida (Gailey, Mandel); Division of Dermatology, Atlanta Veterans Affairs Medical Center, Decatur, Georgia (Chen); Department of Dermatology, Emory University, Atlanta, Georgia (Chen). Corresponding Author: Marjana Tomic-Canic, PhD, Department of Dermatology and Cutaneous Surgery, University of Miami Miller School of Medicine, 1600 NW 10th Ave, Rosensteil Medical Science Bldg, Room 2023-A, Miami, FL 33136 ([email protected]).

paired balance, gait, and walk speed5,6 and require more walking aids than patients with healed ulcers.7 Evidence also suggests an associationbetweenexercisefrequencyandVLUreoccurrence.8 Anargument could be made that exercises that target ankle ROM could improve calf muscle pump function, which in turn would help reduce healing time, diminish ulcer size, and lessen the risk of recurrences. Physical therapy is an individualized treatment regimen based on a patient’s comprehensive evaluative findings on measures such as strength, ROM, sensation, proprioception, circulation, functional performance, and medical history. Individualized physical therapy interventions are routinely prescribed for people with peripheral vascular diseaseandarefrequentlystandardprotocolintherehabilitationofpatients after cardiac surgery. However, little evidence exists with regard to the effect of physical therapy interventions for people with VLUs. In addition, quality of life (QOL) is increasingly being assessed as animportantoutcomemeasurewhencoupledwithobjectivemeasures, enabling a more accurate representation of the global effect a specific interventionormodalityhasonaparticularpatientorapopulationwith the same diagnosis.9,10 Numerous health-related QOL (HRQoL) instru-

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Physical Therapy in Patients With Leg Ulcers

ments exist. Most common are the generic instruments, such as the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) and its adaptations,11-14 the Nottingham Health Profile,15-17 and EuroQol-5.18 The SF-36 is the most commonly used instrument in measuringHRQoL.19 Itisa36-itemquestionnairethatconsistsof8domains. Fouraresummarizedintoaphysicalcomponentscore(functioncapacity,physicalrole,pain,andgeneralhealth),andtheremaining4aresummarized into a mental component score (vitality, social role, emotional role,andmentalhealth).Thescorerangesfrom0to100,andthehigher thescore,thebettertheperceptionoftheindividualoftheirQOL.Inaddition to generic QOL measures, there is also a wide variety of VLUspecific HRQoL instruments, including but not limited to the Chronic Lower Limb Venous Insufficiency Questionnaire, Venous Insufficiency Epidemiologic and Economic Study Questionnaire,20 the Hyland instrument,21 and the Charing Cross Venous Leg Ulcer Questionnaire. Many studies12,15,17,19-21 have found that HRQoL is low in patients with VLUs. Although healing of an ulcer may not necessarily lead to an improvement in QOL, treatments such as compression therapy22,23 or bilayered skin constructs10 improve HRQoL, in particular, pain.15 Despite evidence that HRQoL, specifically physical components such as pain and physical function, in patients with VLUs is reduced, the role of physical therapy interventions in improving HRQoL in patients with VLUs is not known.

Review Clinical Review & Education

Figure 1. Summary Flowchart of the Systematic Review 885 Total citations identified through database searches 644 PubMed (MEDLINE) 118 Cochrane 73 CINAHL 804 Potential relevant citations 659 Citations rejected 627 Not relevant to review 32 No abstract 148 Abstracts screened 101 Abstracts rejected 71 Not relevant to topic 24 Duplicates 6 Systematic or literature reviews 47 Articles screened 39 Articles rejected 24 QOL questionnaire validations 6 Observational studies 5 Qualitative methods 4 Behavioral studies 9 Snowball method 7 Articles rejected 3 Not related to VLU 2 Literature review 1 Expert opinion 1 Acute wounds

Methods We sought to review the current literature with regard to the effect of physical therapy on healing and QOL outcomes in patients with VLUs. We performed a systematic search of the PubMed (MEDLINE), CINAHL, and Cochrane databases in April 2014, using the keywords venous ulcer, venous leg ulcer, quality of life, health-related quality of life,physicaltherapy,andexercise.Thesetermswerecombinedorused individually, if necessary. We only included articles that were available in English. We also searched the references of selected studies to identify studies not retrieved in the initial search (the snowball method). There was no restriction on statistical methods. After the initial search, we then excluded systematic and literature reviews, observational studies, and topics unrelated to the interested topic. We also excluded articles validating QOL questionnaires or measuring QOL as outcomes for treatment modalities other than physical therapy or exercise regimen. Articles considered to be expert opinion or poorly constructed were excluded. Articles that investigated the effect of motivation or behavioral changes on adherence to physical activity were also excluded. Although interviews provide qualitative value, qualitative methods were excluded because the authors were interested in objective measures of QOL. We included articles that investigated patients with healed VLUs but excluded studies that consisted of patients with only mild CVI. Thequalityofevidencewasassessedbasedongradingrecommendations by Robinson et al.24 The grades for quality of evidence were as follows: grade A, systematic review or meta-analysis, randomized clinical trial (RCT) with consistent findings, or all-or-none observational study;gradeB,systematicreviewormeta-analysisoflower-qualityclinical trials or studies with limitations and inconsistent findings, lowerquality clinical trials, cohort studies, or case-control studies; or grade C, consensus guidelines, practice, expert opinions, or case series. Studies with grade C level of evidence were not included for analysis. jamadermatology.com

10 Accepted articles after read in full and application of inclusion criteria

Number of studies identified, screened, included, and excluded at each stage of study selection. Of 804 citations and 148 abstracts screened, 10 randomized clinical trials and cohort studies were identified as appropriate for review. QOL indicates quality of life; VLU, venous leg ulcers.

Although the end point of complete healing is often used as the criterion standard for wound healing trials, this singular end point has been challenged.25 Wound size reduction, faster time to healing, and improved QOL are clinically significant end points, and as such we have included them as part of our review.

Results A search, detailed in Figure 1, was performed in April 2014, which identified 804 potential citations. After exclusion as defined in the Methods section, we screened 47 articles and found 10 articles that were specifically related to the aforementioned topics and determined to be appropriate for review. Five articles were identified as RCTs, 1 as a non-RCT, and 4 as single-arm cohort studies. All 10 articles were graded with a B level of evidence. Some studies26-29 defined the severity of disease using the clinical component of ClinicalEtiology-Anatomy-Pathophysiology classification: C1, telangiectasia or reticular veins; C2, varicose veins; C3, edema; C4, skin changes (pigmentation, venous eczema, or lipodermatosclerosis); C5, healed ulceration; and C6, active ulceration. Other studies30,31 simply stated (Reprinted) JAMA Dermatology March 2015 Volume 151, Number 3

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that they included patients with ulcers that appeared clinically venous and had been present for more than 6 weeks. Others27,28 required an objective diagnosis of a VLU with ultrasonography for the presence of reflux. The reported mean or median age ranged from 54 to 76 years. Body mass index (BMI; calculated as the weight in kilograms divided by height in meters squared) was not reported for all studies. When reported, the mean or median BMI was greater than 33.9.26,27,31 In the study by Meagher et al,32 although not listing mean BMI, most patients (>60%) had a BMI greater than 25.

Physical Therapy in Patients With VLUs We found 10 articles that applied to our inclusion criteria. They consisted of RCTs and single-arm cohort studies with small sample sizes. We found 7 studies27,30-35 that used physical therapy or exercise for patients with VLUs and 3 studies26,28,29 for patients with healed VLUs. The Table lists these studies, their exercise regimens, and their results. The duration and regimen of exercise, as well as use of compression, varied among the studies. Two studies26,34 had interventions that lasted only 7 days. The exercise interventions ranged from walking,32 standing heel-raises (tip-toe exercise),28,30,31 use of a treadmill, cycling, and use of elastic resistance bands.33 Some studies28,30,31,33 required a written log or diary. Four of the home-based programs were individualized by a physical therapist or a nurse.28,30,31 Exercise interventions with supervision took place at the clinics or in the individual’s home. Supervision consisted of a nurse,35 a physical therapy assistant,27 or an exercise physiologist.29 However, in the study29 that was supervised by an exercise physiologist, no patients with VLUs were included. One study34 did not explain in detail who provided the supervision. Only 1 supervised study27 provided exercise tailored to each participant, and 2 studies27,31 used exercises that were prescribed by a physical therapist. Calf Muscle Pump Function and Ankle ROM

There is substantial evidence that exercise focused on strengthening the calf musculature improves calf muscle pump function, as demonstrated by improvement in ejection fraction and residual volume fraction27,28,30,31,34 and ankle ROM.18,20,22,23 Szewczyk et al35 compared individuals with nurse-supervised exercises to unsupervised exercises after 9 weeks and reported increases in ankle ROM for both groups, although the group under supervision achieved significantly improved ankle joint mobility. Ulcer Size

We found only 3 studies30-32 that investigated the effect of physical therapy or exercise and ulcer size, all with conflicting results. In 2009, Jull et al30 reported no improvement in area reduction or time to healing after 12 weeks of a home-based exercise program. Ankle ROM was not measured. O’Brien et al31 published a study that investigated ankle ROMandulcerhealingparametersin13patientswithVLUs.Theirstudy reported that patients with VLUs had improvement in healing, but this finding was not statistically significant (P = .34).31 However, Meagher et al32 found an association between the number of steps a patient took and the time it took for patients with VLUs to heal. Patients were randomized to prescribed walking to achieve a goal of 10 000 steps per day or to not increase their steps. Steps were selfreported (patients were asked to record their steps using a pedometer)andalsoobjectivelymeasuredusinganaccelerometerdevicethat was attached to the patient. 322

Physical Therapy and QOL We found 2 studies31,32 that measured QOL in individuals who participated in prescribed physical therapy programs. Both studies reported that there was no change in QOL after physical therapy. However, in the study by O’Brien et al,31 QOL was not reported individually for the control or the intervention groups. In addition, the specific instrument used to measure QOL was not mentioned. In a study of leg ulcers, Padberg et al27 assessed QOL using the Chronic Lower Limb Venous Insufficiency Questionnaire and the physical component score of the SF-36 and also reported no difference in QOL or in ankle ROM between the groups. However, in that study of 31 patients, only 3 patients had VLUs in the control or intervention group, which makes it difficult to interpret the results because there were so few patients with VLUs in thisparticularstudy.Apartfromthesestudies,wedidnotfindadditional studiesthatusedVLU-specificHRQoLinstrumentstomeasurechanges in QOL with physical therapy intervention. Zajkowski et al29 observed an improvement in SF-12 scores from 52.2 to 54.8; however, statistical significance was not noted. This study did not include patients with VLUs, and all patients performed a standard exercise regimen. In addition, calf muscle pump function did not improve after 10 weeks of supervised exercise sessions in this study. The lack of significance can be attributed to a small sample size and absence of individualized exercises, which would be helpful in such a studyinwhichtherewerepatientswithvariousCVIclassifications,such as C2 (varicose veins), C4 (skin changes), and C5 (healed VLU).

Discussion Evidence has revealed that patients with CVI compared with their healthy counterparts have impaired balance and gait5 and decreased ankle ROM.2 A structured physical activity program compared with a health education program has been reported to be more effective in reducing mobility disability in older adults,36 which are more at risk for developing CVI and VLUs. Exercise that improves ankle ROM can result in improved calf muscle pump function; however, the number of studies that investigated the effect of these exercises on QOL and ulcer healing parameters is limited. They consist of mostly studies with small sample sizes and exercise programs rather than physical therapy sessions. Most of the exercise programs were designed by a physical therapist, but few studies involved supervision, and when supervision occurred,anurseorphysicaltherapistassistantprovidedit.Patientswere instructed to exercise at home several times per week, but it is unknown whether patients performed these exercises. With the exception of one study32 in which steps were recorded objectively and subjectively, most activity levels were self-reported. Journals and diaries were distributed,31,33 but validity for this technique to assess patient adherence does not exist. In one study, few and sometimes none of the patients returned these diaries, making it difficult to compare daily activity levels between intervention and control groups.31 With supervision, there was a greater effect on improving ankle ROM and calf pump function than home-based exercises with little supervision, as indicated by the study by Szewczyk et al.35 However, one caveat of this study is that the exercise was not designed by a physical therapist and was under nurse supervision. Kelechi et al26 also offered an alternative to physical therapy with Internet-based coaching sessions, which reported increase adherence and significant improve-

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Table. Summary of Studies Investigating Exercise Programs for Patients With Venous Leg Ulcers

Source O'Brien et al,31 2013

Exercise (Level) Home-based exercise (heelrises and calf and hamstring stretching) individualized by physical therapist vs control (standard advice) (RCT) Meagher Prescribed walking 32 et al, with a target of 10 000 steps per 2012 day in the intervention group vs control group (no change in steps) (RCT)

Szewczyk Nurse-supervised et al,35 vs unsupervised standard exercise 2010 regimen (circular foot movements, lifting body weight while standing on toes, alternate dorsiflexion and plantar flexion, cycling) (RCT) Jull Home-based et al,30 exercise (heel-rises) 2009 vs control (usual care and compression) with exercise regimen individualized by nurse (RCT) Davies Home-based 33 et al, standard exercise 3 times weekly with 2007 ankle elastic resistance bands and stretching (single-arm cohort) Padberg 3 Months of et al,27 heel-rises, uphill treadmill 2004 supervised by physical therapy assistant, and unsupervised vs control (compression) exercises individualized per person (RCT)

CVI Classification/ No. of Patients/ Durationa Compression C6/13/ Multilayer 12 wk compression bandaging

Calf Muscle Pump EF increased by 21% vs 2% (P = .05) and RVF decreased by 26% vs 3% (P = .05) ND

Ankle ROM 30% Increase in exercise group vs 0% control (P = .01)

ND

C6/40/ 12 wk

Multilayer compression bandages

C6/32/ 9 wk

ND 2-Layer compression, short-stretch bandages

C6/40/ 12 wk

ND Mean difference between 2 groups: EF of 18.5% (P < .05) and RVF −10.4% (P = .30) ND 8.7° and No 7.6° compression improvement therapy at 12 during (P = .006) exercise and 24 weeks (P = .01) 0.9° vs 2.3° Compression EF stockings improved improvement (P = .48) by 3.5% vs −1.4% in controls (P = .03) and RVF decreased by −8.8% vs 3.4% in controls (P = .03)

C6/11/ 24 wk

C4-C6/31/ 24 wkb

8.3° vs 3.7° increases in ankle ROM (P < .05)

Compression (type up to patient and physician’s discretion)

Ulcer Size/ Area Reduction 77% Intervention vs 45% control (P = .34)

No significance between increase in steps with ulcer size (P = .72) and greatest reduction within 4 weeks of treatment: 55% exercise group vs 47% control group achieved 61%-99% ulcer healing ND

Time to Healing ND

QOL or Pain Healed No change 50% intervention reported in QOL vs 40% control (P = .74)

50% of patients in intervention group increased mean number of steps, whereas 33% achieved 10 000 steps per day

83% of No. of exercise steps was associated group vs with time it 76% control took to heal group (P = .12) at week 1 and week 4 (P = .052, P = .008, respectively)

ND

ND

Comments

ND

−1.47 vs −2.92 cm2 (P = .08)

No changes 38% in exercise observed group vs (P = .49) 53% in usual care group

ND

ND

ND

ND

ND

ND

ND

Median pain scores (scale, 1-10) reduced from 5.2 to 2 No changes No observed comparison of supervised vs unsupervised exercise

(continued)

ment in ankle strength and plantar flexion. However, with a very specific target population of obese patients with healed ulcers and a very small sample size of 5 patients, no other significant changes were observed, and calf muscle pump or endurance was not studied. However, their results provide an alternative method that may address barjamadermatology.com

riers, such as lack of transportation and cost, as well as improving adherence by providing not only supervision but also motivation. In addition, no studies investigated how long the improvement in calf muscle pump function and ankle ROM persisted or was maintained after the prescribed physical therapy regimen ended. (Reprinted) JAMA Dermatology March 2015 Volume 151, Number 3

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Table. Summary of Studies Investigating Exercise Programs for Patients With Venous Leg Ulcers (continued)

Source Kan and Delis,34 2001

Exercise (Level) Supervised resistant calf muscle exercise standard regimen (3 sets of plantar flexion 6 min each) with a 4-kg resistance pedal ergometer vs control (standard ulcer care) (prospective controlled study)

Zajkowski Supervised et al,29 standard regimen (by exercise 2006 physiologist) of 18 session 1 hour each 2-3 times per week (treadmill, cycling, steps) (single-arm cohort) Yang Home-based 28 et al, exercise (heel-rises) individualized per 1999 person (single-arm cohort)

Kelechi et al,26 2010

CVI Classification/ No. of Patients/ Durationa Compression Short-stretch C6/21/ compression 7 consecutive bandages days

C2-C5/11/ 22 limbs (8 with no CVI and 14 with CVI)/ 10 wk

C5/20/ 6 wk

Obese C5 2 Home visits (90 minutes each) and 3 (BMI >30)/ one-on-one Skype 5/1 wk coaching sessions with a nursing student (15 minutes each) using elastic resistance and pedal exercises individualized and with a physical therapist consultant (single-arm cohort)

Calf Muscle Ankle Pump ROM ND EF improved by 67.5% vs −4.5% (P = .006), RVF decreased by 28.6% vs 0% (P = .008), and endurance increased by 135% (P < .001) ND Compression No stockings significant improvement in EF or RVF and a greater increase in EF for C2 vs C4-C5 ND EF No compression improved 20% therapy (P = .001) during and RVF exercise decreased by 41% (P = .001) Not ND Plantar reported flexion improved by 4.4° (P = .09), and dorsiflexion improved by 0.90° (P = .40) (significance set at α = .10)

Abbreviations: BMI, body mass index; CVI, chronic venous insufficiency; EF, ejection fraction; ND, not done; QOL, quality of life; RCT, randomized clinical trial; ROM, range of motion; RVF, residual volume fraction; SF-12, Medical Outcomes Study 12-Item Short Form Health Survey. a

Classification of CVI based on the clinical component of the clinical-etiology-

None of the studies were longitudinal or designed to investigate the prevention of VLU recurrence. Jull et al30 published one of the earliest studies to investigate the effect of exercise on healing parameters and found significant improvement in calf muscle pump function but no effect on ulcer healing parameters. However, ankle ROM was not measured, and compression was up to the patient’s and physician’s discretion. The study by O’Brien et al31 was one of the first to examine the effect of exercise on improving ankle ROM and healing in addition to multilayer compression. The authors found that ankle ROM significantly improved (P = .01). In addition, there was improvement in the reduction of ulcer size and in the number of healed participants, but no statistical significance was reached. The authors attributed their statistically insignificant results (P = .34) to their small sample size and suggested a larger sample size was needed. In the study by Meagher et al, patients who walked more steps at baseline and 4 weeks 324

QOL or Pain ND

Ulcer Size/ Area Reduction ND

Time to Healing ND

Healed ND

ND

ND

ND

Improvement in SF-12 scores from 52.2 to 54.8 (significance unknown)

ND

ND

ND

ND

ND

ND

ND

ND

Comments

No change in calf or ankle circumference; adherence was 100%, 4 admitted they did exercises more frequently

anatomy-pathophysiology classification: C1, telangiectasia or reticular veins; C2, varicose veins; C3, edema; C4, skin changes (pigmentation, venous eczema, and lipodermatosclerosis); C5, healed ulceration; and C6, active ulceration. b

C5 and C6 only had 3 patients in each group.

were more likely to have healed ulcers, regardless of the intervention. This finding suggests that perhaps a certain level of activity or steps needs to be achieved before an effect on healing is seen. Physical therapy has a positive effect on QOL in patients with VLUs, in particular the physical component scores, which was significantly lower compared with healthy patients or patients with milder CVI in many studies.19,37-40 Despite the increasing number of studies suggesting the implication of exercise to strengthen the calf pump on improving QOL of patients with VLU, evidence of the clinical effect is scarce. Moreover, there is limited evidence addressing its influence on ulcer healing and QOL. One particular domain of the physical component score, pain, was the most frequently identified factor that was affected in QOL.18,21,41-43 However, because few studies investigated the effect of physical therapy exercise on QOL, the change in painlevelshasalsonotbeenaddressedadequately,eventhoughphysical therapy itself may include pain modalities.

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Figure 2. Physical Therapy Evaluation Physical Therapy Evaluation One or more of the following impairments Decreased ankle active and passive ROM Decreased ankle plantar flexion muscle strength Decreased ankle dorsiflexion muscle strength Increased limb girth Impaired gait and functional mobility

Yes

No

Physical therapist treatment intervention at an outpatient clinic or in the home Leg strengthening, stretching, edema management, functional mobility, and gait training Patient education and/or caregiving training Frequency: twice a week

One-time physical therapy session for: Instructing patient and/or caregiver on exercises to maintain ankle ROM and strength, physical activity, and lifestyle management

Reassess

No

Improvement in ankle ROM and ankle muscle strength to equal to the uninvolved limb or to within 10% of age-related normal values, resulting in improved calf muscle pump Improvement in functional mobility and gait pattern to near prior level

Discontinue physical therapy Reassess if patient condition changes

Yes

The steps used to determine when physical therapy intervention is required and when it can be discontinued for the patient or caregiver. ROM indicates range of motion.

Discontinue physical therapy Instruct patient and/or caregiver on maintenance exercises, physical activity, and lifestyle management Reassess if patient’s condition changes

Although there are a wide variety of generic and venous-specific HRQoL instruments currently in use, we found that all but one study27 investigating physical therapy exercise used only generic instruments, such as SF-12, for measuring HRQoL. Disease-specific HRQoL instruments, which are able to distinguish between healing and nonhealing ulcers, would have been more beneficial for clinical use and might have ledtosignificantresults.However,becauseoftheheterogeneityofQOL instruments being used, selecting one standard has the advantage of allowing readers to compare the results of different studies. Direct care of physical therapy provides the necessary supervision and timely adjustments in treatment for improved outcomes.35 For guidance, we have created a flowchart to illustrate steps when physical therapy and supervision are recommended (Figure 2). Clear direction on exercise and physical activity prevents confusion with respect to a proper and safe exercise program that increases confidence and promotes adherence. Personal interactions between the physical therapist and the individual decrease fear, creating an environment for individuals to become engaged in their treatment and empowered to continue managing their health.44 In addition, physical activity may provide patients with venous insufficiency an opportunity to regain and maintain their health and function.44 Ashealthcareprovisioncontinuestomoveawayfromthehospitalbased models and toward more home care and independent patient caremodels,comparativeeffectivenessresearchwithsupervisedphysical therapy exercise needs to be explored. What needs to be determined is the effect of supervision by physical therapists for people with VLUs and whether it can reduce time for ulcer healing, lessen reoccurrence rates, improve physical well-being, enhance QOL, and ultimately create a reduction in total health care costs. The findings of this review have identified gaps, in particular in the effect of physical therapy exercise, ulcer healing, and QOL in individuals with VLUs. jamadermatology.com

Evidence exists that physical therapy–directed exercise improves calfmusclepumpfunction;however,furtherinvestigationwithrespect to changes in HRQoL and healing parameters in VLUs is needed. In addition, studies that use clinic- or hospital-based interventions designed and implemented by a physical therapist are lacking. In addition, no studies evaluated how long the achieved increase in ankle joint mobility is maintained after supervised physical therapy is discontinued. Numerous studies20,37-40 have found diminished QOL as evidenced by lower QOL scores for patients with VLUs compared with the general population or patients with milder CVI; however, studies investigating the effect of physical therapy–directed intervention on QOL with this population are lacking. Currently, there is no reimbursement for QOL improvement. However, integration of routine measurement of HRQoL and pain into clinical practice might be beneficial in highlighting patient-specific concerns, thereby improving overall quality of care, leading to a healthier lifestyle, greater adherence, and ultimately a reduction in health care costs. The association of a specific physical therapy intervention on individuals with VLUs with emotional and physical well-being, functional performance, activities of daily living, and overall health care costs should also be determined.

Conclusions We hope that this review will highlight the lack of evidence-based research in this area and the potential for physical therapy to be an integral component of VLU management and therapy during and after healing of a VLU. Physicians and physical therapists should be encouraged to work together to provide well-designed and supervised physical therapy for patients with VLUs that may affect their QOL and healing outcomes. (Reprinted) JAMA Dermatology March 2015 Volume 151, Number 3

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Physical Therapy in Patients With Leg Ulcers

ARTICLE INFORMATION Accepted for Publication: August 27, 2014. Published Online: December 17, 2014. doi:10.1001/jamadermatol.2014.3459. Author Contributions: Ms Yim had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Study concept and design: Yim, Kirsner, Gailey, Mandel, Tomic-Canic. Acquisition, analysis, or interpretation of data: Yim, Kirsner, Chen. Drafting of the manuscript: Yim, Mandel. Critical revision of the manuscript for important intellectual content: All authors. Administrative, technical, or material support: Gailey, Mandel. Statistical analysis: Yim. Study supervision: Kirsner, Chen, Tomic-Canic. Conflict of Interest Disclosures: None reported. REFERENCES 1. Margolis DJ, Bilker W, Santanna J, Baumgarten M. Venous leg ulcer: incidence and prevalence in the elderly. J Am Acad Dermatol. 2002;46(3):381-386. 2. Yim E, Vivas A, Maderal A, Kirsner RS. Neuropathy and ankle mobility abnormalities in patients with chronic venous disease. JAMA Dermatol. 2014;150(4):385-389. 3. Dix FP, Brooke R, McCollum CN. Venous disease is associated with an impaired range of ankle movement. Eur J Vasc Endovasc Surg. 2003;25(6): 556-561. 4. Barwell JR, Taylor M, Deacon J, Davies C, Whyman MR, Poskitt KR. Ankle motility is a risk factor for healing of chronic venous leg ulcers. Phlebology. 2001;16:38-40. 5. Pieper B, Templin TN, Birk TJ, Kirsner RS. Chronic venous disorders and injection drug use: impact on balance, gait, and walk speed. J Wound Ostomy Continence Nurs. 2008;35(3):301-310. 6. Pieper B, Templin TN, Kirsner RS, Birk TJ. Injection-related venous disease and walking mobility. J Addict Dis. 2010;29(4):481-492. 7. Hjerppe A, Saarinen JP, Venermo MA, Huhtala HS, Vaalasti A. Prolonged healing of venous leg ulcers: the role of venous reflux, ulcer characteristics and mobility. J Wound Care. 2010;19(11):474, 476, 478 passim. 8. Finlayson K, Edwards H, Courtney M. Relationships between preventive activities, psychosocial factors and recurrence of venous leg ulcers: a prospective study. J Adv Nurs. 2011;67(10): 2180-2190. 9. O’Meara S, Cullum N, Nelson EA, Dumville JC. Compression for venous leg ulcers. Cochrane Database Syst Rev. 2012;11:CD000265. 10. Mathias SD, Prebil LA, Boyko WL, Fastenau J. Health-related quality of life in venous leg ulcer patients successfully treated with Apligraf: a pilot study. Adv Skin Wound Care. 2000;13(2):76-78. 11. Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36), I: conceptual framework and item selection. Med Care. 1992;30 (6):473-483.

12. Ware JE Jr, Gandek B. Overview of the SF-36 Health Survey and the International Quality of Life Assessment (IQOLA) Project. J Clin Epidemiol. 1998; 51(11):903-912. 13. Ware JE Jr, Kosinski M, Bayliss MS, McHorney CA, Rogers WH, Raczek A. Comparison of methods for the scoring and statistical analysis of SF-36 health profile and summary measures: summary of results from the Medical Outcomes Study. Med Care. 1995;33(4)(suppl):AS264-AS279. 14. Ware JE Jr, Kosinski M, Gandek B, et al. The factor structure of the SF-36 Health Survey in 10 countries: results from the IQOLA Project. J Clin Epidemiol. 1998;51(11):1159-1165. 15. Lindholm C, Bjellerup M, Christensen OB, Zederfeldt B. Quality of life in chronic leg ulcer patients: an assessment according to the Nottingham Health Profile. Acta Derm Venereol. 1993;73(6):440-443. 16. Lamping DL. Measuring health-related quality of life in venous disease: practical and scientific considerations. Angiology. 1997;48(1):51-57. 17. Franks PJ, Moffatt CJ. Health related quality of life in patients with venous ulceration: use of the Nottingham health profile. Qual Life Res. 2001;10 (8):693-700. 18. Iglesias CP, Birks Y, Nelson EA, Scanlon E, Cullum NA. Quality of life of people with venous leg ulcers: a comparison of the discriminative and responsive characteristics of two generic and a disease specific instruments. Qual Life Res. 2005;14 (7):1705-1718. 19. Kaplan RM, Criqui MH, Denenberg JO, Bergan J, Fronek A. Quality of life in patients with chronic venous disease: San Diego population study. J Vasc Surg. 2003;37(5):1047-1053. 20. Andreozzi GM, Cordova RM, Scomparin A, Martini R, D’Eri A, Andreozzi F; Quality of Life Working Group on Vascular Medicine of SIAPAV. Quality of life in chronic venous insufficiency: an Italian pilot study of the Triveneto Region. Int Angiol. 2005;24(3):272-277. 21. González-Consuegra RV, Verdú J. Quality of life in people with venous leg ulcers: an integrative review. J Adv Nurs. 2011;67(5):926-944. 22. Charles H. Does leg ulcer treatment improve patients’ quality of life? J Wound Care. 2004;13(6): 209-213. 23. Clarke-Moloney M, O’Brien JF, Grace PA, Burke PE. Health-related quality of life during four-layer compression bandaging for venous ulcer disease: a randomised controlled trial. Ir J Med Sci. 2005;174 (2):21-25. 24. Robinson JK, Dellavalle RP, Bigby M, Callen JP. Systematic reviews: grading recommendations and evidence quality. Arch Dermatol. 2008;144(1):97-99. 25. Eaglstein WH, Kirsner RS, Robson MC. Food and Drug Administration (FDA) drug approval end points for chronic cutaneous ulcer studies. Wound Repair Regen. 2012;20(6):793-796. 26. Kelechi TJ, Green A, Dumas B, Brotherton SS. Online coaching for a lower limb physical activity program for individuals at home with a history of venous ulcers. Home Healthc Nurse. 2010;28(10): 596-605.

function in chronic venous insufficiency: a randomized trial. J Vasc Surg. 2004;39(1):79-87. 28. Yang D, Vandongen YK, Stacey MC. Effect of exercise on calf muscle pump function in patients with chronic venous disease. Br J Surg. 1999;86(3): 338-341. 29. Zajkowski PJ, Draper T, Bloom J, Henke PK, Wakefield TW. Exercise with compression stockings improves reflux in patients with mild chronic venous insufficiency. Phlebology. 2006;21(2):100104. 30. Jull A, Parag V, Walker N, Maddison R, Kerse N, Johns T. The prepare pilot RCT of home-based progressive resistance exercises for venous leg ulcers. J Wound Care. 2009;18(12):497-503. 31. O’Brien J, Edwards H, Stewart I, Gibbs H. A home-based progressive resistance exercise programme for patients with venous leg ulcers: a feasibility study. Int Wound J. 2013;10(4):389-396. 32. Meagher H, Ryan D, Clarke-Moloney M, O’Laighin G, Grace PA. An experimental study of prescribed walking in the management of venous leg ulcers. J Wound Care. 2012;21(9):421-422, 424426, 428 passim. 33. Davies JA, Bull RH, Farrelly IJ, Wakelin MJ. A home-based exercise programme improves ankle range of motion in long-term venous ulcer patients. Phlebology. 2007;22(2):86-89. 34. Kan YM, Delis KT. Hemodynamic effects of supervised calf muscle exercise in patients with venous leg ulceration: a prospective controlled study. Arch Surg. 2001;136(12):1364-1369. 35. Szewczyk MT, Jawień A, Cwajda-Białasik J, Cierzniakowska K, Mościcka P, Hancke E. Randomized study assessing the influence of supervised exercises on ankle joint mobility in patients with venous leg ulcerations. Arch Med Sci. 2010;6(6):956-963. 36. Pahor M, Guralnik JM, Ambrosius WT, et al; LIFE study investigators. Effect of structured physical activity on prevention of major mobility disability in older adults: the LIFE study randomized clinical trial. JAMA. 2014;311(23):2387-2396. 37. Kahn SR, M’lan CE, Lamping DL, Kurz X, Bérard A, Abenhaim LA; VEINES Study Group. Relationship between clinical classification of chronic venous disease and patient-reported quality of life: results from an international cohort study. J Vasc Surg. 2004;39(4):823-828. 38. Lozano Sánchez FS, Marinel lo Roura J, Carrasco Carrasco E, et al; Sociedades Españolas de Angiología y Cirugía Vascular (SEACV); Capítulo Español de Flebologia, the Médicos de Atención Primaria (SEMERGEN); Medicina Familiar y Comunitaria (SemFYC). Venous leg ulcer in the context of chronic venous disease. Phlebology. 2014;29(4):220-226. 39. Lozano Sánchez FS, Sánchez Nevarez I, González-Porras JR, et al; Sociedad Española de Angiología y Cirugía Vascular (SEACV); Sociedad Española de Médicos de Atención Primaria (SEMERGEN); Sociedad Española de Medicina Familiar y Comunitaria (SEMFYC). Quality of life in patients with chronic venous disease: influence of the socio-demographical and clinical factors. Int Angiol. 2013;32(4):433-441.

27. Padberg FT Jr, Johnston MV, Sisto SA. Structured exercise improves calf muscle pump 326

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Physical Therapy in Patients With Leg Ulcers

Review Clinical Review & Education

40. Moura RM, Gonçalves GS, Navarro TP, Britto RR, Dias RC. Relationship between quality of life and the CEAP clinical classification in chronic venous disease. Rev Bras Fisioter. 2010;14(2):99-105.

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Invited Commentary PRACTICE GAPS

Enhancing the Role of Physical Therapy in Venous Leg Ulcer Management Joseph McCulloch, PT, PhD, CWS, FAPTA; Edward Mahoney, PT, DPT, CWS; Stanley McCallon, PT, DPT, CWS

The role of the calf muscle pump in addressing complications associated with ambulatory venous hypertension and venous leg ulcers (VLUs) has received a great deal of attention in recent years. Any serious look at the rehabilitation of individuals Related article page 320 with calf muscle pump dysfunction should logically include the expertise of a physical therapist uniquely positioned to evaluate and manage the biomechanical system. Improvement in musculoskeletal function has the potential to facilitate the healing of VLUs and improve the quality of life (QOL) in cases where ambulation and function are compromised. The shortcomings in the literature surrounding exercise and QOL assessments for individuals with VLUs were well addressed by Yim et al.1 The importance of exercise in general for any patient for whom the goal is to improve overall health and cardiovascular performance is without question; however, when one looks at evidence to support exercise to improve calf muscle pump dysfunction, greater specificity is required. An appropriate exercise plan developed by the physical therapist should address the mode, frequency, duration, and intensity and should be implemented in a supervised program to facilitate adherence. A recent Consumer Reports article outlined 5 physical therapy interventions that are improperly used, including underdosing strength training for older adults.2 Evidence suggests that older adults are often treated with exercises that are at intensities too low to cause adaptations out of an unfounded fear that the individual may be hurt. In actuality, a challenging program monitored by the physical ARTICLE INFORMATION Author Affiliations: School of Allied Health Professions, Louisiana State University Health Sciences Center, Shreveport. Corresponding Author: Joseph McCulloch, PT, PhD, CWS, FAPTA, School of Allied Health Professions, Louisiana State University Health Sciences Center, PO Box 33932, Shreveport, LA 71130 ([email protected]).

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therapist offers the greatest benefit to the elderly patient, including elderly, otherwise healthy, sedentary patients with VLUs. When planning any exercise program for patients with VLUs, the physical therapist needs to assess the effect of compression dressings and how the particular wrap or sleeve affects ankle range of motion. In addition, shoe wear needs to be considered. Bulky dressings often necessitate the wearing of inappropriate footwear, such as cast boots or slippers that prevent a proper heel-toe gait. Quality of life issues are also poorly addressed when looking at the benefits of physical therapy for patients with VLUs. Many physical therapists, working in a general rehabilitation setting, would be less aware of specialized QOL assessment tools, such as the Charing Cross Venous Ulcer Questionnaire (CCVUQ). They would instead be more likely to use patient-reported functional outcome tools, such as the Medical Outcomes Study 36Item Short-Form Health Survey or the Lower Extremity Functional Scale, which do not have great specificity for items that affect patients with VLUs. In addition to VLU-specific QOL assessments, objective functional assessments, such as walking distance, balance, and speed, should be assessed. In summary, practice patterns and research in physical therapy need to be developed to address the following for patients with VLUs: (1) individualized exercise programs developed by the physical therapist that include mode, frequency, duration, and intensity and address proper footwear; (2) QOL assessments pertinent to lower-extremity dysfunction; and (3) additional functional outcome measures.

Published Online: December 17, 2014. doi:10.1001/jamadermatol.2014.4042.

online December 17, 2014]. JAMA Dermatol. doi:10.1001/jamadermatol.2014.3459.

Conflict of Interest Disclosures: None reported.

2. Five physical therapy treatments you probably don’t need: here’s what you should try instead. September 15, 2014. http://www.consumerreports .org/cro/news/2014/09/5-physical-therapy -treatments-you-probably-do-not-need/index.htm. Accessed on October 2, 2014.

REFERENCE 1. Yim E, Kirsner RS, Gailey RS, Mandel DW, Chen SC, Tomic-Canic M. Effect of physical therapy on wound healing and quality of life in patients with venous leg ulcers: a systematic review [published

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Effect of physical therapy on wound healing and quality of life in patients with venous leg ulcers: a systematic review.

Patients with venous leg ulcers (VLUs) have calf muscle pump dysfunction, which is associated with reduced ankle range of motion (ROM). Physical thera...
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