Aging Clin Exp Res DOI 10.1007/s40520-015-0356-x

ORIGINAL ARTICLE

Focal muscle vibration as a possible intervention to prevent falls in elderly women: a pragmatic randomized controlled trial Claudia Celletti1 • Luigi Fattorini2 • Filippo Camerota1 • Diego Ricciardi3 Giuseppe La Torre4 • Francesco Landi3 • Guido Maria Filippi5



Received: 21 December 2014 / Accepted: 23 March 2015 Ó Springer International Publishing Switzerland 2015

Abstract Backgrounds Different and new approaches have been proposed to prevent the risk of falling of elderly people, particularly women. Aims This study investigates the possibility that a new protocol based on the focal mechanical muscle vibration may reduce the risk of falling of elderly women. Methods A pragmatic randomized controlled triple-blind trial with a 6-month follow-up after intervention randomized 350 women (mean age 73.4 years ? 3.11), members of local senior citizen centers in Rome, into two groups: vibrated group (VG) and control group (CG). For VG participants a mechanical vibration (lasting 10 min) was focally applied on voluntary contracted quadriceps muscles, three times a day during three consecutive days. CG subjects received a placebo vibratory stimulation. Subjects were tested immediately before (T0) and 30 (T1) and 180 (T2) days after the intervention with the PerformanceOriented Mobility Assessment (POMA) test. All subjects

& Claudia Celletti [email protected] 1

Physical Medicine and Rehabilitation Division, Umberto I Hospital, Sapienza University, Piazzale Aldo Moro 5, 00185 Rome, Italy

2

Department of Physiology and Pharmacology, Sapienza University, Rome, Italy

3

Department of Gerontology and Geriatrics, Catholic University, Rome, Italy

4

Department of Public Health and Infectious Diseases, Sapienza University, Rome, Italy

5

Institute of Human Physiology, Catholic University, Rome, Italy

were asked not to change their lifestyle during the study. CG underwent sham vibratory treatment. Results While CG did not show any statistically significant change of POMA at T1 and T2, VG revealed significant differences. At T2, &47 % of the subjects who completed the study obtained the full score on the POMA test and &59 % reached the full POMA score. Conclusions The new protocol seems to be promising in reducing the risk of falling of elderly subjects. Keywords Fall  Muscle vibration  PerformanceOriented Mobility Assessment  Postural instability  Rehabilitation  Tinetti test Abbreviations CG Control group POMA Performance-Oriented Mobility Assessment rMV Repetitive muscle vibration VG Vibrated group

Introduction Falls and fall-related injuries among older people are one of the major issues for health and social care providers in Europe and also in the world, since they enhance the loss of autonomy, illness and sometimes induce early death [1]. Actually, about one-third of adults aged C65 years fall annually and, in terms of sex, women are more frequently involved than men [2]. Finally, falls are a source of considerable health-care expenditure: annual costs for direct care of fatal and nonfatal falls in the USA amount to more than 20 billion US$ [3], while in 1999 falls cost the UK

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exchequer £981 million (€1414 million) in National Health Service and Personal Social Service costs [4]. In elderly individuals, even healthy ones, muscle– skeletal physiological decay along with a parallel reduction of sensorial and cognitive performances reduces the ability to react with efficiency and promptly to obstacles and so there is a greater risk of falling [5], especially in a housing environment. Since there are multiple causes underlying the risk of falls in elderly people, multifactorial fall prevention programs have been developed, involving combinations of physical exercises targeting muscular strength, resistance and flexibility as well as adequate nutritional interventions [6]. Recently, a non-invasive approach, focused on the possibility of enhancing some motor performances, was proposed [6] to target aging motor decline. In particular, a relatively short protocol of repeated muscle vibration (rMV), based on a small amplitude sinusoidal vibration focally applied on the quadriceps muscles of women aged approximately 65 years, produced a significant decrease in the area of sway of the center of pressure (*30 %), while the height of the vertical jump and leg power significantly increased, respectively, by *55 and by *35 % [7]. These effects persisted up to the 90-day follow-up, without other interventions and/or changes in the subjects’ lifestyle. Experimental evidence, by magnetic transcranial stimulation [8, 9], reported cortical plastic changes after rMV showing a decrease in motor threshold in agonist–antagonist muscle balance. These two effects might explain the increase in the muscle performance [7–14]. In elderly people, there is a clear tendency to alter the motor strategies by increasing cocontractions, which leads to a muscle force reduction and an increase of energy expenditure [15–17]. On the basis of these previous reports, this study aimed to verify, using the Performance-Oriented Mobility Assessment (POMA) scale originally developed by Tinetti [18], if a single rMV treatment could reduce the risk of falling of a large sample of 68? year-old females, for a period of up to 6 months.

Methods We used a triple-blind parallel-group study design. The study was conducted on a pool of 350 women, out of 538 interviewed female individuals that were divided by block randomization (Random Allocation Software, a free share software) into two groups: the vibrated group (VG) and the control group (CG). Research participants The experimental protocol was designed in accordance with the Declaration of Helsinki (1964) and approved by

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the Catholic University ethics committee (P/1218/CE/ 2012). All study participants provided informed consent. Three teams performed intervention, data collection and evaluation, respectively. Patients were allocated by sequentially numbered sealed envelopes, which were opened just before the treatment. Treatment was applied by two trained researchers; clinical evaluation was performed by two physiatrists who were unaware of the intervention. Always the same physiatrists clinically evaluated the patients. Data analysts were not informed of the allocation. All subjects were recruited from social centers in Roman municipalities and all of them were autonomous and living at home. Exclusion criteria were the presence of dementia, vestibular diseases, acute orthopedic injuries and drug therapies that could alter movement or spatial perception. Intervention Intervention protocol was the same as the one used in the previous research [7–14], to allow for a better comparison among the different studies. In VG, vibration was simultaneously applied on the quadriceps tendon insertion of the two legs. Vibratory stimulation was applied to the quadriceps by a specific device, consisting of an electromechanical transducer, a mechanical support rigidly fixed to the floor and an electronic control device. A mechanical arm allowed the transducer to be placed on the distal end of the vastus medialis and the common tendon of the rectus and intermedius femoris, at about 2 cm from the medial edge of the patella [7]. Soft tissues were compressed to ensure better transmission of vibrations to the quadriceps muscles. The transducer was applied perpendicular to the muscle, near its distal tendon insertion generating a sinusoidal displacement at 100 Hz, 0.2–0.5 mm peak-to-peak. The vibration frequency was set at 100 Hz. The vibration amplitude was evaluated using a light X–Y infrared sensor detecting the displacement of an infraredLED placed orthogonally on the lateral face of the vibrator tip [7]. During vibratory stimulation, the participants were supine and contracted their quadriceps. To maintain this contraction, the subjects were asked to keep the cavum popliteus in contact with the bed since, thanks to previous experiments, specific contraction intensity during vibratory application does not appear to be important. The researchers monitored muscle contraction throughout the entire series of applications, by palpation and visual inspection, as in the previous studies. Mechanical stimulation was applied over three consecutive days. Each of these applications lasted 30 min; for every 10 min of vibrations, there was a 1-min interval during which the mechanical application was interrupted and the subject relaxed her quadriceps.

Aging Clin Exp Res Table 1 Baseline demographic and clinical characteristics of participants Vibrated group SA Mean

Control group SB

SD

Mean

SC SD

Mean

SA SD

Mean

SB SD

Mean

SC SD

Mean

SD

Age (years)

73.8

3.11

73.8

3.92

72.2

2.5

73.8

3.65

75.2

3.24

71.9

2.5

Height (cm)

161.8

3.03

160.1

3.92

160.3

3.8

160.4

3.59

160.2

3.51

159.9

3.43

66 16.1

3.67 1.98

64.6 21.4

4.57 0.83

66.4 24.9

4.4 0.87

66.3 16.5

5.18 1.71

63.3 21.1

6.49 0.83

64.7 24.6

4.48 1.34

Weight (kg) POMA-T score (T0)

CG underwent sham vibratory treatment, while quadriceps were kept contracted. In this group, the vibrator was positioned close to the extensor tendon, but without touching the skin. Thus, patients were subjected only to the faint buzzing sound of the vibrator. Like the subjects from the other groups, however, they were told that they were being treated with a vibrating electromagnetic device [7]. In both groups, the intervention was not repeated during the 6-month follow-up period, and all the subjects continued their normal daily activities without introducing any extra type of physical training. This was monitored every month during interviews. Outcomes To assess the role of rMV intervention in enhancement proprioception and in reducing postural instability, participants of both groups were evaluated using the Performance-Oriented Mobility Assessment (POMA) scale, originally developed by Tinetti [18]. POMA is a widely reliable and commonly used tool for assessing mobility and the risk of falling of the elderly [19]. It is easily applied in clinical setting and requires less than 15 min to be administered. Several adapted versions of POMA have been published [20], but in this study only the original 28-point version was applied. The total POMA scale (POMA-T) consists of a balance scale (POMA-B) and a gait scale (POMA-G). POMA-B carries the subject through positions and changes in position, reflecting on stability tasks. In POMA-G, several qualitative aspects of the locomotion pattern are examined. Each item is scored on a two- or three-point scale, resulting in a maximum score of 28 on POMA-T and 16 and 12 on POMA-B and POMA-G, respectively [19]. POMA-T has been shown to have high intra- and inter-rater reliability [21] and is a suitable performance measure for evaluating balance among the elderly [22]. More specifically, the POMA-T score is able to identify different risks of falling among groups: individuals with a score B19 have a ‘‘high’’ risk of falling; subjects who showed this score were assigned in this study to the

subgroup A (SA). Participants showing a score between 20 and 22 were classified as having a ‘‘moderate’’ risk of falling and were assigned to ‘‘subgroup B’’ (SB). Individuals with a score between 23 and 27 have a ‘‘low’’ risk of falling and were assigned to ‘‘subgroup C’’ (SC). Participants were evaluated immediately before treatment (T0), 30 days after treatment (T1) and 180 days after treatment (T2) to evaluate if an improvement in balance and gait parameters among participants of the VG and the CG does exist on the POMA-T scale. Sample size Sample size was determined using the following parameters: alpha error, 5 %; power, 80 %; improvement of POMA-T score of 2.5 points (SD = 2.5) in the intervention group in the period T0–T2 vs no difference in the control group. The calculation of the sample size, conducted using EpiCalc 2000, revealed the need to recruit at least 15 subjects per group. Statistical analysis Normality assumption was tested using the skewness and kurtosis statistics and the normal probability plot. The statistical analysis of the continuous variables (POMA-T score at T0, Delta T1–T0, Delta T2–T0) was conducted calculating median and range (min–max), since these variables were not normally distributed. Time trends of these variables were plotted with box plot. Multivariate analysis was conducted using a double approach: (a) multiple linear regression analysis; (b) analysis of variance (ANOVA) for repeated measurements, using the F test (Pillai’s trace). In these analyses, the impact of the following factors was evaluated: treatment (intervention vs no intervention); age (continuous variable); risk class subgroups (SB and SC vs SA); BMI (continuous variable). The statistical significance was set at p \ 0.05. The analysis was carried out using SPSS 19.0. The presentation of the study respects the CONSORT Statement [23].

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0.053

-1.950 (p \ 0.001) -1.514 (p = 0.005)

0.077

-0.703 (p = 0.073) -1.640 (p \ 0.001)

0.499 0.117

-1.896 (p = 0.014) -2.992 (p \ 0.001)

0.446 R2 of the model

0.438 -0.14 (p = 0.006) Age

-0.984 (p = 0.018) -3.210 (p \ 0.001) Class C

0.871

4.978 (p \ 0.001) 8.492 (p \ 0.001) Class B

-1.183 (p = 0.017) -2.528 (p \ 0.001)

0.670

3.034 (p \ 0.001) 5.183 (p \ 0.001)

0.149

-1.458 (p = 0.024) -3.124 (p \ 0.001)

3.299 (p \ 0.001) 3.028 (p \ 0.001) 5.484 (p \ 0.001) 4.352 (p \ 0.001) Treatment

POMA-T T1–POMA-T T0

POMA-T T2–POMA-T T0

POMA-B T0

POMA-B T1–POMA-B T0

POMA-B T2–POMA-B T0

POMA-G T0

1.944 (p \ 0.001) 3.310 (p \ 0.001)

0.985 (p = 0.002)

0.930 (p = 0.027)

Results

POMA-T T0

Dependent variables Variables

Table 2 Beta coefficients (p value) of the multiple linear regression models considering the POMA-T, POMA-B and POMA-G scores

POMA-G T1–POMA-G T0

POMA-G T2–POMA-G T0

Aging Clin Exp Res

Three hundred and fifty women were enrolled (mean age was 73.4 ? 3.4 years, range 68–84). The clinical and demographic characteristics of participants at baseline are shown in Table 1. 303 and 281 women were, respectively, evaluated at T1 and T2. None of the participants reported muscle fatigue, discomfort or other side effects during or immediately after rMV treatment. Furthermore, as also reported in the previous paper [7], none of the participants claimed fatigue in maintaining isometric contraction throughout the treatment. In each individual, POMA-T evaluations over time always referred to the T0 score. CG participants at T1 amounted to 43, 63, 40 and at T2 to 41, 57 and 37, respectively, in SA, SB and SC. At T1 no changes were recognized, while at T2 12 individuals belonging to SB had worsened risk class, however, not statistically significantly. VG showed important changes after rMV administration. In VG, at T1 42 subjects of SA and 62 of SB were studied. In SA, 30 decreased their risk of falling: 14 and 16 participants, initially at ‘‘high risk of falling’’, improved and were assessed as being at ‘‘moderate risk’’ and at ‘‘low risk’’, respectively. In SB, 22 subjects achieved the maximum POMA-T score. On the other hand, at T1, none of the SC participants had enhanced score, while one individual had worsened score. At the time of T2, 146 women ended the trial, 40, 55 and 51 subjects in the three subgroups A, B and C respectively and their distribution within the classes of risk once again appeared to have changed. More specifically, 38, 55 and 30 women, initially in SA, SB and SC, had reduced risk of falling. Among these, 14, 25 and 30 reached the full test score, 21 did not change their risk level and only 2 women, initially at ‘‘low risk of fall’’, had worsened their situation, showing a ‘‘moderate risk of fall’’ at T2. If a change of risk class is a clinically relevant datum, it also seems interesting to consider the numerical magnitude of the score changes. SA, SB and SC increased their POMA-T score at T1 of 6.5 ?3.44, 5.34 ?1.34 and 1.17 ?1.28 points, respectively. At T2, the mean score, in the three vibrated subgroups, further increased by 8.3 ?3.21, 5.76 ?1.84 and 2.37 ?1.43 points, respectively, from the baseline. Data were statistically analyzed by separating POMA-T score according to the balance (POMA-B) and gait (POMA-G) subscores and as a total score. Taking into account the POMA-T score and the POMA-B and POMAG subscores, the multiple line regression analysis is reported in Table 2. The POMA-T, POMA-B and POMA-G scores were evaluated by ANOVA for repeated measurements and

Aging Clin Exp Res Table 3 F test (Pillai’s trace) and p values of between-factor variables influencing POMA-T, POMA-B and POMA-G scores between T0 and T2 Variables

POMA-T score-p (Pillai’s trace)

POMA-B score-p (Pillai’s trace)

POMA-G score-p (Pillai’s trace)

Treatment

128.033 (p \ 0.001)

18.580 (p \ 0.001)

4.387 (p = 0.008)

Class

13.199 (p \ 0.001)

6.118 (p \ 0.001)

7.259 (p \ 0.001)

Treatment 9 class

20.087 (p \ 0.001)

1.619 (p = 0.168)

2.586 (p = 0.023)

revealed that differences between T0 and T1 were statistically significant for treatment (p \ 0.001; p \ 0.001; p = 0.002) in SA, class B (p = 0.018; p = 0.024; p = 0.073) and class C (p \ 0.001, p \ 0.001, p \ 0.001). Between T2 and T1 for the POMA-T score, there is a statistically significant difference only for treatment (p \ 0.001). F test (Pillai’s trace) and p values between factor variables influencing POMA-T, POMA-B and POMA-G scores between T0 and T2 are shown in Table 3, confirming the changes are statistically relevant over the period. The trends of POMA-T, POMA-B and POMA-G scores in CG and VG are plotted in Fig. 1, considering the different classes of risk (SA ‘‘high’’ risk of falling, POMA-T \19; SB ‘‘moderate’’ risk of falling, POMA-T score between 20 and 22; ‘‘low’’ risk of falling, POMA-T score between 23 and 27) the POMA-T trends in the different classes are shown in Fig. 2. As the plots show, while at T1 and T2 patients belonging to CG showed no changes in comparison with T0, the VG patients increased their POMA-T at T1.

Discussion Previous studies showed the effectiveness of the rMV protocol, based on a mechanical vibratory stimulation focally applied on voluntary contracted muscles to improve neuromuscular functionality [7–14]. In the present study, the influence of such a protocol applied as a unique intervention on the risk of falling was assessed over a 6-month period on an elderly population. None of the subjects altered their daily activities throughout all the observational period, and POMA-T was adopted to evaluate changes in the risk of falling immediately before (T0) and at 30 (T1) and 180 (T2) days after the intervention. In each individual, POMA-T evaluations over time are always referred to as the T0 score. The CG group did not demonstrate statistically significant changes after sham treatment, while the VG group showed results that were statistically significant and potentially clinically relevant. In this latter group, it particularly worth noting that in terms of T0: (1) at T1, 29.71 % individuals had globally decreased risk of falling

and, in terms of percentage, 63.82 % in SA; (2) at T2, 142 subjects out of the 146 who completed the study had reduced risk of falling and 86 of them (49.14 %) obtained the full score in the POMA-T test, while 14 of them started in SA. Only 2 individuals worsened their risk class. The results raise questions concerning the magnitude of their effects and the duration of their persistence. The magnitude of the effects in the present study seems in tune with the reported increases of stability and power [6]. It seems also relevant that in all the previous studies [7–14], and in the present one as well, such effects were observed in all the tested individuals. In this research, the follow-up period was increased to 180 days after treatment, while in the previous study [7] subjects were followed up to 90 days and in both the studies the effects did not show any sign of decline. As previously documented [7], it seems reasonable to explain such persistence by suggesting two mechanisms: the above considered capacity of rMV in inducing persisting changes in the central nervous system [8, 9] and a spontaneous increase of the daily activities, induced by the increase in strength [7] and fatigue resistance [10], which might create new virtuous circles. The research team carefully monitored individual participants by phone calls to make sure that new physical activity programs, i.e., dance, physical therapy, rehabilitation therapies, gym, swimming, etc., were not introduced into the subject’s life. However, it was impossible and not desirable to avoid that the daily motor tasks could be performed in different ways. A subject who, at T0, could not stand up from a seated position without help but after rMV, at T1, could stand up without using her arms, will have introduced a not negligible daily physical activity into her life that is potentially able to maintain and reinforce the rMV effects. This hypothesis arose on interviewing the participants of the VG in the present study and in the previous one [7]. Even though these reports were not collected by a systematic and adequate assessment questionnaire, subjects often reported an increased facility and less fatigue in their daily activities, in particular while going up stairs, rising from a chair and walking. Finally, an additive factor may be the rebalance of the agonist–antagonist muscle activity induced by rMV [8, 9], since elderly people develop poorly efficient motor strategies based on increased co-contractions which is considered an

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Fig. 1 The box plot diagram shows the changes of the POMA-T (a), POMA-B (b) and POMA-G (c) scores in the vibrated (VG) and in the control group (CG) evaluated before (T0) and after 30 days (T1) and 180 days (T2) of treatment

expression and also a probable cause of a motor control deterioration that most likely contributes to the risk of falling [15–17].

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Fig. 2 The box plot diagram shows the changes of the POMA-T score in the different classes of risk of falls (class A: high risk of fall, class B: moderate risk of fall, class C: low risk of fall) between the vibrated (VG) and the control group (CG), evaluated before (T0) and after 30 days (T1) and 180 days (T2) of treatment

Aging Clin Exp Res

Conclusions This study has some limitations. All the participant women were living at home and regularly and spontaneously participating in social events. All subjects could perform their daily activities without any help. Moreover, the study was based on only one clinical test evaluation. Nevertheless, the study suggests the possibility of introducing rMV as a possible coadjutant in multifactoring protocols to improve motor control in elderly subjects. In fact, rMV treatment in VG showed large and important effects in improving motor performances and counteract the risk of falling. In particular, rMV allows for the enhancement of strength, power and stability without loading the joints, having a relatively short application time (90 min distributed over 3 consecutive days) and longlasting effects. Moreover, this approach shows some interesting features, since it is non-invasive, painless, and does not have any significant side effects. Conflict of interest We certify that Filippi G.M. is a consultant with the dealer of the device used in this study. None of the other authors has a conflict of interest which could alter the primary interest of this study. Human and Animal Rights The experimental protocol was designed in accordance with the Declaration of Helsinki (1964) and was approved by the Catholic University ethics committee (P/1218/CE/ 2012). Informed consent consent.

All study participants provided informed

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Focal muscle vibration as a possible intervention to prevent falls in elderly women: a pragmatic randomized controlled trial.

Different and new approaches have been proposed to prevent the risk of falling of elderly people, particularly women...
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