Lung Cancer 83 (2014) 102–108

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Lung Cancer journal homepage: www.elsevier.com/locate/lungcan

Short and long-term effects of supervised versus unsupervised exercise training on health-related quality of life and functional outcomes following lung cancer surgery – A randomized controlled trial Barbara Cristina Brocki a,b,∗ , Jane Andreasen a , Lene Rodkjaer Nielsen c , Vytautas Nekrasas c , Anders Gorst-Rasmussen d , Elisabeth Westerdahl b,e a

Department of Occupational Therapy and Physiotherapy, Aalborg University Hospital, Denmark School of Health and Medical Sciences, Örebro University, Sweden c Department of Cardiothoracic Surgery, Aalborg University Hospital, Denmark d Centre for Cardiovascular Research, Department of Cardiothoracic Surgery, Aalborg University Hospital, Denmark e Department of Physiotherapy, Örebro University Hospital, Sweden b

a r t i c l e

i n f o

Article history: Received 8 May 2013 Received in revised form 30 September 2013 Accepted 21 October 2013 Keywords: Lung cancer Surgery Rehabilitation Exercise Quality of life

a b s t r a c t Objective: Surgical resection enhances long-term survival after lung cancer, but survivors face functional deficits and report on poor quality of life long time after surgery. This study evaluated short and long-term effects of supervised group exercise training on health-related quality of life and physical performance in patients, who were radically operated for lung cancer. Methods: A randomized, assessor-blinded, controlled trial was performed on 78 patients undergoing lung cancer surgery. The intervention group (IG, n = 41) participated in supervised out-patient exercise training sessions, one hour once a week for ten weeks. The sessions were based on aerobic exercises with target intensity of 60–80% of work capacity, resistance training and dyspnoea management. The control group (CG, n = 37) received one individual instruction in exercise training. Measurements consisted of: healthrelated quality of life (SF36), six minute walk test (6MWT) and lung function (spirometry), assessed three weeks after surgery and after four and twelve months. Results: Both groups were comparable at baseline on demographic characteristic and outcome values. We found a statistically significant effect after four months in the bodily pain domain of SF36, with an estimated mean difference (EMD) of 15.3 (95% CI:4 to 26.6, p = 0.01) and a trend in favour of the intervention for role physical functioning (EMD 12.04, 95% CI: −1 to 25.1, p = 0.07) and physical component summary (EMD 3.76, 95% CI:-0.1 to 7.6, p = 0.06). At 12 months, the tendency was reversed, with the CG presenting overall slightly better measures. We found no effect of the intervention on 6MWT or lung volumes at any time-point. Conclusion: Supervised compared to unsupervised exercise training resulted in no improvement in healthrelated quality of life, except for the bodily pain domain, four months after lung cancer surgery. No effects of the intervention were found for any outcome after one year. © 2013 Elsevier Ireland Ltd. All rights reserved.

1. Background Patients radically operated for lung cancer (LC) experience impairments in physical functioning [1] and report on persistent

∗ Corresponding author at: Department of Occupational Therapy and Physiotherapy, Aalborg University Hospital, Post box 365, 9100 Aalborg, Denmark. Tel.: +45 99324404; fax: +45 99323109. E-mail addresses: [email protected] (B.C. Brocki), [email protected] (J. Andreasen), [email protected] (L.R. Nielsen), [email protected] (V. Nekrasas), [email protected] (A. Gorst-Rasmussen), [email protected] (E. Westerdahl). 0169-5002/$ – see front matter © 2013 Elsevier Ireland Ltd. All rights reserved. http://dx.doi.org/10.1016/j.lungcan.2013.10.015

respiratory problems, mostly dyspnoea [1–3]. Besides restricting physical capability, dyspnoea may contribute to poorer physical, social and mental well-being, leading to an impaired health-related quality of life (HRQoL) [4–6]. As improvements in early diagnosis, surgical and multi-modality treatment increase survival rates after LC surgery, interventions targeting enhanced physical functioning and HRQoL become highly relevant. There is increasing evidence supporting exercise training as an important component in general cancer rehabilitation. Exercise training during cancer treatment has been shown to be safe [7] and associated with strong and consistent improvement in cardiorespiratory fitness [8], reduced fatigue, enhanced physical and

B.C. Brocki et al. / Lung Cancer 83 (2014) 102–108

functional activity as well as emotional well-being, in a mixed cancer population including colon, breast and prostate cancer [9–11]. Despite LC being the most prevalent type of cancer worldwide [12], research investigating the benefits of exercise interventions after lung cancer surgery is scarce [8]. Combined aerobic and muscle strength exercises after LC surgery have shown benefits regarding physical capacity [13–16], relief of dyspnoea [17], fatigue and shoulder pain [15]. However, these results are based on small cohort or case studies, mostly performed as inpatient intervention. Likewise, randomized studies of the short-term impact of outpatient exercise training on HRQoL provide no clear evidence: no benefit was found by Arbane et al. [18] while Granger et al. found positive results [19]. Randomized controlled studies with a longer follow-up period are needed to establish the benefits of combined aerobic and muscle strength exercises after LC surgery [8]. The present trial aimed to evaluate the effects of a physiotherapy-supervised, outpatient, group based exercise programme on HRQoL and functional outcomes in patients radically operated for lung cancer. We hypothesized that the intervention would improve HRQoL and physical capacity, compared to a control group performing unsupervised training. Moreover, we hypothesized that improvements were sustained over time. 2. Materials and methods This study was designed according to the Consort guidelines [20] and approved by the regional biomedical research ethics committee (VN/2004/72). Written informed consent was obtained from all patients. 2.1. Study design An assessor-blinded, 1:1parallel-group, randomized controlled trial was conducted at Aalborg University Hospital, serving a population of approximately 600,000 inhabitants within a radius of 150 km. 2.2. Participants and randomization procedure Eligible for inclusion were patients radically operated for LC, aged over 18 years, able to understand written and spoken Danish and living within a radius of 80 km from the hospital. Exclusion criteria were cognitive or physical deficits and patients transferred to other medical centres (not available for inclusion). Patients were informed about the study by one of the investigators (BB and LN) after receiving the histology results at the out-patient clinic, two weeks after surgery. Baseline measurements were performed approximately three weeks after surgery, with randomization taking place afterwards. Group allocation was revealed to the patients by the main investigator. Computer-generated randomization tables, stratified for pneumonectomy (expected low performance status) were used. Individual allocations were placed in consecutively numbered and sealed opaque envelopes by an external person. 2.3. Interventions The treatment group participated in a 10 week group-based supervised exercise programme, with one session a week, starting three weeks after surgery. Each session included 15 min warming up, followed by 20 min aerobic exercise, 15 min muscle strength training and 10 min cooling down/relaxation (detail provided in Table 1). Dyspnoea management techniques were also introduced.

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The exercise programme was tailored according to physical capability and based on a sub maximal exercise test [21] performed at the first training session. Both intervention and control groups were instructed on home exercises (strength training at least twice a week and a daily 30 min walk or a bicycle ride with an intensity of 11–12 on the Borg Scale) [22]. A training diary was used to record compliance to home training. For the control group, the instruction on home exercising was given individually, took place three weeks after the operation and lasted one hour. Furthermore, all participants received usual postoperative nurse counselling, consisting of up to 3 individual one-hour sessions placed within the period of three weeks to four months after surgery. The number of sessions was scheduled according to individual needs and comprised of advice regarding emotional reactions, pain management, pharmacological treatment, nutrition, sexual life and work situation. Except for the advice on being physical active for at least 30 min per day (recommendations from the Danish Health and Medicines Authority) [23], no intervention was given for any group after the four months follow-up. 2.4. Outcomes HRQoL measured by the 36-Item Short Form Health Survey version 2 (SF36), functional exercise capacity measured by the 6 min walk test (6MWT) and lung function (spirometry) were assessed three weeks after surgery (baseline), four and 12 months after baseline. The primary outcome was changes in HRQoL after four months. Assessment was standardized and performed by two physiotherapists who were trained in the test procedures, to minimize the test variation. Assessors were blinded to the patient’s group allocation. 2.4.1. Health-related quality of life The SF36 v2 is a generic questionnaire with 36 questions measuring functional health and well-being [24,25], which has been validated for pulmonary diseases [26]. It comprises of eight domains: physical functioning, physical role functioning, bodily pain, general health, vitality, social functioning, emotional role functioning, and mental health. Two summary components, each derived from four domain scores, are also calculated; the physical component summary (PCS) and the mental component summary (MCS). Domains and summary components are transformed into 0–100. Higher scores indicate better HRQoL. 2.4.2. Functional capacity The 6MWT was used to assess functional capacity. The test was performed according to current guidelines [27] on a 20 m corridor. Patients were instructed to walk at their fastest pace and cover the longest possible distance in six minutes; no encouragement was given during the test. Measurement of peripheral oxygen saturation was performed before and immediately after the test. A pulse desaturation

Short and long-term effects of supervised versus unsupervised exercise training on health-related quality of life and functional outcomes following lung cancer surgery - a randomized controlled trial.

Surgical resection enhances long-term survival after lung cancer, but survivors face functional deficits and report on poor quality of life long time ...
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