Randomised controlled trial to determine the benefit of daily home-based exercise in addition to self-care in the management of breast cancer-related lymphoedema: a feasibility study
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Exercise is considered to be a key aspect of lymphoedema treatment, although there is little evidence for the therapeutic effect of exercise in managing breast cancer-related lymphoedema (BCRL). This small randomised controlled trial (RCT) was designed to determine the feasibility, prior to undertaking a larger RCT, of researching a daily home-based exercise programme to treat stable BCRL. An experimental design compared the exercise intervention combined with standard lymphoedema self-care to self-care alone over a 6-month period. Twenty-three women with stable unilateral BCRL of ≥10 % excess limb volume (ELV) were randomly allocated to a daily home-based exercise programme and self-care (n = 11) or self-care measures alone (n = 12). The primary objective was to determine difference in limb volume reduction for the two groups. Secondary objectives were to monitor change in other areas that impact BCRL: quality of life, arm function and range of shoulder movement. All 23 women completed the trial, providing full data for each time point. The intervention group showed a clinically and statistically significant improvement in relative ELV at week 26 (95 % confidence interval (CI) −26.57 to −5.12), whereas the control group improvement crossed the line of no effect (95 %CI −17.71 to 1.1). This study demonstrated the feasibility of conducting a RCT of exercise as a therapeutic intervention in the management of BCRL. Although the sample was small, the results support the findings of other exercise studies which have shown trends towards improvement.
KeywordsArm swelling Breast cancer Home-based exercise programme Lymphoedema
Breast cancer-related lymphoedema
Excess limb volume
Relative excess limb volume
This study was supported by a grant from the Guy’s and St Thomas’ Charity and sponsored by Guy’s and St Thomas’ NHS Foundation Trust. We would like to thank the following people: the patients who provided feedback on the exercise programme during its development; lymphoedema clinical nurse specialists Martine Huit and Sian Thomason (Guy’s and St Thomas’ NHS Foundation Trust, London) and physiotherapists Barbara Lyle (Western General Hospital, Edinburgh), Saskia Krijsman (Guy’s and St Thomas’ NHS Foundation Trust, London) and Siobhan McGarry (King’s College Hospital, London) who reviewed the exercise programme; Mairead Griffin, Head of Nursing and Lead Cancer Nurse at Guy’s and St Thomas’ NHS Foundation Trust, for her management support; Martine Huit and Siobhan McGarry who kindly reviewed the final draft of this paper; Dr Toby Prevost, Kings College London, who provided statistical advice during the writing of this paper. We wish also to thank Medi UK and BSN Medical UK who provided the compression garments worn during the study. This study complied with the UK Good Clinical Practice guidelines for research and has therefore been performed in accordance with the ethical standards laid down in the 1964 Declaration of Helsinki.
Conflict of interest
The authors declare that they have no conflict of interest and no disclosures. The authors have full control of all primary data and agree to allow the journal to review the data if requested.
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