posted on 2021-01-05, 16:44authored byHannah Young, Daniel March, Patrick Highton, Matthew Graham-Brown, Darren Churchward, Charlotte Grantham, Samantha Goodliffe, William Jones, Mei-Mei Cheung, Sharlene Greenwood, Helen Eborall, Simon Conroy, Sally Singh, Alice Smith, James Burton
Objectives Frailty is highly prevalent in haemodialysis (HD) patients, leading to poor outcomes. This study aimed to determine whether a randomised controlled trial (RCT) of intradialytic exercise is feasible for frail HD patients, and explore how the intervention may be tailored to their needs.
Design Mixed-methods feasibility.
Setting and participants Prevalent adult HD patients of the CYCLE-HD trial with a Clinical Frailty Scale Score of 4–7 (vulnerable to severely frail) were eligible for the feasibility study.
Interventions Participants in the exercise group undertook 6 months of three times per week, progressive, moderate intensity intradialytic cycling (IDC).
Outcomes Primary outcomes were related to feasibility. Secondary outcomes were falls incidence measured from baseline to 1 year following intervention completion, and exercise capacity, physical function, physical activity and patient-reported outcomes measured at baseline and 6 months. Acceptability of trial procedures and the intervention were explored via diaries and interviews with n=25 frail HD patients who both participated in (n=13, 52%), and declined (n=12, 48%), the trial.
Results 124 (30%) patients were eligible, and of these 64 (52%) consented with 51 (80%) subsequently completing a baseline assessment. n=24 (71% male; 59±13 years) dialysed during shifts randomly assigned to exercise and n=27 (81% male; 65±11 years) shifts assigned to usual care. n=6 (12%) were lost to follow-up. The exercise group completed 74% of sessions. 27%–89% of secondary outcome data were missing. Frail HD patients outlined several ways to enhance trial procedures. Maintaining ability to undertake activities of daily living and social participation were outcomes of primary importance. Participants desired a varied exercise programme.
Conclusions A definitive RCT is feasible, however a comprehensive exercise programme may be more efficacious than IDC in this population.
Funding
National Institute for Health Research (NIHR) Leicester Biomedical Research Centre, Collaboration for Leadership in Applied Health Research and Care East Midlands (CLAHRC EM) and partly funded by the Stoneygate Trust.
History
Citation
BMJ Open 2020;10:e041227. doi: 10.1136/bmjopen-2020-041227
Author affiliation
Department of Health Sciences, University of Leicester