An interventional study of Exercise Rehabilitation in End-stage Renal Disease and Renal Failure Chronic Requiring Hemodialysis, sponsored by University of Manitoba. Completed at 3 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-04.
Sponsored by University of Manitoba · Not applicable, Interventional, and Treatment
The purpose of this study is to determine whether participation in a 26-week exercise rehabilitation program is effective at reducing symptom burden and improving quality of life in individuals receiving chronic hemodialysis.
Individuals with end-stage kidney disease requiring HD suffer from multiple symptoms, which have limited effective treatments. Symptom burden, the combined impact of number and severity of symptoms, negatively impacts functional status and health-related quality of life (HRQOL) in HD. Small interventional trials suggest exercise can mitigate specific individual symptoms, but impact of exercise on overall symptom burden in HD is unknown. Dialysis patients have identified improving symptom burden and HRQOL as research priorities. We propose the first randomized controlled trial (RCT) investigating the effect of exercise rehabilitation on symptom burden in individuals on HD.
Hypothesis: In individuals on HD, participation in a 26-week exercise rehabilitation (rehab) program will reduce symptom burden and improve HRQOL, resulting in reduced disability and improved long-term clinical outcomes as compared with standard care.
Study Design: Single-centre RCT with one-to-one parallel design, allocation concealment and assessor blinding
Study Population: Adults receiving chronic in-centre HD for > 3 months with at least one dialysis-related symptom; n=150
Intervention: Standard care plus 26-week structured rehab program (lifestyle education, resistance exercise and cycling during HD).
Control: Standard care (baseline exercise counseling)
Outcomes measured at baseline, 12, 26 and 52 weeks.
Data Analysis: Will be performed on an intention to treat, available case basis with t-tests or Mann Whitney U for continuous outcomes, as per data distribution and Chi square tests for categorical outcomes. Mixed effects modeling will account for repeated outcome measures over time. Poisson regression will be performed for hospitalization analysis.
Anticipated Outcomes: Mean symptom burden severity score will decrease by 20% from baseline in the intervention group at 12 weeks. Due to sustained physical activity in the intervention group, symptom burden will remain lower in this group at 6 months. In contrast, the control group will see no improvement in symptom burden from baseline.
2,085 studies on the registry are indexed under Kidney Failure, Chronic; 260 are open to participants now.
This study's enrollment of 133 is above the median of 55 across 1,557 interventional studies indexed under Kidney Failure, Chronic.
Browse Kidney Failure, Chronic studies →University of Manitoba is the lead sponsor of 542 studies on the registry; 87 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 5 (42%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will receive baseline exercise counselling as per Standard Care group. Participants will then participate in a 26-week exercise rehabilitation program incorporating 3 components: 1. One-to-one self-management/resistance education once per week during the first 4 weeks of intervention. Participants will subsequently receive resistance training material to allow for home exercise for the remaining 22 weeks of the intervention. 2. Intradialytic aerobic exercise on a cycle ergometer 3 times weekly for 26 weeks at their usual hemodialysis sessions. 3. Four additional one-to-one standardized education sessions will be completed during the intervention period.
Behavioral: Exercise Rehabilitation
Participants will receive one exercise counseling session as part of their baseline assessment. Participants in the control group will not undergo any other exercise counseling or formal exercise intervention, but will not be prohibited from participating in exercise outside of the study protocol.
This intervention will consist of lifestyle education, home-based resistance exercise and stationary cycling during hemodialysis sessions. Duration of the intervention will be 26 weeks
Change in dialysis symptom burden at 12 weeks
Measured using change in the Dialysis Symptom Index
Time frame: Measured at study baseline and 12 weeks after study start
Change in dialysis symptom burden at 26 and 52 weeks
Measured using change in the Dialysis Symptom Index
Time frame: Measured at study baseline, 26 and 52 weeks after study start
Change in modified symptom burden
Measured using change in modified Dialysis Symptom Index
Time frame: Measured at study baseline, 12, 26 and 52 weeks after study start
Change in health-related quality of life
Measured by self-report using the EuroQol 5D-5L (EQ5D-5L) and EuroQol Visual Analogue Scale.
Time frame: Measured at study baseline, 12, 26 and 52 weeks after study start
Change in time for recovery post-dialysis
Measured in minutes with the question "Approximately how much time does it take to recover from a dialysis session"
Time frame: Measured at study baseline, 12, 26 and 52 weeks after study start
Change in endurance/exercise capacity
Measured using the Incremental Shuttle Walk Test
Time frame: Measured at study baseline, 12, 26 and 52 weeks after study start
Change in frailty status
Measured using the Modified Fried Criteria for frailty.
Time frame: Measured at study baseline, 12, 26 and 52 weeks after study start
Change in self-efficacy for exercise
Measured using the Self-Efficacy for Exercise Survey a 9 item self-reported assessment tool
Time frame: Measured at study baseline, 12, 26 and 52 weeks after study start
Change in physical activity behaviour pattern
Measured in 2 ways: 1. Subjectively using the self-reported Godin-Shephard Leisure Time Physical Activity Questionnaire 2. Objectively using multi-directional accelerometers (Actical Physical Activity Monitors TM) which will be worn for 7 days at each measurement time point 2\.
Time frame: Measured at study baseline, 12, 26 and 52 weeks after study start
Hospitalization rate
Measured by number of hospitalizations and length of stay for each hospitalization
Time frame: Measured at study baseline, 12, 26 and 52 weeks after study start
Mortality
Measured as the proportion of people who died during the first year on dialysis
Time frame: Measured at 1 year after starting dialysis
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Plan to share: No
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University of Manitoba