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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
133
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
Health Sciences Centre
Winnipeg, Manitoba, Canada
Seven Oaks General Hospital
Winnipeg, Manitoba, Canada
St. Boniface Hospital
Winnipeg, Manitoba, Canada
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
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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