Effect of an Exercise Rehabilitation Program on Symptoms in Hemodialysis
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|ClinicalTrials.gov Identifier: NCT02259413|
Recruitment Status : Active, not recruiting
First Posted : October 8, 2014
Last Update Posted : November 1, 2022
|Condition or disease||Intervention/treatment||Phase|
|End-stage Renal Disease Renal Failure Chronic Requiring Hemodialysis||Behavioral: Exercise Rehabilitation||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||172 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Effect of an Exercise Rehabilitation Program on Symptom Burden and Quality of Life in Hemodialysis: A Randomized Controlled Study|
|Actual Study Start Date :||May 2015|
|Estimated Primary Completion Date :||February 28, 2023|
|Estimated Study Completion Date :||May 31, 2023|
Experimental: Exercise Rehabilitation
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:
Behavioral: Exercise Rehabilitation
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
No Intervention: Standard Care
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.
- Change in dialysis symptom burden at 12 weeks [ Time Frame: Measured at study baseline and 12 weeks after study start ]Measured using change in the Dialysis Symptom Index
- Change in dialysis symptom burden at 26 and 52 weeks [ Time Frame: Measured at study baseline, 26 and 52 weeks after study start ]Measured using change in the Dialysis Symptom Index
- Change in modified symptom burden [ Time Frame: Measured at study baseline, 12, 26 and 52 weeks after study start ]Measured using change in modified Dialysis Symptom Index
- Change in health-related quality of life [ Time Frame: Measured at study baseline, 12, 26 and 52 weeks after study start ]Measured by self-report using the EuroQol 5D-5L (EQ5D-5L) and EuroQol Visual Analogue Scale.
- Change in time for recovery post-dialysis [ Time Frame: Measured at study baseline, 12, 26 and 52 weeks after study start ]Measured in minutes with the question "Approximately how much time does it take to recover from a dialysis session"
- Change in endurance/exercise capacity [ Time Frame: Measured at study baseline, 12, 26 and 52 weeks after study start ]Measured using the Incremental Shuttle Walk Test
- Change in frailty status [ Time Frame: Measured at study baseline, 12, 26 and 52 weeks after study start ]Measured using the Modified Fried Criteria for frailty.
- Change in self-efficacy for exercise [ Time Frame: Measured at study baseline, 12, 26 and 52 weeks after study start ]Measured using the Self-Efficacy for Exercise Survey a 9 item self-reported assessment tool
- Change in physical activity behaviour pattern [ Time Frame: Measured at study baseline, 12, 26 and 52 weeks after study start ]
Measured in 2 ways:
- Subjectively using the self-reported Godin-Shephard Leisure Time Physical Activity Questionnaire
- Objectively using multi-directional accelerometers (Actical Physical Activity Monitors TM) which will be worn for 7 days at each measurement time point
- Hospitalization rate [ Time Frame: Measured at study baseline, 12, 26 and 52 weeks after study start ]Measured by number of hospitalizations and length of stay for each hospitalization
- Mortality [ Time Frame: Measured at 1 year after starting dialysis ]Measured as the proportion of people who died during the first year on dialysis
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02259413
|Health Sciences Centre|
|Winnipeg, Manitoba, Canada, R3A1R9|
|Seven Oaks General Hospital|
|Winnipeg, Manitoba, Canada|
|St. Boniface Hospital|
|Winnipeg, Manitoba, Canada|
|Principal Investigator:||Clara J Bohm, MD, MPH||University of Manitoba|