Effect of an Exercise Rehabilitation Program on Symptoms in Hemodialysis
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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. Due to sustained physical activity in the intervention group, symptom burden will remain lower in this group at 6 and 12 months. In contrast, the control group will see no improvement in symptom burden from baseline.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Exercise Rehabilitation Participants will receive baseline exercise counseling as per Standard Care group. Participants will then participate in a 26-week exercise rehabilitation program incorporating 3 components: 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. Intradialytic aerobic exercise on a cycle ergometer 3 times weekly for 26 weeks at their usual hemodialysis sessions. Four additional one-to-one standardized education sessions will be completed during the intervention period. |
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. |
Outcome Measures
Primary Outcome Measures
- Change in dialysis symptom burden [Measured at study baseline, 12, 26 and 52 weeks after study start]
Measured using the Dialysis Symptom Index
Secondary Outcome Measures
- Change in modified symptom burden [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 [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 [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 [Measured at study baseline, 12, 26 and 52 weeks after study start]
Measured using the Incremental Shuttle Walk Test
- Change in frailty status [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 [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
Other Outcome Measures
- Change in physical activity behaviour pattern [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 2.
- Hospitalization rate [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 [Measured at 1 year after starting dialysis]
Measured as the proportion of people who died during the first year on dialysis
Eligibility Criteria
Criteria
Inclusion Criteria:
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greater than 3 months after starting chronic hemodialysis
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no planned change in hemodialysis modality or relocation outside of Winnipeg during study intervention period (26 weeks)
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assessed to be safe and able to exercise by HD unit nephrologist
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ability to communicate in English and provide informed written consent
Exclusion Criteria:
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acute coronary syndrome in past 3 months
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unstable arrhythmia
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shortness of breath at rest or with minimal activity (NYHA Class 4)
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symptomatic hypoglycaemia (> 2x/week in week prior to enrolment)
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currently participating in the Manitoba Renal Program clinical intradialytic cycling program
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score of 0 on Dialysis Symptom Index when administered at time of consent
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Health Sciences Centre | Winnipeg | Manitoba | Canada | R3A1R9 |
| 2 | Seven Oaks General Hospital | Winnipeg | Manitoba | Canada | |
| 3 | St. Boniface Hospital | Winnipeg | Manitoba | Canada |
Sponsors and Collaborators
- University of Manitoba
- The Wellness Institute at Seven Oaks General Hospital
Investigators
- Principal Investigator: Clara J Bohm, MD, MPH, University of Manitoba
Study Documents (Full-Text)
More Information
Publications
None provided.- B2014:088