Effect of an Exercise Rehabilitation Program on Symptom Burden and Quality of Life in Hemodialysis: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 133
- 试验地点
- 3
- 主要终点
- Change in dialysis symptom burden at 12 weeks
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •greater than 3 months after starting chronic hemodialysis
- •no planned change in hemodialysis modality or relocation outside of Winnipeg during study intervention period (26 weeks)
- •assessed to be safe and able to exercise by HD unit nephrologist
- •ability to communicate in English and provide informed written consent
排除标准
- •acute coronary syndrome in past 3 months
- •unstable arrhythmia
- •shortness of breath at rest or with minimal activity (NYHA Class 4)
- •symptomatic hypoglycaemia (> 2x/week in week prior to enrolment)
- •currently participating in the Manitoba Renal Program clinical intradialytic cycling program
- •score of 0 on Dialysis Symptom Index when administered at time of consent
研究组 & 干预措施
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:
- 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.
干预措施: Exercise Rehabilitation (Behavioral)
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.
结局指标
主要结局
Change in dialysis symptom burden at 12 weeks
时间窗: Measured at study baseline and 12 weeks after study start
Measured using change in the Dialysis Symptom Index
次要结局
- Change in frailty status(Measured at study baseline, 12, 26 and 52 weeks after study start)
- Change in dialysis symptom burden at 26 and 52 weeks(Measured at study baseline, 26 and 52 weeks after study start)
- Change in modified symptom burden(Measured at study baseline, 12, 26 and 52 weeks after study start)
- Change in health-related quality of life(Measured at study baseline, 12, 26 and 52 weeks after study start)
- Change in endurance/exercise capacity(Measured at study baseline, 12, 26 and 52 weeks after study start)
- Change in time for recovery post-dialysis(Measured at study baseline, 12, 26 and 52 weeks after study start)
- Change in self-efficacy for exercise(Measured at study baseline, 12, 26 and 52 weeks after study start)
研究者
Clara Bohm
Associate Professor
University of Manitoba