Effect of an Exercise Rehabilitation Program on Symptoms in Hemodialysis

University of Manitoba

Status: Completed

Conditions: Renal Failure Chronic Requiring Hemodialysis; End-stage Renal Disease

Treatments: Behavioral: Exercise Rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT02259413

B2014:088

Details and patient eligibility

About

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.

Full 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 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.

Enrollment: 133 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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133 participants in 2 patient groups

Exercise Rehabilitation

Experimental group

Description:

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.

Treatment:

Behavioral: Exercise Rehabilitation

Standard Care

No Intervention group

Description:

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.