Clinical trial NCT02259413: Effect of an Exercise Rehabilitation Program on Symptoms in Hemodialysis
Official title: Effect of an Exercise Rehabilitation Program on Symptom Burden and Quality of Life in Hemodialysis: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End-stage Renal Disease
Renal Failure Chronic Requiring Hemodialysis
Keywords: Hemodialysis
End-stage renal disease
Exercise
Symptom Burden
Lead sponsor: University of Manitoba
Sponsor class: OTHER
Collaborators: name: The Wellness Institute at Seven Oaks General Hospital
First posted: 2014-10-08
Enrollment: 133
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in dialysis symptom burden at 12 weeks
timeFrame: Measured at study baseline and 12 weeks after study start
Secondary outcomes:
measure: Change in dialysis symptom burden at 26 and 52 weeks
timeFrame: Measured at study baseline, 26 and 52 weeks after study start
measure: Change in modified symptom burden
timeFrame: Measured at study baseline, 12, 26 and 52 weeks after study start
measure: Change in health-related quality of life
timeFrame: Measured at study baseline, 12, 26 and 52 weeks after study start
measure: Change in time for recovery post-dialysis
timeFrame: Measured at study baseline, 12, 26 and 52 weeks after study start
measure: Change in endurance/exercise capacity
timeFrame: Measured at study baseline, 12, 26 and 52 weeks after study start
measure: Change in frailty status
timeFrame: Measured at study baseline, 12, 26 and 52 weeks after study start
measure: Change in self-efficacy for exercise
timeFrame: Measured at study baseline, 12, 26 and 52 weeks after study start
Other outcomes:
measure: Change in physical activity behaviour pattern
timeFrame: Measured at study baseline, 12, 26 and 52 weeks after study start
measure: Hospitalization rate
timeFrame: Measured at study baseline, 12, 26 and 52 weeks after study start
measure: Mortality
timeFrame: Measured at 1 year after starting dialysis
Locations:
city: Winnipeg
country: Canada
facility: Health Sciences Centre
state: Manitoba
city: Winnipeg
country: Canada
facility: Seven Oaks General Hospital
state: Manitoba
city: Winnipeg
country: Canada
facility: St. Boniface Hospital
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Clara J Bohm, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: