End-stage Renal Disease, Renal Failure Chronic Requiring Hemodialysis
Conditions
Keywords
Hemodialysis, End-stage renal disease, Exercise, Symptom Burden
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.
Interventions
BEHAVIORALExercise 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
Sponsors
University of Manitoba
The Wellness Institute at Seven Oaks General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in dialysis symptom burden at 12 weeks | Measured at study baseline and 12 weeks after study start | Measured using change in the Dialysis Symptom Index |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in dialysis symptom burden at 26 and 52 weeks | Measured at study baseline, 26 and 52 weeks after study start | Measured using change in the Dialysis Symptom Index |
| 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 |
Countries
Canada
Contacts
PRINCIPAL_INVESTIGATORClara J Bohm, MD, MPH
University of Manitoba
Outcome results
None listed