Effect of an Exercise Rehabilitation Program on Symptoms in Hemodialysis

Effect of an Exercise Rehabilitation Program on Symptom Burden and Quality of Life in Hemodialysis: A Randomized Controlled Study

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.

Study Overview

• Status: Completed
• Conditions: End-stage Renal Disease; Renal Failure Chronic Requiring Hemodialysis
• Intervention / Treatment: Behavioral: Exercise Rehabilitation

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.

• Study Type: Interventional
• Enrollment (Actual): 172
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada
      • St. Boniface Hospital
    • Winnipeg, Manitoba, Canada, R3A1R9
      • Health Sciences Centre
    • Winnipeg, Manitoba, Canada
      • Seven Oaks General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in dialysis symptom burden at 12 weeks	Measured using change in the Dialysis Symptom Index	Measured at study baseline and 12 weeks after study start

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in dialysis symptom burden at 26 and 52 weeks	Measured using change in the Dialysis Symptom Index	Measured at study baseline, 26 and 52 weeks after study start
Change in modified symptom burden	Measured using change in modified Dialysis Symptom Index	Measured at study baseline, 12, 26 and 52 weeks after study start
Change in health-related quality of life	Measured by self-report using the EuroQol 5D-5L (EQ5D-5L) and EuroQol Visual Analogue Scale.	Measured at study baseline, 12, 26 and 52 weeks after study start
Change in time for recovery post-dialysis	Measured in minutes with the question "Approximately how much time does it take to recover from a dialysis session"	Measured at study baseline, 12, 26 and 52 weeks after study start
Change in endurance/exercise capacity	Measured using the Incremental Shuttle Walk Test	Measured at study baseline, 12, 26 and 52 weeks after study start
Change in frailty status	Measured using the Modified Fried Criteria for frailty.	Measured at study baseline, 12, 26 and 52 weeks after study start
Change in self-efficacy for exercise	Measured using the Self-Efficacy for Exercise Survey a 9 item self-reported assessment tool	Measured at study baseline, 12, 26 and 52 weeks after study start

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in physical activity behaviour pattern	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.	Measured at study baseline, 12, 26 and 52 weeks after study start
Hospitalization rate	Measured by number of hospitalizations and length of stay for each hospitalization	Measured at study baseline, 12, 26 and 52 weeks after study start
Mortality	Measured as the proportion of people who died during the first year on dialysis	Measured at 1 year after starting dialysis

Collaborators and Investigators

• Sponsor: University of Manitoba
• Collaborators: The Wellness Institute at Seven Oaks General Hospital
• Investigators: Principal Investigator: Clara J Bohm, MD, MPH, University of Manitoba

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2015
• Primary Completion (Actual): June 8, 2023
• Study Completion (Actual): June 8, 2023

Study Registration Dates

• First Submitted: October 3, 2014
• First Submitted That Met QC Criteria: October 3, 2014
• First Posted (Estimated): October 8, 2014

Study Record Updates

• Last Update Posted (Actual): August 3, 2023
• Last Update Submitted That Met QC Criteria: August 2, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Exercise; End-stage renal disease; Hemodialysis; Symptom Burden
• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Disease Attributes; Renal Insufficiency; Renal Insufficiency, Chronic; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Kidney Failure, Chronic
• Other Study ID Numbers: B2014:088

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO