Effect of an Exercise Rehabilitation Program on Symptoms in Hemodialysis

• ClinicalTrials.gov Identifier: NCT02259413
• Recruitment Status: Active, not recruiting
• First Posted: October 8, 2014
• Last Update Posted: November 1, 2022
• Sponsor: University of Manitoba
• Collaborator: The Wellness Institute at Seven Oaks General Hospital
• Information provided by (Responsible Party): University of Manitoba

Tracking Information

• First Submitted Date: October 3, 2014
• First Posted Date: October 8, 2014
• Last Update Posted Date: November 1, 2022
• Actual Study Start Date: May 2015
• Estimated Primary Completion Date: February 28, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 23, 2022)

Change in dialysis symptom burden at 12 weeks [ Time Frame: Measured at study baseline and 12 weeks after study start ]

Measured using change in the Dialysis Symptom Index

Original Primary Outcome Measures (submitted: October 3, 2014)

Change in physical function [ Time Frame: measured at baseline, 16 and 24 weeks ]

Measured using the Short Physical Performance Battery which combines the results of balance, gait speed and chair stand testing.

Current Secondary Outcome Measures (submitted: August 23, 2022)

• Change in dialysis symptom burden at 26 and 52 weeks [ Time Frame: Measured at study baseline, 26 and 52 weeks after study start ]
  Measured using change in the Dialysis Symptom Index
• Change in modified symptom burden [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Measured at study baseline, 12, 26 and 52 weeks after study start ]
  Measured using the Incremental Shuttle Walk Test
• Change in frailty status [ Time Frame: 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 [ Time Frame: 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

Original Secondary Outcome Measures (submitted: October 3, 2014)

• Change in health-related quality of life [ Time Frame: Measured at baseline, 16 and 24 weeks ]
  Measured by self-report using the EQ5D-3L and EQ5D Visual Analogue Scale.
• Change in frailty status [ Time Frame: Measured at baseline, 16 and 24 weeks ]
  Measured using the Modified Fried Criteria for frailty.
• Change in self-efficacy for exercise [ Time Frame: Measured at baseline, 16 and 24 weeks ]
  Measured using the Self-Efficacy for Exercise Survey a 9 item self-reported assessment tool
• Change in physical fitness [ Time Frame: Measured at baseline, 16 and 24 weeks ]
  Measured using the Endurance Shuttle Walk Test.

Current Other Pre-specified Outcome Measures (submitted: October 22, 2018)

• Change in physical activity behaviour pattern [ Time Frame: Measured at study baseline, 12, 26 and 52 weeks after study start ]
  Measured in 2 ways:

  1. Subjectively using the self-reported Godin-Shephard Leisure Time Physical Activity Questionnaire
  2. Objectively using multi-directional accelerometers (Actical Physical Activity Monitors TM) which will be worn for 7 days at each measurement time point

  2.
• Hospitalization rate [ Time Frame: Measured at study baseline, 12, 26 and 52 weeks after study start ]
  Measured by number of hospitalizations and length of stay for each hospitalization
• Mortality [ Time Frame: Measured at 1 year after starting dialysis ]
  Measured as the proportion of people who died during the first year on dialysis

Original Other Pre-specified Outcome Measures (submitted: October 3, 2014)

Change in physical activity behaviour pattern [ Time Frame: Measured at baseline, 16 and 24 weeks ]

Measured in 2 ways: 1. Subjectively using:

1. The self-reported Human Activity Profile which is a 94-item self-administered questionnaire in which activities that the individual is still doing and has stopped doing are identified to calculate a Maximal Activity Score and an Actual Activity Score
2. The International Physical Activity Questionnaire Short Version which is a 7 item tool designed to identify the amount and type of physical activity performed in the 7 days preceding questionnaire administration. 2. Objectively using:
3. multi-directional accelerometers (Actical Physical Activity Monitors TM) which will be worn for 7 days at each measurement time point 2.

Descriptive Information

• Brief Title: 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
• 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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment

Condition

• End-stage Renal Disease
• Renal Failure Chronic Requiring Hemodialysis

Intervention

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

Study Arms

• 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:

  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.
  Intervention: Behavioral: Exercise Rehabilitation
• 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.

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: October 31, 2022): 172
• Original Estimated Enrollment (submitted: October 3, 2014): 28
• Estimated Study Completion Date: May 31, 2023
• Estimated Primary Completion Date: February 28, 2023 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada

Administrative Information

• NCT Number: NCT02259413
• Other Study ID Numbers: B2014:088
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: University of Manitoba
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Manitoba
• Original Study Sponsor: Same as current
• Collaborators: The Wellness Institute at Seven Oaks General Hospital

Investigators

• Principal Investigator: Clara J Bohm, MD, MPH; University of Manitoba

• PRS Account: University of Manitoba
• Verification Date: November 2021