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Effect of an Exercise Rehabilitation Program on Symptoms in Hemodialysis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02259413
Recruitment Status : Active, not recruiting
First Posted : October 8, 2014
Last Update Posted : November 1, 2022
Sponsor:
Collaborator:
The Wellness Institute at Seven Oaks General Hospital
Information provided by (Responsible Party):
University of Manitoba

Tracking Information
First Submitted Date  ICMJE October 3, 2014
First Posted Date  ICMJE October 8, 2014
Last Update Posted Date November 1, 2022
Actual Study Start Date  ICMJE May 2015
Estimated Primary Completion Date February 28, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE
 (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.
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE
 (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  ICMJE Effect of an Exercise Rehabilitation Program on Symptoms in Hemodialysis
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • End-stage Renal Disease
  • Renal Failure Chronic Requiring Hemodialysis
Intervention  ICMJE 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  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: October 31, 2022)
172
Original Estimated Enrollment  ICMJE
 (submitted: October 3, 2014)
28
Estimated Study Completion Date  ICMJE May 31, 2023
Estimated Primary Completion Date February 28, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02259413
Other Study ID Numbers  ICMJE B2014:088
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party University of Manitoba
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Manitoba
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE The Wellness Institute at Seven Oaks General Hospital
Investigators  ICMJE
Principal Investigator: Clara J Bohm, MD, MPH University of Manitoba
PRS Account University of Manitoba
Verification Date November 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP