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Effect of an Exercise Rehabilitation Program on Symptoms in Hemodialysis

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ClinicalTrials.gov Identifier: NCT02259413
Recruitment Status : Active, not recruiting
First Posted : October 8, 2014
Last Update Posted : September 29, 2021
Sponsor:
Collaborator:
The Wellness Institute at Seven Oaks General Hospital
Information provided by (Responsible Party):
University of Manitoba

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.

Condition or disease Intervention/treatment Phase
End-stage Renal Disease Renal Failure Chronic Requiring Hemodialysis Behavioral: Exercise Rehabilitation Not Applicable

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. Due to sustained physical activity in the intervention group, symptom burden will remain lower in this group at 6 and 12 months. In contrast, the control group will see no improvement in symptom burden from baseline.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of an Exercise Rehabilitation Program on Symptom Burden and Quality of Life in Hemodialysis: A Randomized Controlled Study
Actual Study Start Date : May 2015
Estimated Primary Completion Date : May 31, 2022
Estimated Study Completion Date : November 30, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Exercise Rehabilitation

Participants will receive baseline exercise counseling 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.
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.



Primary Outcome Measures :
  1. Change in dialysis symptom burden [ Time Frame: Measured at study baseline, 12, 26 and 52 weeks after study start ]
    Measured using the Dialysis Symptom Index


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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"

  4. 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

  5. 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.

  6. 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


Other Outcome Measures:
  1. 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.


  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

  3. Mortality [ Time Frame: Measured at 1 year after starting dialysis ]
    Measured as the proportion of people who died during the first year on dialysis



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02259413


Locations
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Canada, Manitoba
Health Sciences Centre
Winnipeg, Manitoba, Canada, R3A1R9
Seven Oaks General Hospital
Winnipeg, Manitoba, Canada
St. Boniface Hospital
Winnipeg, Manitoba, Canada
Sponsors and Collaborators
University of Manitoba
The Wellness Institute at Seven Oaks General Hospital
Investigators
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Principal Investigator: Clara J Bohm, MD, MPH University of Manitoba
  Study Documents (Full-Text)

Documents provided by University of Manitoba:
Informed Consent Form  [PDF] September 5, 2019

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Responsible Party: University of Manitoba
ClinicalTrials.gov Identifier: NCT02259413    
Other Study ID Numbers: B2014:088
First Posted: October 8, 2014    Key Record Dates
Last Update Posted: September 29, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of Manitoba:
Hemodialysis
End-stage renal disease
Exercise
Symptom Burden
Additional relevant MeSH terms:
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Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency