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Completed

NCT Number: NCT02259413

Effect of an Exercise Rehabilitation Program on Symptoms in Hemodialysis

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.

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Key information

Conditions

End-stage Renal Disease Behavior Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Motor Activity Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Failure Chronic Requiring Hemodialysis Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Health Sciences Centre, Winnipeg, Manitoba, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise Rehabilitation

Behavioral

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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.

  4. 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"

  5. 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

  6. 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.

  7. 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 outcomes

  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:

    • 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.

  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

Sponsors and collaborators

Lead sponsor

University of Manitoba

Other

Collaborators

  • The Wellness Institute at Seven Oaks General Hospital

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2023
Study completion
2023
First posted
Oct 8, 2014
Registry last updated
Mar 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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