End-stage Renal DiseaseNCT02259413
Effect of an Exercise Rehabilitation Program on Symptoms in Hemodialysis
A study testing Exercise Rehabilitation in people with End-stage Renal Disease and Renal Failure Chronic Requiring Hemodialysis, run by University of Manitoba at 3 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End-stage Renal Disease, Renal Failure Chronic Requiring Hemodialysis
- What is being tested?
- Exercise Rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 133 participants
- Where
- 3 sitesCanada
- Study dates
- May 2015to 8 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Health Sciences Centre
Winnipeg, Manitoba, R3A1R9
Seven Oaks General Hospital
Winnipeg, Manitoba
St. Boniface Hospital
Winnipeg, Manitoba
About this study
Official title: 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.
Read the 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.
- Being tested
- Exercise Rehabilitation
- Keywords
- Hemodialysis, End-stage renal disease, Exercise, Symptom Burden
- Medical subject headings
- Kidney Failure, Chronic, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise RehabilitationBehavioural
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 group | Role | What they receive |
|---|---|---|
| Exercise Rehabilitation | Experimental | 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. Receives: Behavioral: Exercise Rehabilitation |
| Standard Care | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Change in dialysis symptom burden at 12 weeks
Measured using change in the Dialysis Symptom Index
Measured: Measured at study baseline and 12 weeks after study start
Secondary outcomes (7)
Change in dialysis symptom burden at 26 and 52 weeks
Measured using change in the Dialysis Symptom Index
Measured: 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: 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: 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: 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: 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: 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: Measured at study baseline, 12, 26 and 52 weeks after study start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2014 (estimated)
- Study startMay 2015
- Primary completion8 Jun 2023
- Study completion8 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End-stage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- The Wellness Institute at Seven Oaks General Hospital
- Responsible party
- Principal investigator, Clara Bohm, University of Manitoba
- Investigators
- Clara J Bohm, MD, MPH, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02259413
- Sponsor's protocol ID
- B2014:088
- Status last verified
- Mar 2026
- First submitted
- 3 Oct 2014
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of an Exercise Rehabilitation Program on Symptom Burden and Quality of Life in Hemodialysis: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT02259413
- Acronym / sponsor ID
- B2014:088
- Keywords
- Hemodialysis, End-stage renal disease, Exercise, Symptom Burden
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- The Wellness Institute at Seven Oaks General Hospital
- Study start
- May 2015 (actual)
- Primary completion
- 8 Jun 2023 (actual)
- Study completion
- 8 Jun 2023 (actual)
- First posted
- 8 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise Rehabilitation | Experimental | Behavioral: Exercise RehabilitationParticipants 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. |
| Standard Care | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise RehabilitationThis intervention will consist of lifestyle education, home-based resistance exercise and stationary cycling during hemodialysis sessions. Duration of the intervention will be 26 weeks | Behavioural | Exercise Rehabilitation |
Primary outcome
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
7 secondary outcomes
Change in dialysis symptom burden at 26 and 52 weeks
Time frame: Measured at study baseline, 26 and 52 weeks after study start
Change in modified symptom burden
Time frame: Measured at study baseline, 12, 26 and 52 weeks after study start
Change in health-related quality of life
Time frame: Measured at study baseline, 12, 26 and 52 weeks after study start
Change in time for recovery post-dialysis
Time frame: Measured at study baseline, 12, 26 and 52 weeks after study start
Change in endurance/exercise capacity
Time frame: Measured at study baseline, 12, 26 and 52 weeks after study start
Change in frailty status
Time frame: Measured at study baseline, 12, 26 and 52 weeks after study start
Change in self-efficacy for exercise
Time frame: Measured at study baseline, 12, 26 and 52 weeks after study start
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
- Study Protocol PublicationLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clara J Bohm, MD, MPH principal investigator
University of Manitoba
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Rehabilitation in people with End-stage Renal Disease and Renal Failure Chronic Requiring Hemodialysis, run by University of Manitoba at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in dialysis symptom burden at 12 weeks (time frame: Measured at study baseline and 12 weeks after study start). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026.