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| Name | Class |
|---|---|
| The Wellness Institute at Seven Oaks General Hospital | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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:
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in dialysis symptom burden at 12 weeks | Measured using change in the Dialysis Symptom Index | Measured at study baseline and 12 weeks after study start |
| Measure | Description | Time Frame |
|---|---|---|
| Change in dialysis symptom burden at 26 and 52 weeks | Measured using change in the Dialysis Symptom Index | Measured at study baseline, 26 and 52 weeks after study start |
| Change in modified symptom burden |
| Measure | Description | Time Frame |
|---|---|---|
| Change in physical activity behaviour pattern | Measured in 2 ways:
2. | Measured at study baseline, 12, 26 and 52 weeks after study start |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clara J Bohm, MD, MPH | University of Manitoba | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Health Sciences Centre | Winnipeg | Manitoba | R3A1R9 | Canada | ||
| Seven Oaks General Hospital |
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| Label | URL |
|---|---|
| Study Protocol Publication | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan: Formal protocol | Jul 11, 2022 | Nov 3, 2023 | Prot_SAP_003.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 5, 2019 | Mar 6, 2020 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
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Measured using change in modified Dialysis Symptom Index
| 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 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 at study baseline, 12, 26 and 52 weeks after study start |
| Change in endurance/exercise capacity | Measured using the Incremental Shuttle Walk Test | 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 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 at study baseline, 12, 26 and 52 weeks after study start |
| Hospitalization rate | Measured by number of hospitalizations and length of stay for each hospitalization | Measured at study baseline, 12, 26 and 52 weeks after study start |
| Mortality | Measured as the proportion of people who died during the first year on dialysis | Measured at 1 year after starting dialysis |
| Winnipeg |
| Manitoba |
| Canada |
| St. Boniface Hospital | Winnipeg | Manitoba | Canada |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
| D013812 |
| Therapeutics |
| D026741 | Physical Therapy Modalities |