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Randomized controlled trial comparing effects of ergometer exercise during hemodialysis to effects of pedometer use outside of hemodialysis on exercise capacity, functional status, quality of life and adequacy of hemodialysis.
Study Design:
Prospective, randomized, controlled trial of chronic hemodialysis outpatients within the Manitoba Renal Program.
Potential patients include any individual receiving chronic outpatient hemodialysis in Winnipeg (Seven Oaks, Sherbrook, Central and St. Boniface dialysis units) and the Brandon hemodialysis unit.
Exercise Interventions:
Patients will be block randomized to one of the following 2 interventions:
Group A: Cycling on an ergometer GOAL 60 minutes 3 times per week on hemodialysis for 24 weeks A cycling ergometer will be placed on the floor in front of the patient's dialysis chair or at the foot of the bed (if there are only beds available in that unit). The patient will be allowed to exercise anytime during the first half of each dialysis treatment. Goal frequency will be 3 times per week during their usual scheduled hemodialysis treatments.
Group B: Pedometers This group will each receive a pedometer (StepsCount®) at the onset of the study following exercise testing. They will be educated regarding the technical use of the pedometer and will receive the handout entitled "Pedometer Information Sheet: Get Physically Active One Step at a Time!" They will also receive verbal education regarding use of the pedometer and goal activity levels from the exercise study supervisor.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator | Ergometer during hemodialysis |
|
| B | Active Comparator | Pedometer use outside of hemodialysis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ergometer exercise during hemodialysis | Behavioral |
| ||
| pedometer activity outside of hemodialysis |
| Measure | Description | Time Frame |
|---|---|---|
| Aerobic exercise capacity as measured by VO2 peak | 3 and 6 months | |
| physical function as measured by sit to stand to sit; sit and reach and 6 minute walk test | 3 and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| quality of life measured by SF36 | 3 and 6 months | |
| dialysis adequacy as measured by ktV | 3 and 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clara J Bohm, MD | University of Manitoba; Manitoba Renal Program | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sherbrook Dialysis Unit | Winnipeg | Manitoba | R3A1M2 | Canada | ||
| Central Dialysis Unit, Health Sciences Centre |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35018639 | Derived | Bernier-Jean A, Beruni NA, Bondonno NP, Williams G, Teixeira-Pinto A, Craig JC, Wong G. Exercise training for adults undergoing maintenance dialysis. Cochrane Database Syst Rev. 2022 Jan 12;1(1):CD014653. doi: 10.1002/14651858.CD014653. |
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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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| Behavioral |
|
| Winnipeg |
| Manitoba |
| R3A1R9 |
| Canada |
| Seven Oaks General Hospital | Winnipeg | Manitoba | Canada |
| St. Boniface General 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 |