Trial of Aerobic Exercise in Patients Undergoing Outpatient Hemodialysis
NCT ID: NCT00492362
Last Updated: 2008-06-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2007-07-31
2008-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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A
Ergometer during hemodialysis
ergometer exercise during hemodialysis
B
Pedometer use outside of hemodialysis
pedometer activity outside of hemodialysis
Interventions
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ergometer exercise during hemodialysis
pedometer activity outside of hemodialysis
Eligibility Criteria
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Inclusion Criteria
* Treated with hemodialysis for \> 3 months
* Hemoglobin \> 100 g/L over the previous 2 months
* Kt/V \> 1.2 for last month and no history of shortened dialysis due to hemodialysis access issues or frequent alarming during dialysis due to poor access will be eligible for the study.
* Study patients must also be likely able to complete 12 consecutive weeks of exercise (i.e. no travel, change of modality, elective surgery planned) and must be able to comprehend instructions in English.
Exclusion Criteria
* Unstable hemodialysis with frequent hypotension over the past month
* Active cardiovascular disease (stroke or acute coronary syndrome, unstable angina) in last 3 months
* Lower extremity amputation with no prosthesis (inability to pedal a bike)
* Spine compression fractures
* Severe musculoskeletal pain at rest or with minimal activity
* Inability to sit, stand or walk unassisted (walking devices such as cane will be allowed)
* Shortness of breath at rest or with activities of daily living (NYHA Class IV)
* Labile glycemic control with hypoglycaemic episodes \> 1x/week.
18 Years
ALL
No
Sponsors
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University of Manitoba
OTHER
Principal Investigators
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Clara J Bohm, MD
Role: PRINCIPAL_INVESTIGATOR
University of Manitoba; Manitoba Renal Program
Locations
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Sherbrook Dialysis Unit
Winnipeg, Manitoba, Canada
Central Dialysis Unit, Health Sciences Centre
Winnipeg, Manitoba, Canada
Seven Oaks General Hospital
Winnipeg, Manitoba, Canada
St. Boniface General Hospital
Winnipeg, Manitoba, Canada
Countries
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References
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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.
Other Identifiers
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B2007:067
Identifier Type: -
Identifier Source: org_study_id