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Tracking Information | |||||
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First Received Date † | June 26, 2007 | ||||
Last Updated Date | June 2, 2008 | ||||
Start Date † | July 2007 | ||||
Current Primary Outcome Measures † |
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Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00492362 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
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Original Secondary Outcome Measures † | Same as current | ||||
Descriptive Information | |||||
Brief Title † | Trial of Aerobic Exercise in Patients Undergoing Outpatient Hemodialysis | ||||
Official Title † | A Randomized Controlled Trial of Aerobic Exercise in Patients With End Stage Renal Disease During Outpatient Hemodialysis | ||||
Brief Summary | 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. |
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Detailed Description | 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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Study Phase | |||||
Study Type † | Interventional | ||||
Study Design † | Supportive Care, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study | ||||
Condition † | Kidney Failure, Chronic | ||||
Intervention † |
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Study Arms / Comparison Groups |
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Completed | ||||
Enrollment † | 60 | ||||
Completion Date | May 2008 | ||||
Primary Completion Date | May 2008 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | Canada | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00492362 | ||||
Responsible Party | |||||
Secondary IDs †† | |||||
Study Sponsor † | University of Manitoba | ||||
Collaborators †† | |||||
Investigators † |
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Information Provided By | University of Manitoba | ||||
Verification Date | June 2008 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |