Trial of Aerobic Exercise in Patients Undergoing Outpatient Hemodialysis
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.
Kidney Failure, Chronic
Behavioral: ergometer exercise during hemodialysis
Behavioral: pedometer activity outside of hemodialysis
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||A Randomized Controlled Trial of Aerobic Exercise in Patients With End Stage Renal Disease During Outpatient Hemodialysis|
- Aerobic exercise capacity as measured by VO2 peak [ Time Frame: 3 and 6 months ]
- physical function as measured by sit to stand to sit; sit and reach and 6 minute walk test [ Time Frame: 3 and 6 months ]
- quality of life measured by SF36 [ Time Frame: 3 and 6 months ]
- dialysis adequacy as measured by ktV [ Time Frame: 3 and 6 months ]
|Study Start Date:||July 2007|
|Study Completion Date:||May 2008|
|Primary Completion Date:||May 2008 (Final data collection date for primary outcome measure)|
Active Comparator: A
Ergometer during hemodialysis
|Behavioral: ergometer exercise during hemodialysis|
Active Comparator: B
Pedometer use outside of hemodialysis
|Behavioral: pedometer activity outside of hemodialysis|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00492362
|Sherbrook Dialysis Unit|
|Winnipeg, Manitoba, Canada, R3A1M2|
|Seven Oaks General Hospital|
|Winnipeg, Manitoba, Canada|
|St. Boniface General Hospital|
|Winnipeg, Manitoba, Canada|
|Central Dialysis Unit, Health Sciences Centre|
|Winnipeg, Manitoba, Canada, R3A1R9|
|Principal Investigator:||Clara J Bohm, MD||University of Manitoba; Manitoba Renal Program|