NCT Number: NCT00492362
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.
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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Central Dialysis Unit, Health Sciences Centre, Winnipeg, Manitoba, Canada
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- All adult (>18 years old) patients
- 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
- Acute medical illness in last month
- 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.
Treatment and study plan
pedometer activity outside of hemodialysis
BehavioralPrimary outcomes
-
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
Secondary outcomes
-
quality of life measured by SF36
Time frame: 3 and 6 months
-
dialysis adequacy as measured by ktV
Time frame: 3 and 6 months
Sponsors and collaborators
Lead sponsor
University of Manitoba
Other
Registry information
Official study title
A Randomized Controlled Trial of Aerobic Exercise in Patients With End Stage Renal Disease During Outpatient Hemodialysis
Important dates
- Study start
- 2007
- Primary completion
- 2008
- Study completion
- 2008
- First posted
- Jun 27, 2007
- Registry last updated
- Jun 4, 2008
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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