Kidney Failure, Chronic
Conditions
Keywords
hemodialysis, exercise, physical fitness, dialysis adequacy
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.
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.
Interventions
BEHAVIORALergometer exercise during hemodialysis
BEHAVIORALpedometer activity outside of hemodialysis
Sponsors
University of Manitoba
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | Time frame |
|---|---|
| quality of life measured by SF36 | 3 and 6 months |
| dialysis adequacy as measured by ktV | 3 and 6 months |
Countries
Canada
Outcome results
None listed