End Stage Renal Disease
Conditions
Keywords
hemodialysis, aerobic exercise, resistance training, walking speed, randomized controlled trial
Brief summary
Study Hypothesis: The combination of aerobic and resistance exercise training will improve walking speed compared to either individual intervention. Brief Summary: Sixty hemodialysis participants who meet inclusion and exclusion criteria will be randomized to 20 weeks of supervised exercise, using either: (i) on-dialysis aerobic exercise using a bike ergometer; (ii) pre-dialysis leg strength training using weights; or (iii) both. The primary outcome is walking speed over 4-metres. Secondary outcomes will include: (i) short physical performance battery; (ii) health-related quality of life \[EuroQOL-5D-5L\]; (iii) Dialysis recovery time; (iv) Nottingham extended activities of daily living (EADL) index; (v) Leg strength; (vi) body composition and anthropometry.
Interventions
OTHERaerobic exercise
OTHERresistance training
Sponsors
St. Joseph's Healthcare Hamilton
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* At least 18 years of age * On hemodialysis minimum of 3 times per week * On hemodialysis \> 3 consecutive months
Exclusion criteria
* Inability to provide consent * Inability to walk 4-metres * Chest pain with exertion or myocardial infarction in past 6-months * Pre-dialysis systolic blood pressure \> 200 mm Hg or diastolic BP \> 100 mm Hg in past 2-weeks * Functional or cardiorespiratory limitations preventing use of cycle ergometer for at least five-minutes or the ability to perform single maximum rep with each of resistance exercises described * Joint replacement or lower extremity fracture in previous 6-months * Severe cognitive impairment * Currently using corticosteroids \>5 mg/day * Pre-dialysis serum potassium in previous month less than 3.5 or greater than 6.0 mmol/L. * Attending nephrologist feels exercise is medically contraindicated * Scheduled living related kidney transplant in next 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in walking speed over 20 weeks | 10 and 20 weeks | repeated measures analysis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change in EuroQOL-5D-5L over 20 weeks | 10 and 20 weeks | Health-related quality of life. Repeated measures analysis |
| change in dialysis recovery time over 20 weeks | 10 and 20 weeks | repeated measures analysis |
| change in Nottingham extended activities of daily living index over 20 weeks | 10 and 20 weeks | repeated measures analysis |
| change in short physical performance battery over 20 weeks | 10 and 20 weeks | repeated measures analysis |
| change in inflammation measures over 20 weeks | 10 and 20 weeks | serum albumin, C-reactive protein, interleukin-6 and tumor necrosis factor-alpha. Repeated measures analysis |
| hospitalization | continuous over 20 weeks | — |
| death | continuous over 20 weeks | — |
| change in body anthropometry and composition over 20 weeks. | 10 and 20 weeks | weight, waist-hip ratio, bioimpedance analysis-determined fat-free mass, percentage body fat, phase angle. Repeated measures analysis |
Countries
Canada
Outcome results
None listed