Trial of Hemodialysis Based Exercise for Strength Improvement Study
- Conditions
- End Stage Renal Disease
- Interventions
- Other: resistance trainingOther: aerobic exercise
- Registration Number
- NCT01962597
- Lead Sponsor
- St. Joseph's Healthcare Hamilton
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
- At least 18 years of age
- On hemodialysis minimum of 3 times per week
- On hemodialysis > 3 consecutive months
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description resistance training resistance training patients will undergo supervised lower extremity strength training three times per week pre-hemodialysis aerobic exercise aerobic exercise patients will undergo supervised exercise on a bike ergometer for 30 minutes three times per week during hemodialysis aerobic exercise and resistance training resistance training patients will undergo a combination of aerobic exercise and resistance training on an alternating schedule three time per week aerobic exercise and resistance training aerobic exercise patients will undergo a combination of aerobic exercise and resistance training on an alternating schedule three time per week
- Primary Outcome Measures
Name Time Method change in walking speed over 20 weeks 10 and 20 weeks repeated measures analysis
- Secondary Outcome Measures
Name Time Method death continuous over 20 weeks change in short physical performance battery over 20 weeks 10 and 20 weeks repeated measures analysis
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
change in EuroQOL-5D-5L over 20 weeks 10 and 20 weeks Health-related quality of life. Repeated measures analysis
change in Nottingham extended activities of daily living index over 20 weeks 10 and 20 weeks repeated measures analysis
change in dialysis recovery time 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
Trial Locations
- Locations (1)
St. Josephs Healthcare Hamilton
🇨🇦Hamilton, Ontario, Canada