Trial of Hemodialysis Based Exercise for Strength Improvement Study

Study Overview
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Brief Summary
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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.

Official Title
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Comparison of Aerobic Exercise, Strength Training, or Its Combination in Hemodialysis Patients: a Randomized Controlled Trial

Conditions
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End Stage Renal Disease

Intervention / Treatment
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* Other: aerobic exercise
* Other: resistance training


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: aerobic exercise<br>patients will undergo supervised exercise on a bike ergometer for 30 minutes three times per week during hemodialysis | Other: aerobic exercise<br> <br> |
| Active Comparator: resistance training<br>patients will undergo supervised lower extremity strength training three times per week pre-hemodialysis | Other: resistance training<br> <br> |
| Experimental: aerobic exercise and resistance training<br>patients will undergo a combination of aerobic exercise and resistance training on an alternating schedule three time per week | Other: aerobic exercise<br> <br> Other: resistance training<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in walking speed over 20 weeks | repeated measures analysis | 10 and 20 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in short physical performance battery over 20 weeks | repeated measures analysis | 10 and 20 weeks | 
| change in EuroQOL-5D-5L over 20 weeks | Health-related quality of life. Repeated measures analysis | 10 and 20 weeks | 
| change in dialysis recovery time over 20 weeks | repeated measures analysis | 10 and 20 weeks | 
| change in Nottingham extended activities of daily living index over 20 weeks | repeated measures analysis | 10 and 20 weeks | 
| change in body anthropometry and composition over 20 weeks. | weight, waist-hip ratio, bioimpedance analysis-determined fat-free mass, percentage body fat, phase angle. Repeated measures analysis | 10 and 20 weeks | 
| change in inflammation measures over 20 weeks | serum albumin, C-reactive protein, interleukin-6 and tumor necrosis factor-alpha. Repeated measures analysis | 10 and 20 weeks | 
| hospitalization |  | continuous over 20 weeks | 
| death |  | continuous over 20 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hemodialysis, aerobic exercise, resistance training, walking speed, randomized controlled trial