Trial of Hemodialysis Based Exercise for Strength Improvement Study (THESIS)
Comparison of Aerobic Exercise, Strength Training, or Its Combination in Hemodialysis Patients: a Randomized Controlled Trial
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.
연구 개요
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Ontario
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Hamilton, Ontario, 캐나다, L8N 4A6
- St. Josephs Healthcare Hamilton
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: aerobic exercise
patients will undergo supervised exercise on a bike ergometer for 30 minutes three times per week during hemodialysis
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활성 비교기: resistance training
patients will undergo supervised lower extremity strength training three times per week pre-hemodialysis
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실험적: aerobic exercise and resistance training
patients will undergo a combination of aerobic exercise and resistance training on an alternating schedule three time per week
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
change in walking speed over 20 weeks
기간: 10 and 20 weeks
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repeated measures analysis
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10 and 20 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
change in short physical performance battery over 20 weeks
기간: 10 and 20 weeks
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repeated measures analysis
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10 and 20 weeks
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change in EuroQOL-5D-5L over 20 weeks
기간: 10 and 20 weeks
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Health-related quality of life.
Repeated measures analysis
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10 and 20 weeks
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change in dialysis recovery time over 20 weeks
기간: 10 and 20 weeks
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repeated measures analysis
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10 and 20 weeks
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change in Nottingham extended activities of daily living index over 20 weeks
기간: 10 and 20 weeks
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repeated measures analysis
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10 and 20 weeks
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change in body anthropometry and composition over 20 weeks.
기간: 10 and 20 weeks
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weight, waist-hip ratio, bioimpedance analysis-determined fat-free mass, percentage body fat, phase angle.
Repeated measures analysis
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10 and 20 weeks
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change in inflammation measures over 20 weeks
기간: 10 and 20 weeks
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serum albumin, C-reactive protein, interleukin-6 and tumor necrosis factor-alpha.
Repeated measures analysis
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10 and 20 weeks
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hospitalization
기간: continuous over 20 weeks
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continuous over 20 weeks
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death
기간: continuous over 20 weeks
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continuous over 20 weeks
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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