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.
調査の概要
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Ontario
-
Hamilton、Ontario、カナダ、L8N 4A6
- St. Josephs Healthcare Hamilton
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：aerobic exercise
patients will undergo supervised exercise on a bike ergometer for 30 minutes three times per week during hemodialysis
|
|
|
アクティブコンパレータ：resistance training
patients will undergo supervised lower extremity strength training three times per week pre-hemodialysis
|
|
|
実験的：aerobic exercise and resistance training
patients will undergo a combination of aerobic exercise and resistance training on an alternating schedule three time per week
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
change in walking speed over 20 weeks
時間枠：10 and 20 weeks
|
repeated measures analysis
|
10 and 20 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
change in short physical performance battery over 20 weeks
時間枠：10 and 20 weeks
|
repeated measures analysis
|
10 and 20 weeks
|
|
change in EuroQOL-5D-5L over 20 weeks
時間枠：10 and 20 weeks
|
Health-related quality of life.
Repeated measures analysis
|
10 and 20 weeks
|
|
change in dialysis recovery time over 20 weeks
時間枠：10 and 20 weeks
|
repeated measures analysis
|
10 and 20 weeks
|
|
change in Nottingham extended activities of daily living index over 20 weeks
時間枠：10 and 20 weeks
|
repeated measures analysis
|
10 and 20 weeks
|
|
change in body anthropometry and composition over 20 weeks.
時間枠：10 and 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
時間枠：10 and 20 weeks
|
serum albumin, C-reactive protein, interleukin-6 and tumor necrosis factor-alpha.
Repeated measures analysis
|
10 and 20 weeks
|
|
hospitalization
時間枠：continuous over 20 weeks
|
continuous over 20 weeks
|
|
|
death
時間枠：continuous over 20 weeks
|
continuous over 20 weeks
|
協力者と研究者
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。