Resistance Exercise for the Prevention of Age-related Sarcopenia (REPAiRS)
Negative Work Exercise as a Novel Treatment for Sarcopenia in Older Men
調査の概要
詳細な説明
研究の種類
段階
- 適用できない
連絡先と場所
研究場所
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District of Columbia
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Washington、District of Columbia、アメリカ、20422
- VA Medical Center, DC
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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:
Adult, ambulatory males > 60 years old (n=30) will be recruited for this proposed study. Participant inclusion criteria also includes having clinically significant sarcopenia based on the body composition assessment showing an aLM that is < 2 SD below the mean values of a young adult reference group using DEXA scanning.
Exclusion Criteria:
Exclusion criteria include BMI scores > 30 or a Mini-Mental Status exam score of < 22. The second tier of screening will include the following blood tests, obtained between 8-9 AM, following a 12-hour overnight fast: CBC, routine chemistry profile (e.g., glucose, kidney and liver function tests). Veterans with an elevated fasting blood glucose by WHO criteria (FBG >110 mg/dl), triglyceride levels > 200 mg/dL, and/or known DM, or abnormalities of other routine blood tests (i.e., > 2 SD beyond normal) will be excluded from the study. Uncontrolled cardiovascular disease, non-ambulatory status, evidence of a major disease exacerbation over the last six months, and current participation in a supervised exercise program (minimum of three months, twice per week) would also preclude participation in this study.
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：クロスオーバー割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：1
Exercise group 1: Negative work exercise
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Submaximal negative work exercise using an isokinetic dynamometer will be performed twice per week for 12 weeks.
Exercise volume will be 3 sets of 10 repetitions for the knee and shoulder extensors.
他の名前：
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他の：2
Exercise group 2: Negative work exercise (delayed start for single-arm crossover trial)
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Submaximal negative work exercise using an isokinetic dynamometer will be performed twice per week for 12 weeks.
Exercise volume will be 3 sets of 10 repetitions for the knee and shoulder extensors.
他の名前：
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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 |
|---|---|---|
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Changes in insulin sensitivity following the exercise intervention as estimated with the QUICKI algorithm (quantitative insulin sensitivity check index)
時間枠：Change from baseline in QUICKI values at week 6, week 12, and week 24
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Blood tests will be obtained after a 12- hour overnight fast at baseline, weeks 6, week 12 and week 24: glucose and insulin values will be determined before and during a standard (75 g) 2 hour oral glucose tolerance test (to determine insulin sensitivity via QUICKI algorithm.
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Change from baseline in QUICKI values at week 6, week 12, and week 24
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Peak isokinetic torque
時間枠：Treatment weeks: 1, 6, and 12; post-treatment weeks: 6 and 12
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Isokinetic knee and shoulder extension torques will be obtained bilaterally using the Biodex System 3
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Treatment weeks: 1, 6, and 12; post-treatment weeks: 6 and 12
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Diagnostic ultrasongraphy
時間枠：Treatment weeks: 1, 6, and 12; post-treatment weeks: 6 and 12
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Muscle thickness, pennation angle, and area at the flexor digitorum superficialis, lower-trapezius, rectus femoris and tibialis anterior (dominant side only).
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Treatment weeks: 1, 6, and 12; post-treatment weeks: 6 and 12
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協力者と研究者
捜査官
- 主任研究者：Michael Harris-Love, DSc MPT BS、VA Medical Center, DC
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。