健康な高齢者のための反応性バランストレーニングの最適な強度
Falls in daily life are a serious risk for older adults. A new type of balance training, called reactive balance training (RBT) involves people losing balance many times so that they can practice fast balance reactions, like stepping reactions. Differences in training program features might explain differences in the results of previous RBT studies. Training intensity is the difficulty or challenge of the training program. It would be valuable to know if high-intensity RBT improves balance reactions quickly. The main goal of this study is to see if more intense RBT improves balance reactions faster than less intense RBT. The investigators will compare how quickly people improve balance reactions between high- and moderate-intensity RBT, and between RBT and a control program that does not include RBT. The investigators will also test if the improvements in balance reactions last after the training program is over. The secondary goals are to understand exactly how balance reactions improve with training, and to determine if people who complete RBT improve their general balance skills, and falls efficacy more than people who do not complete RBT.
調査の概要
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Avril Mansfield, PhD
- 電話番号：7831 416-597-3422
- メール：avril.mansfield@uhn.ca
研究連絡先のバックアップ
- 名前：David Jagroop
- 電話番号：7614 416-597-3422
- メール：david.jagroop@uhn.ca
研究場所
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Ontario
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Toronto、Ontario、カナダ、M5G 2A2
- 募集
- University Health Network
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コンタクト：
- David Jagroop
- 電話番号：7614 416-597-3422
- メール：david.jagroop@uhn.ca
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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:
- Community-dwelling older adults (65-80 years old)
Exclusion Criteria:
- Unable to stand independently without upper-limb support for >30 seconds and/or walk independently (without a gait aid) for ≥10 metres;
- Diagnosed neurological condition that could affect balance control (e.g., stroke, Parkinson's disease);
- Score below normative values on the Montreal Cognitive Assessment;
- Score below age-matched normative values for sensory and motor function, as assessed using the FallScreen battery;
- Have insufficient English language comprehension such that they cannot understand instructions;
- Have contraindications to reactive balance training such as severe osteoporosis; and/or
- Are currently attending physiotherapy or supervised exercise.
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：防止
- 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 |
|---|---|
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実験的：High intensity reactive balance training
Participants will complete 5 1-hour training sessions over 11 days. During each training session, participants will complete 36 multi-directional (left-, right-, and forward-fall) perturbations. Participants assigned to high-intensity RBT will experience perturbations at 150% of the multi-step threshold; for example, for a multi-step threshold of 2 m/s^2 the high intensity perturbation will be 3 m/s^2. |
Reactive balance training involves clients experiencing repeated balance perturbations so that they can practice and improve control of reactions to avoid falling after a loss of balance.
他の名前：
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アクティブコンパレータ：Moderate intensity reactive balance training
Participants will complete 5 1-hour training sessions over 11 days. During each training session, participants will complete 36 multi-directional (left-, right-, and forward-fall) perturbations. Participants assigned to moderate-intensity RBT will experience perturbations at 100% of the multi-step threshold; for example, for a multi-step threshold of 2 m/s^2 the high intensity perturbation will be 2 m/s^2. |
Reactive balance training involves clients experiencing repeated balance perturbations so that they can practice and improve control of reactions to avoid falling after a loss of balance.
他の名前：
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偽コンパレータ：Walking control group
Participants assigned to the walking control group will complete 36 trials of unperturbed walking in each training session. |
Overground walking |
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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Number of reactive steps
時間枠：Two weeks
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Learning rate for number of steps to recover from 'backward fall' balance perturbations |
Two weeks
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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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Step initiation time
時間枠：One week and 12 weeks post-training
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Time from perturbation onset time to foot off time |
One week and 12 weeks post-training
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Step execution time
時間枠：One week and 12 weeks post-training
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Time from foot off to foot contact of the first step |
One week and 12 weeks post-training
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Step length
時間枠：One week and 12 weeks post-training
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Difference in foot position from foot off to foot contact |
One week and 12 weeks post-training
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Braking impulse
時間枠：One week and 12 weeks post-training
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Antero-posterior shear force generated over time on step contact |
One week and 12 weeks post-training
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Mechanical margin of stability
時間枠：One week and 12 weeks post-training
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Distance between the extrapolated centre of mass (incorporating centre of mass position and velocity) and the edge of the base of support |
One week and 12 weeks post-training
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Balance evaluation systems test
時間枠：One week and 12 weeks post-training
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Scale ranges from 0-100, with higher scores indicating better outcome |
One week and 12 weeks post-training
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Falls efficacy scale - International
時間枠：One week, 12 weeks, and 12 months post-training
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Scale range: 10-100; higher values indicate worse outcome |
One week, 12 weeks, and 12 months post-training
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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転倒による負傷の発生率
時間枠：トレーニング後 12 か月
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トレーニング後 12 か月
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転倒の恐れがある参加者の数
時間枠：トレーニング後 1 週間、12 週間、12 か月後
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トレーニング後 1 週間、12 週間、12 か月後
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転倒の恐怖により活動が制限された参加者の数
時間枠：トレーニング後 1 週間、12 週間、12 か月後
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トレーニング後 1 週間、12 週間、12 か月後
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Fall incidence
時間枠：12 months post-training
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Falls in daily life |
12 months post-training
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5-level EuroQoL health status measure (EQ-5D-5L)
時間枠：One week, 12 weeks, and 12 months post-training
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Scale range for descriptive component: 5-25, higher values indicate worse outcome; Scale range for visual analogue scale: 0-100, higher values indicate better outcome |
One week, 12 weeks, and 12 months post-training
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協力者と研究者
捜査官
- 主任研究者：Avril Mansfield, PhD、University Health Network, Toronto
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
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 (実際)
学習記録の更新
投稿された最後の更新 (実際)
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。