A Randomized Control Trial of an Intervention to Reverse Frailty and Enhance Resilience Through Exercise and Education (REFEREE)
A Randomized Control Trial of a Primary Care Intervention to Reverse Frailty and Enhance Resilience Through Resistance Exercise and Dietary Protein Education (REFEREE) Among Community Dwelling Adults Aged 65 and Over
Resistance training done at home and protein supplementation may be the most effective and easiest to implement interventions to reverse frailty and build resilience. However, it is not common practice to offer and support such interventions in primary care.
This study provides an opportunity to assess the effectiveness of an optimised intervention with community-dwelling adults aged 65 and over, whose baseline clinical frailty score is not worse than mild (i.e. 5 or less), evaluate improvements in health outcomes and demonstrate how the intervention may be incorporated efficiently in clinical practice. The results are intended to encourage mainstream adoption of practical interventions to reverse clinical frailty and build resilience in primary care.
An intervention with ten recommended resistance exercises and dietary guidance on protein consumption has been derived from findings of our systematic review and meta-analysis and optimised through a patient and public involvement (PPI) process and feasibility study.
調査の概要
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Dublin、アイルランド
- Beechlawn Medical Centre
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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:
- Aged 65 or older at baseline
- Rockwood clinical frailty scale score 4 or 5 (vulnerable or mildly frail)
- Able and willing to provide informed consent and to comply with the requirements of this study protocol
Exclusion Criteria:
- Rockwood clinical frailty scale score > 5
- End of life care
- Persons in residential care home
- Concurrent malignancy CKD stage 3 or 4
- Coded diagnosis of severe dementia as per GP or consultant geriatrician diagnosis or baseline Montreal Cognitive assessment (MoCA) score <= 10
- Persons unable to engage in discussion on frailty due to acute care needs or determined to be inappropriate by GP (e.g., needing transfer to ED or acutely unwell or disorders resulting in intolerance of the intervention)
- Subjects unable to provide written informed consent
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：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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介入なし：コントロール
普段のお手入れ
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実験的：Intervention
Resistance exercise and dietary protein guidance
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Home based exercise regime and dietary protein guidance
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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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Frailty status
時間枠：3 months
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Frailty status as measured by SHARE-frailty instrument measurement
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3 months
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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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Clinical frailty status
時間枠：3 months
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Clinical frailty status measured by Clinical Frailty Scale 1 to 9, 9 is worse
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3 months
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Sarcopenia/ muscle mass
時間枠：3 months
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Sarcopenia/ muscle mass measured by bioelectrical impedance
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3 months
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Ease of the intervention
時間枠：3 months
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Ease of the intervention measured on a five-point scale: 'very easy', 'somewhat easy', 'neither easy nor hard', 'somewhat hard', or 'very hard'
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3 months
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Subjective difference to general health
時間枠：3 months
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Difference to general health as a result of the exercises measured on a five-point scale: 'much better', 'slightly better', 'about the same', 'slightly worse' or 'much worse'
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3 months
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Bone mass
時間枠：3 months
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Bone mass measured by bioelectrical impedance
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3 months
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Body fat
時間枠：3 months
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measured by bioelectrical impedance
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3 months
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Biological age
時間枠：3 months
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measured by bioelectrical impedance
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3 months
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協力者と研究者
捜査官
- スタディディレクター：Marie Therese Cooney, PhD、University College Dublin
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
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。
Exercise and proteinの臨床試験
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