Collaborative-care Intervention to Promote Physical Activity After Total Knee Arthroplasty
調査の概要
詳細な説明
More than 650,000 total knee arthroplasties (TKAs) are performed annually to alleviate pain and disability associated with osteoarthritis (OA); a chronic, degenerative condition that compromises the quality of life of 37% of adults over age 60. With the aging of the population, an estimated 3.5 million TKAs will be performed annually by 2030. Despite improvements in pain and self-reported function, physical activity after TKA remains at pre-operative, sedentary levels (<5,000 steps/day). Physical activity in TKA confers powerful protective effects against common post-surgical sequelae including increased weight gain (mean=6.4 kg, 2 years post TKA), decreased functional performance, increased risk/progression of co-morbid conditions (e.g. type 2 diabetes mellitus, cardiovascular disease), and progression of knee and hip osteoarthritis which may necessitate additional joint replacement in the contralateral limb. An intervention aimed at improved self-management of physical activity may aid patients in overcoming habitual lifestyle patterns of low physical activity secondary to knee pain prior to TKA.
Recent investigations on the effects of real-time, user-friendly, electronic physical activity feedback (PAF) systems and face-to-face (FTF) patient group meetings aimed to promote self-management of physical activity suggest that such interventions can successfully increase physical activity. Therefore, the investigators propose a randomized, controlled trial to assess efficacy and feasibility of a physical activity intervention combined with FTF group meetings (PAF+FTF) initiated within one month of patients' discharge from outpatient rehabilitation for TKA compared to a control group receiving standard care (CON). This type of intervention is surprisingly novel to this patient population and is not common practice in rehabilitation following TKA.
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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Colorado
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Aurora、Colorado、アメリカ、80045
- University of Colorado School of Medicine
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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:
- undergone unilateral total knee arthroplasty
Exclusion Criteria:
- severe contralateral leg osteoarthritis (>4/10 with stair climbing)
- unstable orthopaedic condition that limits function
- neurological conditions that affect muscle function
- vascular or cardiac conditions that limit function
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: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:Physical Activity Feedback
The physical activity feedback intervention will involve real-time physical activity monitoring using a device to provide activity feedback directly to patients in combination with patient group meetings held monthly during the 12 week intervention for the purposes of mutual support in attaining physical activity goals.
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Physical activity feedback
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アクティブコンパレータ:Control
The control represents the current standard of care post total knee arthroplasty.
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介入なし
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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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Change in Physical activity
時間枠:Change from baseline to immediately post-12 week intervention
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Daily step and activity counts
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Change from baseline to immediately post-12 week intervention
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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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Change in Functional performance
時間枠:Change from baseline to immediately post-12 week intervention
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Six-minute walk test, timed up-and-go, 10 meter walk test
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Change from baseline to immediately post-12 week intervention
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Change in Self-reported physical function
時間枠:Change from baseline to immediately post-12 week intervention
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Knee injury and Osteoarthritis Outcome Score, Physical Activity Scale for the Elderly
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Change from baseline to immediately post-12 week intervention
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協力者と研究者
捜査官
- 主任研究者:Jennifer Stevens-Lapsley, MPT, PhD、Associate professor
研究記録日
主要日程の研究
研究開始
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 (見積もり)
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。