Identifying and Treating Physical Function Impairment in Elders
Sedentary older adults are more likely to develop physical function impairments than active older adults. Physical function measured by slow usual gait speed predicts the risk of future falls, disability, institutionalization and mortality. Behavioral physical activity interventions have improved physical activity and physical function, but have not generally been implemented where they may have the most impact -- primary care settings. In part, this is due to the limited time and training for clinical staff to screen for physical function impairment and to treat with physical activity counseling. The proposed scientific goal is to overcome these barriers by adapting an evidence-based screening tool and telephone-based physical activity intervention into primary care settings.
Aim1: Among older adults who screen positive for physical function impairment, to determine the estimated intervention effect size of a 12-week behavioral intervention on physical activity and physical function.
Hypothesis 1a: Physical activity levels will increase more in the intervention vs. usual care group.
Hypothesis 1b: Physical function will increase more in the intervention vs. usual care group.
Aim 2: Among Aim 1 participants and clinical staff who deliver the functional screening and Aim 1 intervention, to evaluate standard implementation science process metrics of reach, acceptability, and implementation
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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Colorado
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Aurora、Colorado、アメリカ、80045
- University of Colorado Anschutz Medical Campus
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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:
- Sedentary patients aged 65-85 years who screen positive for physical function impairment (Physical function impairment includes any of the following: time to complete 4-meter walk ≥4.82 seconds (i.e., ≥0.83 meters/second); a reported fall in the past 3 months; or a reported fear of falling)
Exclusion Criteria:
- Inability to walk ≥30 feet without human assistance7
- Dementia, as assessed by either a Folstein Mini-Mental Status Examination <24 or by patient's primary care provider's assessment
- Severe vision loss (legally blind)
- Severe hearing loss
- Medical condition that precludes increasing physical activity per primary care provider's assessment
- Terminal diagnosis per primary care provider's assessment
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：単一グループの割り当て
- 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：Behavioral Intervention
Behavioral Counseling Intervention: 6 telephone calls that include physical activity goal-setting, tracking,and problem-solving of barriers
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介入なし：Usual Care
Monthly mailed print materials on aging topics (that would generally be administered by subjects' primary care clinic).
No behavioral counseling.
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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 physical activity as determined by accelerometer
時間枠：12 weeks
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Subjects' physical activity levels will be determined by accelerometer measures during week 1 and after a 12-week behavioral intervention.
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12 weeks
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Changes in physical function as assessed by 400-meter walk speed
時間枠：12 weeks
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Subjects' physical function will be assessed by 400-meter walk speed before and after 12-week behavioral intervention.
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12 weeks
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Changes in physical function as assessed by Short Physical Performance Battery
時間枠：12 weeks
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Subjects' physical function will be assessed by the Short Physical Performance Battery before and after a 12-week intervention
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12 weeks
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Change in physical function as assessed by lower extremity strength testing
時間枠：12 weeks
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Subjects' physical function will be assessed by lower extremity strength testing before and after a 12-week behavioral intervention .
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12 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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Evaluation of standard implementation science process of reach
時間枠：1 year
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Reach is the percent of patients consented divided by the number eligible.
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1 year
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Assessment of standard implementation science process metrics of acceptability
時間枠：1 year
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Acceptability will be assessed through structured surveys.
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1 year
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Assessment of standard implementation science process metrics of implementation
時間枠：1 year
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Implementation process will be assessed by structured surveys
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1 year
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協力者と研究者
捜査官
- 主任研究者：Amy Huebschmann, MD、University of Colorado - Anschutz Medical Campus
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。