Increasing Exercise and Decreasing Sedentary Behavior Among Patients in a Cardiac Rehabilitation Clinic
2017年9月1日 更新者：Andrew Busch、The Miriam Hospital
Cardiac rehabilitation patients often fail to exercise as prescribed on days they are not attending rehabilitation and there is a steep drop off in exercise following rehabilitation completion.
Moreover, little is known about the amount of time that cardiac rehabilitation patients spend in sedentary behavior, which is associated with increased risk of cardiovascular morbidity and mortality, independent of time spent in exercise.
This pilot study aims to test acceptability, feasibility, and preliminary efficacy of a smartphone application (B-MOBILE-CARDIAC) for increasing time spent in moderate-to-vigorous intensity physical activity accumulated in bouts of at least 10 minutes in duration (i.e.
bout-related MVPA) and decrease time spent in sedentary behavior.
Up to 32 patients will be recruited, enrolled, and randomized during the first 2 weeks of cardiac rehabilitation to either: 1) B-MOBILE-CARDIAC plus cardiac rehabilitation or 2) cardiac rehabilitation alone.
Participants will complete 7 days of objective activity monitoring to measure daily minutes spent in bout-related MVPA and sedentary behavior (primary outcomes) at baseline, mid-rehabilitation (6 weeks), end of cardiac rehabilitation (12 weeks), and 4-week follow-up (16 weeks).
At these same time points, participants will complete questionnaires assessing sedentary behavior, MVPA, exercise tolerance, health-related quality of life, mood, and affect.
At baseline and end of cardiac rehabilitation participants will undergo a blood draw to measure cardiometabolic and inflammatory risk factors and complete a test of cognitive functioning.
Feasibility and acceptability of the B-MOBILE-CARDIAC application will be assessed at the 4-week follow-up.
調査の概要
状態
完了
研究の種類
介入
入学 (実際)
23
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Rhode Island
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Providence、Rhode Island、アメリカ、02903
- The Miriam Hospital
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～75年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- within one week of starting rehabilitation,
- self-report that they can walk for 10 minutes without assistance from others,
- were approved for and are planning to complete 12 weeks of rehabilitation,
- own a compatible Android phone or are willing to be taught to use one by study staff;
- no evidence of cognitive impairment
- able to speak and read English,
- aged 18-75 years,
- no known nickel allergy, and
- willing to follow the protocol (e.g., carry a smartphone for 16 weeks).
Exclusion Criteria:
-
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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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他の：Cardiac rehabilitation as usual
Participants will receive cardiac rehabilitation as usual (i.e., as offered in the clinical setting).
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実験的：Cardiac rehabilitation plus B-MOBILE-CARDIAC smartphone app
Participants will receive cardiac rehabilitation as usual, plus access to the B-MOBILE-CARDIAC smartphone application through 4 weeks post-rehabilitation.
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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 |
時間枠 |
|---|---|
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Change in objectively measured time engaged in sedentary behavior
時間枠：Change from Baseline to 12 weeks (i.e., end of rehabilitation)
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Change from Baseline to 12 weeks (i.e., end of rehabilitation)
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Change in objectively measured time engaged in moderate-to-vigorous intensity physical activity
時間枠：Change from Baseline to 12 weeks (i.e., end of rehabilitation)
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Change from Baseline to 12 weeks (i.e., end of rehabilitation)
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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Self-reported sedentary behavior (The Sedentary Behavior Questionnaire)
時間枠：Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
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Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
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Self-reported sedentary behavior (SIT-Q-7d Questionnaire)
時間枠：Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
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Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
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Self-reported physical activity (Paffenbarger Physical Activity Questionnaire)
時間枠：Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
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Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
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Self-reported exercise tolerance (Duke activity status index)
時間枠：Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
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Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
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Health related quality of life (SF-12 Health Survey)
時間枠：Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
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Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
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Depressed Mood (Patient Health Questionnaire-9)
時間枠：Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
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Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
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Affect (Positive Affect Negative Affect Scales)
時間枠：Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
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Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
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Cognitive status (Montreal Cognitive Assessment score)
時間枠：Baseline and 12 weeks (i.e., end of rehabilitation).
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Baseline and 12 weeks (i.e., end of rehabilitation).
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Smartphone application acceptability (study specific scale)
時間枠：Baseline through 16 weeks.
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Baseline through 16 weeks.
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Change in objectively measured time engaged in sedentary behavior
時間枠：Change from Baseline to 16 weeks
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Change from Baseline to 16 weeks
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Change in objectively measured time engaged in moderate-to-vigorous intensity physical activity
時間枠：Change from Baseline to 16 weeks
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Change from Baseline to 16 weeks
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Lipid profile
時間枠：Baseline and 12 weeks (i.e., end of rehabilitation)
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Baseline and 12 weeks (i.e., end of rehabilitation)
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C-reactive protein
時間枠：Baseline and 12 weeks (i.e., end of rehabilitation)
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Baseline and 12 weeks (i.e., end of rehabilitation)
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haemoglobin A1c (HbA1C)
時間枠：Baseline and 12 weeks (i.e., end of rehabilitation)
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Baseline and 12 weeks (i.e., end of rehabilitation)
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Blood pressure
時間枠：Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
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Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
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Waist circumference
時間枠：Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
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Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
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Body Mass Index (kg/m^2, weight in kilograms, height in meters)
時間枠：Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
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Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2016年3月1日
一次修了 (実際)
2017年4月1日
研究の完了 (実際)
2017年4月1日
試験登録日
最初に提出
2016年2月2日
QC基準を満たした最初の提出物
2016年2月5日
最初の投稿 (見積もり)
2016年2月10日
学習記録の更新
投稿された最後の更新 (実際)
2017年9月6日
QC基準を満たした最後の更新が送信されました
2017年9月1日
最終確認日
2017年9月1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。
心不全の臨床試験
-
Novartis Pharmaceuticals完了EC-MPS による治療に関心があり、コア研究の 12 か月の治療期間を無事に完了した患者 (de novo Heart Recipients)
Cardiac rehabilitation as usualの臨床試験
-
Massachusetts General HospitalNational Institutes of Health (NIH); Samaritans of Bostonまだ募集していません自殺念慮 | 自殺未遂 | 自殺