Yoga And Cardiovascular Health Trial (YACHT)
2016年11月10日 更新者：Imperial College London
The benefits of alternative therapeutic approaches, such as yoga, are poorly understood and this is particularly true of the beneficial effects on cardiovascular disease (CVD) risk.
It is hoped that a better understanding of the value of this therapy will provide a sound scientific basis for including yoga in mainstream clinical practice.
The investigators propose to study a group of 80 participants (40 Indian Asians and 40 Europeans) recruited from a cardiac rehabilitation programme in West London post-angioplasty as treatment for an acute coronary syndrome.
Those who agree will undergo a series of baseline and follow-up measurements.
20 Indian Asians and 20 Europeans will be randomized to the yoga intervention plus their standard cardiac rehabilitation programme (usual care), and the remaining 20 Indian Asians and 20 Europeans will be randomized to usual care alone.
Baseline and follow-up measurements will be performed on all participants.
In order to determine the acute effects of yoga the group randomised to the yoga intervention will also undergo a series of acute tests before and after their first yoga session.
調査の概要
詳細な説明
The benefits of alternative therapeutic approaches, such as yoga, are poorly understood and this is particularly true of the beneficial effects on cardiovascular disease (CVD) risk.
It is hoped that a better understanding of the value of this therapy will provide a sound scientific basis for including yoga in mainstream clinical practice.
The investigators propose to study a group of 80 participants (40 Indian Asians and 40 Europeans) recruited from a cardiac rehabilitation programme in West London post-angioplasty as treatment for an acute coronary syndrome.
Those who agree will undergo a series of baseline and follow-up measurements.
20 Indian Asians and 20 Europeans will be randomized to the yoga intervention plus their standard cardiac rehabilitation programme (usual care), and the remaining 20 Indian Asians and 20 Europeans will be randomized to usual care alone.
Baseline and follow-up measurements will be performed on all participants; these include: Demographic & health questionnaire, Lifestyle questionnaires focusing on diet and exercise, Fasting bloods sampling (for cardiovascular risk factors and markers), Saliva sampling (x 5 samples for salivary cortisol and alpha-amylase), Anthropometrics - height, weight and waist and hip circumference, Bioimpedence - measurement of total body fat, 3D and Doppler echocardiography, Carotid IMT, Resting brachial blood pressure, Central blood pressure (tonometery at the radial artery), Pulse Wave Velocity, 12 lead ECG, Cardiopulmonary exercise testing, Combined 24hr BP & ECG monitor, Accelerometer (3 days).
In order to determine the acute effects of yoga the group randomised to the yoga intervention will also undergo a series of acute tests before and after their first yoga session.
These include: Exercise capacity, Saliva sampling (x 5 samples for salivary cortisol and alpha-amylase) and combined 24hr BP & ECG monitor.
研究の種類
介入
入学 (実際)
80
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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London、イギリス、W2 1LA
- International Centre for Circulatory Health
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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
35年～80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:
- Aged 35-80 years.
- Male or female.
- European or Indian Asian descent.
- Able to understand English or Punjabi.
- Referred to a cardiac rehabilitation programme in West London post-angioplasty as treatment for an acute coronary syndrome.
Exclusion Criteria:
- Adults under 35 years or above 80 years.
- Adults aged 35-80 years who are not competent to give consent.
- Co-morbid disease or mobility limitations that would preclude participation in cardiac rehabilitation and our investigations.
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：基礎科学
- 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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アクティブコンパレータ：Yoga 12 week programme
Usual care (standard cardiac rehabilitation programme) plus yoga intervention.
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Those randomised to usual care plus the yoga intervention will be required to attend yoga classes twice a week for 12 weeks alongside their cardiac rehabilitation programme.
There will be 24 yoga classes in total, of which, we require the participant to attend a minimum of 18.
The yoga classes will be conducted by a teacher certified in yoga and cardiac rehabilitation and will encompass physical fitness (yoga poses), stress reduction (breath control and meditation) and positive lifestyle changes (diet, smoking and alcohol).
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介入なし：Usual care
Usual care (standard cardiac rehabilitation programme) only.
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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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Cardiopulmonary function
時間枠：Week 0 (pre intervention) and week 12 (post intervention)
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To perform a mechanistic study that determines the acute and chronic effects of yoga on cardiopulmonary function, autonomic function, blood pressure and heart rate.
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Week 0 (pre intervention) and week 12 (post 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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Blood pressure
時間枠：Week 0 (pre intervention), week 1 (pre & post 1st yoga class), and week 12 (post intervention)
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Blood pressure will be measured at baseline, at the beginning and end of the first yoga class, and immediately after the 12 week intervention.
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Week 0 (pre intervention), week 1 (pre & post 1st yoga class), and week 12 (post intervention)
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Heart rate and heart rate variability
時間枠：Week 0 (pre intervention), week 1 (pre & post 1st yoga class), and week 12 (post intervention)
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Heart rate and heart rate variability will be measured at baseline, at the beginning and end of the first yoga class, and immediately after the 12 week intervention.
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Week 0 (pre intervention), week 1 (pre & post 1st yoga class), and week 12 (post intervention)
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Stress hormones
時間枠：Week 0 (pre intervention), week 1 (pre & post 1st yoga class), and week 12 (post intervention)
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Stress hormones will be measured at baseline, at the beginning and end of the first yoga class, and immediately after the 12 week intervention.
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Week 0 (pre intervention), week 1 (pre & post 1st yoga class), and week 12 (post intervention)
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Exercise capacity
時間枠：Week 0 (pre intervention), week 1 (pre & post 1st yoga class), and week 12 (post intervention)
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Exercise capacity will be measured at baseline, at the beginning and end of the first yoga class, and immediately after the 12 week intervention.
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Week 0 (pre intervention), week 1 (pre & post 1st yoga class), and week 12 (post intervention)
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Body fat
時間枠：Week 0 (pre intervention) and week 12 (post intervention)
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Body fat will be measured at baseline and immediately after the 12 week intervention.
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Week 0 (pre intervention) and week 12 (post intervention)
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Glucose and lipids
時間枠：Week 0 (pre intervention) and week 12 (post intervention)
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Glucose and lipids will be measured at baseline and immediately after the 12 week intervention.
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Week 0 (pre intervention) and week 12 (post intervention)
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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
捜査官
- 主任研究者：Nishi Chaturvedi、Imperial College London
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
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
2012年6月1日
一次修了 (実際)
2013年4月1日
研究の完了 (実際)
2013年4月1日
試験登録日
最初に提出
2012年5月8日
QC基準を満たした最初の提出物
2012年5月14日
最初の投稿 (見積もり)
2012年5月15日
学習記録の更新
投稿された最後の更新 (見積もり)
2016年11月11日
QC基準を満たした最後の更新が送信されました
2016年11月10日
最終確認日
2012年6月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 12/LO/0597
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個々の参加者データ (IPD) を共有する予定はありますか?
未定
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