The Effects of a Yoga Program in Heart Failure Patients (YOGA)
The Clinical Outcomes Associated With a Modified Yoga Program in Heart Failure
The proposed research will investigate the clinical outcomes associated with a modified yoga training program in patients with heart failure (HF). HF patients (15-20) will participate in a modified yoga program during an 8 week period, two times per week with instruction for home practice. Baseline measures and follow-up will be taken after 8 weeks. The underlying hypothesis to be tested is that yoga-induced improvements in nervous system and skeletal muscle function will yield positive effects on clinical outcomes, functional ability, and health-related quality of life in patients with HF.
The effect of combined yoga and breathing training on the natural history of HF and its potential to decrease negative clinical outcomes and improve symptoms is unknown. The relevance of this research is related to the important information it will provide to clinicians caring for patients with HF and will be the basis for pilot data for future NIH funding applications.
調査の概要
詳細な説明
The proposed research project is a pilot study designed to delineate the clinical outcomes associated with a modified yoga program in a population of adults with ventricular dysfunction and clinical heart failure (HF). The researchers hypothesize that patients in a modified yoga training program will have a significant improvement in clinical outcomes, functional ability, and health-related quality of life (HRQOL). The researchers propose to evaluate 15-20 subjects with chronic HF and New York Heart Association Functional Class (NYHA) II-III and obtain baseline physiological, functional, and HRQOL measurements. After obtaining baseline measurements, patients will participate in a modified yoga program with instruction for home practice for 8 weeks. Baseline measurements include: Vital signs, oxygen saturation, heart rate variability, exercise distance, muscular strength and flexibility determination, and various indices of HRQOL. At the conclusion of 8 weeks of yoga training the same measurements will be obtained.
In a group of chronic HF patients, the specific aims are the following:
- To develop a safe and feasible yoga program;
- To determine whether clinical outcomes (vital signs, oxygen saturation, heart rate variability), functional ability (exercise distance, muscular strength and flexibility determination), and HRQOL are positively affected by a modified yoga program.
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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California
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San Francisco、California、アメリカ、94143
- UCSF Osher Center and UCSF Cardiology Faculty Practice
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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:
- NYHA class I-III
- normal sinus rhythm
- able to walk
- ability to read or understand English
- age 30-75
Exclusion Criteria:
- cognitive impairment
- inability to consent
- 100% paced with pacemaker
- hospitalization within 3 months
- MI or recurrent angina within 6 months
- severe stenotic valve disease
- history of sudden cardiac death
- history of uncontrolled ventricular tachyarrhythmias
- pulmonary hypertension
- FEV1 less than 1 liter by spirometry
- orthopedic impediments to yoga
- medication noncompliance
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：なし
- 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 |
|---|---|
|
他の：Yoga group
Patients with heart failure
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8 weeks of yoga training that occurs 2 times per week.
The patients will also perform yoga breathing at home 3 times per week.
他の名前：
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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 |
|---|---|
|
Improvement in heart rate variability
時間枠：8 weeks
|
8 weeks
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
健康関連の生活の質
時間枠：8週間
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8週間
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muscle strength
時間枠：8 weeks
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8 weeks
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協力者と研究者
捜査官
- 主任研究者：Jill Howie-Esquivel, PhD、University of California, San Francisco
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 (見積もり)
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。
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)