Tai Chi Mind-Body Therapy for Chronic Heart Failure (NEXT-Heart)
調査の概要
詳細な説明
HF is a major public health problem in the United States, affecting approximately 5 million adults. Despite recent advances in pharmacologic therapy and technologic devices, HF is the most common reason for hospitalization among Medicare patients and is reaching epidemic proportions as the population ages. New and inexpensive interventions that can improve functional capacity and quality of life and can delay disease progression are needed. Tai chi is a popular mind-body exercise that is a potential treatment for heart disease. This exercise incorporates both gentle physical activity and meditation, and it may be particularly suited to frail patients with HF. This study will examine the effects of a tailored tai chi program on functional capacity and quality of life in patients with HF.
Participants will be randomly assigned to either a tai chi program or heart health education for 12 weeks. Participants in both groups will undergo a bicycle stress test at study entry and will receive weekly training sessions of their assigned intervention. Self-report scales and questionnaires will be used to assess participants at study start and at the end of 12 weeks.
研究の種類
入学 (実際)
段階
- フェーズ 3
連絡先と場所
研究場所
-
-
Massachusetts
-
Boston、Massachusetts、アメリカ、02114
- Massachusetts General Hospital
-
Boston、Massachusetts、アメリカ、02215
- Brigham and Women's Hospital
-
Boston、Massachusetts、アメリカ、02215
- Beth Israel Deaconess Medical Center, Harvard Medical School
-
Brookline、Massachusetts、アメリカ、02446
- Lown Cardiovascular Center
-
-
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:
- Diagnosis of chronic HF
- Percentage of blood pumped from the left ventricle (ventricular ejection fraction) less than 40% for at least 1 year prior to study entry
- Stable medical regimen, defined as no major changes in medication, in the 3 months prior to study entry
- New York Heart Association Classification of Class I (no activity limitations), Class II (slight activity limitations), or Class III (marked activity limitations)
- English-speaking
Exclusion Criteria:
- Unstable angina, myocardial infarction, cardiac resynchronization, or major cardiac surgery within 3 months prior to study entry
- History of cardiac arrest or diagnosis of peripartum cardiomyopathy within 6 months prior to study entry
- Unstable ventricular arrhythmias or structural valvular disease
- Current participation in a conventional cardiac rehabilitation program
- Inability to perform a bicycle stress test at study entry
- Lower extremity amputation or other inability to walk due to conditions other than HF
- Severe cognitive dysfunction preventing informed consent and understanding of tai chi concept
- Current regular practice of tai chi
- Current participation in a tai chi pilot study or other studies
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：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Tai Chi
12-week tai chi program
|
24 tai chi sessions.
2 sessions/week for 12 weeks.
|
|
アクティブコンパレータ：Heart Health Education
12-week attention control
|
24 Educational sessions.
2 sessions/week for 12 weeks.
|
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 |
|---|---|
|
HF-specific quality of life
時間枠：baseline, midpoint, endpoint, 6mo
|
baseline, midpoint, endpoint, 6mo
|
|
functional capacity
時間枠：baseline and endpoint
|
baseline and endpoint
|
|
Walking Test
時間枠：baseline, midpoint, endpoint
|
baseline, midpoint, endpoint
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
General quality of life
時間枠：baseline, midpoint, endpoint, 6mo
|
baseline, midpoint, endpoint, 6mo
|
|
mood and emotional status
時間枠：baseline, midpoint, endpoint, 6mo
|
baseline, midpoint, endpoint, 6mo
|
|
exercise self-efficacy
時間枠：baseline, midpoint, endpoint, 6mo
|
baseline, midpoint, endpoint, 6mo
|
|
sense of coherence
時間枠：baseline, midpoint, endpoint, 6mo
|
baseline, midpoint, endpoint, 6mo
|
|
utility assessment
時間枠：baseline, midpoint, endpoint, 6mo
|
baseline, midpoint, endpoint, 6mo
|
|
beliefs, attitudes, and expectations
時間枠：baseline, midpoint, endpoint
|
baseline, midpoint, endpoint
|
|
physical activity level
時間枠：baseline, midpoint, endpoint
|
baseline, midpoint, endpoint
|
|
perceived social support
時間枠：baseline, midpoint, endpoint
|
baseline, midpoint, endpoint
|
|
neurohormonal status
時間枠：baseline, midpoint, endpoint
|
baseline, midpoint, endpoint
|
|
autonomic tone, heart rate variability
時間枠：baseline and endpoint
|
baseline and endpoint
|
|
echocardiography
時間枠：baseline and endpoint
|
baseline and endpoint
|
|
costs and use of HF services
時間枠：baseline and endpoint
|
baseline and endpoint
|
協力者と研究者
捜査官
- 主任研究者：Russell S. Phillips, MD、Beth Israel Deaconess Medical Center, Harvard Medical School
- スタディディレクター：Ellen P. McCarthy, PhD、Beth Israel Deaconess Medical Center, Harvard Medical School
出版物と役立つリンク
一般刊行物
- Yeh GY, Wood MJ, Lorell BH, Stevenson LW, Eisenberg DM, Wayne PM, Goldberger AL, Davis RB, Phillips RS. Effects of tai chi mind-body movement therapy on functional status and exercise capacity in patients with chronic heart failure: a randomized controlled trial. Am J Med. 2004 Oct 15;117(8):541-8. doi: 10.1016/j.amjmed.2004.04.016.
- Yeh GY, McCarthy EP, Wayne PM, Stevenson LW, Wood MJ, Forman D, Davis RB, Phillips RS. Tai chi exercise in patients with chronic heart failure: a randomized clinical trial. Arch Intern Med. 2011 Apr 25;171(8):750-7. doi: 10.1001/archinternmed.2011.150.
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。