Study of the Effect of Exercise Training on Patients in Atrial Fibrillation
Randomised Study of the Effect of Exercise Training on Patients in Atrial Fibrillation
PURPOSE Physical exercise is beneficial for patients with ischemic heart disease and chronic heart failure, while little is known about the effect in atrial fibrillation (AF). The investigators studied the effect of physical exercise on cardiac output (CO), max. exercise capacity, biomarkers and quality of life (Qol) in patients with AF in a randomised study of physical exercise training three times weekly for twelve weeks.
HYPOTHESIS Exercise training improves cardiac output (CO), max. exercise capacity, biomarkers and quality of life (Qol) in patients with AF.
METHODS Assessment of exercise capacity, CO, Qol, body composition, six minute walk test and muscular strength was performed before and after 12 weeks.
Resting echocardiography was done at baseline. CO was measured using impedance cardiography at rest and during maximal exercise testing on an ergometer bicycle. Body composition, muscular strength and six minutes walking capacity were measured before and after the training period. Qol was evaluated by the use of the standardized validated questionnaires Short Form 36 (SF-36) and the Minnesota Living with Heart Failure Questionnaire (MLHF-Q).
Training consisted of aerobic exercise at 70 percent of max. capacity estimated by Borg-scale.
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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Hvidovre
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Copenhagen、Hvidovre、デンマーク、2650
- Hvidovre Hospital
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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:
- Adult subjects in permanent atrial fibrillation, willing to participate in a 12 weeks training program and able to give informed consent to participation were eligible for the study.
Exclusion Criteria:
- Subjects with severe refractory hypertension
- previous heart valve surgery, moderate to severe COPD
- restrictive lung disease, moderate to severe asthma
- pregnant or lactating subjects
- patients with a very low life expectancy
- patients who were unable to exercise or comply with the study protocol
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：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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介入なし：No intervention
Observation only
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実験的：Exercise training group
Group exercise training, three times weekly high-intensity
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group based exercise training
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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 |
|---|---|---|
|
cardiac output
時間枠：participants will be followed for the duration of the intervention, an average of 12 weeks
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participants will be followed for the duration of the intervention, an average of 12 weeks
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participants will be followed for the duration of the intervention, an average of 12 weeks
|
|
Quality of life
時間枠：participants will be followed for the duration of the intervention, an average of 12 weeks
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participants will be followed for the duration of the intervention, an average of 12 weeks
|
participants will be followed for the duration of the intervention, an average of 12 weeks
|
|
exercise capacity
時間枠：participants will be followed for the duration of the intervention, an average of 12 weeks
|
participants will be followed for the duration of the intervention, an average of 12 weeks
|
participants will be followed for the duration of the intervention, an average of 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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muscle strength
時間枠：participants will be followed for the duration of the intervention, an average of 12 weeks
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participants will be followed for the duration of the intervention, an average of 12 weeks
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participants will be followed for the duration of the intervention, an average of 12 weeks
|
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biomarkers ANB, BNP
時間枠：participants will be followed for the duration of the intervention, an average of 12 weeks
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participants will be followed for the duration of the intervention, an average of 12 weeks
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participants will be followed for the duration of the intervention, an average of 12 weeks
|
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Body composition DEXA-scan
時間枠：participants will be followed for the duration of the intervention, an average of 12 weeks
|
participants will be followed for the duration of the intervention, an average of 12 weeks
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participants will be followed for the duration of the intervention, an average of 12 weeks
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協力者と研究者
捜査官
- 主任研究者：Philip S Osbak, MD、Hvidovre University Hospital
出版物と役立つリンク
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。
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