Dietary Intervention and Physical Activity in Patients With Heart Failure and Reduced Ejection Fraction
Heart failure with reduced ejection fraction (HFrEF) is frequently associated with abnormalities in body composition, including reduced skeletal muscle mass and sarcopenia, which are independent predictors of reduced exercise tolerance, impaired quality of life, and increased mortality. Despite advances in pharmacological therapy, evidence-based non-pharmacological strategies aimed at preventing muscle mass loss remain limited.
This randomized controlled trial aims to evaluate the effects of dietary intervention based on the DASH diet with high-protein elements, resistance exercise training, and their combination on skeletal muscle mass, functional capacity, echocardiographic parameters, biochemical markers, and quality of life in patients with HFrEF.
調査の概要
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究場所
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Silesian Voivodeship
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Zabrze、Silesian Voivodeship、ポーランド、41-800
- 募集
- 2nd Department and Clinical Ward of Cardiology Specialist Hospital in Zabrze, Poland
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コンタクト：
- Andrzej Tomasik PhD Andrzej Tomasik
- 電話番号：+48 32 271 10 10
- メール：atomasik@sum.edu.pl
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
Written informed consent obtained prior to participation Age >30 years Diagnosis of chronic heart failure, NYHA functional class I-III Left ventricular ejection fraction <40%
Exclusion Criteria:
NYHA functional class IV heart failure Potentially reversible cause of heart failure Estimated glomerular filtration rate <30 mL/min Severe anemia (hemoglobin <9 g/dL) Uncontrolled thyroid disease Severe hepatic dysfunction History of hyperkalemia or hyperkalemia at baseline Epilepsy Presence of joint endoprostheses Gastrointestinal disorders limiting adherence to the DASH diet Physical limitations precluding participation in structured exercis
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：防止
- 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 |
|---|---|
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介入なし：標準的な医療
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実験的：Resistance Exercise Training
Elastic resistance bands and structured exercise education provided by a medical rehabilitation specialist.
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The exercise intervention includes resistance training using elastic bands, with instruction and follow-up provided by a medical rehabilitation specialist.
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実験的：Dietary Intervention
Individualized 14-day meal plan based on the DASH diet with high-protein components.
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Individualized 14-day meal plan based on the DASH diet with high-protein components.
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実験的：Combined Dietary and Exercise Intervention
Combination of dietary counseling and resistance exercise training as described above.
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The exercise intervention includes resistance training using elastic bands, with instruction and follow-up provided by a medical rehabilitation specialist.
Individualized 14-day meal plan based on the DASH diet with high-protein components.
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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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Change in skeletal muscle mass
時間枠：Baseline to 6 months
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Quantitative assessment of skeletal muscle mass change over the study period.
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Baseline to 6 months
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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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Change in quality of life
時間枠：Baseline to 6 months
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Assessed using the Minnesota Living With Heart Failure Questionnaire.
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Baseline to 6 months
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Change in exercise capacity
時間枠：Baseline to 6 months
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Assessed by the 6-minute walk test.
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Baseline to 6 months
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Change in echocardiographic parameters of diastolic function
時間枠：Baseline to 6 months
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Changes in left ventricular diastolic function assessed by transthoracic echocardiography, including early transmitral inflow velocity (E), the ratio of early to late transmitral inflow velocities (E/A), and early diastolic mitral annular velocity (e').
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Baseline to 6 months
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Change in laboratory biomarkers
時間枠：Baseline to 6 months
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Includes NT-proBNP, HbA1c, K+ creatine, triglycerides, cholesterol,
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Baseline to 6 months
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
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 (実際)
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。
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