From Prehabilitation to Rehabilitation (Prehab2Rehab): Digitally Supported Short-Term Prehabilitation Prior to Cardiac Surgery (Prehab2Rehab)
From Prehabilitation to Rehabilitation (Prehab2Rehab): Digitally Supported Short-Term Prehabilitation Prior to Cardiac Surgery - A Prospective Observational Feasibility Trial
調査の概要
状態
詳細な説明
Background
Patients awaiting elective cardiac surgery frequently experience reduced physical capacity, psychological distress, and modifiable lifestyle-related risk factors that may negatively influence perioperative recovery. While advances in cardiac surgery have substantially improved survival, optimizing patients' physical and psychological condition before surgery has become an increasingly important component of perioperative care.
Multimodal prehabilitation has shown promising results in several surgical populations by combining exercise, nutritional support, psychological interventions, and patient education. However, structured prehabilitation programs are not routinely implemented in Austria because of organizational, logistical, and resource-related barriers. Digital health technologies provide an opportunity to integrate multidisciplinary prehabilitation into existing clinical pathways while minimizing disruption to routine care.
The Prehab2Rehab project was developed to establish an integrated, digitally supported care pathway that connects the preoperative waiting period with postoperative rehabilitation. Rather than replacing routine care, the intervention complements existing clinical services by providing structured support before surgery and facilitating patient engagement throughout the perioperative pathway.
Study Design
This prospective, single-arm observational feasibility study will be conducted at the Vienna General Hospital (Medical University of Vienna). Approximately 40 adults scheduled for elective low-risk cardiac surgery (NYHA class I-II) will participate in a multimodal prehabilitation program delivered during the routine preoperative waiting period of approximately 6-10 weeks.
The primary objective is to evaluate the feasibility of implementing the intervention in routine clinical practice. Feasibility outcomes include recruitment and retention, adherence to intervention components, completeness of data collection, usability and acceptability of the digital support tools, and intervention safety.
Secondary exploratory analyses will estimate within-group changes in functional performance, psychological well-being, nutritional status, health-related quality of life, and selected perioperative clinical outcomes. These data will be used to estimate effect sizes and inform the design of future randomized controlled trials.
Intervention
The Prehab2Rehab intervention is a personalized, multimodal prehabilitation program integrated into routine perioperative care. It includes:
structured patient education regarding surgery, recovery, and self-management, psychosocial support focusing on stress management, coping strategies, motivation, and self-efficacy, nutritional assessment and individualized nutritional counselling, individualized home-based physical activity guidance, including aerobic exercise, resistance exercises, breathing exercises, and inspiratory muscle training, digital support for education, communication, activity documentation, and care coordination through study-specific digital platforms.
The intervention is individualized according to participants' clinical status and preferences and is delivered by a multidisciplinary team including physicians, psychologists, dietitians, physiotherapists/sports scientists, and study staff. Participation in the study does not alter routine surgical management or postoperative rehabilitation.
Assessments
Participants are assessed at baseline before prehabilitation, immediately before surgery, and after completion of structured Phase II cardiac rehabilitation. Assessments include measures of functional capacity, nutritional status, patient-reported outcomes, digital engagement, intervention adherence, safety, and routinely collected perioperative clinical outcomes. In addition, semi-structured qualitative interviews with patients and healthcare professionals will explore acceptability, user experiences, implementation barriers, and facilitators to support future implementation in routine clinical practice.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Tanja A Stamm, Univ. Prof. Dr.
- 電話番号：+43 1 40400 16370
- メール：tanja.stamm@meduniwien.ac.at
研究連絡先のバックアップ
- 名前：Valentin Ritschl, PhD
- 電話番号：+43 1 40400 16300
- メール：valentin.ritschl@meduniwien.ac.at
研究場所
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State of Vienna
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Vienna、State of Vienna、オーストリア、1090
- Medical University of Vienna
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コンタクト：
- Valentin Ritschl, PhD
- 電話番号：+43 1 40400 16300
- メール：valentin.ritschl@meduniwien.ac.at
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コンタクト：
- Valentina Schmolik, MSc
- 電話番号：+43 1 40400 16330
- メール：valentina.schmolik@meduniwien.ac.at
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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:
- Age ≥ 18 years
- Classification as New York Heart Association (NYHA) functional class I-II
- Low surgical risk profile, defined as a EuroSCORE between 0 and 3
Scheduled for one of the following elective cardiac surgical procedures:
- Open-heart valve surgery
- Coronary artery bypass grafting (CABG)
- Combined valve surgery and CABG
- Surgical closure of an atrial septal defect (ASD)
- Primary residence in Vienna to ensure the feasibility of in-person assessments and supervised sessions
- Sufficient German language proficiency to participate in assessments and educational components
- Adequate digital literacy to engage with the digital support tools used in the intervention
- Clinical and physical assessment confirming that participation in exercise training is medically safe
Exclusion Criteria:
- Emergency, urgent, or otherwise non-elective cardiac surgery
- Highly complex or specialized surgical procedures (e.g., aortic aneurysm repair, cardiac tumor resections)
- Interventional cardiac procedures (e.g., transcatheter aortic valve implantation [TAVI], MitraClip interventions)
- Neuromotor or physical impairments that might prevent adherence to the study protocol or informed participation
- Contraindications to spiroergometry according to current guidelines:
Absolute contraindications:
- Acute coronary syndrome
- Symptomatic cardiac arrhythmias and/or hemodynamic instability
- Decompensated heart failure
- Acute pulmonary embolism
- Acute endocarditis, myocarditis, or pericarditis
- Febrile infections
- Acute deep vein thrombosis of the lower extremities
Relative contraindications:
- Left main coronary artery stenosis
- Electrolyte imbalances
- Arterial hypertension (>160 mmHg systolic)
- Tachyarrhythmias
- Hypertrophic obstructive cardiomyopathy (HOCM)
- High-grade atrioventricular block
- Anemia
- Physical or psychological impairments
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：他の
- 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 |
|---|---|
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実験的：Digitally Supported Prehabilitation
Participants receive a personalized, multimodal, digitally supported prehabilitation program during the routine preoperative waiting period before elective cardiac surgery.
The program includes patient education, psychosocial support, nutritional counselling, individualized home-based physical activity guidance, and digital self-management support in addition to routine clinical care.
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The Prehab2Rehab intervention is a personalized, multimodal, digitally supported prehabilitation program delivered during the routine 6-10 week preoperative waiting period before elective cardiac surgery.
The program includes structured patient education, psychosocial support, nutritional assessment and counselling, individualized home-based physical activity guidance (including aerobic exercise, resistance training, breathing exercises, and inspiratory muscle training), and digital tools to support education, communication, self-management, and documentation.
The intervention is delivered by a multidisciplinary team and complements routine perioperative care without altering standard clinical management.
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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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Proportion of eligible patients providing written informed consent (Recruitment rate)
時間枠：From study initiation until completion of recruitment (approximately 6 months)
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Proportion of eligible patients who provide written informed consent and are enrolled in the study.
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From study initiation until completion of recruitment (approximately 6 months)
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Proportion of enrolled participants completing the study (Participant retention)
時間枠：From baseline until completion of follow-up after Phase II cardiac rehabilitation (approximately 4-6 months)
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Proportion of enrolled participants who complete the prehabilitation program and scheduled study assessments through follow-up.
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From baseline until completion of follow-up after Phase II cardiac rehabilitation (approximately 4-6 months)
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Proportion of completed intervention components (Adherence to the prehabilitation program)
時間枠：Throughout the preoperative intervention period (approximately 6-10 weeks)
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Participant adherence to the planned intervention components, including educational sessions, psychosocial support, nutritional counselling, home-based physical activity guidance, and use of digital support tools, assessed using attendance records and digital activity logs.
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Throughout the preoperative intervention period (approximately 6-10 weeks)
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Proportion of completed study assessments and available study data (Data completeness)
時間枠：From baseline until completion of follow-up after Phase II cardiac rehabilitation (approximately 4-6 months)
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Proportion of planned study assessments, questionnaires, and clinical data successfully completed at each scheduled assessment time point.
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From baseline until completion of follow-up after Phase II cardiac rehabilitation (approximately 4-6 months)
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Participant-reported usability and acceptability scores for the digital support tools
時間枠：At the preoperative assessment following completion of the prehabilitation program (approximately 6-10 weeks after baseline)
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Participant-reported usability and acceptability of the digital applications used during the prehabilitation program, assessed using a study-specific evaluation questionnaire and digital usage metrics.
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At the preoperative assessment following completion of the prehabilitation program (approximately 6-10 weeks after baseline)
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Number, severity, and type of intervention-related adverse events
時間枠：From enrolment until completion of the prehabilitation program (approximately 6-10 weeks)
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Number, severity, and type of intervention-related adverse events occurring during participation in the prehabilitation program.
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From enrolment until completion of the prehabilitation program (approximately 6-10 weeks)
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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 (推定)
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
本研究に関する用語
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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