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From Prehabilitation to Rehabilitation (Prehab2Rehab): Digitally Supported Short-Term Prehabilitation Prior to Cardiac Surgery (Prehab2Rehab)

23 juli 2026 uppdaterad av: Ludwig Boltzmann Institute for Digital Health and Prevention

From Prehabilitation to Rehabilitation (Prehab2Rehab): Digitally Supported Short-Term Prehabilitation Prior to Cardiac Surgery - A Prospective Observational Feasibility Trial

Prehab2Rehab is a prospective single-arm feasibility study evaluating the implementation of a multimodal, digitally supported prehabilitation program for adults awaiting elective cardiac surgery. During the routine preoperative waiting period, participants receive individualized education, psychosocial support, nutritional counselling, home-based physical activity guidance, and digital self-management support. The study aims to determine the feasibility, acceptability, usability, and safety of integrating this multidisciplinary prehabilitation pathway into routine clinical care. Exploratory outcomes include functional capacity, psychological well-being, nutritional status, digital engagement, and selected perioperative clinical outcomes to inform the design of future confirmatory trials.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

40

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

Studieorter

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Övrig
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Övrig: Digitally supported prehabilitation program
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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Proportion of eligible patients providing written informed consent (Recruitment rate)
Tidsram: From study initiation until completion of recruitment (approximately 6 months)
Proportion of eligible patients who provide written informed consent and are enrolled in the study.
From study initiation until completion of recruitment (approximately 6 months)
Proportion of enrolled participants completing the study (Participant retention)
Tidsram: From baseline until completion of follow-up after Phase II cardiac rehabilitation (approximately 4-6 months)
Proportion of enrolled participants who complete the prehabilitation program and scheduled study assessments through follow-up.
From baseline until completion of follow-up after Phase II cardiac rehabilitation (approximately 4-6 months)
Proportion of completed intervention components (Adherence to the prehabilitation program)
Tidsram: Throughout the preoperative intervention period (approximately 6-10 weeks)
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.
Throughout the preoperative intervention period (approximately 6-10 weeks)
Proportion of completed study assessments and available study data (Data completeness)
Tidsram: From baseline until completion of follow-up after Phase II cardiac rehabilitation (approximately 4-6 months)
Proportion of planned study assessments, questionnaires, and clinical data successfully completed at each scheduled assessment time point.
From baseline until completion of follow-up after Phase II cardiac rehabilitation (approximately 4-6 months)
Participant-reported usability and acceptability scores for the digital support tools
Tidsram: At the preoperative assessment following completion of the prehabilitation program (approximately 6-10 weeks after baseline)
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.
At the preoperative assessment following completion of the prehabilitation program (approximately 6-10 weeks after baseline)
Number, severity, and type of intervention-related adverse events
Tidsram: From enrolment until completion of the prehabilitation program (approximately 6-10 weeks)
Number, severity, and type of intervention-related adverse events occurring during participation in the prehabilitation program.
From enrolment until completion of the prehabilitation program (approximately 6-10 weeks)

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Ludwig Boltzmann Institute for Digital Health and Prevention

Samarbetspartners

Medical University of Vienna

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 augusti 2026

Primärt slutförande (Beräknad)

30 april 2027

Avslutad studie (Beräknad)

31 oktober 2027

Studieregistreringsdatum

Först inskickad

16 juli 2026

Först inskickad som uppfyllde QC-kriterierna

16 juli 2026

Första postat (Faktisk)

21 juli 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

24 juli 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

23 juli 2026

Senast verifierad

1 juli 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Andra studie-ID-nummer

  • Prehab2Rehab_CardiacSurgery

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

IPD-planbeskrivning

Individual participant data will not be made publicly available because of privacy and data protection regulations (GDPR) and the small sample size, which may increase the risk of participant identification. Aggregated study results will be reported in scientific publications.

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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