Feasibility of Physical Prehabilitation for High-Risk Patients Undergoing Cardiac Surgery Via Sternotomy

NCT07893184 | Enrolling By Invitation DMC

• 1 other identifier: NL011105-304211
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Rationale Cardiac surgery via median sternotomy carries an elevated risk of postoperative complications and delayed functional recovery. Preoperative physical therapy aims to reduce the incidence and severity of postoperative adverse outcomes and to accelerate functional recovery. However, current evidence on prehabilitation is inconsistent due to methodological heterogeneity. This study addresses the limitations of previous studies in four ways. First, a validated preoperative prediction model is used to select patients at high risk of in-hospital postoperative complications and delayed functional recovery. Second, a Cardiopulmonary Exercise Test (CPET) is performed at baseline to guide safe and effective intensity prescription. Third, as different patient populations are expected to benefit from different training programs, the prehabilitation program is tailored to the surgical indication: patients undergoing coronary artery bypass grafting (CABG) receive high-intensity interval training (HIIT), and patients undergoing aortic valve replacement (AVR) receive moderate continuous training. Fourth, physical activity and self-management are promoted by using a wearable physical activity monitor and Shared Decision-Making (SDM) to stimulate and track daily physical activity. Primary Objective To investigate the feasibility of a personalized, procedure-specific prehabilitation program (four to six weeks) for high-risk patients scheduled for elective cardiac surgery via sternotomy, with respect to recruitment, adherence, drop-out, safety, and acceptance. The program consists of two physiotherapist-supervised group training sessions per week, promotion of physical activity, and unsupervised home-based exercise. Secondary Objective To provide a preliminary evaluation of participant responses to the intervention, focusing on changes in cardiorespiratory fitness (WRpeak), peripheral muscle strength (1RM), inspiratory muscle strength (MIP), physical activity (time spent active per day), and health-related quality of life (SF-36). Study design A prospective, single-center, longitudinal, mixed-methods pilot study conducted at Maastricht University Medical Center (MUMC+). Study population High-risk patients (n=24), defined by EuroSCORE II, who are scheduled for elective cardiac surgery via sternotomy (CABG or AVR). Main study parameters/endpoints The primary endpoint is the feasibility of the prehabilitation intervention with respect to recruitment, adherence, drop-out, safety, and acceptance. Burden Participation involves a structured time commitment with clinic and home components. Total supervised clinic time is estimated at 11-15 hours, covering two baseline assessments, 8-12 training sessions, and the final evaluation and interview. Total time at home is estimated at 16.5-19 hours, covering daily diary completion and unsupervised home exercises. These ranges depend on the patient's time to surgery. Risks and mitigation The risk of acute cardiac events during exercise is elevated in this high-risk population. This risk is mitigated by strict adherence to NVVC/MUMC+ absolute stop criteria, continuous medical supervision during all testing and training sessions, and individualized intensity prescription based on CPET. The risk is considered acceptable in relation to the scientific value of studying this specific high-risk cohort, which makes the study group-related. Benefit and group relatedness Direct clinical benefit cannot be guaranteed, as this is a feasibility study. However, patients receive an intensive, personalized prehabilitation program that is designed to reduce the incidence and severity of postoperative adverse outcomes.

Conditions

Prehabilitation; Cardiac Surgery; Risk Assesment; Aortic Valve; Coronary Artery Bypass Graft; Training

Keywords

Prehabilitation; Perioperative care; Cardiac surgery; CABG; AVR; Training intervention; Promotion of physical activity; Interval training; CPET; Preoperative exercise; preoperative training

Outcome Measures

Primary Outcomes (14)

• Recruitment - Recruitment rate

  Number of included patients within the study period (n,%)

  Week 0

• Recruitment (Ineligibility rate due to CPET safety criteria

  Number of patients withdrawn due to safety criteria (n,%)

  Week 0

• Adherence - Attendance rate for physiotherapist-supervised groups sessions

  Number of attended sessions / total number of planned sessions (n,%)

  Week 0-4~6

• Adherence rate - Exercise Relative Dose Intensity ExRDI cardiorespiratory training (%)

  ExRDI cardiorespiratory training = completed exercise dose intensity / prescribed exercise dose intensity. Interval training (CABG) • Completed = Σ (completed work-interval duration \[min\] × completed work rate \[WR\]). • Prescribed = Σ (prescribed work-interval duration \[min\] × prescribed work rate \[WR\]). Continuous training (AVR) • Completed = total completed duration \[min\] × completed work rate \[WR\]. • Prescribed = total prescribed duration \[min\] × prescribed work rate \[WR\]. ExRDI cardiorespiratory training is calculated for each participant individually, cumulative for all training sessions; and cumulative for all participants.

  Week 0-4~6

• Adherence rate - EXRDI peripheral strength training (%)

  ExRDI peripheral strength training = completed exercise dose intensity / prescribed exercise dose intensity. * Completed = completed weight \[kg\] × sets \[N\] × repetitions \[N\] per exercise. * Prescribed = prescribed weight \[kg\] × sets \[N\] × repetitions \[N\] per exercise. ExRDI peripheral strength training is calculated per participant per training session for each exercise and for all four exercises cumulative. And cumulative for all training sessions; and cumulative for all participants.

  Week 0-4~6

• Adherence rate - ErXDI inspiratory strength training (%)

  ExRDI inspiratory strength training = completed exercise dose intensity / prescribed exercise dose intensity. * Completed volume = completed resistance × sets \[N\] × repetitions \[N\]. * Prescribed volume = prescribed resistance × sets \[N\] × repetitions \[N\]. ExRDI inspiratory strength training will be calculated once weekly for each participant during the supervised training session. The weekly value will be accumulated across all supervised sessions and aggregated across participants. For unsupervised inspiratory strength training, diary entries will be reviewed with the participant during the weekly supervised session. Patients will record the number of sets and repetitions performed each day, from which the completed exercise dose intensity will be derived. Prescribed volumes will be based on the individual's target resistance, sets, and repetitions for that week. Supervised and unsupervised ExRDI values will be calculated and analyzed separately.

  Week 0-4~6

• Adherence - ExRDI Physical activity and unsupervised home-based exercises (%)

  ExRDI physical activity and unsupervised home-based exerises = completed physical activity volume / prescribed physical activity volume. * Completed volume = PAM measured activity (min/day) * Prescribed volume = goal activity (min/day) ExRDI physical activity and unsupervised home-based exercises is calculated and evaluated per participant in the week during supervised training session. And cumulative for all weeks; and cumulative for all participants.

  Week 0-4~6

• Reasons for not having executed a training session as intended

  Reasons for not having executed a training session as intended (e.g., low saturation, high blood pressure, the intended training intensity could not be sustained, tiredness, etc.)

  Week 0-4~6

• Reasons for not having executed a training session as intended stratified by trainings type

  Reasons for not having executed a training session as intended (e.g., low saturation, high blood pressure, the intended training intensity could not be sustained, tiredness, etc.)

  Week 0-4~6

• Drop-out rate (%)

  Number of participants who dropped out divided by the total number of participants

  Week 0-4~6

• Reasons for drop-out

  Reasons for drop-out

  Week 0-4~6

• Acceptance - Experiences with the physical prehabilitation intervention

  Patient-reported experiences with the prehabilitation program (semi-structured interviews).

  Evaluation (after the whole training intervention).

• Acceptance - Suitability of the physical prehabilitation intervention and study procedures

  Patient-perceived suitability of the intervention and study procedures (semi-structured interviews).

  Evaluation (after the whole training intervention).

• Acceptance - Barriers and enablers regarding participation in the study

  Patient-perceived barriers and facilitators to participation (semi-structured interviews).

  Evaluation (after the whole training intervention).

Secondary Outcomes (8)

• Safety - Serious adverse events

  From baseline to three month after surgery

• Safety - Study related adverse events

  From baseline to three month after surgery

• Preliminary evaluation of changes in cardiorespiratory fitness

  Baseline (Week 0) and evaluation (after the whole training intervention).

• Preliminary evaluation of changes in peripheral muscle strength

  Baseline (Week 0) and evaluation (after the whole training intervention).

• Preliminary evaluation of changes in inspiratory muscle strength

  Baseline (Week 0) and evaluation (after the whole training intervention).

Study Arms (1)

High risk patients awaiting Coronary Artery Bypass Grafting or Aortic Valve Replacement

EXPERIMENTAL

Elective patients awaiting cardiac surgery via sternotomy (CABG or AVR) and are considerd through a two stage screening proces as high risk for in-hospital complications or delayed recovery of physical functioning. two-stage screening process: * Elevated Surgical Risk (Stage 1): Defined by a EuroSCORE II ≥1.33. * Multivariable Confirmation (Stage 2): Further screening using the prediction model that integrates EuroSCORE II, cardiorespiratory fitness (FITmáx), frailty (EFS), and BMI.

Behavioral: Physical Prehabilitation Intervention

Interventions

Physical Prehabilitation Intervention BEHAVIORAL

All study participants will undergo elective CABG or AVR within approximately five weeks or more following baseline assessment. The preoperative physical inter-vention will span a minimum of four to a maximum of six weeks (which means that they minimally participated in 8 to maximal 12 supervised training sessions) and consists of: • Two physiotherapist-supervised group training sessions per week consisting of: 1.Cardiorespiratory Fitness Training (based on CPET): CABG follow interval training; AVR follow continue training; 2.Peripheral Muscle Strength Training; 3.Inspiratory Muscle Strength Training (on indication); • Promotion of physical activity using wearable physical activity monitoring and goal-setting tailored to the individual's capacity and preferences.• Unsupervised home-based exercise (e.g., walking or cycling, strength exercises) tailored to the individual's capacity and preferences.

Also known as: Preoperative physical exercise, Prehabilitation

High risk patients awaiting Coronary Artery Bypass Grafting or Aortic Valve Replacement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: ≥18 years.
• Surgical procedure: Scheduled to undergo elective CABG or AVR via median sternotomy;
• Allowed concomitant procedures: Isolated procedures or in combination with concomitant procedures (i.e., MAZE, Pulmonary Vein Isolation (PVI), clip Left Arterial Appendage (LAA)).
• High risk classification: Classified as High-Risk for postoperative complications or delayed functional recovery, identified via a two-stage screening process:
• Elevated Surgical Risk (Stage 1): Defined by a EuroSCORE II ≥1.33.
• Multivariable Confirmation (Stage 2): Further screening using the prediction model that integrates EuroSCORE II, cardiorespiratory fitness (FITmáx), frailty (EFS), and BMI.
• Waiting time: Expected waiting time \> 4 weeks before surgery
• Communication: Able to understand and communicate in Dutch.

You may not qualify if:

• Procedure-related: Scheduled for combined CABG and AVR, or combined with MVP and/or TVP, or combined with aortic aneurysm repair
• Medical conditions, as described in the electronic medical record (EMR):
• Patients with a known Ascending Aorta Diameter (AAD) \>45mm or any patient with an AAD \> 40mm if they have an associated high-risk condition, including a known genetic connective tissue disorder or a history of aortic dissection.
• Recent acute coronary syndrome (\< 3 weeks)
• Recent inflammatory myo-pericardial syndrome (\< 1 month after remission) as recommended in the ESC Guidelines for the management of myo- and peri-carditis
• Conduction disturbances and/or arrhythmias with pacemaker (PM) or Implant-able Cardioverter Defibrillator (ICD) indication without a device implanted yet.
• Decompensated heart failure or cardiomyopathy contraindicating exercise.
• Atrial fibrillation or other tachyarrhythmias with resting heart rate \>120 bpm.
• Exercise and functional limitations, as described in the EMR:
• Left main coronary artery stenosis \>80%
• History of frequent exercise-induced syncope's in Aortic valve Stenosis (AoS) and Aortic valve Insufficiency (AoI) patients
• Physical impairments that makes it impossible to complete the assessments and the prehabilitation program, as determined by an experienced physiother-apist.
• Cognitive impairment (e.g. dementia) that would impede understanding of study procedures, informed consent, or study questionnaires described by the medical specialist in the EMR.
• Incapacitated subjects as reported by the attending medical specialist in the medical record. (When any doubt arises, the patient will not be considered eligible).
• Exercise safety issues during the CPET at baseline measurement

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Maastricht University Medical Center

Maastricht, Limburg, 6229HX, Netherlands

Location

Related Publications (6)

• Marmelo F, Rocha V, Moreira-Goncalves D. The impact of prehabilitation on post-surgical complications in patients undergoing non-urgent cardiovascular surgical intervention: Systematic review and meta-analysis. Eur J Prev Cardiol. 2018 Mar;25(4):404-417. doi: 10.1177/2047487317752373. Epub 2018 Jan 17.

  PMID: 29338307 BACKGROUND

• Steinmetz C, Bjarnason-Wehrens B, Walther T, Schaffland TF, Walther C. Efficacy of Prehabilitation Before Cardiac Surgery: A Systematic Review and Meta-analysis. Am J Phys Med Rehabil. 2023 Apr 1;102(4):323-330. doi: 10.1097/PHM.0000000000002097. Epub 2022 Sep 23.

  PMID: 36149383 BACKGROUND

• Lopez-Hernandez A, Gimeno-Santos E, Navarro-Ripoll R, Arguis MJ, Lopez-Baamonde M, Sanz-de la Garza M, Sandoval E, Castella M, Martinez-Palli G. Multimodal prehabilitation as a strategy to reduce postoperative complications in cardiac surgery: A randomised controlled trial. Eur J Anaesthesiol. 2025 Nov 1;42(11):987-996. doi: 10.1097/EJA.0000000000002236. Epub 2025 Jul 16.

  PMID: 40673713 BACKGROUND

• van der Hoofd Z, van Dijk-Huisman HC, Bongers BC, Scheenstra B, Maessen J, Lenssen AF. Preoperative Physical Fitness and Short-Term Postoperative Outcomes in Patients Undergoing Elective Cardiac Surgery: A Retrospective Cohort Study. Semin Cardiothorac Vasc Anesth. 2026 Sep;30(3):160-171. doi: 10.1177/10892532261427827. Epub 2026 Feb 21.

  PMID: 41721796 BACKGROUND

• van der Hoofd, Z., et al., Predicting In-Hospital Complications and Delayed Recovery in Patients undergoing Cardiac Surgery via Sternotomy: Development and Internal Validation of Multivariable Predictions Models Submitted, 2025.

  BACKGROUND

• Steinmetz C, Bjarnason-Wehrens B, Baumgarten H, Walther T, Mengden T, Walther C. Prehabilitation in patients awaiting elective coronary artery bypass graft surgery - effects on functional capacity and quality of life: a randomized controlled trial. Clin Rehabil. 2020 Oct;34(10):1256-1267. doi: 10.1177/0269215520933950. Epub 2020 Jun 16.

  PMID: 32546065 BACKGROUND

MeSH Terms

Interventions

Preoperative Exercise

Intervention Hierarchy (Ancestors)

Perioperative Care; Patient Care; Therapeutics; Surgical Procedures, Operative; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pilot - Feasibility study

Study Record Dates

• First Submitted: December 31, 2025
• First Posted: October 23, 2026
• Study Start: September 17, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): August 30, 2027
• Last Updated: October 23, 2026

Record last verified: 2026-10

Locations

NL (1)