UnknownNot Applicable

'Cardiac and Intramuscular Adaptations Following Short-term Exercise Prehabilitation in Unfit Patients Scheduled to Undergo Hepatic- or Pancreatic Surgery'

Netherlands12 participantsStarted 2023-04-01

Plain-language summary

Surgery remains an important treatment modality in the treatment of hepatopancreatobiliary (HPB) malignancies, but the physiological stress caused by surgery is at the same time a challenge for the homeostasis of patients. A patient's preoperative aerobic capacity has been found to have a consistent relation with postoperative outcomes in major abdominal surgery, with low aerobic capacity being associated with a higher risk of postoperative morbidity and mortality. Preoperative exercise prehabilitation programs can effectively increase the ability of patients to cope with surgical-induced allostatic load, by improving aerobic capacity, and functioning of the respiratory, cardiovascular, and/or musculoskeletal systems. However, besides the effect of exercise prehabilitation on physical fitness in terms of improvement of aerobic capacity as measured by the cardiopulmonary exercise test (CPET), the exact role of adaptations in cardiac and/or skeletal muscle function contributing to the improvement in aerobic capacity is still unknown. Insight in the physiological adaptations that lead to improvement in aerobic capacity after prehabilitation in patients with low aerobic capacity will enable caregivers to individually optimize the exercise program (e.g. by changing exercise frequency, intensity, duration and type) and better explain the rationale and effectiveness behind the short-term physical exercise training program to patients. Therefore, the main objective of this study is to assess the central (cardiac function) and peripheral (skeletal muscle function) physiological adaptations in response to short-term exercise prehabilitation. Secondary objective is to assess the relationship between immune function and exercise. In this study, unfit patients are asked to undergo additional in-magnet exercise testing to investigate the central and peripheral physiological adaptations in response to exercise prehabilitation.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * VO2 at the VAT ≤13 ml/kg/min and/or VO2peak ≤18 ml/kg/min, as determined during the baseline CPET; * More than 18 years of age; * Scheduled for elective liver- or pancreatic resection at the UMCG; * Willing to participate in the home-based bimodal prehabilitation program; * Has given consent to participate in the study. Exclusion Criteria: * Patients requiring acute (emergency) surgery; * Patients not capable of cycling on a cycle ergometer; * Patients with contraindications to physical exercise training; * Patients receiving neoadjuvant chemotherapy * Contraindications for exCMR (e.g., claustrophobia, implanted cardiac devices) * Atrial fibrillation or other significant arrhythmia during the CPET; * Body weight \>140 kg; * Body height \>190 cm; * History of myocardial infarction, percutaneous coronary intervention or coronary artery bypass graft \<3 months or untreated severe obstructive coronary artery stenosis; * More than moderate left-sided valve disease; * Complex congenital heart disease.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Central physiological adaptations

Timeframe: through study completion, an average of 1 year

Peripheral physiological adaptations

Timeframe: through study completion, an average of 1 year

Trial details

NCT IDNCT05772819

SponsorUniversity Medical Center Groningen

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-04-01

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