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

NCT05772819 | Unknown

• 1 other identifier: NL83611.042.23
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prehabilitation; Surgery; Exercise Prehabilitation; Perioperative Care

Outcome Measures

Primary Outcomes (2)

• Central physiological adaptations

  Central adjustments will be determined by differences in LV/RV diastolic strain rate, LV and RV volumes, slope of early LV/RV filling, left and right atrial reservoir strain and emptying fraction, pulmonary artery distensibility and pulsatility, and cardiac output measurements using exCMR, before and after the prehabilitation program.

  through study completion, an average of 1 year

• Peripheral physiological adaptations

  Peripheral adjustments will be determined by differences in quadriceps PCr, Pi and pH at rest and during progressive exercise and post-exercise recovery rates of quadriceps PCr, Pi and pH using 31P MRS, before and after the prehabilitation program.

  through study completion, an average of 1 year

Secondary Outcomes (1)

• Postoperative outcomes

  through study completion, an average of 1 year

Study Arms (1)

Imaging arm

EXPERIMENTAL

Participants are subjected to in-magnet exercise test consisting of in vivo exercise cardiac magnetic resonance (exCMR) imaging and 31P-magnetic resonance spectroscopy (31P-MRS) during exercise testing in a MR-compatible ergometer, before and after the 4-week prehabilitation program.

Diagnostic Test: exercise MRI

Interventions

exercise MRI DIAGNOSTIC_TEST

All patients are subjected to two types of in-magnet exercise tests consisting of exercise cardiac magnetic resonance imaging (exCMR) and Phosphorus 31 magnetic resonance spectrography (31P MRS) of the quadriceps muscle, during exercise at various exercise intensities in a supine position using a MR-compatible ergometer (Lode MR Ergometer Pedal, Lode BV, Groningen, the Netherlands).

Imaging arm

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Medical Center Groningen: lead
• Nationaal Fonds tegen Kanker: collaborator

Study Sites (1)

University Medical Center Groningen

Groningen, 9713GZ, Netherlands

Location

Related Publications (1)

• Wijma AG, Driessens H, Jeneson JAL, Janssen-Heijnen MLG, Willems TP, Klaase JM, Bongers BC. Cardiac and intramuscular adaptations following short-term exercise prehabilitation in unfit patients scheduled to undergo hepatic or pancreatic surgery: study protocol of a multinuclear MRI study. BMJ Open Gastroenterol. 2023 Nov 23;10(1):e001243. doi: 10.1136/bmjgast-2023-001243.

  PMID: 37996121 DERIVED

Study Design

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

Study Record Dates

• First Submitted: February 10, 2023
• First Posted: March 16, 2023
• Study Start: April 1, 2023
• Primary Completion: April 1, 2024
• Study Completion: June 1, 2024
• Last Updated: March 16, 2023

Record last verified: 2023-03

Locations

NL (1)