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

NCT05772819 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2023-03-16

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

exercise MRI

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).

Sponsors & Collaborators

  • Nationaal Fonds tegen Kanker

    collaborator UNKNOWN

  • University Medical Center Groningen

    lead OTHER

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-01
Primary Completion
2024-04-01
Completion
2024-06-01

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05772819 on ClinicalTrials.gov