Physical Exercise Prehabilitation Program in MEtabolic SuRgery (NCT06889207) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Physical Exercise Prehabilitation Program in MEtabolic SuRgery
Netherlands58 participantsStarted 2022-03-14
Plain-language summary
The goal of this clinical trial is to learn if an exercise program before bariatric surgery works to treat obesity, could improve physical condition and weight loss before bariatric surgery and induce a lifestyle behavior change. The main questions it aims to answer are:
* Does a supervised exercise program lead to improved physical condition prior to bariatric surgery?
* Does a supervised exercise program prior to bariatric surgery lead to reduced surgery related complications?
* Does a supervised exercise program prior to bariatric surgery lead to maintained lifestyle changes after surgery?
Participants will:
* Receive either no training program or physical exercise training program twice a week, supervised by a physical therapist, for a duration of 8 weeks.
* Have their fitness measured at the start and at the end of the 8 weeks, measured with a six minute walking test.
* Fill in a survey on their perceived quality of life and exercise habits at the start of the trial, and at 1 year after surgery.
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:
* Adult patients (≥18 years)
* Body-Mass-Index (BMI) 40 kg/m2 or higher, or 35 kg/m2 or higher with the presence of at least one comorbidity (type 2 diabetes, high blood pressure, heart and/or vascular diseases, obstructive sleep apnea (OSA), dyslipidemia, or arthritis).
* Primary bariatric patients; without previous bariatric surgery. For inclusion the investigators will follow the National Guidelines on metabolic surgery.
Exclusion Criteria:
Patients with:
* mobility problems (patients who are not able to exercise)
* cognitive disabilities
* illiteracy (patients who are not able to read and understand the language of the country where the study will be performed)
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.