Physical Exercise Prehabilitation Program in MEtabolic SuRgery

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Obesity and Overweight Bariatric Surgery Behavior Body Weight Exercise Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Physical Fitness Prehabilitation Signs and Symptoms Six Minute Walk Test

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

FlevoZiekenhuis

Almere Stad, Flevoland, 1315RA, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Physical exercise prehabilitation

Behavioral

Patients in the intervention group will have two supervised training sessions per week for eight weeks in group sessions supervised by a physiotherapist.

Other names: Prehabilitation, Exercise program

Primary outcomes

six-minute walk test

Time frame: 2 months

Preoperative physical condition, assessed by using the six-minute walk test (6MWT). The target increase of the 6MWT is 10% in the intervention group.

Sponsors and collaborators

Lead sponsor

Flevoziekenhuis

Other

Registry information

Acronym: PEPPER

Important dates

Study start: 2022
Primary completion: 2025
Study completion: 2026
First posted: Mar 21, 2025
Registry last updated: Mar 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Not Yet Recruiting