Physical Exercise Prehabilitation Program in MEtabolic SuRgery (PEPPER)

March 25, 2025 updated by: Flevoziekenhuis

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

58

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Flevoland
      • Almere, Flevoland, Netherlands, 1315RA
        • Flevoziekenhuis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Prehabilitation
Patients in the intervention group will have two supervised training sessions per week for eight weeks in group sessions supervised by a physiotherapist.
Behavioral: Physical exercise prehabilitation
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
No Intervention: No prehabilitation
Receives no exercise prehabilitation program

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Flevoziekenhuis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 14, 2022

Primary Completion (Estimated)

April 1, 2025

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

March 17, 2025

First Submitted That Met QC Criteria

March 17, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 28, 2025

Last Update Submitted That Met QC Criteria

March 25, 2025

Last Verified

October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL74088.018.20

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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