Physical Exercise Prehabilitation Program in MEtabolic SuRgery
PEPPER
1 other identifier
interventional
58
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 14, 2022
CompletedFirst Submitted
Initial submission to the registry
March 17, 2025
CompletedFirst Posted
Study publicly available on registry
March 21, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2026
CompletedMarch 28, 2025
October 1, 2024
3.1 years
March 17, 2025
March 25, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
six-minute walk test
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
Study Arms (2)
Prehabilitation
ACTIVE COMPARATORPatients in the intervention group will have two supervised training sessions per week for eight weeks in group sessions supervised by a physiotherapist.
No prehabilitation
NO INTERVENTIONReceives no exercise prehabilitation program
Interventions
Patients in the intervention group will have two supervised training sessions per week for eight weeks in group sessions supervised by a physiotherapist.
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Flevoziekenhuislead
Study Sites (1)
FlevoZiekenhuis
Almere Stad, Flevoland, 1315RA, Netherlands
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 17, 2025
First Posted
March 21, 2025
Study Start
March 14, 2022
Primary Completion
April 1, 2025
Study Completion
May 1, 2026
Last Updated
March 28, 2025
Record last verified: 2024-10