CClinicalTrials.gg
Sign In
Active, not recruitingNCT06889207PEPPERUpdated Mar 28, 2025

Physical Exercise Prehabilitation Program in MEtabolic SuRgery

An interventional study of Physical exercise prehabilitation in Obesity and Overweight, Bariatric Surgery and Prehabilitation, sponsored by Flevoziekenhuis. Active, not recruiting at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-28.

Sponsored by Flevoziekenhuis · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Apr 2025, 1 year 6 months ago, but the record still lists the study as active, not recruiting.
  • Registered 3 years after the study started (first participant enrolled Mar 2022, registered Mar 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
58
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.
02

Conditions studied

  • Obesity and Overweight
  • Bariatric Surgery
  • Prehabilitation
  • Exercise
  • Physical Fitness
  • Six Minute Walk Test

Browse trials for

03

In context

Overweight

3,670 studies on the registry are indexed under Overweight; 849 are open to participants now.

This study's planned enrollment of 58 is below the median of 73 across 3,175 interventional studies indexed under Overweight.

Browse Overweight studies →

Lead sponsor

Flevoziekenhuis is the lead sponsor of 3 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
58 participants (estimated)

Study arms

  • 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

  • No intervention
    No prehabilitation

    Receives no exercise prehabilitation program

Interventions

  • BehavioralPhysical 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.

    Also known as: Prehabilitation, Exercise program

06

What researchers measure

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.

    Time frame: 2 months

07

Study locations

1 site
  • FlevoZiekenhuis
    Almere, Flevoland 1315RA, Netherlands
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 28, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06889207
Lead sponsor
Flevoziekenhuis
Responsible party
Sponsor
First posted
Mar 21, 2025
Start date
Mar 14, 2022
Primary completion
Apr 2025 (estimated)
Completion
May 2026 (estimated)
Last update
Mar 28, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Overweight→

Other studies from this sponsor

Flevoziekenhuis

Start the discussion