Obesity and OverweightPEPPERNCT06889207
Physical Exercise Prehabilitation Program in MEtabolic SuRgery
A study testing Physical exercise prehabilitation in people with Obesity and Overweight and Bariatric Surgery, run by Flevoziekenhuis at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity and Overweight, Bariatric Surgery, Prehabilitation
- What is being tested?
- Physical exercise prehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteNetherlands
- Study dates
- 14 Mar 2022to May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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?
Read more
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.
- Conditions
- Obesity and Overweight, Bariatric Surgery, Prehabilitation, Exercise, Physical Fitness, Six Minute Walk Test
- Being tested
- Physical exercise prehabilitation
- Medical subject headings
- Obesity, Overweight, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical exercise prehabilitationBehavioural
Also called Prehabilitation, Exercise program
Patients in the intervention group will have two supervised training sessions per week for eight weeks in group sessions supervised by a physiotherapist.
| Study group | Role | What they receive |
|---|---|---|
| Prehabilitation | Active comparator | Patients in the intervention group will have two supervised training sessions per week for eight weeks in group sessions supervised by a physiotherapist. Receives: Behavioral: Physical exercise prehabilitation |
| No prehabilitation | No intervention | Receives no exercise prehabilitation program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2025
- Study start14 Mar 2022
- Primary completionApr 2025 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity and OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Flevoziekenhuis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06889207
- Sponsor's protocol ID
- NL74088.018.20
- Acronym
- PEPPER
- Status last verified
- Oct 2024
- First submitted
- 17 Mar 2025
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Exercise Prehabilitation Program in MEtabolic SuRgery
- ClinicalTrials.gov ID
- NCT06889207
- Acronym / sponsor ID
- PEPPER / NL74088.018.20
- Conditions
- Obesity and Overweight, Bariatric Surgery, Prehabilitation, Exercise, Physical Fitness, Six Minute Walk Test
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- FlevoziekenhuisUniversity, hospital or other
- Study start
- 14 Mar 2022 (actual)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 21 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prehabilitation | Active comparator | Behavioral: Physical exercise prehabilitationPatients 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 intervention | –Receives no exercise prehabilitation program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical exercise prehabilitationAlso: Prehabilitation, Exercise programPatients in the intervention group will have two supervised training sessions per week for eight weeks in group sessions supervised by a physiotherapist. | Behavioural | Prehabilitation |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical exercise prehabilitation in people with Obesity and Overweight and Bariatric Surgery, run by Flevoziekenhuis at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
six-minute walk test (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2025.