Physical Exercise Prehabilitation Program in MEtabolic SuRgery

NCT ID: NCT06889207

Last Updated: 2025-03-28

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-14
• Study Completion Date: 2026-05-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Prehabilitation

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

Group Type: ACTIVE_COMPARATOR

Physical exercise prehabilitation

Intervention Type: BEHAVIORAL

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

No prehabilitation

Receives no exercise prehabilitation program

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Prehabilitation; Exercise program

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Flevoziekenhuis

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

FlevoZiekenhuis

Almere Stad, Flevoland, Netherlands

Countries

Netherlands

Other Identifiers

NL74088.018.20

Identifier Type: -

Identifier Source: org_study_id