Physical Exercise Prehabilitation Program in MEtabolic SuRgery (PEPPER)

Flevoziekenhuis

Status: Active, not recruiting

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

Treatments: Behavioral: Physical exercise prehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT06889207

NL74088.018.20

Details and patient eligibility

About

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.

Enrollment: 58 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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58 participants in 2 patient groups

Prehabilitation

Active Comparator group

Description:

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

Treatment:

Behavioral: Physical exercise prehabilitation

No prehabilitation

No Intervention group

Description:

Receives no exercise prehabilitation program