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Physical Exercise Prehabilitation Program in mEtabolic suRgery

Physical Exercise Prehabilitation Program in mEtabolic suRgery - PEPPER trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON54307
Enrollment
58
Registered
2020-10-20
Start date
2022-02-21
Completion date
Unknown
Last updated
2025-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

morbid obesity

Interventions

The intervention that is given to the intervention group is: 8 weeks of prehabilitation, exercise two times a week in a group setting supervised by a physiotherapist.

Sponsors

Flevoziekenhuis
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: Adult patients (>18 years) were eligible for inclusion if their body-mass index (BMI) was 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. For inclusion we will follow our National Guidelines on metabolic surgery.

Exclusion criteria

Exclusion criteria: previous bariatric surgery patients with/who: 1. mobility problems (patients who are not able to exercise) 2. cognitive disabilities 3. illiteracy (patients who are not able to read) 4. do not understand the Dutch language

Design outcomes

Primary

MeasureTime frame
The initial primary outcome will be preoperative physical condition by using the 6-minute walking test (6MWT). The 6MWT is measured at the beginning of the prehabilitation program (baseline) and after the prehabilitation program (group 1). For the control group the 6MWT is measured at baseline and after 2 months.

Secondary

MeasureTime frame
Secondary outcomes will include the Comprehensive Complication Index (CCI) for post-operative outcome (Clavien-Dindo class III-V complications), length of hospital stay (LOS), preoperative weight loss, Excess Weight Loss (excess weight = actual weight * ideal weight ) and percentage excess BMI loss at 1 year postoperative, satisfaction of the prehabilitation program by an questionnaire and we will measure physical activity at baseline and 1 year postoperative with the NNGB questionaire. Furthermore we will measure health related Quality of Life with the RAND-36 questionnaire at baseline and 1 year postoperative.

Countries

Netherlands

Contacts

Public ContactS Adel

Flevoziekenhuis

s.eladel@amsterdamumc.nl+31642048082

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)