MedPath

Physical Exercise Prehabilitation Program in mEtabolic suRgery

Recruiting
Conditions
morbid obesity
overweight
10000546
10017998
Registration Number
NL-OMON54307
Lead Sponsor
Flevoziekenhuis
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Not specified
Target Recruitment
58
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

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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>The initial primary outcome will be preoperative physical condition by using<br /><br>the 6-minute walking test (6MWT). The 6MWT is measured at the beginning of the<br /><br>prehabilitation program (baseline) and after the prehabilitation program (group<br /><br>1). For the control group the 6MWT is measured at baseline and after 2 months.</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>Secondary outcomes will include the Comprehensive Complication Index (CCI) for<br /><br>post-operative outcome (Clavien-Dindo class III-V complications), length of<br /><br>hospital stay (LOS), preoperative weight loss, Excess Weight Loss (excess<br /><br>weight = actual weight * ideal weight ) and percentage excess BMI loss at 1<br /><br>year postoperative, satisfaction of the prehabilitation program by an<br /><br>questionnaire and we will measure physical activity at baseline and 1 year<br /><br>postoperative with the NNGB questionaire. Furthermore we will measure health<br /><br>related Quality of Life with the RAND-36 questionnaire at baseline and 1 year<br /><br>postoperative.</p><br>
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