The aim of this study is to investigate whether prehabilitation could enhance preoperative physical condition and weight loss before bariatric surgery and induce a lifestyle behavior change.
ID
Source
Brief title
Condition
- Metabolism disorders NEC
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
Obesity is a major public health burden and there are many national health
programs to encounter this problem. Bariatric surgery is the most effective
intervention in obese adults who do not respond to conservative treatment.
People with obesity have high surgical risk and long-term outcomes are related
to preoperative physical condition and preoperative weight. Evidence shows that
the preoperative period is the optimal moment for intervention. This study will
determine the impact of prehabilitation on bariatric patients* preoperative
physical condition and postoperative outcomes.
Study objective
The aim of this study is to investigate whether prehabilitation could enhance
preoperative physical condition and weight loss before bariatric surgery and
induce a lifestyle behavior change.
Study design
This, prospective, randomized controlled trial will include 58 patients
undergoing bariatric surgery. Patients will be divided in two groups: the
intervention group (group 1) will receive 8 weeks of prehabilitation and
standard preoperative counseling with a dietician and the control group (group
2) will only receive preoperative counseling with a dietician.
Intervention
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.
Study burden and risks
Both groups of patients will receive regular care. This includes a mandatory
screening of the dietician, psychologist, nurse and surgeon followed by the
bariatric multidisciplinary team (BMDT) meeting to decide on the patient's
individual treatment strategy. If necessary, patients will receive extended
consultations from the dietician or psychologist. Within this study: The
intervention group receives a prehabilitation program of eight weeks, exercise
two times a week in a group setting. Risks associated with this intervention
are sports injuries. A possible benefit of particpants in the prehabilitation
group could be: more fit before surgery, may lead to decreased postoperative
complications. Overall, the complication rate after bariatric surgery is low.
The overall complication rate after bariatric surgery is approximately <1%.
Hospitaalweg 1
Almere 1315RA
NL
Hospitaalweg 1
Almere 1315RA
NL
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL74088.018.20 |