Sahlgrenska University Hospital
Gothenburg, 413 45, Sweden
NCT Number: NCT03641027
There are limited knowledge about the impact of increased pre-operative physical training on postoperative physical activity levels as well as on recovery and complication rates after bariatric surgery.
The primary aim of this study is to investigate whether an intervention including individual coaching to improve level of physical activity before and after gastric bypass surgery leads to a changed of level physical activity post-operatively at eight weeks, one and two years.
Secondary aims of the study are to investigate whether increased physical activity has effects on complication rates, re-admissions and re-operations, post-operative weight-loss, gastrointestinal pain, recovery measured as hospital stay, sick-leave and QoL, resumption of normal physical activity.
METHODS 300 patients will be recruited and randomized to an intervention group or control group. The patients in the intervention group will receive individual coaching by a physical therapist to:
* increase physical activity 30 minutes/day (At least 150 min/week) * decrease time spent sitting/lying The patients in the control group will receive standard care.
Before surgery, 6 weeks, and one year after surgery patient will fill in a questionnaire including level of physical activity, sick leave, quality of life and gastrointestinal pain. In addition blood test will be taken and complication rates recorded.
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Interventional
Not applicable
Gothenburg, 413 45, Sweden
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion Criterion:
Exclusion criteria
Preoperatively
Individual coaching by a physical therapist to:
Telephone follow up one week after the intervention starts
At the hospital
-Frequent mobilization
After discharge
A telephone follow up one week postoperatively with coaching by a physical therapist to:
The intervention includes a prescribed FaR (Fysisk aktivitet på recept) with frequency, duration and intensity of the activity corresponding 12-15 on the BORG-RPE scale.
Time frame: From inclusion 1 year postoperatively
Physical activity level measured in METS (Metabolic Equivalent)
Time frame: From inclusion to 1 year postoperatively
Physical activity level, 1-4 (4 highest activity level).
Time frame: From inclusion to 30 days postoperatively
Anastomotic leakages, bleedings that require intervention, thrombosis, re-admissions and re-operations derived from the patient medical records
Time frame: From surgery to discharge. On average two days
Days at hospital
Time frame: From surgery to at latest 1 year postoperatively
Sick-leave is prescribed one week at a time, patients are required to call the doctor, to ask for prolonged sick-leave a week at a time.
Time frame: From surgery to 2 years postoperatively
Glucose metabolism-
Time frame: From surgery to 2 years postoperatively
Metabolic change lipids
Time frame: From surgery to 2 years postoperatively
HbA1c
Time frame: From surgery to 2 years postoperatively
Fasting P-glucose
Time frame: From surgery to 2 years postoperatively
Blood lipids
Time frame: From surgery to 2 years postoperatively
Actual weight measured during clinical visits
Time frame: From inclusion 1 year postoperatively
EQ5D, 5 questions with 3 different answers each (1 best value) leaving a 5 digit code which is transfered to a score from 0.3403-0.9694
Time frame: From inclusion 1 year postoperatively
Gastrointestinal Symptom Rating Scale, 16 questions rated on scales with 7 levels (a-low symptoms to g- worst symtoms)
Time frame: From inclusion 1 year postoperatively
Number of patients with diabetes and with dyslipidemia medications
Time frame: From inclusion 1 year postoperatively
Number of patients with medication because of diabetes, high blood pressure and dyslipidemia.
Göteborg University
Other
Acronym: PABOS
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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