Physical Activity Before Obesity Surgery

Not Applicable

Completed

• Conditions: Obesity; Physical Activity
• Interventions: Other: Increased physical activity; Other: Standard care

• Registration Number: NCT03641027
• Lead Sponsor: Göteborg University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02-16
• Study First Submitted: 2018-08-06
• Study First Submitted QC: 2018-08-20
• Study First Posted: 2018-08-21
• Primary Completion: 2020-12-31
• Study Completion: 2021-12-31
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-17
• Last Update Posted: 2022-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Not provided

Exclusion Criteria

• Inability to understand given information.
• Inability to perform the intervention

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Increased physical activity	Increased physical activity	Increased physical activity daily before surgery. Standard care during hospital stay and continued training after discharge.
Standard care	Standard care	Standard care

Primary Outcome Measures

Name	Time	Method
Saltin-Grimby Physical Activity Scale (SGPAS)	From inclusion to 1 year postoperatively	Physical activity level, 1-4 (4 highest activity level).
INTERNATIONAL PHYSICAL ACTIVITY QUESTIONNAIRES (IPAQ)	From inclusion 1 year postoperatively	Physical activity level measured in METS (Metabolic Equivalent)

Secondary Outcome Measures

Name	Time	Method
Sick-leave	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.
Blood test- Blood lipids	From surgery to 2 years postoperatively	Metabolic change lipids
Blood tests, fasting blood suger	From surgery to 2 years postoperatively	Fasting P-glucose
Complication rates	From inclusion to 30 days postoperatively	Anastomotic leakages, bleedings that require intervention, thrombosis, re-admissions and re-operations derived from the patient medical records
Blood test- glucose metabolism	From surgery to 2 years postoperatively	Glucose metabolism-
Blood tests, Blood sugar	From surgery to 2 years postoperatively	HbA1c
Blood tests	From surgery to 2 years postoperatively	Blood lipids
General Quality of Life, QoL By EQ5D	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
Gastrointestinal pain by Gastrointestinal Symptom Rating Scale (GSRS)	From inclusion 1 year postoperatively	Gastrointestinal Symptom Rating Scale, 16 questions rated on scales with 7 levels (a-low symptoms to g- worst symtoms)
Weight	From surgery to 2 years postoperatively	Actual weight measured during clinical visits
Self reported co-morbidity	From inclusion 1 year postoperatively	Number of patients with diabetes and with dyslipidemia medications
Length of stay	From surgery to discharge. On average two days	Days at hospital
Self reported medication because of co-morbidity	From inclusion 1 year postoperatively	Number of patients with medication because of diabetes, high blood pressure and dyslipidemia.

Trial Locations

Locations (1)

Sahlgrenska University Hospital; 🇸🇪 Gothenburg, Sweden