Physical Activity Before Obesity Surgery

Study Overview
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Brief Summary
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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.

Official Title
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Physical Activity Before Obesity Surgery

Conditions
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Obesity, Physical Activity

Intervention / Treatment
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* Other: Increased physical activity
* Other: Standard care


Participation Criteria
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Eligibility Criteria
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Inclusion Criterion: - Patients at including hospitals scheduled for gastric bypass surgery Exclusion Criteria: Inability to understand given information. Inability to perform the intervention
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel Assignment A single blind, randomized, controlled, intervention study. Evaluation of the addition of increased physical activity for patients undergoing obesity surgery compared to standard care.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Increased physical activity<br>Increased physical activity daily before surgery. Standard care during hospital stay and continued training after discharge. | Other: Increased physical activity<br>* Preoperatively Individual coaching by a physical therapist to: increase physical activity 30 minutes/day (At least 150 min/week) decrease time spent sitting/lying 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: increase physical activity 30 minutes/day (At least 150 min/week) until 8 weeks postoperatively decrease time spent sitting/lying 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.<br>|
| Other: Standard care<br>Standard care | Other: Standard care<br> <br> |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Physical Activity