PABOS: Physical Activity Before Obesity Surgery
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Increased physical activity Increased physical activity daily before surgery. Standard care during hospital stay and continued training after discharge. |
Other: Increased physical activity
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.
|
Other: Standard care Standard care |
Other: Standard care
|
Outcome Measures
Primary Outcome Measures
- INTERNATIONAL PHYSICAL ACTIVITY QUESTIONNAIRES (IPAQ) [From inclusion 1 year postoperatively]
Physical activity level measured in METS (Metabolic Equivalent)
- Saltin-Grimby Physical Activity Scale (SGPAS) [From inclusion to 1 year postoperatively]
Physical activity level, 1-4 (4 highest activity level).
Secondary Outcome Measures
- 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
- Length of stay [From surgery to discharge. On average two days]
Days at hospital
- 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- glucose metabolism [From surgery to 2 years postoperatively]
Glucose metabolism-
- Blood test- Blood lipids [From surgery to 2 years postoperatively]
Metabolic change lipids
- Blood tests, Blood sugar [From surgery to 2 years postoperatively]
HbA1c
- Blood tests, fasting blood suger [From surgery to 2 years postoperatively]
Fasting P-glucose
- Blood tests [From surgery to 2 years postoperatively]
Blood lipids
- Weight [From surgery to 2 years postoperatively]
Actual weight measured during clinical visits
- 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)
- Self reported co-morbidity [From inclusion 1 year postoperatively]
Number of patients with diabetes and with dyslipidemia medications
- 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.
Eligibility Criteria
Criteria
Inclusion Criterion:
- Patients at including hospitals scheduled for gastric bypass surgery
Exclusion Criteria:
-
Inability to understand given information.
-
Inability to perform the intervention
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Sahlgrenska University Hospital | Gothenburg | Sweden | 413 45 |
Sponsors and Collaborators
- Göteborg University
- Borås Lasarett
- Centrallasarettet i Växjö
- Karlshamns lasarett
- Torsby sjukhus
- Mora sjukhus
Investigators
- Principal Investigator: Monika Fagevik Olsén, pHd, Sahlgrenska Academy at Gothenburg university, Sweden
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- FoU i VGR: 202291