Physical Activity Before Obesity Surgery

Obesity Clinical Trial

— PABOS  

Official title:

Physical Activity Before Obesity Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03641027
• Other study ID #: FoU i VGR: 202291
• Status: Completed
• Phase: N/A
• Start date: February 16, 2016
• Est. completion date: December 31, 2021

Study information

• Verified date: March 2022
• Source: Göteborg University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criterion:

• Patients at including hospitals scheduled for gastric bypass surgery

Exclusion Criteria:

• Inability to understand given information.

• Inability to perform the intervention

Related Conditions & MeSH terms

• Obesity
• Physical Activity

Intervention

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.
• Standard care

Locations

Country	Name	City	State
Sweden	Sahlgrenska University Hospital	Gothenburg

Sponsors (6)

Lead Sponsor	Collaborator
Göteborg University	Borås Lasarett, Centrallasarettet i Växjö, Karlshamns lasarett, Mora sjukhus, Torsby sjukhus

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	INTERNATIONAL PHYSICAL ACTIVITY QUESTIONNAIRES (IPAQ)	Physical activity level measured in METS (Metabolic Equivalent)	From inclusion 1 year postoperatively
Primary	Saltin-Grimby Physical Activity Scale (SGPAS)	Physical activity level, 1-4 (4 highest activity level).	From inclusion to 1 year postoperatively
Secondary	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
Secondary	Length of stay	Days at hospital	From surgery to discharge. On average two days
Secondary	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
Secondary	Blood test- glucose metabolism	Glucose metabolism-	From surgery to 2 years postoperatively
Secondary	Blood test- Blood lipids	Metabolic change lipids	From surgery to 2 years postoperatively
Secondary	Blood tests, Blood sugar	HbA1c	From surgery to 2 years postoperatively
Secondary	Blood tests, fasting blood suger	Fasting P-glucose	From surgery to 2 years postoperatively
Secondary	Blood tests	Blood lipids	From surgery to 2 years postoperatively
Secondary	Weight	Actual weight measured during clinical visits	From surgery to 2 years postoperatively
Secondary	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
Secondary	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
Secondary	Self reported co-morbidity	Number of patients with diabetes and with dyslipidemia medications	From inclusion 1 year postoperatively
Secondary	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