Physical Activity Before Obesity Surgery (PABOS)

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Physical Activity
• Intervention / Treatment: Other: Increased physical activity; Other: Standard care

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Gothenburg, Sweden, 413 45
    • Sahlgrenska University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criterion:

- Patients at including hospitals scheduled for gastric bypass surgery

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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	Other: Standard care

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Göteborg University
• Collaborators: 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 record dates

Study Major Dates

• Study Start (Actual): February 16, 2016
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: August 6, 2018
• First Submitted That Met QC Criteria: August 20, 2018
• First Posted (Actual): August 21, 2018

Study Record Updates

• Last Update Posted (Actual): March 18, 2022
• Last Update Submitted That Met QC Criteria: March 17, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Physical Activity; Obesity
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: FoU i VGR: 202291

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No