Physical Activity Before Obesity Surgery (PABOS)

• ClinicalTrials.gov Identifier: NCT03641027
• Recruitment Status: Active, not recruiting
• First Posted: August 21, 2018
• Last Update Posted: January 6, 2021
• Sponsor: Göteborg University
• Collaborators: Borås Lasarett; Centrallasarettet i Växjö; Karlshamns lasarett; Torsby sjukhus; Mora sjukhus
• Information provided by (Responsible Party): Göteborg University

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
Obesity; Physical Activity	Other: Increased physical activity; Other: Standard care	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 300 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention 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 (Outcomes Assessor)
• Masking Description: Assessor will not be aware of which group the patients are included in.
• Primary Purpose: Treatment
• Official Title: Physical Activity Before Obesity Surgery
• Actual Study Start Date: February 16, 2016
• Actual Primary Completion Date: December 31, 2020
• Estimated Study Completion Date: December 31, 2021

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.
Standard care; Standard care	Other: Standard care

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criterion:

- All 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

Sweden

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

More Information

• Responsible Party: Göteborg University
• ClinicalTrials.gov Identifier: NCT03641027
• Other Study ID Numbers: FoU i VGR: 202291
• First Posted: August 21, 2018
• Last Update Posted: January 6, 2021
• Last Verified: January 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Göteborg University:

Obesity; Physical Activity

Additional relevant MeSH terms:

Obesity; Overnutrition; Nutrition Disorders; Overweight; Body Weight