Physical Activity Before Obesity Surgery (PABOS)
Primary Purpose
Obesity, Physical Activity
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Increased physical activity
Standard care
Sponsored by

About this trial
This is an interventional treatment trial for Obesity focused on measuring Obesity, Physical Activity
Eligibility Criteria
Inclusion Criterion:
- Patients at including hospitals scheduled for gastric bypass surgery
Exclusion Criteria:
- Inability to understand given information.
- Inability to perform the intervention
Sites / Locations
- Sahlgrenska University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Increased physical activity
Standard care
Arm Description
Increased physical activity daily before surgery. Standard care during hospital stay and continued training after discharge.
Standard care
Outcomes
Primary Outcome Measures
INTERNATIONAL PHYSICAL ACTIVITY QUESTIONNAIRES (IPAQ)
Physical activity level measured in METS (Metabolic Equivalent)
Saltin-Grimby Physical Activity Scale (SGPAS)
Physical activity level, 1-4 (4 highest activity level).
Secondary Outcome Measures
Complication rates
Anastomotic leakages, bleedings that require intervention, thrombosis, re-admissions and re-operations derived from the patient medical records
Length of stay
Days at hospital
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.
Blood test- glucose metabolism
Glucose metabolism-
Blood test- Blood lipids
Metabolic change lipids
Blood tests, Blood sugar
HbA1c
Blood tests, fasting blood suger
Fasting P-glucose
Blood tests
Blood lipids
Weight
Actual weight measured during clinical visits
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
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)
Self reported co-morbidity
Number of patients with diabetes and with dyslipidemia medications
Self reported medication because of co-morbidity
Number of patients with medication because of diabetes, high blood pressure and dyslipidemia.
Full Information
NCT ID
NCT03641027
First Posted
August 6, 2018
Last Updated
March 17, 2022
Sponsor
Göteborg University
Collaborators
Borås Lasarett, Centrallasarettet i Växjö, Karlshamns lasarett, Torsby sjukhus, Mora sjukhus
1. Study Identification
Unique Protocol Identification Number
NCT03641027
Brief Title
Physical Activity Before Obesity Surgery
Acronym
PABOS
Official Title
Physical Activity Before Obesity Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
February 16, 2016 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
December 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Göteborg University
Collaborators
Borås Lasarett, Centrallasarettet i Växjö, Karlshamns lasarett, Torsby sjukhus, Mora sjukhus
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Physical Activity
Keywords
Obesity, Physical Activity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Masking Description
Assessor will not be aware of which group the patients are included in.
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Increased physical activity
Arm Type
Experimental
Arm Description
Increased physical activity daily before surgery. Standard care during hospital stay and continued training after discharge.
Arm Title
Standard care
Arm Type
Other
Arm Description
Standard care
Intervention Type
Other
Intervention Name(s)
Increased physical activity
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard care
Primary Outcome Measure Information:
Title
INTERNATIONAL PHYSICAL ACTIVITY QUESTIONNAIRES (IPAQ)
Description
Physical activity level measured in METS (Metabolic Equivalent)
Time Frame
From inclusion 1 year postoperatively
Title
Saltin-Grimby Physical Activity Scale (SGPAS)
Description
Physical activity level, 1-4 (4 highest activity level).
Time Frame
From inclusion to 1 year postoperatively
Secondary Outcome Measure Information:
Title
Complication rates
Description
Anastomotic leakages, bleedings that require intervention, thrombosis, re-admissions and re-operations derived from the patient medical records
Time Frame
From inclusion to 30 days postoperatively
Title
Length of stay
Description
Days at hospital
Time Frame
From surgery to discharge. On average two days
Title
Sick-leave
Description
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.
Time Frame
From surgery to at latest 1 year postoperatively
Title
Blood test- glucose metabolism
Description
Glucose metabolism-
Time Frame
From surgery to 2 years postoperatively
Title
Blood test- Blood lipids
Description
Metabolic change lipids
Time Frame
From surgery to 2 years postoperatively
Title
Blood tests, Blood sugar
Description
HbA1c
Time Frame
From surgery to 2 years postoperatively
Title
Blood tests, fasting blood suger
Description
Fasting P-glucose
Time Frame
From surgery to 2 years postoperatively
Title
Blood tests
Description
Blood lipids
Time Frame
From surgery to 2 years postoperatively
Title
Weight
Description
Actual weight measured during clinical visits
Time Frame
From surgery to 2 years postoperatively
Title
General Quality of Life, QoL By EQ5D
Description
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
Time Frame
From inclusion 1 year postoperatively
Title
Gastrointestinal pain by Gastrointestinal Symptom Rating Scale (GSRS)
Description
Gastrointestinal Symptom Rating Scale, 16 questions rated on scales with 7 levels (a-low symptoms to g- worst symtoms)
Time Frame
From inclusion 1 year postoperatively
Title
Self reported co-morbidity
Description
Number of patients with diabetes and with dyslipidemia medications
Time Frame
From inclusion 1 year postoperatively
Title
Self reported medication because of co-morbidity
Description
Number of patients with medication because of diabetes, high blood pressure and dyslipidemia.
Time Frame
From inclusion 1 year postoperatively
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criterion:
- Patients at including hospitals scheduled for gastric bypass surgery
Exclusion Criteria:
Inability to understand given information.
Inability to perform the intervention
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Monika Fagevik Olsén, pHd
Organizational Affiliation
Sahlgrenska Academy at Gothenburg university, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sahlgrenska University Hospital
City
Gothenburg
ZIP/Postal Code
413 45
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
No
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Physical Activity Before Obesity Surgery
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