ObesityPABOSNCT03641027
Physical Activity Before Obesity Surgery
A study testing Increased physical activity in people with Obesity and Physical Activity, run by Göteborg University at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Obesity, Physical Activity
- What is being tested?
- Increased physical activity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSweden
- Study dates
- 16 Feb 2016to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients at including hospitals scheduled for gastric bypass surgery
Who cannot join
- Inability to understand given information.
- Inability to perform the intervention
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Obesity, Physical Activity
- Being tested
- Increased physical activity, Standard care
- Keywords
- Obesity, Physical Activity
- Medical subject headings
- Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Increased physical activityOther
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 careOther
| Study group | Role | What they receive |
|---|---|---|
| Increased physical activity | Experimental | Increased physical activity daily before surgery. Standard care during hospital stay and continued training after discharge. Receives: Other: Increased physical activity |
| Standard care | Other | Standard care Receives: Other: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
INTERNATIONAL PHYSICAL ACTIVITY QUESTIONNAIRES (IPAQ)
Physical activity level measured in METS (Metabolic Equivalent)
Measured: From inclusion 1 year postoperatively
Saltin-Grimby Physical Activity Scale (SGPAS)
Physical activity level, 1-4 (4 highest activity level).
Measured: From inclusion to 1 year postoperatively
Secondary outcomes (13)
Complication rates
Anastomotic leakages, bleedings that require intervention, thrombosis, re-admissions and re-operations derived from the patient medical records
Measured: From inclusion to 30 days postoperatively
Length of stay
Days at hospital
Measured: 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.
Measured: From surgery to at latest 1 year postoperatively
Blood test- glucose metabolism
Glucose metabolism-
Measured: From surgery to 2 years postoperatively
Blood test- Blood lipids
Metabolic change lipids
Measured: From surgery to 2 years postoperatively
Blood tests, Blood sugar
HbA1c
Measured: From surgery to 2 years postoperatively
Blood tests, fasting blood suger
Fasting P-glucose
Measured: From surgery to 2 years postoperatively
Blood tests
Blood lipids
Measured: From surgery to 2 years postoperatively
Weight
Actual weight measured during clinical visits
Measured: 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
Measured: 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)
Measured: From inclusion 1 year postoperatively
Self reported co-morbidity
Number of patients with diabetes and with dyslipidemia medications
Measured: 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.
Measured: From inclusion 1 year postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2018
- Study start16 Feb 2016
- Primary completion31 Dec 2020
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Göteborg UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Collaborators
- Borås Lasarett, Centrallasarettet i Växjö, Karlshamns lasarett, Torsby sjukhus, Mora sjukhus
- Responsible party
- Sponsor
- Investigators
- Monika Fagevik Olsén, pHd, Principal investigator, Sahlgrenska Academy at Gothenburg university, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03641027
- Sponsor's protocol ID
- FoU i VGR: 202291
- Acronym
- PABOS
- Status last verified
- Mar 2022
- First submitted
- 6 Aug 2018
- Last updated
- 18 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schubert-Hjalmarsson E, Albertsson L, Englund E, Olsen MF. Joint Pain Outcomes After Metabolic and Bariatric Surgery in Patients With and Without Hypermobility. Obes Sci Pract. 2026 Jan 13;12(1):e70115. doi: 10.1002/osp4.70115. eCollection 2026 Feb.
PubMed 41541615
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity Before Obesity Surgery
- ClinicalTrials.gov ID
- NCT03641027
- Acronym / sponsor ID
- PABOS / FoU i VGR: 202291
- Conditions
- Obesity, Physical Activity
- Keywords
- Obesity, Physical Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Collaborators
- Borås Lasarett, Centrallasarettet i Växjö, Karlshamns lasarett, Torsby sjukhus, Mora sjukhus
- Study start
- 16 Feb 2016 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 21 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Increased physical activity | Experimental | Other: Increased physical activityIncreased physical activity daily before surgery. Standard care during hospital stay and continued training after discharge. |
| Standard care | Other | Other: Standard careStandard care |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients at including hospitals scheduled for gastric bypass surgery
Key exclusion criteria (2 listed)
- Inability to understand given information.
- Inability to perform the intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Increased physical activityPreoperatively 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 | Increased physical activity |
| Standard care | Other | Standard care |
Primary outcome
INTERNATIONAL PHYSICAL ACTIVITY QUESTIONNAIRES (IPAQ)
Time frame: From inclusion 1 year postoperatively
Physical activity level measured in METS (Metabolic Equivalent)
Saltin-Grimby Physical Activity Scale (SGPAS)
Time frame: From inclusion to 1 year postoperatively
Physical activity level, 1-4 (4 highest activity level).
13 secondary outcomes
Complication rates
Time frame: From inclusion to 30 days postoperatively
Length of stay
Time frame: From surgery to discharge. On average two days
Sick-leave
Time frame: From surgery to at latest 1 year postoperatively
Blood test- glucose metabolism
Time frame: From surgery to 2 years postoperatively
Blood test- Blood lipids
Time frame: From surgery to 2 years postoperatively
Blood tests, Blood sugar
Time frame: From surgery to 2 years postoperatively
Blood tests, fasting blood suger
Time frame: From surgery to 2 years postoperatively
Blood tests
Time frame: From surgery to 2 years postoperatively
Weight
Time frame: From surgery to 2 years postoperatively
General Quality of Life, QoL By EQ5D
Time frame: From inclusion 1 year postoperatively
Gastrointestinal pain by Gastrointestinal Symptom Rating Scale (GSRS)
Time frame: From inclusion 1 year postoperatively
Self reported co-morbidity
Time frame: From inclusion 1 year postoperatively
Self reported medication because of co-morbidity
Time frame: From inclusion 1 year postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2022.
- Derived from this study: PubMed 41541615Schubert-Hjalmarsson E, Albertsson L, Englund E, Olsen MF. Joint Pain Outcomes After Metabolic and Bariatric Surgery in Patients With and Without Hypermobility. Obes Sci Pract. 2026 Jan 13;12(1):e70115. doi: 10.1002/osp4.70115. eCollection 2026 Feb.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Monika Fagevik Olsén, pHd principal investigator
Sahlgrenska Academy at Gothenburg university, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Increased physical activity in people with Obesity and Physical Activity, run by Göteborg University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
INTERNATIONAL PHYSICAL ACTIVITY QUESTIONNAIRES (IPAQ) (time frame: From inclusion 1 year postoperatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03641027, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2022.