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Physical Activity Before Obesity Surgery

Physical Activity Before Obesity Surgery

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03641027
Acronym
PABOS
Enrollment
150
Registered
2018-08-21
Start date
2016-02-16
Completion date
2021-12-31
Last updated
2022-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Physical Activity

Keywords

Obesity, Physical Activity

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.

Interventions

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.

OTHERStandard care

Sponsors

Borås Lasarett
CollaboratorOTHER
Centrallasarettet i Växjö
CollaboratorUNKNOWN
Karlshamns lasarett
CollaboratorUNKNOWN
Torsby sjukhus
CollaboratorUNKNOWN
Mora sjukhus
CollaboratorUNKNOWN
Göteborg University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

Assessor will not be aware of which group the patients are included in.

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.

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

Inclusion Criterion: \- Patients at including hospitals scheduled for gastric bypass surgery

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
INTERNATIONAL PHYSICAL ACTIVITY QUESTIONNAIRES (IPAQ)From inclusion 1 year postoperativelyPhysical activity level measured in METS (Metabolic Equivalent)
Saltin-Grimby Physical Activity Scale (SGPAS)From inclusion to 1 year postoperativelyPhysical activity level, 1-4 (4 highest activity level).

Secondary

MeasureTime frameDescription
Sick-leaveFrom surgery to at latest 1 year postoperativelySick-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 metabolismFrom surgery to 2 years postoperativelyGlucose metabolism-
Blood test- Blood lipidsFrom surgery to 2 years postoperativelyMetabolic change lipids
Blood tests, Blood sugarFrom surgery to 2 years postoperativelyHbA1c
Blood tests, fasting blood sugerFrom surgery to 2 years postoperativelyFasting P-glucose
Complication ratesFrom inclusion to 30 days postoperativelyAnastomotic leakages, bleedings that require intervention, thrombosis, re-admissions and re-operations derived from the patient medical records
WeightFrom surgery to 2 years postoperativelyActual weight measured during clinical visits
General Quality of Life, QoL By EQ5DFrom inclusion 1 year postoperativelyEQ5D, 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)From inclusion 1 year postoperativelyGastrointestinal Symptom Rating Scale, 16 questions rated on scales with 7 levels (a-low symptoms to g- worst symtoms)
Self reported co-morbidityFrom inclusion 1 year postoperativelyNumber of patients with diabetes and with dyslipidemia medications
Self reported medication because of co-morbidityFrom inclusion 1 year postoperativelyNumber of patients with medication because of diabetes, high blood pressure and dyslipidemia.
Blood testsFrom surgery to 2 years postoperativelyBlood lipids
Length of stayFrom surgery to discharge. On average two daysDays at hospital

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026