Clinical trial NCT03641027: Physical Activity Before Obesity Surgery
Official title: Physical Activity Before Obesity Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Physical Activity
Keywords: Obesity
Physical Activity
Lead sponsor: Göteborg University
Sponsor class: OTHER
Collaborators: name: Borås Lasarett
name: Centrallasarettet i Växjö
name: Karlshamns lasarett
name: Torsby sjukhus
name: Mora sjukhus
First posted: 2018-08-21
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: INTERNATIONAL PHYSICAL ACTIVITY QUESTIONNAIRES (IPAQ)
timeFrame: From inclusion 1 year postoperatively
measure: Saltin-Grimby Physical Activity Scale (SGPAS)
timeFrame: From inclusion to 1 year postoperatively
Secondary outcomes:
measure: Complication rates
timeFrame: From inclusion to 30 days postoperatively
measure: Length of stay
timeFrame: From surgery to discharge. On average two days
measure: Sick-leave
timeFrame: From surgery to at latest 1 year postoperatively
measure: Blood test- glucose metabolism
timeFrame: From surgery to 2 years postoperatively
measure: Blood test- Blood lipids
timeFrame: From surgery to 2 years postoperatively
measure: Blood tests, Blood sugar
timeFrame: From surgery to 2 years postoperatively
measure: Blood tests, fasting blood suger
timeFrame: From surgery to 2 years postoperatively
measure: Blood tests
timeFrame: From surgery to 2 years postoperatively
measure: Weight
timeFrame: From surgery to 2 years postoperatively
measure: General Quality of Life, QoL By EQ5D
timeFrame: From inclusion 1 year postoperatively
measure: Gastrointestinal pain by Gastrointestinal Symptom Rating Scale (GSRS)
timeFrame: From inclusion 1 year postoperatively
measure: Self reported co-morbidity
timeFrame: From inclusion 1 year postoperatively
measure: Self reported medication because of co-morbidity
timeFrame: From inclusion 1 year postoperatively
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
Study officials:
affiliation: Sahlgrenska Academy at Gothenburg university, Sweden
name: Monika Fagevik Olsén, pHd
role: PRINCIPAL_INVESTIGATOR
References: