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Clinical Trials/NCT03641027
NCT03641027
Completed
Not Applicable

Physical Activity Before Obesity Surgery

Göteborg University1 site in 1 country150 target enrollmentFebruary 16, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obesity
Sponsor
Göteborg University
Enrollment
150
Locations
1
Primary Endpoint
Saltin-Grimby Physical Activity Scale (SGPAS)
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 16, 2016
End Date
December 31, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Göteborg University
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

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

Outcomes

Primary Outcomes

Saltin-Grimby Physical Activity Scale (SGPAS)

Time Frame: From inclusion to 1 year postoperatively

Physical activity level, 1-4 (4 highest activity level).

INTERNATIONAL PHYSICAL ACTIVITY QUESTIONNAIRES (IPAQ)

Time Frame: From inclusion 1 year postoperatively

Physical activity level measured in METS (Metabolic Equivalent)

Secondary Outcomes

  • Blood tests, Blood sugar(From surgery to 2 years postoperatively)
  • Sick-leave(From surgery to at latest 1 year postoperatively)
  • Blood test- Blood lipids(From surgery to 2 years postoperatively)
  • Blood tests, fasting blood suger(From surgery to 2 years postoperatively)
  • Blood tests(From surgery to 2 years postoperatively)
  • Complication rates(From inclusion to 30 days postoperatively)
  • Blood test- glucose metabolism(From surgery to 2 years postoperatively)
  • General Quality of Life, QoL By EQ5D(From inclusion 1 year postoperatively)
  • Gastrointestinal pain by Gastrointestinal Symptom Rating Scale (GSRS)(From inclusion 1 year postoperatively)
  • Weight(From surgery to 2 years postoperatively)
  • Self reported co-morbidity(From inclusion 1 year postoperatively)
  • Length of stay(From surgery to discharge. On average two days)
  • Self reported medication because of co-morbidity(From inclusion 1 year postoperatively)

Study Sites (1)

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