Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
150 participants
INTERVENTIONAL
2016-02-16
2021-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Increased physical activity
Increased physical activity daily before surgery. Standard care during hospital stay and continued training after discharge.
Increased physical activity
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 care
Standard care
Standard care
Interventions
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Increased physical activity
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 care
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Inability to perform the intervention
ALL
No
Sponsors
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Borås Lasarett
OTHER
Centrallasarettet i Växjö
UNKNOWN
Karlshamns lasarett
UNKNOWN
Torsby sjukhus
UNKNOWN
Mora sjukhus
UNKNOWN
Göteborg University
OTHER
Responsible Party
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Principal Investigators
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Monika Fagevik Olsén, pHd
Role: PRINCIPAL_INVESTIGATOR
Sahlgrenska Academy at Gothenburg university, Sweden
Locations
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Sahlgrenska University Hospital
Gothenburg, , Sweden
Countries
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Other Identifiers
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FoU i VGR: 202291
Identifier Type: -
Identifier Source: org_study_id
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