Physical Activity Before Obesity Surgery

NCT03641027 | Completed

• 1 other identifier: FoU i VGR: 202291
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Physical Activity

Keywords

Obesity; Physical Activity

Outcome Measures

Primary Outcomes (2)

• INTERNATIONAL PHYSICAL ACTIVITY QUESTIONNAIRES (IPAQ)

  Physical activity level measured in METS (Metabolic Equivalent)

  From inclusion 1 year postoperatively

• Saltin-Grimby Physical Activity Scale (SGPAS)

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

  From inclusion to 1 year postoperatively

Secondary Outcomes (13)

• Complication rates

  From inclusion to 30 days postoperatively

• Length of stay

  From surgery to discharge. On average two days

• Sick-leave

  From surgery to at latest 1 year postoperatively

• Blood test- glucose metabolism

  From surgery to 2 years postoperatively

• Blood test- Blood lipids

  From surgery to 2 years postoperatively

Study Arms (2)

Increased physical activity

EXPERIMENTAL

Increased physical activity daily before surgery. Standard care during hospital stay and continued training after discharge.

Other: Increased physical activity

Standard care

OTHER

Standard care

Other: Standard care

Interventions

Increased physical activity OTHER

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.

Increased physical activity

Standard care OTHER

Standard care

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

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

Sponsors & Collaborators

• Göteborg University: lead
• Borås Lasarett: collaborator
• Centrallasarettet i Växjö: collaborator
• Karlshamns lasarett: collaborator
• Torsby sjukhus: collaborator
• Mora sjukhus: collaborator

Study Sites (1)

Sahlgrenska University Hospital

Gothenburg, 413 45, Sweden

Location

Related Publications (1)

• 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.

  PMID: 41541615 DERIVED

MeSH Terms

Conditions

Obesity; Motor Activity

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Monika Fagevik Olsén, pHd

  Sahlgrenska Academy at Gothenburg university, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessor will not be aware of which group the patients are included in.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 6, 2018
• First Posted: August 21, 2018
• Study Start: February 16, 2016
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2021
• Last Updated: March 18, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)