Fostering Exercise After Bariatric Surgery

NCT04413812 | Completed

• 1 other identifier: FREEBASE
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

While the benefits of engagement in regular physical activity after bariatric surgery has been established in various studies, little is known about the effectiveness of an interdisciplinary intervention including nutritional and psychological advice, hands-on training experience and motivational education to promote long-term adherence to a self-motivated active lifestyle in the bariatric surgery population. This randomized pilot intervention study called Fostering Exercise After Bariatric Surgery (FREEBASE) explores the efficacy of an interdisciplinary approach to promote physical activity-related health competence and an active lifestyle after bariatric surgery.

Conditions

Bariatric Surgery; Physical Activity

Keywords

Training Intervention; Health Competence; Active Lifestyle; Bariatric Surgery; Lifestyle Modification

Outcome Measures

Primary Outcomes (1)

• Change from baseline in physical activity-related health competence.

  The physical activity-related health competence will be assessed using items from different areas (self-efficacy, self-control, emotional attitudes, cognitive attitudes, motivational competence, control of physical load, affect regulation). A composite score will be calculated as the mean score of the individual areas. For each area, the mean score of its items assessed on a 5-point Likert scale ranging from 1 (does not apply at all) to 5 (does apply exactly) will be calculated.

  The questionnaires will be completed at baseline, after completion of the exercise program (visit 2, at 10-12 weeks) and at the follow-up (visit 3, at 16-18 weeks).

Secondary Outcomes (6)

• Relative change from baseline in physical activity level.

  Physical activity will be measured during one week at baseline and during one week at follow-up (visit 3, at 16-18 weeks).

• Change from baseline in self-reported physical activity.

  The questionnaires will be completed at baseline, after completion of the exercise program (visit 2, at 10-12 weeks) and at the follow-up (visit 3, at 16-18 weeks).

• Change from baseline in self-reported sport and exercise activity.

  The questionnaires will be completed at baseline, after completion of the exercise program (visit 2, at 10-12 weeks) and at the follow-up (visit 3, at 16-18 weeks).

• Absolute change in 6-min walking distance (m)

  The test will be conducted at baseline and at visit 2 (after 10-12 weeks).

• Absolute change in Time (s) in the "Timed up and go" test.

  The test will be conducted at baseline and at visit 2 (after 10-12 weeks).

Other Outcomes (8)

• Change from baseline in health status

  The questionnaires will be completed at baseline, after completion of the exercise program (visit 2, at 10-12 weeks) and at the follow-up (visit 3, at 16-18 weeks).

• Change from baseline in vitality.

  The questionnaires will be completed at baseline, after completion of the exercise program (visit 2, at 10-12 weeks) and at the follow-up (visit 3, at 16-18 weeks).

• Change from baseline in self-concordance.

  The questionnaires will be completed at baseline, after completion of the exercise program (visit 2, at 10-12 weeks) and at the follow-up (visit 3, at 16-18 weeks).

Study Arms (2)

Experimental Group

EXPERIMENTAL

The experimental group will participate in a 3-months training programme focusing on health competence related outcomes.

Behavioral: FREEBASE exercise programme

Control Group

NO INTERVENTION

The control group does not participate in the exercise programme but undergoes identical outcome assessments.

Interventions

FREEBASE exercise programme BEHAVIORAL

The exercise programme will be initialized 1-10 months following bariatric surgery and last for 3 months. The programme will be mainly delivered in two groups consisting of 10-12 subjects each and will be held in the facilities of a fitness studio and remotely at home. The programme consists of 24 units (two per week, the lesson in the fitness studio lasting for 75 minutes and the remote lesson lasting for 45 minutes.This is due to the COVID-19-related social distancing restrictions. The intervention combines the following elements: a) exercise training in a group, b) interactive workshops on basic knowledge of training sciences and techniques of behavior change and c) an individual exercise counselling session. The programme will be medically supervised and the content will be taught and instructed by members of the research team qualified in exercise science and sports physiology.

Experimental Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged ≥18 years
• Bariatric surgery within the past 1-6 months according to the guidelines of the Swiss Society for the Study of Morbid Obesity and Metabolic Disorders (SMOB)
• Willingness to comply with study-related activities
• Literate in German

You may not qualify if:

• Incapacity to give informed consent
• Contraindication to participation in the study exercise programme as judged by the clinical investigator or treating physical
• Physical or physiological condition likely to interfere with the normal conduct of the study and interpretation of the study results as judged by the clinical investigator or treating physical
• Evidence of malnutrition as judged by the clinical investigator or treating physician
• Pregnancy, planned pregnancy, or breast feeding (females of childbearing potential are advice to use safe-contraception for up to 18 months post-bariatric surgery as part of usual care)
• Illicit or prescription drug abuse

Sponsors & Collaborators

• Lia Bally: lead

Study Sites (1)

Department of Diabetes, Endocrinology, Clinical Nutrition and Metabolism, Inselspital, Bern University Hospital

Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Lia Bally, MD, PhD

  University Hospital Bern & University of Bern, Bern, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: Randomized single-centre open-label clinical trial with two parallel groups. The randomization will be stratified according to age, sex, current BMI, surgical procedure, and educational level using a dedicated software.

Study Record Dates

• First Submitted: April 16, 2020
• First Posted: June 4, 2020
• Study Start: July 1, 2020
• Primary Completion: January 17, 2021
• Study Completion: April 23, 2021
• Last Updated: April 28, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)