Fostering Exercise After Bariatric Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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Bariatric surgery is quickly emerging as a standard treatment for people with obesity stage II and III (BMI ≥35 kg/m2) because of its beneficial long-term effects on body weight and obesity-related comorbidities. In Switzerland, approximately 5,000 bariatric surgeries are performed every year. There is a growing body of evidence demonstrating that engagement in physical activity benefits the bariatric surgery population in many aspects. These entail the prevention of surgery-induced metabolic complications such as sarcopenia and osteopenia on the one hand, but also the mitigation against the commonly observed weight regain and relapse of metabolic comorbidities. Despite these obvious health benefits, inactivity and poor health literacy are common problems amongst people who underwent bariatric surgery. Although the Swiss healthcare system offers well designed post-operative follow-up programmes, exercise is currently not to being considered. Additionally the lower educational level of bariatric surgery patients is a well known problem. Addressing physical activity-related health competence and self-empowerment in this population currently remains an unmet need. Previous studies investigating exercise interventions in the bariatric surgery population have demonstrated efficacy on metabolic outcomes but also indicated that adherence wanes over time. To overcome the challenge of changing lifestyle in a sustainable way, individuals need to have a complex set of abilities, skills, knowledge, motivation and willingness. In Germany, diverse models have been developed to describe this specific set of competences, all inspired by the concept of health literacy, which is internationally recognised in research and clinical practice. Physical activity-related health competence comprises three components: (1) Movement competence, enabling individuals to meet the movement-related requirements of physical activities (e.g. motor abilities, motor skills for cycling or gymnastics) (2) control competence for physical activity enabling people to gear their own activity to achieve positive effects in health and well-being, and (3) physical activity-specific self-regulation competence enabling individuals to be regularly active, which involves both motivational and volitional factors. The relevance of physical activity-related health competence for the promotion of an active lifestyle has been demonstrated in various studies in healthy and physical inactive adults at metabolic risk. However, the concept has not yet been addressed in the bariatric surgery population. The investigators therefore hypothesize, that targeting the various components of physical activity-related health competence by means of a comprehensive exercise programme has the potential to result in a more effective promotion of physical activity in the bariatric surgery population, thereby benefitting their long-term health and well-being.

Official Title
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Fostering Exercise After Bariatric Surgery

Conditions
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Bariatric Surgery, Physical Activity

Intervention / Treatment
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* Behavioral: FREEBASE exercise programme


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group<br>The experimental group will participate in a 3-months training programme focusing on health competence related outcomes. | Behavioral: FREEBASE exercise programme<br>* 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.<br>|
| No Intervention: Control Group<br>The control group does not participate in the exercise programme but undergoes identical outcome assessments. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relative change from baseline in physical activity level. | Physical activity level will be assessed using accelerometry and is defined as the overall daily mean acceleration (mg). | 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. | Self-reported physical activity will be assessed using the German Physical Activity, Exercise, and Sport Questionnaire Bewegungs- und Sportaktivität Fragebogen; BSA-F. This questionnaire asks for frequency and duration of daily physical activities such as walking, cycling, garden work, house work, caring for others in the last four weeks. The frequency and duration for each question are multiplied and the products are added up in an overall physical activity index (in minutes/week). | 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. | Self-reported sport and exercise activity will be assessed using the German Physical Activity, Exercise, and Sport Questionnaire Bewegungs- und Sportaktivität Fragebogen; BSA-F. This questionnaire includes questions about regular exercise and sport activities. People can indicate up to three exercise and sport activities and indicate frequency and duration in the last four weeks. The frequency and duration for the named exercise and sport activity are multiplied and the products are added up to an exercise and sport activity index (in minutes/week). | 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). | 
| Absolute change in Time (s) in the Unilateral hip bridge test |  | The test will be conducted at baseline and at visit 2 (after 10-12 weeks). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Training Intervention, Health Competence, Active Lifestyle, Bariatric Surgery, Lifestyle Modification