Clinical trial NCT04413812: Fostering Exercise After Bariatric Surgery
Official title: Fostering Exercise After Bariatric Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bariatric Surgery
Physical Activity
Keywords: Training Intervention
Health Competence
Active Lifestyle
Bariatric Surgery
Lifestyle Modification
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2020-06-04
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in physical activity-related health competence.
timeFrame: 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:
measure: Relative change from baseline in physical activity level.
timeFrame: Physical activity will be measured during one week at baseline and during one week at follow-up (visit 3, at 16-18 weeks).
measure: Change from baseline in self-reported physical activity.
timeFrame: 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).
measure: Change from baseline in self-reported sport and exercise activity.
timeFrame: 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).
measure: Absolute change in 6-min walking distance (m)
timeFrame: The test will be conducted at baseline and at visit 2 (after 10-12 weeks).
measure: Absolute change in Time (s) in the "Timed up and go" test.
timeFrame: The test will be conducted at baseline and at visit 2 (after 10-12 weeks).
measure: Absolute change in Time (s) in the "Unilateral hip bridge" test
timeFrame: The test will be conducted at baseline and at visit 2 (after 10-12 weeks).
Other outcomes:
measure: Change from baseline in health status
timeFrame: 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).
measure: Change from baseline in vitality.
timeFrame: 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).
measure: Change from baseline in self-concordance.
timeFrame: 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).
measure: Change from baseline in the intention to perform physical activity.
timeFrame: 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).
measure: Participant satisfaction.
timeFrame: Within the first week after completion of the exercise program.
measure: Perception of usefulness of the program.
timeFrame: Within the first week after completion of the exercise program.
measure: Change from baseline in self-regulation competence.
timeFrame: The questionnaire will be completed at baseline, after completion of the exercise program (at 10-12 weeks) and at follow-up (at 16-18 weeks).
measure: Change from baseline in control competence
timeFrame: The questionnaire will be completed at baseline, after completion of the exercise program (visit 2, at 10-12 weeks) and at follow-up (visit 3, at 16-18 weeks).
Locations:
city: Bern
country: Switzerland
facility: Department of Diabetes, Endocrinology, Clinical Nutrition and Metabolism, Inselspital, Bern University Hospital
Study officials:
affiliation: University Hospital Bern & University of Bern, Bern, Switzerland
name: Lia Bally, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: