Bariatric SurgeryFREEBASENCT04413812
Fostering Exercise After Bariatric Surgery
A study testing FREEBASE exercise programme in people with Bariatric Surgery and Physical Activity, run by Lia Bally at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bariatric Surgery, Physical Activity
- What is being tested?
- FREEBASE exercise programme
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jul 2020to 23 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Diabetes, Endocrinology, Clinical Nutrition and Metabolism, Inselspital, Bern University Hospital
Bern, 3010
About this study
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.
Read the 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.
- Conditions
- Bariatric Surgery, Physical Activity
- Being tested
- FREEBASE exercise programme
- Keywords
- Training Intervention, Health Competence, Active Lifestyle, Bariatric Surgery, Lifestyle Modification
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FREEBASE exercise programmeBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | The experimental group will participate in a 3-months training programme focusing on health competence related outcomes. Receives: Behavioral: FREEBASE exercise programme |
| Control Group | No intervention | The control group does not participate in the exercise programme but undergoes identical outcome assessments. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 level will be assessed using accelerometry and is defined as the overall daily mean acceleration (mg).
Measured: 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).
Measured: 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).
Measured: 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)
Measured: 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.
Measured: 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
Measured: The test will be conducted at baseline and at visit 2 (after 10-12 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start1 Jul 2020
- Primary completion17 Jan 2021
- Study completion23 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lia Bally
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lia Bally, Insel Gruppe AG, University Hospital Bern
- Investigators
- Lia Bally, MD, PhD, Principal investigator, University Hospital Bern & University of Bern, Bern, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04413812
- Sponsor's protocol ID
- FREEBASE
- Acronym
- FREEBASE
- Status last verified
- Apr 2021
- First submitted
- 16 Apr 2020
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fostering Exercise After Bariatric Surgery
- ClinicalTrials.gov ID
- NCT04413812
- Acronym / sponsor ID
- FREEBASE / FREEBASE
- Conditions
- Bariatric Surgery, Physical Activity
- Keywords
- Training Intervention, Health Competence, Active Lifestyle, Bariatric Surgery, Lifestyle Modification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Lia BallyUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 17 Jan 2021 (actual)
- Study completion
- 23 Apr 2021 (actual)
- First posted
- 4 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Behavioral: FREEBASE exercise programmeThe experimental group will participate in a 3-months training programme focusing on health competence related outcomes. |
| Control Group | No intervention | –The control group does not participate in the exercise programme but undergoes identical outcome assessments. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FREEBASE exercise programmeThe 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. | Behavioural | Experimental Group |
Primary outcome
Change from baseline in physical activity-related health competence.
Time frame: 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).
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.
6 secondary outcomes
Relative change from baseline in physical activity level.
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: 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.
Time frame: 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
Time frame: The test will be conducted at baseline and at visit 2 (after 10-12 weeks).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lia Bally, MD, PhD principal investigator
University Hospital Bern & University of Bern, Bern, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FREEBASE exercise programme in people with Bariatric Surgery and Physical Activity, run by Lia Bally at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in physical activity-related health competence. (time frame: 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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2021; AzTrials last refreshed its copy on 30 Oct 2026.