Viewing Study NCT04413812



Ignite Creation Date: 2024-05-06 @ 2:45 PM
Last Modification Date: 2024-10-26 @ 1:36 PM
Study NCT ID: NCT04413812
Status: COMPLETED
Last Update Posted: 2021-04-28
First Post: 2020-04-16

Brief Title: Fostering Exercise After Bariatric Surgery
Sponsor: Lia Bally
Organization: Insel Gruppe AG University Hospital Bern

Study Overview

Official Title: Fostering Exercise After Bariatric Surgery
Status: COMPLETED
Status Verified Date: 2021-04
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: FREEBASE
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 kgm2 because of its beneficial long-term effects on body weight and obesity-related comorbidities In Switzerland approximately 5000 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 eg 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None