EFFECTS OF SUPERVISED PHYSICAL EXERCISE AFTER BARIATRIC SURGERY ON MUSCLE MASS AND BONE DENSITY (OBEFIT STUDY)
NCT ID: NCT07324447
Last Updated: 2026-01-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
54 participants
INTERVENTIONAL
2026-02-01
2028-11-01
Brief Summary
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Detailed Description
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Objectives
As main objective the investigators focus on:
\- To determine the differences in muscle mass and bone density in patients undergoing bariatric surgery who have undergone a post-operative supervised physical exercise programme and no exercise programme.
* To determine the differences in muscle function using the hand grip test.
* To determine BMD loss using densitometry.
Secondary objectives:
* To analyse maximal fat oxidation throughout the whole process from metabolic inflexibility to metabolic flexibility).
* To determine differences in body composition.
* To determine the resolution of type 2 diabetes mellitus and arterial hypertension (AHT).
* To determine the improvement in quality of life by means of an accredited test.
Null hypothesis:
1\. There are no differences in muscle mass and bone density in patients who undergo supervised physical exercise postoperatively versus patients who do not exercise.
Alternative hypothesis:
1\. There are differences in muscle mass and bone density in patients undergoing supervised physical exercise postoperatively versus non-exercising patients.
Trial design The trial will consist of a randomised controlled study of patients currently on the surgical waiting list for bariatric surgery who meet the inclusion criteria until the sample size is completed.
Two groups (control and intervention) will be established and will come in waves.
Methods Participants, interventions and results Scope of the study The assessment and intervention of the study will take place at the Pablo de Olavide University in Seville. The medical assessment and surgical intervention will be carried out at the General and Digestive System Surgery Management Unit of the Virgen del Rocío University Hospital in Seville.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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physical exercise program
he primary objective is to try to minimise the loss of muscle mass that occurs in the patient. During the first 4 weeks of training, the objective is to familiarise the patient with the type of training to be carried out. The patient will do an initial block of strength work, followed by a block of cardiovascular work on a cycloergometer (continuous and variable) in the same session. Work will be done in order to progress in volume and intensity. Training sessions of approximately 50-60 minutes will be carried out 2 days a week for 12 months.
physical exercise programme
patients undergoing bariatric surgery who have undergone a post-operative supervised physical exercise programme and no exercise programme.
Standard of care
They will have all the follow-up provided by the hospital in the same way as the intervention group in addition to the relevant assessments carried out throughout the clinical trial, throughout the study they will be encouraged to have an active lifestyle.
No interventions assigned to this group
Interventions
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physical exercise programme
patients undergoing bariatric surgery who have undergone a post-operative supervised physical exercise programme and no exercise programme.
Eligibility Criteria
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Inclusion Criteria
* Be 18 years of age or older.
* Suitable for physical exercise.
Exclusion Criteria
* Distance from the place of residence to the Pablo de Olavide University in Seville greater than 60 km or 45 minutes by car.
* Having any of the following conditions: lipedema, cancer survivors, metabolic bone diseases, consumption of medication or presence of pathology that affects bone health.
* Patients undergoing dialysis.
18 Years
ALL
No
Sponsors
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Universidad Pablo de Olavide
OTHER
Hospitales Universitarios Virgen del Rocío
OTHER
Responsible Party
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Isaías Alarcón de Agua
Principal Investigator and Coordinator of the Esophagogastric and Bariatric Surgery Unit
Locations
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Hospital virgen del rocio
Seville, Sevilla, Spain
Universidad Pablo de Olavide
Seville, Sevilla, Spain
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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OBEFIT STUDY
Identifier Type: -
Identifier Source: org_study_id
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