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EFFECTS OF SUPERVISED PHYSICAL EXERCISE AFTER BARIATRIC SURGERY ON MUSCLE MASS AND BONE DENSITY (OBEFIT STUDY)

CLINICAL TRIAL ON THE EFFECT OF SUPERVISED PHYSICAL EXERCISE AFTER BARIATRIC SURGERY ON MUSCLE MASS AND BONE DENSITY (OBEFIT STUDY)

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07324447
Acronym
BARIATRIC
Enrollment
54
Registered
2026-01-07
Start date
2026-02-01
Completion date
2028-11-01
Last updated
2026-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bariatric Surgery, Obesity &Amp;Amp; Overweight, Physical Exercise

Keywords

Obesity Surgery, Physical exercise, Bariatric Surgery

Brief summary

CLINICAL TRIAL ON THE EFFECT OF SUPERVISED PHYSICAL EXERCISE AFTER BARIATRIC SURGERY ON MUSCLE MASS AND BONE DENSITY (OBEFIT STUDY)

Detailed description

Introduction Background and rationale Obesity is currently a complex disease that has reached pandemic proportions and affects millions of people worldwide. Bariatric surgery can generate adverse side effects such as loss of bone mineral density, loss of muscle mass, reduction in cardiorespiratory capacity. Therefore, accompanying medical treatment with an individualised physical exercise intervention can generate a multitude of health benefits for the patient. 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.

Interventions

patients undergoing bariatric surgery who have undergone a post-operative supervised physical exercise programme and no exercise programme.

Sponsors

Universidad Pablo de Olavide
CollaboratorOTHER
Hospitales Universitarios Virgen del Rocío
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Patients who are on the waiting list for bariatric surgery (gastric bypass or sleeve) at the Hospital Universitario Virgen del Rocío in Seville, in addition to: * Be 18 years of age or older. * Suitable for physical exercise. * Signature of informed consent.

Exclusion criteria

. * Body weight greater than 150kg. * 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.

Design outcomes

Primary

MeasureTime frameDescription
Differences in muscle mass12 monthsTo 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. o To determine the differences in muscle function using the hand grip test.

Other

MeasureTime frameDescription
differences in bone density12 monthsTo determine the differences in bone density in patients undergoing bariatric surgery who have undergone a post-operative supervised physical exercise programme and no exercise programme. o To determine BMD loss using densitometry.

Countries

Spain

Contacts

Primary ContactIsaias Alarcon, MD PhD
isaiasalarcon@gmail.com+34646357875

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026