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

January 7, 2026 updated by: Isaías Alarcón de Agua, Hospitales Universitarios Virgen del Rocío

CLINICAL TRIAL ON THE EFFECT 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)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
    • Sevilla
      • Seville, Sevilla, Spain, 41013
        • Recruiting
        • Hospital Virgen del Rocío
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Francisco José Almoguera González, MSc
        • Principal Investigator:
          • Isaías Alarcón del Agua, PHD
        • Sub-Investigator:
          • Ana Senent Boza, PHD
      • Seville, Sevilla, Spain, 41013
        • Recruiting
        • Universidad Pablo de Olavide
        • Contact:
          • Diego Munguía izquierdo, PHD
          • Phone Number: 637725733
          • Email: dmunizq@upo.es
        • Contact:
        • Sub-Investigator:
          • Javier Bueno Antequera, PHD
        • Sub-Investigator:
          • Manuel Antonio Pinelo Trancoso, MSc
        • Principal Investigator:
          • Diego Munguía izquierdo, PHD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Behavioral: physical exercise programme
patients undergoing bariatric surgery who have undergone a post-operative supervised physical exercise programme and no exercise programme.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Differences in muscle mass
Time Frame: 12 months

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.

o To determine the differences in muscle function using the hand grip test.
12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
differences in bone density
Time Frame: 12 months

To 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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospitales Universitarios Virgen del Rocío

Collaborators

Universidad Pablo de Olavide

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

November 1, 2028

Study Registration Dates

First Submitted

September 15, 2025

First Submitted That Met QC Criteria

December 30, 2025

First Posted (Estimated)

January 7, 2026

Study Record Updates

Last Update Posted (Actual)

January 8, 2026

Last Update Submitted That Met QC Criteria

January 7, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OBEFIT STUDY

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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