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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
54

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospitales Universitarios Virgen del Rocío

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 15, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 30, 2025

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 7, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 8, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 7, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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