Obesity &Amp;Amp; OverweightBARIATRICNCT07324447
EFFECTS OF SUPERVISED PHYSICAL EXERCISE AFTER BARIATRIC SURGERY ON MUSCLE MASS AND BONE DENSITY (OBEFIT STUDY)
A study testing physical exercise programme in people with Obesity &Amp;Amp; Overweight and Bariatric Surgery, run by Hospitales Universitarios Virgen del Rocío at 2 sites in Spain.
Trial summary
CLINICAL TRIAL ON THE EFFECT OF SUPERVISED PHYSICAL EXERCISE AFTER BARIATRIC SURGERY ON MUSCLE MASS AND BONE DENSITY (OBEFIT STUDY) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity &Amp;Amp; Overweight, Bariatric Surgery, Physical Exercise
- What is being tested?
- physical exercise programme
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 2 sitesSpain
- Study dates
- 1 Feb 2026to 1 Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain2 sites, 2 recruiting
- Recruiting
Hospital virgen del rocio
Seville, Sevilla, 41013
Isaias Alarcon del Agua. Isaias Alarcon del Agua., PHD, 646357875, isaiasalarcon@gmail.com
Ana Senent Boza, PHD, 687243532, asenentboza@gmail.com
- Recruiting
Universidad Pablo de Olavide
Seville, Sevilla, 41013
Diego Munguía izquierdo, PHD, 637725733, dmunizq@upo.es
Manuel Pinelo, MSC, 685373684, pinelomanuel7@gmail.com
About this study
Official title: 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)
Read the 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:
- 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:
- 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.
- Being tested
- physical exercise programme
- Keywords
- Obesity Surgery, Physical exercise, Bariatric Surgery
- Medical subject headings
- Obesity, Overweight, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physical exercise programmeBehavioural
patients undergoing bariatric surgery who have undergone a post-operative supervised physical exercise programme and no exercise programme.
| Study group | Role | What they receive |
|---|---|---|
| physical exercise program | Active comparator | 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. Receives: Behavioral: physical exercise programme |
| Standard of care | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Differences in muscle mass
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start1 Feb 2026 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity &Amp;Amp; OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospitales Universitarios Virgen del Rocío
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Pablo de Olavide
- Responsible party
- Principal investigator, Isaías Alarcón de Agua, Hospitales Universitarios Virgen del Rocío
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07324447
- Sponsor's protocol ID
- OBEFIT STUDY
- Acronym
- BARIATRIC
- Status last verified
- Dec 2025
- First submitted
- 15 Sep 2025
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CLINICAL TRIAL ON THE EFFECT OF SUPERVISED PHYSICAL EXERCISE AFTER BARIATRIC SURGERY ON MUSCLE MASS AND BONE DENSITY (OBEFIT STUDY)
- ClinicalTrials.gov ID
- NCT07324447
- Acronym / sponsor ID
- BARIATRIC / OBEFIT STUDY
- Keywords
- Obesity Surgery, Physical exercise, Bariatric Surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Hospitales Universitarios Virgen del RocíoUniversity, hospital or other
- Collaborators
- Universidad Pablo de Olavide
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Nov 2028 (estimated)
- First posted
- 7 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| physical exercise program | Active comparator | Behavioral: physical exercise programmehe 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. |
| Standard of care | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| physical exercise programmepatients undergoing bariatric surgery who have undergone a post-operative supervised physical exercise programme and no exercise programme. | Behavioural | physical exercise program |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing physical exercise programme in people with Obesity &Amp;Amp; Overweight and Bariatric Surgery, run by Hospitales Universitarios Virgen del Rocío at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Isaias Alarcon, MD PhD (+34646357875, isaiasalarcon@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in muscle mass (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2026.