AzTrials
AzTrials

Obesity, MorbidEFIBARNCT03497546

Exercise Following Bariatric Surgery for Severe/Morbid Obesity (EFIBAR)

A study testing Exercise in people with Obesity, Morbid and Bariatric Surgery Candidate, run by Universidad de Almeria at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Severe/morbid obesity is an international public health issue that importantly increases the risk of cardiovascular events and cardiovascular and all-cause mortality. Likewise, severe/morbid obesity increases the risk of illness, reduces quality of life, and raises health-care costs. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Obesity, Morbid, Bariatric Surgery Candidate
What is being tested?
Exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteSpain
Study dates
1 May 2018to 30 Sep 2022
Phase
Interventional
Are there results?
None posted in the registry

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 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • To comply with local bariatric surgery criteria:
  • Patients with BMI ≥ 40 kg/m2 (or 35 kg/m2 with comorbidities).
  • Acceptable surgical risk (defined by the approval of anesthetist).
  • Obesity maintained for over 5 years.
  • Failure of previous treatments.
  • To sign informed consent for surgical treatment.
  • Not to present contraindications for supervised physical exercise.
  • To reside in the city of Almeria (Spain) or willingness/predisposition to attend the training sessions 3 times a week during 16 weeks

Who cannot join

  • Severe psychiatric or neurological disorders such as schizophrenia, epilepsia, Alzheimer, Parkinson, personality disorders, eating behaviour disorders, untreated depression or suicidal tendencies.
  • Adrenal or thyroid pathology that might cause obesity.
  • Uncontrolled addiction to alcohol or drugs.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Complejo Hospitalario Torrecárdenas (CHT)

    Almería, 04009

Other trials in Spain

About this study

Official title: Supervised Exercise Following Bariatric Surgery in the Treatment of Severe/Morbid Obesity: a Randomized Controlled Trial

Severe/morbid obesity is an international public health issue that importantly increases the risk of cardiovascular events and cardiovascular and all-cause mortality. Likewise, severe/morbid obesity increases the risk of illness, reduces quality of life, and raises health-care costs. Bariatric surgery is the election method for the treatment of severe/morbid obesity, resulting in significant weight loss and remission of comorbidities. However, a relatively large proportion of bariatric patients regain weight and continue to be at high risk for cardiovascular disease and premature mortality. A healthy lifestyle following bariatric surgery is essential for optimizing and maintaining weight loss. Observational studies suggest that physical activity following bariatric surgery might be associated with additional weight loss and more effective weigh loss maintenance over time. However, very little experimental evidence exists regarding the effects of supervised exercise on obesity-related outcomes in this specific population.

The aim of the EFIBAR (Ejercicio FÍsico tras cirugía BARiátrica) randomized controlled trial is to determine the effects of a 16-week supervised concurrent (aerobic and strength) exercise intervention program, on weight loss (primary outcome), body composition, cardiometabolic risk, physical fitness and quality of life (secondary outcomes) in patients with severe/morbid obesity following bariatric surgery.

According to the study aims the investigators pursue the following hypothesis: Supervised exercise will result in larger weight loss than control.

Being tested
Exercise
Keywords
Morbid obesity, Exercise, Weight loss, Cardiometabolic risk, Bariatric surgery
Medical subject headings
Obesity, Morbid, Motor Activity, Weight Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ExerciseOther

    Also called Exercise training

    Concurrent (aerobic and strength) supervised exercise program: the program comprises 3 sessions/week (60 min/session) of aerobic and strength exercises of progressive volume and intensity. The program will follow the Consensus on Exercise Reporting Template (CERT) guidelines.

Study groups in NCT03497546
Study groupRoleWhat they receive
ExerciseExperimentalUsual care PLUS concurrent (aerobic and strength) supervised exercise program of 16 weeks (3 sessions/week, 60 min/session, progressively increasing in volume and intensity). The program will be conducted by certified Exercise Science professionals.
Receives: Other: Exercise
ControlNo interventionUsual care routinely delivered after bariatric surgery, based on national (Spanish) and international recommendations, focused on nutritional status monitoring and diet/physical activity counseling.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent total weight loss (%TWL) [Biospace Co., InBody 270, USA]

    %TWL = [(pre-surgery weight - post-surgery weight) / (pre-surgery weight)] x 100

    Measured: Changes from baseline to 4-month and 1-year follow-up

Secondary outcomes (34)

  1. Body composition: body fat

    Percent body fat (%) assessed by bioimpedance analysis (InBody 270, Biospace Co., USA)

    Measured: Changes from baseline to 4-month and 1-year follow-up

  2. Body composition: fat-free mass

    Fat-free mass (kg) assessed by bioimpedance analysis (InBody 270, Biospace Co., USA)

    Measured: Changes from baseline to 4-month and 1-year follow-up

  3. Body composition: fat-free mass index

    Fat-free mass index (kg/m2) assessed by bioimpedance analysis (InBody 270, Biospace Co., USA)

    Measured: Changes from baseline to 4-month and 1-year follow-up

  4. Body composition: central body fat

    Waist and hip circumferences (measured in cm with an anthropometric tape), waist / height ratio

    Measured: Changes from baseline to 4-month and 1-year follow-up

  5. Lipid profile assessed from blood sample

    Total cholesterol (mg/dl), HDL-cholesterol (mg/dl), LDL-cholesterol (mg/dl) and triglycerides (mg/dl)

    Measured: Changes from baseline to 4-month and 1-year follow-up

  6. Blood markers of glucose metabolism: glucose

    Glucose (mg/dL)

    Measured: Changes from baseline to 4-month and 1-year follow-up

  7. Blood markers of glucose metabolism: insulin

    Insulin (μUI/mL)

    Measured: Changes from baseline to 4-month and 1-year follow-up

  8. Blood markers of glucose metabolism: HOMA-IR

    Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)

    Measured: Changes from baseline to 4-month and 1-year follow-up

  9. Blood markers of glucose metabolism: glycated hemoglobin HbA1c

    Glycated hemoglobin HbA1c (%)

    Measured: Changes from baseline to 4-month and 1-year follow-up

  10. Brachial and central blood pressures (mmHg)

    Systolic and diastolic blood pressures assessed by Mobil-O-Graph

    Measured: Changes from baseline to 4-month and 1-year follow-up

  11. Arterial stiffness

    Pulse wave velocity (PWV, m/s) by Mobil-O-Graph

    Measured: Changes from baseline to 4-month and 1-year follow-up

  12. Plasma concentrations of inflammatory markers

    High-sensitivity C-reactive protein (hs-CRP)

    Measured: Changes from baseline to 4-month and 1-year follow-up

  13. Plasma concentrations of inflammatory markers

    Tumor necrosis factor (TNF-alpha)

    Measured: Changes from baseline to 4-month and 1-year follow-up

  14. Plasma concentrations of inflammatory markers

    Interleukin 6 (IL-6)

    Measured: Changes from baseline to 4-month and 1-year follow-up

  15. Plasma concentrations of liver metabolism enzymes

    GGT (gamma-glutamyltransferase)

    Measured: Changes from baseline to 4-month and 1-year follow-up

  16. Plasma concentrations of liver metabolism enzymes

    GPT (glutamate-pyruvate transaminase)

    Measured: Changes from baseline to 4-month and 1-year follow-up

  17. Plasma concentrations of liver metabolism enzymes

    GOT (glutamate-oxalacetate transaminase)

    Measured: Changes from baseline to 4-month and 1-year follow-up

  18. Plasma levels of Vitamin D

    Concentrations of 25-hydroxyvitamin D (ng/mL)

    Measured: Changes from baseline to 4-month and 1-year follow-up

  19. Heart rate variability (HRV)

    Assessed by heart rate monitor (Polar V800)

    Measured: Changes from baseline to 4-month and 1-year follow-up

  20. Health-related physical fitness: cardiorespiratory fitness

    Cardiorespiratory fitness, assessed using a maximal treadmill test

    Measured: Changes from baseline to 4-month and and 1-year follow-up

  21. Health-related physical fitness: upper body muscular strength

    Upper body muscular strength, assessed using handgrip dynamometry (kg)

    Measured: Changes from baseline to 4-month and and 1-year follow-up

  22. Health-related physical fitness: lower body muscular strength

    Lower body muscular strength, assessed using the 30-seconds chair-stand test (number of repetitions)

    Measured: Changes from baseline to 4-month and and 1-year follow-up

  23. Health-related physical fitness: upper body flexibility

    Upper body flexibility, assessed using the back scratch test (cm)

    Measured: Changes from baseline to 4-month and and 1-year follow-up

  24. Objectively-measured physical activity

    Assessed by accelerometry (ActiGraph, software ActiLife)

    Measured: Changes from baseline to 4-month and 1-year follow-up

  25. Health-Related Quality of Life (HRQoL): SF-36

    Measured by the 36-item Short Form Health Survey (SF-36)

    Measured: Changes from baseline to 4-month and 1-year follow-up

  26. Health-Related Quality of Life (HRQoL): EQ-5D-3L

    Measured by European Quality of Life - 5 Dimensions-3Levels (EQ-5D-3L)

    Measured: Changes from baseline to 4-month and 1-year follow-up

  27. Symptomatology and function of hip / knee osteoarthritis: Pain

    Measured by the WOMAC (Western Ontario and McMaster Universities) Osteoarthritis Index. The PAIN scale within the WOMAC questionnaire contains 5 items, each one scoring from 0 (Nothing) to 4 (Very much), what makes a total score ranging from 0 (better) to 20 (worse).

    Measured: Changes from baseline to 4-month and 1-year follow-up

  28. Symptomatology and function of hip / knee osteoarthritis: Function

    Measured by the WOMAC (Western Ontario and McMaster Universities) Osteoarthritis Index. The FUNCTION scale within the WOMAC questionnaire contains 17 items, each one scoring from 0 (No trouble) to 4 (Very much difficult), what makes a total score ranging from 0 (better) to 68 (worse).

    Measured: Changes from baseline to 4-month and 1-year follow-up

  29. Symptomatology and function of hip / knee osteoarthritis: Stiffness

    Measured by the WOMAC (Western Ontario and McMaster Universities) Osteoarthritis Index. The STIFFNESS scale within the WOMAC questionnaire contains 2 items, each one scoring from 0 (Nothing) to 4 (Very much), what makes a total score ranging from 0 (better) to 8 (worse).

    Measured: Changes from baseline to 4-month and 1-year follow-up

  30. Depression, anxiety and stress

    Measured by the Depression, Anxiety and Stress Scale short form (DASS-21). The DASS-21 comprises three sub-scales assessing specific psychiatric symptoms (i.e., depression, anxiety, and stress). Each of these symptoms is assessed using seven items rated on a 4-point Likert-type scale (i.e., 0 = ''Did not apply to me at all''; 3 = ''Applied to me very much, or most of the time''). Summed score for each psychiatric symptom ranges from 0 to 21. Higher scores in each sub-scale indicate higher levels of depressive, anxiety or stress symptomatology. According to the specific nature of the three psychiatric symptoms assessed by the DASS-21, these are treated independently so that no total score is available.

    Measured: Changes from baseline to 4-month and 1-year follow-up

  31. Emotional, psychological and social well-being

    Measured by the Mental Health Continuum-Short Form (MHC-SF)

    Measured: Changes from baseline to 4-month and 1-year follow-up

  32. Cost-effectiveness analysis (CEA)

    The costs will consider those related to the surgery, the exercise program, prescription medication, sick leave, post-surgery complications and readmission rates, time and effort requiring each treatment, as well as possible dietary and informal care costs. Effectiveness will be considered as changes observed in the main clinical outcomes: weight loss and cardiometabolic risk (remission/relapse of hypertension, dyslipidemia and type 2 diabetes).

    Measured: From baseline to 1-year follow-up

  33. Cost-utility analysis (CUA)

    The costs will consider those related to the surgery, the exercise program, prescription medication, sick leave, post-surgery complications and readmission rates, time and effort requiring each treatment, as well as possible dietary and informal care costs. Utility will evaluate variation in quality of life experienced by participants, computed as changes in quality-adjusted life years (QALY) using SF-36 questionnaire.

    Measured: From baseline to 1-year follow-up

  34. Cost-utility analysis (CUA)

    The costs will consider those related to the surgery, the exercise program, prescription medication, sick leave, post-surgery complications and readmission rates, time and effort requiring each treatment, as well as possible dietary and informal care costs. Utility will evaluate variation in quality of life experienced by participants, computed as changes in quality-adjusted life years (QALY) using EQ-5D-3L questionnaire.

    Measured: From baseline to 1-year follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Apr 2018
  2. Study start1 May 2018
  3. Primary completion30 Sep 2022
  4. Study completion30 Sep 2022

Resources

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
Model description
Eligible participants will be randomly assigned (1:1) sequentially, as they will be submitted to bariatric surgery, to one of the two following groups: CON - Usual care (following international guidelines) after bariatric surgery. EX - Usual care plus supervised exercise program.
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03497546
Sponsor's protocol ID
DEP2016-74926-R
Acronym
EFIBAR
Status last verified
Sep 2023
First submitted
7 Mar 2018
Last updated
7 Sep 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All IPD will be shared once the study is finalised and the main results are published. IPD can be obtained by contacting the responsible party (artero@ual.es).

Publications

  • Villa-Gonzalez E, Barranco-Ruiz Y, Rodriguez-Perez MA, Carretero-Ruiz A, Garcia-Martinez JM, Hernandez-Martinez A, Torrente-Sanchez MJ, Ferrer-Marquez M, Soriano-Maldonado A, Artero EG; EFIBAR Study Group. Supervised exercise following bariatric surgery in morbid obese adults: CERT-based exercise study protocol of the EFIBAR randomised controlled trial. BMC Surg. 2019 Sep 5;19(1):127. doi: 10.1186/s12893-019-0566-9.

    PubMed 31488115

  • Artero EG, Ferrez-Marquez M, Torrente-Sanchez MJ, Martinez-Rosales E, Carretero-Ruiz A, Hernandez-Martinez A, Lopez-Sanchez L, Esteban-Simon A, Romero Del Rey A, Alcaraz-Ibanez M, Rodriguez-Perez MA, Villa-Gonzalez E, Barranco-Ruiz Y, Martinez-Forte S, Castillo C, Gomez Navarro C, Aceituno Cubero J, Reyes Parrilla R, Aparicio Gomez JA, Femia P, Fernandez-Alonso AM, Soriano-Maldonado A. Supervised Exercise Immediately After Bariatric Surgery: the Study Protocol of the EFIBAR Randomized Controlled Trial. Obes Surg. 2021 Oct;31(10):4227-4235. doi: 10.1007/s11695-021-05559-8. Epub 2021 Jul 15.

    PubMed 34268680

  • Sicilia A, Socias-Serrano ML, Griffiths MD, Martinez-Rosales E, Artero EG. Narrative and obesity: Managing weight stigma associated with bariatric surgery. Health (London). 2025 Sep;29(5):633-651. doi: 10.1177/13634593241310129. Epub 2025 Jan 4.

    PubMed 39754515

  • Amaro Santos C, Cinza AM, Laranjeira A, Amaro M, Carvalho M, Martins S, Bravo J, Raimundo A. The impact of exercise on prevention of sarcopenia after bariatric surgery: The study protocol of the EXPOBAR randomized controlled trial. Contemp Clin Trials Commun. 2022 Dec 5;31:101048. doi: 10.1016/j.conctc.2022.101048. eCollection 2023 Feb.

    PubMed 36568444

Questions about this trial

What is this clinical trial studying?

A study testing Exercise in people with Obesity, Morbid and Bariatric Surgery Candidate, run by Universidad de Almeria at 1 site 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 3 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: finished, as of the sponsor's last update on 7 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent total weight loss (%TWL) [Biospace Co., InBody 270, USA] (time frame: Changes from baseline to 4-month and 1-year follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03497546, which also lists 4 linked publications.

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 7 Sep 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in