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| Name | Class |
|---|---|
| Ministerio de Economía y Competitividad, Spain | OTHER_GOV |
| Complejo Hospitalario Torrecárdenas (CHT), Almería, Spain | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise | Experimental | Usual 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. |
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| Control | No Intervention | Usual care routinely delivered after bariatric surgery, based on national (Spanish) and international recommendations, focused on nutritional status monitoring and diet/physical activity counseling. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent total weight loss (%TWL) [Biospace Co., InBody 270, USA] | %TWL = [(pre-surgery weight - post-surgery weight) / (pre-surgery weight)] x 100 | Changes from baseline to 4-month and 1-year follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Body composition: body fat | Percent body fat (%) assessed by bioimpedance analysis (InBody 270, Biospace Co., USA) | Changes from baseline to 4-month and 1-year follow-up |
| Body composition: fat-free mass |
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Inclusion Criteria:
To comply with local bariatric surgery criteria:
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
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Enrique G Artero, Ph.D. | Universidad de Almeria | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Complejo Hospitalario Torrecárdenas (CHT) | Almería | 04009 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31488115 | Background | 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. | |
| 34268680 |
| Label | URL |
|---|---|
| Study Protocol of the EFIBAR Randomized Controlled Trial | View source |
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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).
Two years (24 months) after the study completion.
The PI must be contacted and a minimum number of co-authors from the research team must be included in any publication.
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| ID | Term |
|---|---|
| D009767 | Obesity, Morbid |
| D009043 | Motor Activity |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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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.
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Investigators, study coordinators, outcome assessors, and clinical staff will be blinded to the group allocation.
Participants and providers of the exercise delivery will not be blinded to the group allocation.
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|
Fat-free mass (kg) assessed by bioimpedance analysis (InBody 270, Biospace Co., USA)
| Changes from baseline to 4-month and 1-year follow-up |
| Body composition: fat-free mass index | Fat-free mass index (kg/m2) assessed by bioimpedance analysis (InBody 270, Biospace Co., USA) | Changes from baseline to 4-month and 1-year follow-up |
| Body composition: central body fat | Waist and hip circumferences (measured in cm with an anthropometric tape), waist / height ratio | Changes from baseline to 4-month and 1-year follow-up |
| Lipid profile assessed from blood sample | Total cholesterol (mg/dl), HDL-cholesterol (mg/dl), LDL-cholesterol (mg/dl) and triglycerides (mg/dl) | Changes from baseline to 4-month and 1-year follow-up |
| Blood markers of glucose metabolism: glucose | Glucose (mg/dL) | Changes from baseline to 4-month and 1-year follow-up |
| Blood markers of glucose metabolism: insulin | Insulin (μUI/mL) | Changes from baseline to 4-month and 1-year follow-up |
| Blood markers of glucose metabolism: HOMA-IR | Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) | Changes from baseline to 4-month and 1-year follow-up |
| Blood markers of glucose metabolism: glycated hemoglobin HbA1c | Glycated hemoglobin HbA1c (%) | Changes from baseline to 4-month and 1-year follow-up |
| Brachial and central blood pressures (mmHg) | Systolic and diastolic blood pressures assessed by Mobil-O-Graph | Changes from baseline to 4-month and 1-year follow-up |
| Arterial stiffness | Pulse wave velocity (PWV, m/s) by Mobil-O-Graph | Changes from baseline to 4-month and 1-year follow-up |
| Plasma concentrations of inflammatory markers | High-sensitivity C-reactive protein (hs-CRP) | Changes from baseline to 4-month and 1-year follow-up |
| Plasma concentrations of inflammatory markers | Tumor necrosis factor (TNF-alpha) | Changes from baseline to 4-month and 1-year follow-up |
| Plasma concentrations of inflammatory markers | Interleukin 6 (IL-6) | Changes from baseline to 4-month and 1-year follow-up |
| Plasma concentrations of liver metabolism enzymes | GGT (gamma-glutamyltransferase) | Changes from baseline to 4-month and 1-year follow-up |
| Plasma concentrations of liver metabolism enzymes | GPT (glutamate-pyruvate transaminase) | Changes from baseline to 4-month and 1-year follow-up |
| Plasma concentrations of liver metabolism enzymes | GOT (glutamate-oxalacetate transaminase) | Changes from baseline to 4-month and 1-year follow-up |
| Plasma levels of Vitamin D | Concentrations of 25-hydroxyvitamin D (ng/mL) | Changes from baseline to 4-month and 1-year follow-up |
| Heart rate variability (HRV) | Assessed by heart rate monitor (Polar V800) | Changes from baseline to 4-month and 1-year follow-up |
| Health-related physical fitness: cardiorespiratory fitness | Cardiorespiratory fitness, assessed using a maximal treadmill test | Changes from baseline to 4-month and and 1-year follow-up |
| Health-related physical fitness: upper body muscular strength | Upper body muscular strength, assessed using handgrip dynamometry (kg) | Changes from baseline to 4-month and and 1-year follow-up |
| Health-related physical fitness: lower body muscular strength | Lower body muscular strength, assessed using the 30-seconds chair-stand test (number of repetitions) | Changes from baseline to 4-month and and 1-year follow-up |
| Health-related physical fitness: upper body flexibility | Upper body flexibility, assessed using the back scratch test (cm) | Changes from baseline to 4-month and and 1-year follow-up |
| Objectively-measured physical activity | Assessed by accelerometry (ActiGraph, software ActiLife) | Changes from baseline to 4-month and 1-year follow-up |
| Health-Related Quality of Life (HRQoL): SF-36 | Measured by the 36-item Short Form Health Survey (SF-36) | Changes from baseline to 4-month and 1-year follow-up |
| Health-Related Quality of Life (HRQoL): EQ-5D-3L | Measured by European Quality of Life - 5 Dimensions-3Levels (EQ-5D-3L) | Changes from baseline to 4-month and 1-year follow-up |
| 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). | Changes from baseline to 4-month and 1-year follow-up |
| 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). | Changes from baseline to 4-month and 1-year follow-up |
| 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). | Changes from baseline to 4-month and 1-year follow-up |
| 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. | Changes from baseline to 4-month and 1-year follow-up |
| Emotional, psychological and social well-being | Measured by the Mental Health Continuum-Short Form (MHC-SF) | Changes from baseline to 4-month and 1-year follow-up |
| 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). | From baseline to 1-year follow-up |
| 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. | From baseline to 1-year follow-up |
| 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. | From baseline to 1-year follow-up |
| Background |
| 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. |
| 39754515 | Derived | 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. |
| 36568444 | Derived | 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. |
| CERT-based exercise study protocol of the EFIBAR randomised controlled trial | View source |
| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
| D001836 | Body Weight Changes |