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

Bariatric Surgery Candidate Clinical Trial

— EFIBAR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03497546
• Other study ID #: DEP2016-74926-R
• Status: Completed
• Phase: N/A
• Start date: May 1, 2018
• Est. completion date: September 30, 2022

Study information

• Verified date: September 2023
• Source: Universidad de Almeria
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: September 30, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• To comply with local bariatric surgery criteria:

1. Patients with BMI = 40 kg/m2 (or 35 kg/m2 with comorbidities).

2. Acceptable surgical risk (defined by the approval of anesthetist).

3. Obesity maintained for over 5 years.

4. Failure of previous treatments.

5. 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Bariatric Surgery Candidate
• Obesity
• Obesity, Morbid

Intervention

Other:
• Exercise
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.

Locations

Country	Name	City	State
Spain	Complejo Hospitalario Torrecárdenas (CHT)	Almería

Sponsors (3)

Lead Sponsor	Collaborator
Universidad de Almeria	Complejo Hospitalario Torrecárdenas (CHT), Almería, Spain, Ministerio de Economía y Competitividad, Spain

Country where clinical trial is conducted

Spain, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	Body composition: fat-free mass	Fat-free mass (kg) assessed by bioimpedance analysis (InBody 270, Biospace Co., USA)	Changes from baseline to 4-month and 1-year follow-up
Secondary	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
Secondary	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
Secondary	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
Secondary	Blood markers of glucose metabolism: glucose	Glucose (mg/dL)	Changes from baseline to 4-month and 1-year follow-up
Secondary	Blood markers of glucose metabolism: insulin	Insulin (µUI/mL)	Changes from baseline to 4-month and 1-year follow-up
Secondary	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
Secondary	Blood markers of glucose metabolism: glycated hemoglobin HbA1c	Glycated hemoglobin HbA1c (%)	Changes from baseline to 4-month and 1-year follow-up
Secondary	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
Secondary	Arterial stiffness	Pulse wave velocity (PWV, m/s) by Mobil-O-Graph	Changes from baseline to 4-month and 1-year follow-up
Secondary	Plasma concentrations of inflammatory markers	High-sensitivity C-reactive protein (hs-CRP)	Changes from baseline to 4-month and 1-year follow-up
Secondary	Plasma concentrations of inflammatory markers	Tumor necrosis factor (TNF-alpha)	Changes from baseline to 4-month and 1-year follow-up
Secondary	Plasma concentrations of inflammatory markers	Interleukin 6 (IL-6)	Changes from baseline to 4-month and 1-year follow-up
Secondary	Plasma concentrations of liver metabolism enzymes	GGT (gamma-glutamyltransferase)	Changes from baseline to 4-month and 1-year follow-up
Secondary	Plasma concentrations of liver metabolism enzymes	GPT (glutamate-pyruvate transaminase)	Changes from baseline to 4-month and 1-year follow-up
Secondary	Plasma concentrations of liver metabolism enzymes	GOT (glutamate-oxalacetate transaminase)	Changes from baseline to 4-month and 1-year follow-up
Secondary	Plasma levels of Vitamin D	Concentrations of 25-hydroxyvitamin D (ng/mL)	Changes from baseline to 4-month and 1-year follow-up
Secondary	Heart rate variability (HRV)	Assessed by heart rate monitor (Polar V800)	Changes from baseline to 4-month and 1-year follow-up
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Objectively-measured physical activity	Assessed by accelerometry (ActiGraph, software ActiLife)	Changes from baseline to 4-month and 1-year follow-up
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   CERT-based exercise study protocol of the EFIBAR randomised controlled trial
•   Study Protocol of the EFIBAR Randomized Controlled Trial