Clinical trial NCT03497546: Exercise Following Bariatric Surgery for Severe/Morbid Obesity (EFIBAR)
Official title: Supervised Exercise Following Bariatric Surgery in the Treatment of Severe/Morbid Obesity: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity, Morbid
Bariatric Surgery Candidate
Keywords: Morbid obesity
Exercise
Weight loss
Cardiometabolic risk
Bariatric surgery
Lead sponsor: Universidad de Almeria
Sponsor class: OTHER
Collaborators: name: Ministerio de Economía y Competitividad, Spain
name: Complejo Hospitalario Torrecárdenas (CHT), Almería, Spain
First posted: 2018-04-13
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percent total weight loss (%TWL) [Biospace Co., InBody 270, USA]
timeFrame: Changes from baseline to 4-month and 1-year follow-up
Secondary outcomes:
measure: Body composition: body fat
timeFrame: Changes from baseline to 4-month and 1-year follow-up
measure: Body composition: fat-free mass
timeFrame: Changes from baseline to 4-month and 1-year follow-up
measure: Body composition: fat-free mass index
timeFrame: Changes from baseline to 4-month and 1-year follow-up
measure: Body composition: central body fat
timeFrame: Changes from baseline to 4-month and 1-year follow-up
measure: Lipid profile assessed from blood sample
timeFrame: Changes from baseline to 4-month and 1-year follow-up
measure: Blood markers of glucose metabolism: glucose
timeFrame: Changes from baseline to 4-month and 1-year follow-up
measure: Blood markers of glucose metabolism: insulin
timeFrame: Changes from baseline to 4-month and 1-year follow-up
measure: Blood markers of glucose metabolism: HOMA-IR
timeFrame: Changes from baseline to 4-month and 1-year follow-up
measure: Blood markers of glucose metabolism: glycated hemoglobin HbA1c
timeFrame: Changes from baseline to 4-month and 1-year follow-up
measure: Brachial and central blood pressures (mmHg)
timeFrame: Changes from baseline to 4-month and 1-year follow-up
measure: Arterial stiffness
timeFrame: Changes from baseline to 4-month and 1-year follow-up
measure: Plasma concentrations of inflammatory markers
timeFrame: Changes from baseline to 4-month and 1-year follow-up
measure: Plasma concentrations of inflammatory markers
timeFrame: Changes from baseline to 4-month and 1-year follow-up
measure: Plasma concentrations of inflammatory markers
timeFrame: Changes from baseline to 4-month and 1-year follow-up
measure: Plasma concentrations of liver metabolism enzymes
timeFrame: Changes from baseline to 4-month and 1-year follow-up
measure: Plasma concentrations of liver metabolism enzymes
timeFrame: Changes from baseline to 4-month and 1-year follow-up
measure: Plasma concentrations of liver metabolism enzymes
timeFrame: Changes from baseline to 4-month and 1-year follow-up
measure: Plasma levels of Vitamin D
timeFrame: Changes from baseline to 4-month and 1-year follow-up
measure: Heart rate variability (HRV)
timeFrame: Changes from baseline to 4-month and 1-year follow-up
measure: Health-related physical fitness: cardiorespiratory fitness
timeFrame: Changes from baseline to 4-month and and 1-year follow-up
measure: Health-related physical fitness: upper body muscular strength
timeFrame: Changes from baseline to 4-month and and 1-year follow-up
measure: Health-related physical fitness: lower body muscular strength
timeFrame: Changes from baseline to 4-month and and 1-year follow-up
measure: Health-related physical fitness: upper body flexibility
timeFrame: Changes from baseline to 4-month and and 1-year follow-up
measure: Objectively-measured physical activity
timeFrame: Changes from baseline to 4-month and 1-year follow-up
measure: Health-Related Quality of Life (HRQoL): SF-36
timeFrame: Changes from baseline to 4-month and 1-year follow-up
measure: Health-Related Quality of Life (HRQoL): EQ-5D-3L
timeFrame: Changes from baseline to 4-month and 1-year follow-up
measure: Symptomatology and function of hip / knee osteoarthritis: Pain
timeFrame: Changes from baseline to 4-month and 1-year follow-up
measure: Symptomatology and function of hip / knee osteoarthritis: Function
timeFrame: Changes from baseline to 4-month and 1-year follow-up
measure: Symptomatology and function of hip / knee osteoarthritis: Stiffness
timeFrame: Changes from baseline to 4-month and 1-year follow-up
measure: Depression, anxiety and stress
timeFrame: Changes from baseline to 4-month and 1-year follow-up
measure: Emotional, psychological and social well-being
timeFrame: Changes from baseline to 4-month and 1-year follow-up
measure: Cost-effectiveness analysis (CEA)
timeFrame: From baseline to 1-year follow-up
measure: Cost-utility analysis (CUA)
timeFrame: From baseline to 1-year follow-up
measure: Cost-utility analysis (CUA)
timeFrame: From baseline to 1-year follow-up
Other outcomes:
Locations:
city: Almería
country: Spain
facility: Complejo Hospitalario Torrecárdenas (CHT)
Study officials:
affiliation: Universidad de Almeria
name: Enrique G Artero, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.