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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
80
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.
Complejo Hospitalario Torrecárdenas (CHT)
Almería, Spain
Percent total weight loss (%TWL) [Biospace Co., InBody 270, USA]
%TWL = \[(pre-surgery weight - post-surgery weight) / (pre-surgery weight)\] x 100
Time frame: Changes from baseline to 4-month and 1-year follow-up
Body composition: body fat
Percent body fat (%) assessed by bioimpedance analysis (InBody 270, Biospace Co., USA)
Time frame: Changes from baseline to 4-month and 1-year follow-up
Body composition: fat-free mass
Fat-free mass (kg) assessed by bioimpedance analysis (InBody 270, Biospace Co., USA)
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: Changes from baseline to 4-month and 1-year follow-up
Blood markers of glucose metabolism: glucose
Glucose (mg/dL)
Time frame: Changes from baseline to 4-month and 1-year follow-up
Blood markers of glucose metabolism: insulin
Insulin (μUI/mL)
Time frame: 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)
Time frame: Changes from baseline to 4-month and 1-year follow-up
Blood markers of glucose metabolism: glycated hemoglobin HbA1c
Glycated hemoglobin HbA1c (%)
Time frame: 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
Time frame: Changes from baseline to 4-month and 1-year follow-up
Arterial stiffness
Pulse wave velocity (PWV, m/s) by Mobil-O-Graph
Time frame: Changes from baseline to 4-month and 1-year follow-up
Plasma concentrations of inflammatory markers
High-sensitivity C-reactive protein (hs-CRP)
Time frame: Changes from baseline to 4-month and 1-year follow-up
Plasma concentrations of inflammatory markers
Tumor necrosis factor (TNF-alpha)
Time frame: Changes from baseline to 4-month and 1-year follow-up
Plasma concentrations of inflammatory markers
Interleukin 6 (IL-6)
Time frame: Changes from baseline to 4-month and 1-year follow-up
Plasma concentrations of liver metabolism enzymes
GGT (gamma-glutamyltransferase)
Time frame: Changes from baseline to 4-month and 1-year follow-up
Plasma concentrations of liver metabolism enzymes
GPT (glutamate-pyruvate transaminase)
Time frame: Changes from baseline to 4-month and 1-year follow-up
Plasma concentrations of liver metabolism enzymes
GOT (glutamate-oxalacetate transaminase)
Time frame: Changes from baseline to 4-month and 1-year follow-up
Plasma levels of Vitamin D
Concentrations of 25-hydroxyvitamin D (ng/mL)
Time frame: Changes from baseline to 4-month and 1-year follow-up
Heart rate variability (HRV)
Assessed by heart rate monitor (Polar V800)
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Changes from baseline to 4-month and and 1-year follow-up
Objectively-measured physical activity
Assessed by accelerometry (ActiGraph, software ActiLife)
Time frame: 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)
Time frame: 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)
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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)
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: From baseline to 1-year follow-up
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