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

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ClinicalTrials.gov Identifier: NCT03497546
Recruitment Status : Recruiting
First Posted : April 13, 2018
Last Update Posted : July 25, 2019
Sponsor:
Collaborators:
Ministerio de Economía y Competitividad, Spain
Complejo Hospitalario Torrecárdenas (CHT), Almería, Spain
Information provided by (Responsible Party):
Enrique García Artero, Universidad de Almeria

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.


Condition or disease Intervention/treatment Phase
Obesity, Morbid Bariatric Surgery Candidate Other: Exercise Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.

Masking: Double (Investigator, Outcomes Assessor)
Masking Description:

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.

Primary Purpose: Treatment
Official Title: Supervised Exercise Following Bariatric Surgery in the Treatment of Severe/Morbid Obesity: a Randomized Controlled Trial
Actual Study Start Date : May 1, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Exercise
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.
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.
Other Name: Exercise training

No Intervention: Control
Usual care routinely delivered after bariatric surgery, based on national (Spanish) and international recommendations, focused on nutritional status monitoring and diet/physical activity counseling.



Primary Outcome Measures :
  1. Percent total weight loss (%TWL) [Biospace Co., InBody 270, USA] [ Time Frame: Changes from baseline to 4-month and 1-year follow-up ]
    %TWL = [(pre-surgery weight - post-surgery weight) / (pre-surgery weight)] x 100


Secondary Outcome Measures :
  1. Body composition: body fat [ Time Frame: Changes from baseline to 4-month and 1-year follow-up ]
    Percent body fat (%) assessed by bioimpedance analysis (InBody 270, Biospace Co., USA)

  2. Body composition: fat-free mass [ Time Frame: Changes from baseline to 4-month and 1-year follow-up ]
    Fat-free mass (kg) assessed by bioimpedance analysis (InBody 270, Biospace Co., USA)

  3. Body composition: fat-free mass index [ Time Frame: Changes from baseline to 4-month and 1-year follow-up ]
    Fat-free mass index (kg/m2) assessed by bioimpedance analysis (InBody 270, Biospace Co., USA)

  4. Body composition: central body fat [ Time Frame: Changes from baseline to 4-month and 1-year follow-up ]
    Waist and hip circumferences (measured in cm with an anthropometric tape), waist / height ratio

  5. Lipid profile assessed from blood sample [ Time Frame: Changes from baseline to 4-month and 1-year follow-up ]
    Total cholesterol (mg/dl), HDL-cholesterol (mg/dl), LDL-cholesterol (mg/dl) and triglycerides (mg/dl)

  6. Blood markers of glucose metabolism: glucose [ Time Frame: Changes from baseline to 4-month and 1-year follow-up ]
    Glucose (mg/dL)

  7. Blood markers of glucose metabolism: insulin [ Time Frame: Changes from baseline to 4-month and 1-year follow-up ]
    Insulin (μUI/mL)

  8. Blood markers of glucose metabolism: HOMA-IR [ Time Frame: Changes from baseline to 4-month and 1-year follow-up ]
    Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)

  9. Blood markers of glucose metabolism: glycated hemoglobin HbA1c [ Time Frame: Changes from baseline to 4-month and 1-year follow-up ]
    Glycated hemoglobin HbA1c (%)

  10. Brachial and central blood pressures (mmHg) [ Time Frame: Changes from baseline to 4-month and 1-year follow-up ]
    Systolic and diastolic blood pressures assessed by Mobil-O-Graph

  11. Arterial stiffness [ Time Frame: Changes from baseline to 4-month and 1-year follow-up ]
    Pulse wave velocity (PWV, m/s) by Mobil-O-Graph

  12. Plasma concentrations of inflammatory markers [ Time Frame: Changes from baseline to 4-month and 1-year follow-up ]
    High-sensitivity C-reactive protein (hs-CRP)

  13. Plasma concentrations of inflammatory markers [ Time Frame: Changes from baseline to 4-month and 1-year follow-up ]
    Tumor necrosis factor (TNF-alpha)

  14. Plasma concentrations of inflammatory markers [ Time Frame: Changes from baseline to 4-month and 1-year follow-up ]
    Interleukin 6 (IL-6)

  15. Plasma concentrations of liver metabolism enzymes [ Time Frame: Changes from baseline to 4-month and 1-year follow-up ]
    GGT (gamma-glutamyltransferase)

  16. Plasma concentrations of liver metabolism enzymes [ Time Frame: Changes from baseline to 4-month and 1-year follow-up ]
    GPT (glutamate-pyruvate transaminase)

  17. Plasma concentrations of liver metabolism enzymes [ Time Frame: Changes from baseline to 4-month and 1-year follow-up ]
    GOT (glutamate-oxalacetate transaminase)

  18. Plasma levels of Vitamin D [ Time Frame: Changes from baseline to 4-month and 1-year follow-up ]
    Concentrations of 25-hydroxyvitamin D (ng/mL)

  19. Heart rate variability (HRV) [ Time Frame: Changes from baseline to 4-month and 1-year follow-up ]
    Assessed by heart rate monitor (Polar V800)

  20. Health-related physical fitness: cardiorespiratory fitness [ Time Frame: Changes from baseline to 4-month and and 1-year follow-up ]
    Cardiorespiratory fitness, assessed using a maximal treadmill test

  21. Health-related physical fitness: upper body muscular strength [ Time Frame: Changes from baseline to 4-month and and 1-year follow-up ]
    Upper body muscular strength, assessed using handgrip dynamometry (kg)

  22. Health-related physical fitness: lower body muscular strength [ Time Frame: Changes from baseline to 4-month and and 1-year follow-up ]
    Lower body muscular strength, assessed using the 30-seconds chair-stand test (number of repetitions)

  23. Health-related physical fitness: upper body flexibility [ Time Frame: Changes from baseline to 4-month and and 1-year follow-up ]
    Upper body flexibility, assessed using the back scratch test (cm)

  24. Objectively-measured physical activity [ Time Frame: Changes from baseline to 4-month and 1-year follow-up ]
    Assessed by accelerometry (ActiGraph, software ActiLife)

  25. Health-Related Quality of Life (HRQoL): SF-36 [ Time Frame: Changes from baseline to 4-month and 1-year follow-up ]
    Measured by the 36-item Short Form Health Survey (SF-36)

  26. Health-Related Quality of Life (HRQoL): EQ-5D-3L [ Time Frame: Changes from baseline to 4-month and 1-year follow-up ]
    Measured by European Quality of Life - 5 Dimensions-3Levels (EQ-5D-3L)

  27. Symptomatology and function of hip / knee osteoarthritis: Pain [ Time Frame: Changes from baseline to 4-month and 1-year follow-up ]
    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).

  28. Symptomatology and function of hip / knee osteoarthritis: Function [ Time Frame: Changes from baseline to 4-month and 1-year follow-up ]
    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).

  29. Symptomatology and function of hip / knee osteoarthritis: Stiffness [ Time Frame: Changes from baseline to 4-month and 1-year follow-up ]
    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).

  30. Depression, anxiety and stress [ Time Frame: Changes from baseline to 4-month and 1-year follow-up ]
    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.

  31. Emotional, psychological and social well-being [ Time Frame: Changes from baseline to 4-month and 1-year follow-up ]
    Measured by the Mental Health Continuum-Short Form (MHC-SF)

  32. Cost-effectiveness analysis (CEA) [ Time Frame: From baseline to 1-year follow-up ]
    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).

  33. Cost-utility analysis (CUA) [ Time Frame: From baseline to 1-year follow-up ]
    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.

  34. Cost-utility analysis (CUA) [ Time Frame: From baseline to 1-year follow-up ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03497546


Contacts
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Contact: Enrique G Artero, Ph.D. +34950015256 artero@ual.es

Locations
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Spain
Complejo Hospitalario Torrecárdenas (CHT) Recruiting
Almería, Spain, 04009
Contact: Juan Manuel García Torrecillas, MD         
Sponsors and Collaborators
Universidad de Almeria
Ministerio de Economía y Competitividad, Spain
Complejo Hospitalario Torrecárdenas (CHT), Almería, Spain
Investigators
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Principal Investigator: Enrique G Artero, Ph.D. Universidad de Almería

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Enrique García Artero, Principal Investigator, Universidad de Almeria
ClinicalTrials.gov Identifier: NCT03497546     History of Changes
Other Study ID Numbers: DEP2016-74926-R
First Posted: April 13, 2018    Key Record Dates
Last Update Posted: July 25, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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).
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: Two years (24 months) after the study completion.
Access Criteria: 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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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Enrique García Artero, Universidad de Almeria:
Morbid obesity
Exercise
Weight loss
Cardiometabolic risk
Bariatric surgery
Additional relevant MeSH terms:
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Obesity
Obesity, Morbid
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms