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

Universidad de Almeria

Status: Completed

Conditions: Bariatric Surgery Candidate; Obesity, Morbid

Treatments: Other: Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT03497546

DEP2016-74926-R

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups

Exercise

Experimental group

Description:

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.

Treatment:

Other: Exercise

Control

No Intervention group

Description:

Usual care routinely delivered after bariatric surgery, based on national (Spanish) and international recommendations, focused on nutritional status monitoring and diet/physical activity counseling.