NCT03497546

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 7, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 13, 2018

Completed
18 days until next milestone

Study Start

First participant enrolled

May 1, 2018

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

September 7, 2023

Status Verified

September 1, 2023

Enrollment Period

4.4 years

First QC Date

March 7, 2018

Last Update Submit

September 4, 2023

Conditions

Obesity, MorbidBariatric Surgery Candidate

Keywords

Morbid obesityExerciseWeight lossCardiometabolic riskBariatric surgery

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (34)

  • Body composition: body fat

    Changes from baseline to 4-month and 1-year follow-up

  • Body composition: fat-free mass

    Changes from baseline to 4-month and 1-year follow-up

  • Body composition: fat-free mass index

    Changes from baseline to 4-month and 1-year follow-up

  • Body composition: central body fat

    Changes from baseline to 4-month and 1-year follow-up

  • Lipid profile assessed from blood sample

    Changes from baseline to 4-month and 1-year follow-up

  • +29 more secondary outcomes

Study Arms (2)

Exercise

EXPERIMENTAL

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

Control

NO INTERVENTION

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

Interventions

ExerciseOTHER

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.

Also known as: Exercise training
Exercise

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • To comply with local bariatric surgery criteria:
  • Patients with BMI ≥ 40 kg/m2 (or 35 kg/m2 with comorbidities).
  • Acceptable surgical risk (defined by the approval of anesthetist).
  • Obesity maintained for over 5 years.
  • Failure of previous treatments.
  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Complejo Hospitalario Torrecárdenas (CHT)

Almería, 04009, Spain

Location

Related Publications (3)

  • 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.

    PMID: 31488115BACKGROUND

  • 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.

    PMID: 34268680BACKGROUND

  • Amaro Santos C, Cinza AM, Laranjeira A, Amaro M, Carvalho M, Martins S, Bravo J, Raimundo A. The impact of exercise on prevention of sarcopenia after bariatric surgery: The study protocol of the EXPOBAR randomized controlled trial. Contemp Clin Trials Commun. 2022 Dec 5;31:101048. doi: 10.1016/j.conctc.2022.101048. eCollection 2023 Feb.

    PMID: 36568444DERIVED

Related Links

MeSH Terms

Conditions

Obesity, MorbidMotor ActivityWeight Loss

Interventions

Exercise

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehaviorBody Weight Changes

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Enrique G Artero, Ph.D.

    Universidad de Almeria

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 7, 2018

First Posted

April 13, 2018

Study Start

May 1, 2018

Primary Completion

September 30, 2022

Study Completion

September 30, 2022

Last Updated

September 7, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will share

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).

Shared Documents
STUDY PROTOCOL, SAP, ICF, 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.

Locations

ES(1)