NCT03497546: EFIBAR

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

Completed NA Last updated 7 September 2023

What this trial tests

NA trial testing Exercise in Obesity, Morbid in 80 participants. Completed in 30 September 2022.

Timeline

1 May 2018

Primary endpoint
30 September 2022

30 September 2022

Quick facts

Lead sponsor	Universidad de Almeria
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	80
Start date	1 May 2018
Primary completion	30 September 2022
Estimated completion	30 September 2022
Sites	1 location across Spain

Drugs / interventions tested

• Exercise

Conditions studied

• Obesity, Morbid — all drugs for Obesity, Morbid →
• Bariatric Surgery Candidate — all drugs for Bariatric Surgery Candidate →

Sponsor

Universidad de Almeria

Who can join

Adults 18 to 60, any sex, with Obesity, Morbid or Bariatric Surgery Candidate. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Supervised exercise following bariatric surgery in morbid obese adults: CERT-based exercise study protocol of the EFIBAR randomised controlled trial.
   Villa-González E, Barranco-Ruiz Y, Rodríguez-Pérez MA, Carretero-Ruiz A, et al · · 2019 · cited 17× · PMID 31488115 · DOI 10.1186/s12893-019-0566-9
2. The impact of exercise on prevention of sarcopenia after bariatric surgery: The study protocol of the EXPOBAR randomized controlled trial.
   Amaro Santos C, Cinza AM, Laranjeira Â, Amaro M, et al · · 2023 · cited 10× · PMID 36568444 · DOI 10.1016/j.conctc.2022.101048
3. A dataset on skeletal muscle mass index, body composition and strength to determinate sarcopenia in bariatric patients.
   Santos CA, Cinza AM, Laranjeira Â, Amaro M, et al · · 2023 · cited 7× · PMID 36687150 · DOI 10.1016/j.dib.2022.108881
4. Supervised Exercise Immediately After Bariatric Surgery: the Study Protocol of the EFIBAR Randomized Controlled Trial.
   Artero EG, Ferrez-Márquez M, Torrente-Sánchez MJ, Martínez-Rosales E, et al · · 2021 · cited 6× · PMID 34268680 · DOI 10.1007/s11695-021-05559-8
5. Effects of physical exercise in sarcopenia on patients undergoing bariatric surgery: A protocol for a randomized clinical trial.
   Santos CA, Cinza AM, Laranjeira Â, Amaro M, et al · · 2023 · cited 4× · PMID 36798839 · DOI 10.1016/j.mex.2023.102043
6. Effect of a 16-week Combined Supervised Exercise Program after bariatric surgery on Sarcopenia parameters based on FNIH, EWGSOP2, EASO/ESPEN criteria – The results of the EXPOBAR randomized trial program
   Mendes C, Carvalho M, Cabo C, Bravo J, et al · · 2024 · DOI 10.21203/rs.3.rs-4850725/v1
7. The Impact of a Structured Physical Exercise Program after Bariatric Surgery (RYGB) on PROMs – Health-Related Quality of Life (SarQoL) – in Patients with Preoperative Obesity and Sarcopenia
   Mendes C, Carvalho M, Bravo J, Martins S, et al · · 2024 · DOI 10.20944/preprints202408.2171.v1