Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

At a glance: The ONWARDS insulin icodec trials

A round-up of the ONWARDS phase 3 clinical trials evaluating the novel weekly insulin icodec in people with diabetes.
ADVANCED SEARCH
Log in
Top
BMC Surgery
Published in: BMC Surgery 1/2019

Open Access 01-12-2019 | Bariatric Surgery | Study protocol

Supervised exercise following bariatric surgery in morbid obese adults: CERT-based exercise study protocol of the EFIBAR randomised controlled trial

Authors: Emilio Villa-González, Yaira Barranco-Ruiz, Manuel A. Rodríguez-Pérez, Alejandro Carretero-Ruiz, José María García-Martínez, Alba Hernández-Martínez, María José Torrente-Sánchez, Manuel Ferrer-Márquez, Alberto Soriano-Maldonado, Enrique G. Artero, On behalf of the EFIBAR Study Group

Published in: BMC Surgery | Issue 1/2019

Login to get access

Abstract

Background

There is increasing evidence of weight regain in patients after bariatric surgery (BS), generally occurring from 12 to 24 months postoperatively. Postoperative exercise has been suggested to ad long-term weight maintenance and to improve physical function in BS patients. However, there are a limited number of intervention studies investigating the possible benefits of exercise in this population. The aim of the current report is to provide a comprehensive CERT (Consensus on Exercise Reporting Template)-based description of the rationale and details of the exercise programme implemented in the EFIBAR Study (Ejercicio FÍsico tras cirugía BARiátrica), a randomised controlled trial investigating 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, physical activity and quality of life (secondary outcomes) in patients with severe/morbid obesity following bariatric surgery.

Methods

A total of 80 BS patients [60–80% expected women, aged 18 to 60 years, body mass index (BMI) ≥ 40 kg/m2 or ≥ 35 kg/m2 with comorbid conditions)] will be enrolled in the EFIBAR Randomized Control Trial (RCT). Participants allocated in the exercise group (n = 40) will undertake a 16-week supervised concurrent (strength and aerobic) exercise programme (three sessions/week, 60 min/session), starting 7 to 14 days after surgery. The rationale of the exercise programme will be described following the CERT criteria detailing the 16 key items. The study has been reviewed and approved by the Ethics Committee of the Torrecárdenas University Hospital (Almería, Spain) (ref. N° 76/2016).

Discussion

The present study details the exercise programme of the EFIBAR RCT, which may serve: 1) exercise professionals who would like to implement an evidence-based exercise programme for BS patients, and 2) as an example of the application of the CERT criteria.

Trial registration

The trial was prospectively registered at Clinicaltrials.gov NCT03497546 on April 13, 2018.
Appendix
Available only for authorised users
Literature
1.
Ribaric G, Buchwald JN, McGlennon TW. Diabetes and weight in comparative studies of bariatric surgery vs conventional medical therapy: a systematic review and meta-analysis. Obes Surg. 2014;24:437–55.CrossRefPubMed
2.
Sjöström L, Lindroos A-K, Peltonen M, Torgerson J, Bouchard C, Carlsson B, et al. Lifestyle, diabetes, and cardiovascular risk factors 10 years after bariatric surgery. N Engl J Med. 2004;351:2683–93.CrossRefPubMed
3.
Courcoulas AP, Christian NJ, Belle SH, Berk PD, Flum DR, Garcia L, et al. Weight change and health outcomes at 3 years after bariatric surgery among individuals with severe obesity. JAMA. 2013;310:2416–25.PubMedPubMedCentral
4.
Magro DO, Geloneze B, Delfini R, Pareja BC, Callejas F, Pareja JC. Long-term weight regain after gastric bypass: a 5-year prospective study. Obes Surg. 2008;18:648–51.CrossRefPubMed
5.
Steele T, Cuthbertson DJ, Wilding JPH. Impact of bariatric surgery on physical functioning in obese adults. Obes Rev. 2015;16:248–58.CrossRefPubMed
6.
Shah M, Simha V, Garg A. Review: long-term impact of bariatric surgery on body weight, comorbidities, and nutritional status. J Clin Endocrinol Metab. 2006;91:4223–31.CrossRefPubMed
7.
Bond DS, Vithiananthan S, Thomas JG, Trautvetter J, Unick JL, Jakicic JM, et al. Bari-active: a randomized controlled trial of a preoperative intervention to increase physical activity in bariatric surgery patients. Surg Obes Relat Dis. 2015;11:169–77.CrossRefPubMed
8.
Obesity: Identification, Assessment and Management of Overweight and Obesity in Children, Young People and Adults: Partial Update of CG43. Natl Inst Health Clin Excell Guid. London: National Institute for Health and Care Excellence; 2014.
9.
Josbeno DA, Jakicic JM, Hergenroeder A, Eid GM. Physical activity and physical function changes in obese individuals after gastric bypass surgery. Surg Obes Relat Dis. 2010;6:361–6.CrossRefPubMed
10.
Yale CE. Gastric surgery for morbid obesity. Complications and long-term weight control. Arch Surg. 1989;124:941–6.CrossRefPubMed
11.
Wittgrove AC, Clark GW. Laparoscopic gastric bypass, Roux-en-Y- 500 patients: technique and results, with 3–60 month follow-up. Obes Surg. 2000;10:233–9.CrossRefPubMed
12.
13.
Bellicha A, Ciangura C, Poitou C, Portero P, Oppert J-M. Effectiveness of exercise training after bariatric surgery-a systematic literature review and meta-analysis. Obes Rev. 2018;19:1544–56.CrossRefPubMed
14.
Ballor DL, Katch VL, Becque MD, Marks CR. Resistance weight training during caloric restriction enhances lean body weight maintenance. Am J Clin Nutr. 1988;47:19–25.CrossRefPubMed
15.
Geliebter A, Maher MM, Gerace L, Gutin B, Heymsfield SB, Hashim SA. Effects of strength or aerobic training on body composition, resting metabolic rate, and peak oxygen consumption in obese dieting subjects. Am J Clin Nutr. 1997;66:557–63.CrossRefPubMed
16.
Montero D, Roberts CK, Vinet A. Effect of aerobic exercise training on arterial stiffness in obese populations : a systematic review and meta-analysis. Sports Med. 2014;44:833–43.CrossRefPubMed
17.
Coen PM, Goodpaster BH. A role for exercise after bariatric surgery? Diabetes Obes Metab. 2016;18:16–23.CrossRefPubMed
18.
Slade SC, Dionne CE, Underwood M, Buchbinder R. Consensus on Exercise Reporting Template (CERT): Explanation and Elaboration Statement. Br J Sports Med. 2016;50:1428–37.CrossRefPubMed
19.
Slade SC, Keating JL. Exercise prescription: a case for standardised reporting. Br J Sports Med. 2012;46:1110–3.CrossRefPubMed
20.
Soriano-Maldonado A, Villa-González E, Ferrer-Márquez M, Artero EG. Replicability of exercise programs following bariatric surgery. Atherosclerosis. 2018;278:330–1.CrossRefPubMed
21.
Mechanick JI, Youdim A, Jones DB, Garvey WT, Hurley DL, McMahon MM, et al. Clinical practice guidelines for the perioperative nutritional, metabolic, and nonsurgical support of the bariatric surgery patient--2013 update: cosponsored by American Association of Clinical Endocrinologists, The Obesity Society, and American Society f. Obesity. 2013;21(Suppl 1):S1–27.CrossRefPubMed
22.
Colton T, Armitage P. Encyclopedia of biostatistics. New York: Wiley; 2005.
23.
WHO. WHO, Global recommendations on physical activity for health. Switzerland; 2010.
24.
American College of Sports Medicine. American College of Sports Medicine position stand. Progression models in resistance training for healthy adults. Med Sci Sports Exerc. 2014;41:687–708.
25.
Chlif M, Chaouachi A, Ahmaidi S. Effect of aerobic exercise training on ventilatory efficiency and respiratory drive in obese subjects. Respir Care. 2017;62:936–46.CrossRefPubMed
26.
Jones TW, Howatson G, Russell M, French DN. Effects of strength and endurance exercise order on endocrine responses to concurrent training. Eur J Sport Sci. 2017;17:326–34.CrossRefPubMed
27.
28.
Pedersen BK, Saltin B. Exercise as medicine–evidence for prescribing exercise as therapy in 26 different chronic diseases. Scand J Med Sci Sports. 2015;25:1–72.CrossRefPubMed
29.
Garber CE, Blissmer B, Deschenes MR, Franklin BA, Lamonte MJ, Lee IM, et al. American College of Sports Medicine position stand. Quantity and quality of exercise for developing and maintaining cardiorespiratory, musculoskeletal, and neuromotor fitness in apparently healthy adults: guidance for prescribing exercise. Br J Sports Med. 2011;43:1334–59.
30.
Castello-Simoes V, Polaquini Simoes R, Beltrame T, Bassi D, Maria Catai A, Arena R, et al. Effects of aerobic exercise training on variability and heart rate kinetic during submaximal exercise after gastric bypass surgery--a randomized controlled trial. Disabil Rehabil. 2013;35:334–42.CrossRefPubMed
31.
McGill SM, Karpowicz A. Exercises for spine stabilization: motion/motor patterns, stability progressions, and clinical technique. Arch Phys Med Rehabil. 2009;90:118–26.CrossRefPubMed
32.
Coleman KJ, Caparosa SL, Nichols JF, Fujioka K, Koebnick C, McCloskey KN, et al. Understanding the capacity for exercise in post-bariatric patients. Obes Surg. 2017;27:51–8.CrossRefPubMedPubMedCentral
33.
Huck CJ. Effects of supervised resistance training on fitness and functional strength in patients succeeding bariatric surgery. J strength Cond Res. 2015;29:589–95.CrossRefPubMed
34.
Vincent HK, Vincent KR. Considerations for initiating and progressing running programs in obese individuals. PM R. 2013;5:513–9.CrossRefPubMed
35.
36.
Coquart JB, Tourny-Chollet C, Lemaitre F, Lemaire C, Grosbois JM, Garcin M. Relevance of the measure of perceived exertion for the rehabilitation of obese patients. Ann Phys Rehabil Med. 2012;55:623–40.CrossRefPubMed
37.
Lagally KM, Robertson RJ. Construct validity of the OMNI resistance exercise scale. J Strength Cond Res. 2006;20:252–6.PubMed
38.
Ferrari R, Kruel LF, Cadore EL, Alberton CL, Izquierdo M, Conceicao M, et al. Efficiency of twice weekly concurrent training in trained elderly men. Exp Gerontol. 2013;48:1236–42.CrossRefPubMed
39.
Ferrari R, Fuchs SC, Kruel LF, Cadore EL, Alberton CL, Pinto RS, et al. Effects of different concurrent resistance and aerobic training frequencies on muscle power and muscle quality in trained elderly men: a randomized clinical trial. Aging Dis. 2016;7:697–704.CrossRefPubMedPubMedCentral
40.
Schoenfeld BJ, Ratamess NA, Peterson MD, Contreras B, Sonmez GT, Alvar BA. Effects of different volume-equated resistance training loading strategies on muscular adaptations in well-trained men. J Strength Cond Res. 2014;28:2909–18.CrossRefPubMed
41.
Zapico AG, Benito PJ, Gonzalez-Gross M, Peinado AB, Morencos E, Romero B, et al. Nutrition and physical activity programs for obesity treatment (PRONAF study): methodological approach of the project. BMC Public Health. 2012;12:1100.CrossRefPubMedPubMedCentral
42.
Schoenfeld BJ. The mechanisms of muscle hypertrophy and their application to resistance training. J Strength Cond Res. 2010;24:2857–72.CrossRefPubMed
43.
Colado JC, Garcia-Masso X, Triplett NT, Calatayud J, Flandez J, Behm D, et al. Construct and concurrent validation of a new resistance intensity scale for exercise with thera-band(R) elastic bands. Br J Sports Med. 2014;13:758–66.
44.
Swift DL, Dover SE, Nevels TR, Solar CA, Brophy PM, Hall TR, et al. The intervention composed of aerobic training and non-exercise physical activity (I-CAN) study: Rationale, design and methods. Contemp Clin Trials. 2015;45(Pt B):435–42.CrossRefPubMed
45.
Zamuner AR, Moreno MA, Camargo TM, Graetz JP, Rebelo AC, Tamburus NY, et al. Assessment of subjective perceived exertion at the anaerobic threshold with the Borg CR-10 scale. Br J Sports Med. 2011;10:130–6.
46.
Soriano-Maldonado A, Márquez MF, Artero EG. Pain and physical function following bariatric surgery. JAMA. 2016;316:770–1.CrossRefPubMed
47.
Artero EG, Ferrer-Márquez M, Soriano-Maldonado A. When will physical activity be routinely measured in the clinical setting? The case for bariatric surgery. Am J Hypertens. 2016;29:e1.CrossRefPubMed
48.
McAuley E. Self-efficacy and the maintenance of exercise participation in older adults. J Behav Med. 1993;16:103–13.CrossRefPubMed
49.
Gonzalez-Cutre D, Sicilia A, Beas-Jimenez M, Hagger MS. Broadening the trans-contextual model of motivation: a study with Spanish adolescents. Scand J Med Sci Sports. 2014;24:e306–19.CrossRefPubMed
50.
Hecimovich MD, Peiffer JJ, Harbaugh AG. Development and psychometric evaluation of a post exercise exhaustion scale utilising the Rasch measurement model. Psychol Sport Exerc. 2014;15:569–79.CrossRef
51.
52.
Hoffmann TC, Erueti C, Glasziou PP. Poor description of non-pharmacological interventions: analysis of consecutive sample of randomised trials. BMJ. 2013;347:f3755.CrossRefPubMedPubMedCentral
53.
Huck CJ. Effects of supervised resistance training on fitness and functional strength in patients succeeding bariatric surgery. J Strength Cond Res. 2015;29:589–95.CrossRefPubMed
54.
Colato A, Abreu F, Medeiros N, Lemos L, Dorneles G, Ramis T, et al. Effects of concurrent training on inflammatory markers and expression of CD4, CD8, and HLA-DR in overweight and obese adults. J Exerc Sci Fit. 2014;12:55–61.CrossRef
55.
Muth ND, Vargo K, Bryant CX. The role of the fitness professional in the clinical setting. Curr Sports Med Rep. 2015;14:301–12.CrossRefPubMed
56.
Woodard CM, Berry MJ. Enhancing adherence to prescribed exercise: structured behavioral interventions in clinical exercise programs. J Cardiopulm Rehabil. 2001;21:201–9.CrossRefPubMed
57.
Wiklund M, Olsen MF, Willen C. Physical activity as viewed by adults with severe obesity, awaiting gastric bypass surgery. Physiother Res Int. 2011;16:179–86.PubMed
Metadata
Title
Supervised exercise following bariatric surgery in morbid obese adults: CERT-based exercise study protocol of the EFIBAR randomised controlled trial
Authors
Emilio Villa-González
Yaira Barranco-Ruiz
Manuel A. Rodríguez-Pérez
Alejandro Carretero-Ruiz
José María García-Martínez
Alba Hernández-Martínez
María José Torrente-Sánchez
Manuel Ferrer-Márquez
Alberto Soriano-Maldonado
Enrique G. Artero
On behalf of the EFIBAR Study Group
Publication date
01-12-2019
Publisher
BioMed Central
Published in
BMC Surgery / Issue 1/2019
Electronic ISSN: 1471-2482
DOI
https://doi.org/10.1186/s12893-019-0566-9

Other articles of this Issue 1/2019

BMC Surgery 1/2019 Go to the issue

Research article

C-reactive protein elevation ratio as an early predictor of postoperative severe complications after laparoscopic gastrectomy for gastric cancer: a retrospective study

Research article

Doppler-guided transanal hemorrhoidal dearterilization versus conventional hemorrhoidectomy for treatment of hemorrhoids – early and long-term postoperative results

Case report

Acute burst fracture in Kummell’s disease with acute onset neurological deficit: a case report on role of spinal stability and technical notes on “pivot ligamentotaxis”

Research article

Comparison of clinical outcomes of expansive open-door laminoplasty with unilateral or bilateral fixation and fusion for treating cervical spondylotic myelopathy: a multi-center prospective study

Research article

Perioperative fluid dynamics evaluated by bioelectrical impedance analysis predict infectious surgical complications after esophagectomy

Case report

Missed manubriosternal dislocation in patient with thoracolumbar fracture, a case report