Effects of Physical Exercise on Sarcopenia After Bariatric Surgery

Bariatric Surgery Candidate Clinical Trial

— EXPOBAR  

Official title:

Effects of Physical Exercise on Sarcopenia After Bariatric Surgery: Protocol of a Randomized Controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05289219
• Other study ID #: 21051
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: December 2023

Study information

• Verified date: March 2022
• Source: University of Évora
• Contact: Cláudia Amaro Dos Santos, PhD Student
• Phone: 968575053
• Email: cmendes[@]hevora.min-saude.pt
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study will include 60 patients awaiting bariatric surgery. They will be randomized into 2 groups, experimental and control. The intervention will take place 1 month after surgery, for a total of 16 weeks. Parameters of body composition, metabolic risk, quality of life, physical activity and sedentary behavior will be determined

Description:

Bariatric surgery is the treatment of severe obesity with associated pathologies, with proven evidence in its benefits. Treating overweight allows a better and even reversal of pathologies associated with obesity. In this context, we know that physical exercise is important in the process of weight loss, however, and especially in bariatric surgery, the characteristics of physical activity are not consensual, as well as the effect of programs and physical exercise in this population. Weight loss associated with bariatric surgery is greatly associated with a significant reduction of skeletal muscle and bone mineral mass, which leads us to induce that after bariatric surgery, patients incur an increased risk of sarcopenia. The need for prophylactic programs that prevent sarcopenia in bariatric surgery patients seems to be one of the crucial points for the framing of long-term surgical success of bariatric and metabolic surgery. This randomized clinical trial will aim to study the effects of a 16-week supervised exercise intervention program on the prevention of sarcopenia after bariatric surgery This randomized controlled trial study will include 60 patients of both sexes on the waiting list for bariatric surgery and who have subsequently performed the surgery. They will be randomized into 2 groups, experimental and control. The intervention will take place 1 month after surgery, for a total of 16 weeks. Parameters of body composition, metabolic risk, quality of life, physical activity, and sedentary behavior will be determined. Assessments will take place in five moments, the surgery, the intervention, the post-intervention, six months after the intervention, twelve months after the intervention.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• As inclusion criteria, patients should be enrolled for bariatric surgery at the hospital
• Aged between 18 years and 60 years
• Contraindication to the practice of exercise
• Agree to participate in the study

Exclusion Criteria:

• Patients with problems in locomotion
• Surgical complications
• Psychiatric diseases and neurological disorders

Related Conditions & MeSH terms

• Bariatric Surgery Candidate
• Sarcopenia
• Sarcopenic Obesity

Intervention

Behavioral:
• EXPOBAR
Each session will start with 5 minutes of warm-up and finalization with 10 minutes of a cool-down, with work of flexibility and proprioception. The maintenance of balance and postural stability may be compromised in obese individuals, depending on the degree of obesity, although the support base provided by the position of the foot is proportional to the structural morphology of each subject. Flexibility is also gradually impaired in obese individuals and of course, these changes may be related to postural changes aggravated by a sedentary lifestyle and biological aging itself alongside all metabolic alterations inherent to the pathology of obesity (Benetti et al., 2016). And the warm-up and the cool-down will be developed as the component of training with the evolution by phases, both in time and in intensity. The first phase will include 20 minutes of interval training, encompassing circuit strength training. Each phase will have an increment of 10 minutes in the central block.

Locations

Country	Name	City	State
Portugal	Cláudia Amaro dos Santos	Évora
Portugal	Universidade de Évora	Évora

Sponsors (1)

Lead Sponsor	Collaborator
University of Évora

Country where clinical trial is conducted

Portugal, 

References & Publications (15)

Baillot A, Mampuya WM, Comeau E, Méziat-Burdin A, Langlois MF. Feasibility and impacts of supervised exercise training in subjects with obesity awaiting bariatric surgery: a pilot study. Obes Surg. 2013 Jul;23(7):882-91. doi: 10.1007/s11695-013-0875-5. — View Citation

Benetti FA, Bacha IL, Garrido Junior AB, Greve JM. Analyses of balance and flexibility of obese patients undergoing bariatric surgery. Clinics (Sao Paulo). 2016 Feb;71(2):78-81. doi: 10.6061/clinics/2016(02)05. — View Citation

Broughton DE, Moley KH. Obesity and female infertility: potential mediators of obesity's impact. Fertil Steril. 2017 Apr;107(4):840-847. doi: 10.1016/j.fertnstert.2017.01.017. Epub 2017 Mar 11. Review. — View Citation

Campbell WW, Kraus WE, Powell KE, Haskell WL, Janz KF, Jakicic JM, Troiano RP, Sprow K, Torres A, Piercy KL, Bartlett DB; 2018 PHYSICAL ACTIVITY GUIDELINES ADVISORY COMMITTEE*. High-Intensity Interval Training for Cardiometabolic Disease Prevention. Med Sci Sports Exerc. 2019 Jun;51(6):1220-1226. doi: 10.1249/MSS.0000000000001934. — View Citation

Castello V, Simões RP, Bassi D, Catai AM, Arena R, Borghi-Silva A. Impact of aerobic exercise training on heart rate variability and functional capacity in obese women after gastric bypass surgery. Obes Surg. 2011 Nov;21(11):1739-49. doi: 10.1007/s11695-010-0319-4. — View Citation

de Oliveira LF, Tisott CG, Silvano DM, Campos CM, do Nascimento RR. GLYCEMIC BEHAVIOR IN 48 HOURS POSTOPERATIVE PERIOD OF PATIENTS WITH TYPE 2 DIABETES MELLITUS AND NON DIABETIC SUBMITTED TO BARIATRIC SURGERY. Arq Bras Cir Dig. 2015;28 Suppl 1:26-30. doi: 10.1590/S0102-6720201500S100009. English, Portuguese. — View Citation

Hanvold SE, Vinknes KJ, Løken EB, Hjartåker A, Klungsøyr O, Birkeland E, Risstad H, Gulseth HL, Refsum H, Aas AM. Does Lifestyle Intervention After Gastric Bypass Surgery Prevent Weight Regain? A Randomized Clinical Trial. Obes Surg. 2019 Nov;29(11):3419-3431. doi: 10.1007/s11695-019-04109-7. — View Citation

Herring LY, Stevinson C, Carter P, Biddle SJH, Bowrey D, Sutton C, Davies MJ. The effects of supervised exercise training 12-24 months after bariatric surgery on physical function and body composition: a randomised controlled trial. Int J Obes (Lond). 2017 Jun;41(6):909-916. doi: 10.1038/ijo.2017.60. Epub 2017 Mar 6. — View Citation

Jassil FC, Carnemolla A, Kingett H, Paton B, O'Keeffe AG, Doyle J, Morris S, Lewis N, Kirk A, Pucci A, Chaiyasoot K, Batterham RL. Protocol for a 1-year prospective, longitudinal cohort study of patients undergoing Roux-en-Y gastric bypass and sleeve gastrectomy: the BARI-LIFESTYLE observational study. BMJ Open. 2018 Mar 16;8(3):e020659. doi: 10.1136/bmjopen-2017-020659. — View Citation

Kalinowski P, Paluszkiewicz R, Wróblewski T, Remiszewski P, Grodzicki M, Bartoszewicz Z, Krawczyk M. Ghrelin, leptin, and glycemic control after sleeve gastrectomy versus Roux-en-Y gastric bypass-results of a randomized clinical trial. Surg Obes Relat Dis. 2017 Feb;13(2):181-188. doi: 10.1016/j.soard.2016.08.025. Epub 2016 Aug 18. — View Citation

Pekar M, Pekarová A, Bužga M, Holéczy P, Soltes M. The risk of sarcopenia 24 months after bariatric surgery - assessment by dual energy X-ray absorptiometry (DEXA): a prospective study. Wideochir Inne Tech Maloinwazyjne. 2020 Dec;15(4):583-587. doi: 10.5114/wiitm.2020.93463. Epub 2020 Mar 4. — View Citation

Petta S, Ciminnisi S, Di Marco V, Cabibi D, Cammà C, Licata A, Marchesini G, Craxì A. Sarcopenia is associated with severe liver fibrosis in patients with non-alcoholic fatty liver disease. Aliment Pharmacol Ther. 2017 Feb;45(4):510-518. doi: 10.1111/apt.13889. Epub 2016 Dec 27. — View Citation

Soriano-Maldonado A, Martínez-Forte S, Ferrer-Márquez M, Martínez-Rosales E, Hernández-Martínez A, Carretero-Ruiz A, Villa-González E, Barranco-Ruiz Y, Rodríguez-Pérez MA, Torrente-Sánchez MJ, Carmona-Rodríguez L, Soriano-Maldonado P, Vargas-Hitos JA, Casimiro-Andújar AJ, Artero EG, Fernández-Alonso AM. Physical Exercise following bariatric surgery in women with Morbid obesity: Study protocol clinical trial (SPIRIT compliant). Medicine (Baltimore). 2020 Mar;99(12):e19427. doi: 10.1097/MD.0000000000019427. — View Citation

Villa-González E, Barranco-Ruiz Y, Rodríguez-Pérez MA, Carretero-Ruiz A, García-Martínez JM, Hernández-Martínez A, Torrente-Sánchez MJ, Ferrer-Márquez 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. — View Citation

Voican CS, Lebrun A, Maitre S, Lainas P, Lamouri K, Njike-Nakseu M, Gaillard M, Tranchart H, Balian A, Dagher I, Perlemuter G, Naveau S. Predictive score of sarcopenia occurrence one year after bariatric surgery in severely obese patients. PLoS One. 2018 May 14;13(5):e0197248. doi: 10.1371/journal.pone.0197248. eCollection 2018. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body weight	Weight evaluation will be done using a scale	1 year
Primary	Height	Height evaluation will be done using a stadiometer	1 year
Primary	Abdominal circumference	Abdominal circumference will be determined by a measuring tape	1 year
Primary	HDL cholesterol in mg/dl	Blood sample	1 year
Primary	LDL cholesterol in mg/dl	Blood sample	1 year
Primary	Triglycerides in mg/dl	Blood sample	1 year
Primary	Glucose in mg/dl	Blood sample	1 year
Primary	Insulin in µIU/mL	Blood sample	1 year
Primary	Glycated hemoglobin in %	Blood sample	1 year
Primary	Alcohol intake	assessment of daily consumption through clinical data questionnaire	1 year
Primary	Mean blood pressure	Evaluation with Sphygnomanonetro	1 year
Primary	Concentration of ghrelin in pg/mg	blood ghrelin and leptin measurement	1 year
Primary	Concentration of leptin in pg/mg	blood ghrelin and leptin measurement	1 year
Primary	Lower limbs muscle strength	Lower limbs muscle strength will be evaluated with Biodex	1 year
Primary	Upper limbs muscle strength	The muscle strength of the upper limbs will be evaluated by manual pressure dynamometry (Handgrip)	1 year
Primary	Cardiorespiratory fitness	6-minute walk test (TC6)	1 year
Primary	Cardiorespiratory	Sit-to-stand test for 30 seconds	1 year
Secondary	Life Quality	Questionary "BAROS" as a self-report measure, validated for the Portuguese population specific for bariatric surgery	1 year
Secondary	Salivary amylase	Saliva harvest	1 year
Secondary	physical activity level	Accelerometers measure body movement, providing objective information about the frequency, intensity and duration of physical activity	1 year
Secondary	Glycemia Variation in mg/dl	Evaluation continues through an implantable device for 5 days	1 year