Clinical trial NCT05289219: Effects of Physical Exercise on Sarcopenia After Bariatric Surgery
Official title: Effects of Physical Exercise on Sarcopenia After Bariatric Surgery: Protocol of a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sarcopenic Obesity
Bariatric Surgery Candidate
Keywords: bariatric surgery
quality of life
metabolic risk factors,
fat-free mass
sarcopenia
exercise
Lead sponsor: University of Évora
Sponsor class: OTHER
First posted: 2022-03-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled study
Primary purpose: PREVENTION

Brief 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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Body weight
timeFrame: 1 year
measure: Height
timeFrame: 1 year
measure: Abdominal circumference
timeFrame: 1 year
measure: HDL cholesterol in mg/dl
timeFrame: 1 year
measure: LDL cholesterol in mg/dl
timeFrame: 1 year
measure: Triglycerides in mg/dl
timeFrame: 1 year
measure: Glucose in mg/dl
timeFrame: 1 year
measure: Insulin in µIU/mL
timeFrame: 1 year
measure: Glycated hemoglobin in %
timeFrame: 1 year
measure: Alcohol intake
timeFrame: 1 year
measure: Mean blood pressure
timeFrame: 1 year
measure: Concentration of ghrelin in pg/mg
timeFrame: 1 year
measure: Concentration of leptin in pg/mg
timeFrame: 1 year
measure: Lower limbs muscle strength
timeFrame: 1 year
measure: Upper limbs muscle strength
timeFrame: 1 year
measure: Cardiorespiratory fitness
timeFrame: 1 year
measure: Cardiorespiratory
timeFrame: 1 year
Secondary outcomes:
measure: Life Quality
timeFrame: 1 year
measure: Salivary amylase
timeFrame: 1 year
measure: physical activity level
timeFrame: 1 year
measure: Glycemia Variation in mg/dl
timeFrame: 1 year
Other outcomes:
Locations:
city: Évora
country: Portugal
facility: Cláudia Amaro dos Santos
city: Évora
country: Portugal
facility: Universidade de Évora
Study officials:
References:
citation: Baillot A, Mampuya WM, Comeau E, Meziat-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.
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.
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.
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.
citation: Castello V, Simoes 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.
citation: Hanvold SE, Vinknes KJ, Loken EB, Hjartaker A, Klungsoyr 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.
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.
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.
citation: Kalinowski P, Paluszkiewicz R, Wroblewski 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.
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(Suppl 1):26-30. doi: 10.1590/S0102-6720201500S100009.
citation: Pekar M, Pekarova A, Buzga M, Holeczy 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.
citation: Petta S, Ciminnisi S, Di Marco V, Cabibi D, Camma C, Licata A, Marchesini G, Craxi 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.
citation: Soriano-Maldonado A, Martinez-Forte S, Ferrer-Marquez M, Martinez-Rosales E, Hernandez-Martinez A, Carretero-Ruiz A, Villa-Gonzalez E, Barranco-Ruiz Y, Rodriguez-Perez MA, Torrente-Sanchez MJ, Carmona-Rodriguez L, Soriano-Maldonado P, Vargas-Hitos JA, Casimiro-Andujar AJ, Artero EG, Fernandez-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.
citation: 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.
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.