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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | The duration of the program is 16-weeks, 3-times a week, for up to 50 minutes per session, starting 1 month after surgery, based on the recommendations of the WHO and the ACSM, because the guidelines for morbidly obese patients undergoing bariatric surgery are not defined. Information on exercises for morbidly obese adults is limited, so the exercise programs will follow the guidelines for adults aged 18 to 65 years healthy, with chronic diseases or disabilities |
|
| Control Group | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EXPOBAR | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Body weight | Weight evaluation will be done using a scale | 1 year |
| Height | Height evaluation will be done using a stadiometer | 1 year |
| Abdominal circumference | Abdominal circumference will be determined by a measuring tape | 1 year |
| HDL cholesterol in mg/dl | Blood sample | 1 year |
| LDL cholesterol in mg/dl | Blood sample | 1 year |
| Triglycerides in mg/dl | Blood sample | 1 year |
| Glucose in mg/dl | Blood sample | 1 year |
| Insulin in µIU/mL | Blood sample | 1 year |
| Glycated hemoglobin in % | Blood sample | 1 year |
| Alcohol intake |
| Measure | Description | Time Frame |
|---|---|---|
| Life Quality | Questionary "BAROS" as a self-report measure, validated for the Portuguese population specific for bariatric surgery | 1 year |
| Salivary amylase | Saliva harvest |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cláudia Amaro Dos Santos, PhD Student | Contact | 968575053 | +351 | cmendes@hevora.min-saude.pt |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cláudia Amaro dos Santos | Recruiting | Evora | 7000-758 | Portugal |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23430477 | Background | 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. | |
| 26934236 | Background | 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. |
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| ID | Term |
|---|---|
| D055948 | Sarcopenia |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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randomized controlled study
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Randomization is performed using a random selection method from the waiting list and the data will be coded and transferred to the database, depending on the intervention group and control group. Data analysis will be done statistically.
Each participant will be randomly assigned to each group after signing the informed consent and conducting the initial assessments. All laboratory samples and data collected will be identified with identification ID, safeguarding the confidentiality of the collected data.
At the end of this study, all participants of the control group will be offered the same intervention as the exercise group.
|
assessment of daily consumption through clinical data questionnaire |
| 1 year |
| Mean blood pressure | Evaluation with Sphygnomanonetro | 1 year |
| Concentration of ghrelin in pg/mg | blood ghrelin and leptin measurement | 1 year |
| Concentration of leptin in pg/mg | blood ghrelin and leptin measurement | 1 year |
| Lower limbs muscle strength | Lower limbs muscle strength will be evaluated with Biodex | 1 year |
| Upper limbs muscle strength | The muscle strength of the upper limbs will be evaluated by manual pressure dynamometry (Handgrip) | 1 year |
| Cardiorespiratory fitness | 6-minute walk test (TC6) | 1 year |
| Cardiorespiratory | Sit-to-stand test for 30 seconds | 1 year |
| 1 year |
| physical activity level | Accelerometers measure body movement, providing objective information about the frequency, intensity and duration of physical activity | 1 year |
| Glycemia Variation in mg/dl | Evaluation continues through an implantable device for 5 days | 1 year |
| Universidade de Évora | Recruiting | Evora | Portugal |
|
| 28292619 | Background | 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. |
| 31095079 | Background | 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. |
| 21104041 | Background | 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. |
| 31363961 | Background | 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. |
| 28262676 | Background | 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. |
| 29549212 | Background | 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. |
| 27692906 | Background | 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. |
| 26537269 | Background | 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. |
| 33294073 | Background | 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. |
| 28028821 | Background | 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. |
| 32195937 | Background | 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. |
| 31488115 | Background | 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. |
| 29758061 | Background | 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. |
| 41299127 | Derived | Mendes C, Carvalho M, Bravo J, Martins S, Zangao O, Raimundo A. The Impact of an Exercise Program on Health-related Quality of Life (SarQoL) in Patients with Preoperative Sarcopenic Obesity After Bariatric Surgery: A Randomized Controlled Trial. Obes Surg. 2025 Dec;35(12):5000-5012. doi: 10.1007/s11695-025-08326-1. Epub 2025 Nov 26. |
| 40804223 | Derived | Mendes C, Carvalho M, Cabo CA, Bravo J, Martins S, Raimundo A. Effect of a 16-Week Exercise Program After Bariatric Surgery on Sarcopenia Parameters Based on FNIH, EWGSOP2, and EASO/ESPEN Criteria: the Results of the EXPOBAR Randomized Trial Program. Obes Surg. 2025 Sep;35(9):3553-3568. doi: 10.1007/s11695-025-08142-7. Epub 2025 Aug 13. |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D001519 | Behavior |