Effects of Physical Exercise on Sarcopenia After Bariatric Surgery

NCT05289219 | Unknown

• 1 other identifier: 21051
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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

Conditions

Sarcopenic Obesity; Bariatric Surgery Candidate

Keywords

bariatric surgery; quality of life; metabolic risk factors,; fat-free mass; sarcopenia; exercise

Outcome Measures

Primary Outcomes (17)

• 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

  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

Secondary Outcomes (4)

• Life Quality

  1 year

• Salivary amylase

  1 year

• physical activity level

  1 year

• Glycemia Variation in mg/dl

  1 year

Study Arms (2)

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

Behavioral: EXPOBAR

Control Group

NO INTERVENTION

Interventions

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.

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged between 18 years and 60 years
• Contraindication to the practice of exercise
• Agree to participate in the study

You may not qualify if:

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

Sponsors & Collaborators

• University of Évora: lead

Study Sites (2)

Cláudia Amaro dos Santos

Evora, 7000-758, Portugal

RECRUITING

Universidade de Évora

Evora, Portugal

RECRUITING

Related Publications (17)

• 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.

  PMID: 23430477 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.

  PMID: 26934236 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.

  PMID: 28292619 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.

  PMID: 31095079 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.

  PMID: 21104041 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.

  PMID: 31363961 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.

  PMID: 28262676 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.

  PMID: 29549212 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.

  PMID: 27692906 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.

  PMID: 26537269 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.

  PMID: 33294073 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.

  PMID: 28028821 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.

  PMID: 32195937 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.

  PMID: 31488115 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.

  PMID: 29758061 BACKGROUND

• 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.

  PMID: 41299127 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.

  PMID: 40804223 DERIVED

MeSH Terms

Conditions

Sarcopenia; Motor Activity

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Behavior

Central Study Contacts

Cláudia Amaro Dos Santos, PhD Student

CONTACT

968575053; cmendes@hevora.min-saude.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: randomized controlled study

Study Record Dates

• First Submitted: February 15, 2022
• First Posted: March 21, 2022
• Study Start: September 1, 2021
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2023
• Last Updated: March 21, 2022

Record last verified: 2022-03

Locations

PT (2)