Bariatric Surgery Candidate Clinical Trial
— EXPOBAROfficial title:
Effects of Physical Exercise on Sarcopenia After Bariatric Surgery: Protocol of a Randomized Controlled Study
NCT number | NCT05289219 |
Other study ID # | 21051 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | September 1, 2021 |
Est. completion date | December 2023 |
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
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 |
Country | Name | City | State |
---|---|---|---|
Portugal | Cláudia Amaro dos Santos | Évora | |
Portugal | Universidade de Évora | Évora |
Lead Sponsor | Collaborator |
---|---|
University of Évora |
Portugal,
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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
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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
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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
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* Note: There are 15 references in all — Click here to view all references
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 |
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