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Bariatric-metabolic Surgery - the Effect of Postoperative Exercising on Sarcopenia (SarxOb)

Primary Purpose

Sarcopenia, Obesity, Sarcopenic Obesity

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Laparoscopic sleeve gastrectomy
Strength endurance training
Sponsored by
Masaryk University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sarcopenia focused on measuring obesity, bariatric surgery, weight loss, sarcopenia, muscle, exercise, magnetic resonance imaging, gait, kinematics, kinetics, cartilage surfaces

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Body mass index 30-50 kg/m2
  • ability to understand informed consent
  • signed informed consent
  • patient's residence within 100 km from Ostrava Czech Republic

Exclusion Criteria:

  • History of gastric surgery
  • acute gastric ulcers or inflammation
  • Type 1 Diabetes mellitus
  • celiac disease
  • history of malignity
  • previous bariatric-metabolic surgery or endoscopic obesity treatment,
  • specific genetic and humoral diseases connected to obesity (Prader-Willi syndrome, mutation of melanocortin receptor 4, etc.)
  • history of knee surgery
  • non MRI compatible patients' devices and implants
  • severe hematological diseases
  • acute or chronic pancreatitis
  • cirrhosis
  • severe psychiatric diseases
  • uncontrolled hypertense
  • immunological diseases
  • long-term corticoid therapy
  • uncontrolled thyroid diseases
  • renal insufficiency
  • alcohol abuse

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    controlled group

    active group

    Arm Description

    25 patients after bariatric-metabolic surgery without controlled postprocedural training

    25 patients after bariatric-metabolic surgery with controlled postprocedural training

    Outcomes

    Primary Outcome Measures

    changes of lean mass by DXA measures (in kg/m2)
    higher values mean better result
    fat infiltration of muscles by MRI (in %)
    lower content of fat means better result
    muscle strength by handgrip dynamometer (in kg)
    higher values in this physical performance test mean better result
    muscle strength by walk test (in m)
    higher values in this physical performance test mean better result
    muscle strength by Timed Up and Go test (in s)
    lower values in this physical performance test mean better result
    thickness of cartilage surface of the knee by MRI (in mm)
    higher values mean better result

    Secondary Outcome Measures

    changes of fat mass by DXA measures (in kg/m2)
    lower values mean better result

    Full Information

    First Posted
    October 23, 2020
    Last Updated
    November 1, 2020
    Sponsor
    Masaryk University
    Collaborators
    Hospital AGEL Ostrava-Vitkovice, University of Ostrava
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04617392
    Brief Title
    Bariatric-metabolic Surgery - the Effect of Postoperative Exercising on Sarcopenia
    Acronym
    SarxOb
    Official Title
    Research of Sarcopenia in Patients After Bariatric-metabolic Surgery - the Effect of Programmed Aerobic and Power Exercising on the Functionality, Volume and Morphology of Muscle Tissue
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2020
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 1, 2021 (Anticipated)
    Primary Completion Date
    December 31, 2022 (Anticipated)
    Study Completion Date
    December 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Masaryk University
    Collaborators
    Hospital AGEL Ostrava-Vitkovice, University of Ostrava

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The investigators' study published in 2020 (Pekar, M. et al.: The risk of sarcopenia 24 months after bariatric surgery - assessment by dual energy X-ray absorptiometry (DEXA): a prospective study; Videosurgery Miniinv 2020; https://doi.org/10.5114/wiitm.2020.93463) shows that patients are at risk of sar-copenia after bariatric-metabolic (BM) surgery. BM surgery leads to significant changes in body composition. Significant fat loss is followed by unwanted muscle loss. The study shows that the lack of physical activity is typical for these patients. To the algorithm of postoperative care the investigators plan to include controlled exercise programs for these patients. The investigators do not know what the complexity and time required to keep patients in good condition and reduce the risk of sarcopenia is. The investigators want to find the adequate amount of physical activity while maintaining long-term compliance of these patients.
    Detailed Description
    Obesity is an important medical problem. The number of obese individuals is increasing continuously in response to various environmental and genetic factors. For some morbidly obese patients, surgery is the only effective type of therapy. Despite bariatric surgery having good outcomes in terms of weight loss, it is associated with some adverse effects: several studies have reported subsequent alterations in bone and muscle metabolism, patients are getting in risk of sarcopenia. Of the surgical techniques available (laparoscopic gastric banding, Roux-en-Y bypass, biliopancreatic diversion), laparoscopic sleeve gastrectomy (LSG) is currently the technique of choice. This type of surgery leads to significant changes in body composition. Significant fat loss is followed by unwanted muscle loss. To the algorithm of postoperative care the investigators plan to include controlled exercise programs for these patients. The investigators do not know what the complexity and time required to keep patients in good condition and reduce the risk of sarcopenia is. The investigators want to find the adequate amount of physical activity while maintaining long-term compliance of these patients. The study has been designed as a prospective randomized study, which is in conformity with the principles and guidelines of the Helsinki Declaration, good clinical practice and will be approved by the Ethical Committee of the Hospital AGEL Ostrava-Vitkovice, Czech Republic. Potential study participants will undergo an initial examination at the clinical department of the surgical department specializing in obesity. In addition to professional surgical and internal examination, the potential patient will be examined by a clinical psychologist for the ability to participate in this type of study for a long time. Informed consent will be provided to selected study participants. 50 patients who undergo surgery will be randomized in two cohorts: Cohort 1: obese patients with LSG: 25 patients with controlled aerobic / anaerobic activity Cohort 2: obese LSG patients 25 patients without controlled physical activity The patients enrolled in the study are followed for the period of 24 months. Individual will be evaluated before the bariatric procedure and 3, 6, 12, 18 and 24 months after the procedure. Primary goal of the study is to evaluate the Hypothesis 0 : there is no difference between muscle function, volume and morphology between patients after BM operations who are no longer controlled by physical activity and between patients who undergo controlled regular exercise programs under professional supervision. Secondary objectives: Monitoring of knee cartilage during weight reduction after bariatric surgery and monitoring of gait biomechanics during weight reduction after bariatric surgery Patients undergo the following examinations: Weight: body weight will be measured on a calibrated scale. The measurement itself will be performed in underwear, without shoes. Waist circumference: the circumference will be measured using a fixed tape measure. Body composition: measurement of body composition of obese individuals will be performed using DXA (Dual-emission X-ray absorptiometry, Discovery A, Hologic). Examination of muscle mass and muscle strength: Muscle mass: measurement of the composition and structure of skeletal muscles and fat in the thigh will be performed using MRI (Magnetic Resonance Imaging) Muscle strength: the measurement will be performed using a battery of tests: handgrip dynamometer, chair-stand-walk test, test of getting up from a chair, test of 400 meters walk Physical activity: physical activity questionnaire controlled regular exercise programs: patients will be divided into two cohorts - with and without physical intervention. Patients included in the intervention cohort with physical activity will undergo three months of strength endurance training under the supervision of a professional physiotherapist. Quality of life: calibrated 36-Item Short Form Health Survey (SF-36) and The Impact of Weight on Quality of Life (IWQOL) questionnaire Biochemical analyzes: Blood samples will be taken from each test subject after 12 hours of fasting by venipuncture before the actual bariatric procedure and then repeatedly in the follow-up period after the procedure. The samples will be centrifuged under standard conditions and the concentrations of the following substances will then be determined in the serum samples: • glucose, glycated hemoglobin, alkaline phosphatase, total calcium, phosphates, parathyroid hormone, total protein, albumin, aspartate aminotransferase, alanine aminotransferase, gamma-glutamyltransferase, creatinine. After determination of these analytes, serum (plasma) aliquots will be frozen at -80 ° C until analysis of other selected parameters. WITHDRAWAL FROM THE STUDY Persons involved in the study may terminate their participation or be excluded from the study at any time for the following reasons: Death of the subject Voluntary withdrawal from the study: the subject voluntarily decides not to continue in the next part of the study. Loss from follow-up: the subject does not show up for scheduled inspections more than one month after the scheduled inspection or examination. Risk / benefit ratio: while evaluating the results during follow-up, the clinical coordinator finds that continuing the study is not in the best interests of the subject with respect to the subject.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Sarcopenia, Obesity, Sarcopenic Obesity
    Keywords
    obesity, bariatric surgery, weight loss, sarcopenia, muscle, exercise, magnetic resonance imaging, gait, kinematics, kinetics, cartilage surfaces

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    controlled group
    Arm Type
    Active Comparator
    Arm Description
    25 patients after bariatric-metabolic surgery without controlled postprocedural training
    Arm Title
    active group
    Arm Type
    Experimental
    Arm Description
    25 patients after bariatric-metabolic surgery with controlled postprocedural training
    Intervention Type
    Procedure
    Intervention Name(s)
    Laparoscopic sleeve gastrectomy
    Intervention Description
    Sleeve gastrectomy involves removing a part of the stomach, limiting the amount of food the patient can eat.
    Intervention Type
    Other
    Intervention Name(s)
    Strength endurance training
    Intervention Description
    Patients included in the active cohort arm with physical activity will undergo three months of strength endurance training under the supervision of a professional physiotherapist
    Primary Outcome Measure Information:
    Title
    changes of lean mass by DXA measures (in kg/m2)
    Description
    higher values mean better result
    Time Frame
    24 months
    Title
    fat infiltration of muscles by MRI (in %)
    Description
    lower content of fat means better result
    Time Frame
    24 months
    Title
    muscle strength by handgrip dynamometer (in kg)
    Description
    higher values in this physical performance test mean better result
    Time Frame
    24 months
    Title
    muscle strength by walk test (in m)
    Description
    higher values in this physical performance test mean better result
    Time Frame
    24 months
    Title
    muscle strength by Timed Up and Go test (in s)
    Description
    lower values in this physical performance test mean better result
    Time Frame
    24 months
    Title
    thickness of cartilage surface of the knee by MRI (in mm)
    Description
    higher values mean better result
    Time Frame
    24 months
    Secondary Outcome Measure Information:
    Title
    changes of fat mass by DXA measures (in kg/m2)
    Description
    lower values mean better result
    Time Frame
    24 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Body mass index 30-50 kg/m2 ability to understand informed consent signed informed consent patient's residence within 100 km from Ostrava Czech Republic Exclusion Criteria: History of gastric surgery acute gastric ulcers or inflammation Type 1 Diabetes mellitus celiac disease history of malignity previous bariatric-metabolic surgery or endoscopic obesity treatment, specific genetic and humoral diseases connected to obesity (Prader-Willi syndrome, mutation of melanocortin receptor 4, etc.) history of knee surgery non MRI compatible patients' devices and implants severe hematological diseases acute or chronic pancreatitis cirrhosis severe psychiatric diseases uncontrolled hypertense immunological diseases long-term corticoid therapy uncontrolled thyroid diseases renal insufficiency alcohol abuse
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Matej Pekar, Ph.D., MD
    Phone
    00420595633308
    Email
    matej.pekar@gmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    28251287
    Citation
    Beaudart C, Dawson A, Shaw SC, Harvey NC, Kanis JA, Binkley N, Reginster JY, Chapurlat R, Chan DC, Bruyere O, Rizzoli R, Cooper C, Dennison EM; IOF-ESCEO Sarcopenia Working Group. Nutrition and physical activity in the prevention and treatment of sarcopenia: systematic review. Osteoporos Int. 2017 Jun;28(6):1817-1833. doi: 10.1007/s00198-017-3980-9. Epub 2017 Mar 1.
    Results Reference
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    PubMed Identifier
    26620911
    Citation
    Bosaeus I, Rothenberg E. Nutrition and physical activity for the prevention and treatment of age-related sarcopenia. Proc Nutr Soc. 2016 May;75(2):174-80. doi: 10.1017/S002966511500422X. Epub 2015 Dec 1.
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    Citation
    CARSOTE, Mara, Razvan PETRESCU, Adriana Elena NICA, Adina GHEMIGIAN, Dan Nicolae PADURARU a Ana VALEA. BARIATRIC SURGERY AND OSTEOPO-ROSIS. Romanian Medical Journal [online]. 2016, 63(4), 297-299 [cit. 2020-10-12]. ISSN 12205478.
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    Citation
    CARVALHO, Nara, Vinícius BACCIN, Narriane HOLANDA, João FILHO, Marta CA-RVALHO, Gitana SILVA, Flávia PIMENTA a José ALVES. SUN-542 Comparison of Different Muscle Mass Indices for Evaluation of Low Muscle Mass Regarding Muscle Function, Bone Mineral Density and Metabolic Profile in Obese Patients Prior to Bariatric Surgery. Journal of the Endocrine Society [online]. 2019, 3 [cit. 2020-10-12]. ISSN 24721972.
    Results Reference
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    Links:
    URL
    https://pubmed.ncbi.nlm.nih.gov/30312372/
    Description
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