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
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
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
NCT ID
NCT04617392
First Posted
October 23, 2020
Last Updated
November 1, 2020
Sponsor
Masaryk University
Collaborators
Hospital AGEL Ostrava-Vitkovice, University of Ostrava
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
background
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.
Results Reference
background
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.
Results Reference
background
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
background
Citation
CARVALHO, Nara, Caio LIMEIRA, Vinícius BACCIN, et al. SAT-LB018 Different Definitions of Sarcopenia and Its Correlations with Anthropometric Measure-ments, Body Composition, Handgrip Strength, Metabolic Profile and Bone Mine-ral Density in Obese Women. Journal of the Endocrine Society [online]. 2019, 3
Results Reference
background
PubMed Identifier
32565081
Citation
Ciudin A, Simo-Servat A, Palmas F, Barahona MJ. Sarcopenic obesity: a new challenge in the clinical practice. Endocrinol Diabetes Nutr (Engl Ed). 2020 Dec;67(10):672-681. doi: 10.1016/j.endinu.2020.03.004. Epub 2020 Jun 18. English, Spanish.
Results Reference
background
PubMed Identifier
32409493
Citation
Dantas WS, Roschel H, Murai IH, Gil S, Davuluri G, Axelrod CL, Ghosh S, Newman SS, Zhang H, Shinjo SK, das Neves W, Merege-Filho C, Teodoro WR, Capelozzi VL, Pereira RM, Benatti FB, de Sa-Pinto AL, de Cleva R, Santo MA, Kirwan JP, Gualano B. Exercise-Induced Increases in Insulin Sensitivity After Bariatric Surgery Are Mediated By Muscle Extracellular Matrix Remodeling. Diabetes. 2020 Aug;69(8):1675-1691. doi: 10.2337/db19-1180. Epub 2020 May 14. Erratum In: Diabetes. 2021 Jun;70(6):1415.
Results Reference
background
PubMed Identifier
30382930
Citation
Delgado Andre L, Basso-Vanelli RP, Di Thommazo-Luporini L, Angelica Ricci P, Cabiddu R, Pilon Jurgensen S, Ricardo de Oliveira C, Arena R, Borghi-Silva A. Functional and systemic effects of whole body electrical stimulation post bariatric surgery: study protocol for a randomized controlled trial. Trials. 2018 Oct 31;19(1):597. doi: 10.1186/s13063-018-2844-8.
Results Reference
background
PubMed Identifier
23555016
Citation
Esposito A, Campana L, Palmisano A, De Cobelli F, Canu T, Santarella F, Colantoni C, Monno A, Vezzoli M, Pezzetti G, Manfredi AA, Rovere-Querini P, Del Maschio A. Magnetic resonance imaging at 7T reveals common events in age-related sarcopenia and in the homeostatic response to muscle sterile injury. PLoS One. 2013;8(3):e59308. doi: 10.1371/journal.pone.0059308. Epub 2013 Mar 12.
Results Reference
background
PubMed Identifier
20727625
Citation
Gray C, MacGillivray TJ, Eeley C, Stephens NA, Beggs I, Fearon KC, Greig CA. Magnetic resonance imaging with k-means clustering objectively measures whole muscle volume compartments in sarcopenia/cancer cachexia. Clin Nutr. 2011 Feb;30(1):106-11. doi: 10.1016/j.clnu.2010.07.012. Epub 2010 Aug 19.
Results Reference
background
Links:
URL
https://pubmed.ncbi.nlm.nih.gov/30312372/
Description
Related Info
Learn more about this trial
Bariatric-metabolic Surgery - the Effect of Postoperative Exercising on Sarcopenia
We'll reach out to this number within 24 hrs