NCT04617392

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2021

Longer than P75 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 23, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 5, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

November 5, 2020

Status Verified

November 1, 2020

Enrollment Period

2 years

First QC Date

October 23, 2020

Last Update Submit

November 1, 2020

Conditions

SarcopeniaObesitySarcopenic Obesity

Keywords

obesitybariatric surgeryweight losssarcopeniamuscleexercisemagnetic resonance imaginggaitkinematicskineticscartilage surfaces

Outcome Measures

Primary Outcomes (6)

  • changes of lean mass by DXA measures (in kg/m2)

    higher values mean better result

    24 months

  • fat infiltration of muscles by MRI (in %)

    lower content of fat means better result

    24 months

  • muscle strength by handgrip dynamometer (in kg)

    higher values in this physical performance test mean better result

    24 months

  • muscle strength by walk test (in m)

    higher values in this physical performance test mean better result

    24 months

  • muscle strength by Timed Up and Go test (in s)

    lower values in this physical performance test mean better result

    24 months

  • thickness of cartilage surface of the knee by MRI (in mm)

    higher values mean better result

    24 months

Secondary Outcomes (1)

  • changes of fat mass by DXA measures (in kg/m2)

    24 months

Study Arms (2)

controlled group

ACTIVE COMPARATOR

25 patients after bariatric-metabolic surgery without controlled postprocedural training

Procedure: Laparoscopic sleeve gastrectomy

active group

EXPERIMENTAL

25 patients after bariatric-metabolic surgery with controlled postprocedural training

Procedure: Laparoscopic sleeve gastrectomyOther: Strength endurance training

Interventions

Laparoscopic sleeve gastrectomyPROCEDURE

Sleeve gastrectomy involves removing a part of the stomach, limiting the amount of food the patient can eat.

active groupcontrolled group
Strength endurance trainingOTHER

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

active group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (10)

  • 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.

    PMID: 28251287BACKGROUND

  • 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.

    PMID: 26620911BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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

    BACKGROUND

  • 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.

    PMID: 32565081BACKGROUND

  • 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.

    PMID: 32409493BACKGROUND

  • 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.

    PMID: 30382930BACKGROUND

  • 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.

    PMID: 23555016BACKGROUND

  • 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.

    PMID: 20727625BACKGROUND

Related Links

MeSH Terms

Conditions

SarcopeniaObesityWeight LossMotor Activity

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and SymptomsOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightBody Weight ChangesBehavior

Central Study Contacts

Matej Pekar, Ph.D., MD

CONTACT

00420595633308matej.pekar@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2020

First Posted

November 5, 2020

Study Start

January 1, 2021

Primary Completion

December 31, 2022

Study Completion

December 31, 2024

Last Updated

November 5, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share