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Skeletal Muscle as a Mediator of Exercise Induced Effects on Metabolism & Cognitive Function: Role for Myokines & miRNAs (Brain-Muscle)

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ClinicalTrials.gov Identifier: NCT02253732
Recruitment Status : Completed
First Posted : October 1, 2014
Last Update Posted : April 18, 2018
Sponsor:
Collaborator:
University Hospital Bratislava
Information provided by (Responsible Party):
Jozef Ukropec, Slovak Academy of Sciences

Tracking Information
First Submitted Date  ICMJE September 25, 2014
First Posted Date  ICMJE October 1, 2014
Last Update Posted Date April 18, 2018
Actual Study Start Date  ICMJE September 2015
Actual Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 28, 2014)
  • muscle microRNAs and myokines [ Time Frame: up to 24 months ]
    We will determine muscle bioactive secretory products (myokines & miRNAs) that are regulated by acute bout of exercise in patients with neurodegenerative disease as well as in sedentary age, gender and BMI matched controls in association with their metabolic phenotype.
  • whole body energy metabolism [ Time Frame: up to 24 months ]
    changes in whole body energy metabolism will be determined with indirect calorimetry. & oral glucose tolerance test
  • cognitive function [ Time Frame: up to 24 months ]
    exercise related changes in cognitive & motoric functions will be determined with the aid of questionaires, and proton (1H)-magnetic resonance spectroscopy - brain imaging and spectroscopy
  • motoric function [ Time Frame: up to 30 months ]
    Proton (1H)-magnetic resonance spectroscopy - brain imaging and spectroscopy, motoric - balance testing
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 28, 2014)
Muscle functional tests [ Time Frame: up to 30 months ]
Dynamometry will be used to determine maximal voluntary contraction force and the rate of force development, and Phosphorus (31P)-magnetic resonance spectroscopy to measure muscle metabolism in vivo.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Skeletal Muscle as a Mediator of Exercise Induced Effects on Metabolism & Cognitive Function: Role for Myokines & miRNAs
Official Title  ICMJE Skeletal Muscle as a Mediator of Exercise Induced Effects on Metabolism & Cognitive Function: Role for Myokines & miRNAs
Brief Summary The purpose of this study is to determine specific changes in muscle secretory profile (myokines, miRNA) in association with neurodegenerative disease progression and metabolic dysfunction. Next the investigators would like to determine the shift in the muscle secretory activity induced by regular exercise intervention, which the investigators think could be translated into the beneficial changes in clinical phenotypes, determined by neuroimaging, cognitive function tests and metabolic phenotyping.
Detailed Description

Standard Operating Procedures for patient recruitment, data collection, data management, data analysis routinely used in University Hospital Bratislava and in Institute of Experimental Endocrinology Slovak Academy of Sciences will be employed.

Statistical analysis will be employed to address the primary and secondary objectives, as specified in the study protocol.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Mild Cognitive Impairment
  • Alzheimer Disease
  • Parkinson Disease
  • Healthy Volunteers
Intervention  ICMJE Behavioral: 3 months exercise intervention program
3 months exercise intervention program which is given 3-times per week, 60 min session duration, 65-75% repetition maximum or heart rate maximum, combined strength & aerobic exercises
Study Arms  ICMJE Experimental: '3 months exercise intervention program'
all participants will be subjected to 3 months supervised exercise intervention programme
Intervention: Behavioral: 3 months exercise intervention program
Publications * Krumpolec P, Vallova S, Slobodova L, Tirpakova V, Vajda M, Schon M, Klepochova R, Janakova Z, Straka I, Sutovsky S, Turcani P, Cvecka J, Valkovic L, Tsai CL, Krssak M, Valkovic P, Sedliak M, Ukropcova B, Ukropec J. Aerobic-Strength Exercise Improves Metabolism and Clinical State in Parkinson's Disease Patients. Front Neurol. 2017 Dec 22;8:698. doi: 10.3389/fneur.2017.00698. eCollection 2017.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 14, 2018)
30
Original Estimated Enrollment  ICMJE
 (submitted: September 28, 2014)
35
Actual Study Completion Date  ICMJE March 2018
Actual Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Signed informed consent.
  2. Diagnosed with Parkinson disease
  3. Diagnosed with mild cognitive impairment (MCI) or Alzheimer disease (AD)

Exclusion Criteria:

  1. Serious systemic cardiovascular, hepatic, renal disease, cancer.
  2. Lack of compliance.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Slovakia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02253732
Other Study ID Numbers  ICMJE UEE-SAS
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jozef Ukropec, Slovak Academy of Sciences
Study Sponsor  ICMJE Slovak Academy of Sciences
Collaborators  ICMJE University Hospital Bratislava
Investigators  ICMJE
Study Chair: Peter Valkovic, MD, PhD University Hospital Bratislava
Study Chair: Stanislav Sutovsky, MD, PhD University Hospital Bratislava
PRS Account Slovak Academy of Sciences
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP