Working… Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02253732
Recruitment Status : Completed
First Posted : October 1, 2014
Last Update Posted : April 17, 2018
University Hospital Bratislava
Information provided by (Responsible Party):
Jozef Ukropec, Slovak Academy of Sciences

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.

Condition or disease Intervention/treatment Phase
Mild Cognitive Impairment Alzheimer Disease Parkinson Disease Healthy Volunteers Behavioral: 3 months exercise intervention program Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Skeletal Muscle as a Mediator of Exercise Induced Effects on Metabolism & Cognitive Function: Role for Myokines & miRNAs
Actual Study Start Date : September 2015
Actual Primary Completion Date : September 2017
Actual Study Completion Date : March 2018

Arm Intervention/treatment
Experimental: '3 months exercise intervention program'
all participants will be subjected to 3 months supervised exercise intervention programme
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

Primary Outcome Measures :
  1. 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.

  2. 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

  3. 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

  4. motoric function [ Time Frame: up to 30 months ]
    Proton (1H)-magnetic resonance spectroscopy - brain imaging and spectroscopy, motoric - balance testing

Secondary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   60 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02253732

Layout table for location information
Univeristy Hospital in Bratislava
Bratislava, Slovakia, 81369
Inst. Exp. Endocrinology Slovak Acad Sci
Bratislava, Slovakia, 83306
Sponsors and Collaborators
Slovak Academy of Sciences
University Hospital Bratislava
Layout table for investigator information
Study Chair: Peter Valkovic, MD, PhD University Hospital Bratislava
Study Chair: Stanislav Sutovsky, MD, PhD University Hospital Bratislava
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Jozef Ukropec, PhD, Slovak Academy of Sciences Identifier: NCT02253732    
Other Study ID Numbers: UEE-SAS
First Posted: October 1, 2014    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: April 2018
Keywords provided by Jozef Ukropec, Slovak Academy of Sciences:
skeletal muscle
Additional relevant MeSH terms:
Layout table for MeSH terms
Parkinson Disease
Alzheimer Disease
Cognitive Dysfunction
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders