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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 17, 2018
Sponsor:
Collaborator:
University Hospital Bratislava
Information provided by (Responsible Party):
Jozef Ukropec, Slovak Academy of Sciences

Study Description
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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.

Study Design
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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

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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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.


Eligibility Criteria
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Ages Eligible for Study:   60 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT02253732


Locations
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Slovakia
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
Investigators
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Study Chair: Peter Valkovic, MD, PhD University Hospital Bratislava
Study Chair: Stanislav Sutovsky, MD, PhD University Hospital Bratislava
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Jozef Ukropec, PhD, Slovak Academy of Sciences
ClinicalTrials.gov 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:
MicroRNAs
exercise
skeletal muscle
metabolism
Additional relevant MeSH terms:
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Parkinson Disease
Alzheimer Disease
Cognitive Dysfunction
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Movement Disorders
Neurodegenerative Diseases
Dementia
Tauopathies
Neurocognitive Disorders
Mental Disorders
Cognition Disorders