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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Skeletal Muscle as a Mediator of Exercise Induced Effects on Metabolism & Cognitive Function: Role for Myokines & miRNAs

Conditions
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Mild Cognitive Impairment, Alzheimer Disease, Parkinson Disease, Healthy Volunteers

Intervention / Treatment
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* Behavioral: 3 months exercise intervention program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed informed consent. Diagnosed with Parkinson disease Diagnosed with mild cognitive impairment (MCI) or Alzheimer disease (AD) Exclusion Criteria: Serious systemic cardiovascular, hepatic, renal disease, cancer. Lack of compliance.

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: '3 months exercise intervention program'<br>all participants will be subjected to 3 months supervised exercise intervention programme | Behavioral: 3 months exercise intervention program<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| muscle microRNAs and myokines | 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. | up to 24 months | 
| whole body energy metabolism | changes in whole body energy metabolism will be determined with indirect calorimetry. & oral glucose tolerance test | up to 24 months | 
| cognitive function | 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 | up to 24 months | 
| motoric function | Proton (1H)-magnetic resonance spectroscopy - brain imaging and spectroscopy, motoric - balance testing | up to 30 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle functional tests | 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. | up to 30 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MicroRNAs, exercise, skeletal muscle, metabolism