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Completed

NCT Number: NCT02253732

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

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.

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Key information

Conditions

Mild Cognitive Impairment Alzheimer Disease Basal Ganglia Diseases Behavior Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Dementia Healthy Volunteers Mental Disorders Motor Activity Movement Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies Tauopathies

Age range

60 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Inst. Exp. Endocrinology Slovak Acad Sci, Bratislava, Slovakia

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

3 months exercise intervention program

Behavioral

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Slovak Academy of Sciences

Other Gov

Collaborators

  • University Hospital Bratislava

Registry information

Acronym: Brain-Muscle

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
Oct 1, 2014
Registry last updated
Apr 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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