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
|Condition or disease||Intervention/treatment||Phase|
|Mild Cognitive Impairment Alzheimer Disease Parkinson Disease Healthy Volunteers||Behavioral: 3 months exercise intervention program||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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
- 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.
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
|Univeristy Hospital in Bratislava|
|Bratislava, Slovakia, 81369|
|Inst. Exp. Endocrinology Slovak Acad Sci|
|Bratislava, Slovakia, 83306|
|Study Chair:||Peter Valkovic, MD, PhD||University Hospital Bratislava|
|Study Chair:||Stanislav Sutovsky, MD, PhD||University Hospital Bratislava|