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

Not Applicable

Completed

• Conditions: Alzheimer Disease; Healthy Volunteers; Parkinson Disease; Mild Cognitive Impairment
• Interventions: Behavioral: 3 months exercise intervention program

• Registration Number: NCT02253732
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2014-09-25
• Study First Submitted QC: 2014-09-28
• Study First Posted: 2014-10-01
• Study Start: 2015-09
• Primary Completion: 2017-09
• Study Completion: 2018-03
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-14
• Last Update Posted: 2018-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
'3 months exercise intervention program'	3 months exercise intervention program	all participants will be subjected to 3 months supervised exercise intervention programme

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Muscle functional tests	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.

Trial Locations

Locations (2)

Univeristy Hospital in Bratislava; 🇸🇰 Bratislava, Slovakia

Inst. Exp. Endocrinology Slovak Acad Sci; 🇸🇰 Bratislava, Slovakia