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

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.

Study Overview

• Status: Completed
• Conditions: Parkinson Disease; Alzheimer Disease; Healthy Volunteers; Mild Cognitive Impairment
• Intervention / Treatment: Behavioral: 3 months exercise intervention program

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Slovakia
  • Bratislava, Slovakia, 81369
    • Univeristy Hospital in Bratislava
  • Bratislava, Slovakia, 83306
    • Inst. Exp. Endocrinology Slovak Acad Sci

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Slovak Academy of Sciences
• Collaborators: University Hospital Bratislava
• Investigators: Study Chair: Peter Valkovic, MD, PhD, University Hospital Bratislava; Study Chair: Stanislav Sutovsky, MD, PhD, University Hospital Bratislava

Publications and helpful links

General Publications

• Krumpolec P, Vallova S, Slobodova L, Tirpakova V, Vajda M, Schon M, Klepochova R, Janakova Z, Straka I, Sutovsky S, Turcani P, Cvecka J, Valkovic L, Tsai CL, Krssak M, Valkovic P, Sedliak M, Ukropcova B, Ukropec J. Aerobic-Strength Exercise Improves Metabolism and Clinical State in Parkinson's Disease Patients. Front Neurol. 2017 Dec 22;8:698. doi: 10.3389/fneur.2017.00698. eCollection 2017.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2015
• Primary Completion (Actual): September 1, 2017
• Study Completion (Actual): March 1, 2018

Study Registration Dates

• First Submitted: September 25, 2014
• First Submitted That Met QC Criteria: September 28, 2014
• First Posted (Estimate): October 1, 2014

Study Record Updates

• Last Update Posted (Actual): April 17, 2018
• Last Update Submitted That Met QC Criteria: April 14, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: exercise; metabolism; skeletal muscle; MicroRNAs
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Dementia; Tauopathies; Cognition Disorders; Parkinson Disease; Alzheimer Disease; Cognitive Dysfunction
• Other Study ID Numbers: UEE-SAS