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

Primary Purpose

Mild Cognitive Impairment, Alzheimer Disease, Parkinson Disease

Status
Completed
Phase
Not Applicable
Locations
Slovakia
Study Type
Interventional
Intervention
3 months exercise intervention program
Sponsored by
Slovak Academy of Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Mild Cognitive Impairment focused on measuring MicroRNAs, exercise, skeletal muscle, metabolism

Eligibility Criteria

60 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Univeristy Hospital in Bratislava
  • Inst. Exp. Endocrinology Slovak Acad Sci

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

'3 months exercise intervention program'

Arm Description

all participants will be subjected to 3 months supervised exercise intervention programme

Outcomes

Primary Outcome Measures

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.
whole body energy metabolism
changes in whole body energy metabolism will be determined with indirect calorimetry. & oral glucose tolerance test
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
motoric function
Proton (1H)-magnetic resonance spectroscopy - brain imaging and spectroscopy, motoric - balance testing

Secondary Outcome Measures

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.

Full Information

First Posted
September 25, 2014
Last Updated
April 14, 2018
Sponsor
Slovak Academy of Sciences
Collaborators
University Hospital Bratislava
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1. Study Identification

Unique Protocol Identification Number
NCT02253732
Brief Title
Skeletal Muscle as a Mediator of Exercise Induced Effects on Metabolism & Cognitive Function: Role for Myokines & miRNAs
Acronym
Brain-Muscle
Official Title
Skeletal Muscle as a Mediator of Exercise Induced Effects on Metabolism & Cognitive Function: Role for Myokines & miRNAs
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
September 2015 (Actual)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
March 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Slovak Academy of Sciences
Collaborators
University Hospital Bratislava

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment, Alzheimer Disease, Parkinson Disease, Healthy Volunteers
Keywords
MicroRNAs, exercise, skeletal muscle, metabolism

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
'3 months exercise intervention program'
Arm Type
Experimental
Arm Description
all participants will be subjected to 3 months supervised exercise intervention programme
Intervention Type
Behavioral
Intervention Name(s)
3 months exercise intervention program
Intervention Description
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 Outcome Measure Information:
Title
muscle microRNAs and myokines
Description
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.
Time Frame
up to 24 months
Title
whole body energy metabolism
Description
changes in whole body energy metabolism will be determined with indirect calorimetry. & oral glucose tolerance test
Time Frame
up to 24 months
Title
cognitive function
Description
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
Time Frame
up to 24 months
Title
motoric function
Description
Proton (1H)-magnetic resonance spectroscopy - brain imaging and spectroscopy, motoric - balance testing
Time Frame
up to 30 months
Secondary Outcome Measure Information:
Title
Muscle functional tests
Description
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.
Time Frame
up to 30 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Valkovic, MD, PhD
Organizational Affiliation
University Hospital Bratislava
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Stanislav Sutovsky, MD, PhD
Organizational Affiliation
University Hospital Bratislava
Official's Role
Study Chair
Facility Information:
Facility Name
Univeristy Hospital in Bratislava
City
Bratislava
ZIP/Postal Code
81369
Country
Slovakia
Facility Name
Inst. Exp. Endocrinology Slovak Acad Sci
City
Bratislava
ZIP/Postal Code
83306
Country
Slovakia

12. IPD Sharing Statement

Citations:
PubMed Identifier
29312123
Citation
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.
Results Reference
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Skeletal Muscle as a Mediator of Exercise Induced Effects on Metabolism & Cognitive Function: Role for Myokines & miRNAs

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