NCT02253732

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2015

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 25, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 1, 2014

Completed
11 months until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

April 17, 2018

Status Verified

April 1, 2018

Enrollment Period

2 years

First QC Date

September 25, 2014

Last Update Submit

April 14, 2018

Conditions

Mild Cognitive ImpairmentAlzheimer DiseaseParkinson DiseaseHealthy Volunteers

Keywords

MicroRNAsexerciseskeletal musclemetabolism

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (1)

  • Muscle functional tests

    up to 30 months

Study Arms (1)

'3 months exercise intervention program'

EXPERIMENTAL

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

Behavioral: 3 months exercise intervention program

Interventions

3 months exercise intervention programBEHAVIORAL

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

'3 months exercise intervention program'

Eligibility Criteria

Age60 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Signed informed consent.
  • Diagnosed with Parkinson disease
  • Diagnosed with mild cognitive impairment (MCI) or Alzheimer disease (AD)

You may not qualify if:

  • Serious systemic cardiovascular, hepatic, renal disease, cancer.
  • Lack of compliance.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Univeristy Hospital in Bratislava

Bratislava, 81369, Slovakia

Location

Inst. Exp. Endocrinology Slovak Acad Sci

Bratislava, 83306, Slovakia

Location

Related Publications (1)

  • 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.

    PMID: 29312123DERIVED

MeSH Terms

Conditions

Cognitive DysfunctionAlzheimer DiseaseParkinson DiseaseMotor Activity

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersDementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesParkinsonian DisordersBasal Ganglia DiseasesMovement DisordersSynucleinopathiesBehavior

Study Officials

  • Peter Valkovic, MD, PhD

    University Hospital Bratislava

    STUDY CHAIR

  • Stanislav Sutovsky, MD, PhD

    University Hospital Bratislava

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

September 25, 2014

First Posted

October 1, 2014

Study Start

September 1, 2015

Primary Completion

September 1, 2017

Study Completion

March 1, 2018

Last Updated

April 17, 2018

Record last verified: 2018-04

Locations

SL(2)