Clinical trial NCT02253732: Skeletal Muscle as a Mediator of Exercise Induced Effects on Metabolism & Cognitive Function: Role for Myokines & miRNAs
Official title: Skeletal Muscle as a Mediator of Exercise Induced Effects on Metabolism & Cognitive Function: Role for Myokines & miRNAs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Cognitive Impairment
Alzheimer Disease
Parkinson Disease
Healthy Volunteers
Keywords: MicroRNAs
exercise
skeletal muscle
metabolism
Lead sponsor: Slovak Academy of Sciences
Sponsor class: OTHER_GOV
Collaborators: name: University Hospital Bratislava
First posted: 2014-10-01
Enrollment: 30
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: muscle microRNAs and myokines
timeFrame: up to 24 months
measure: whole body energy metabolism
timeFrame: up to 24 months
measure: cognitive function
timeFrame: up to 24 months
measure: motoric function
timeFrame: up to 30 months
Secondary outcomes:
measure: Muscle functional tests
timeFrame: up to 30 months
Other outcomes:
Locations:
city: Bratislava
country: Slovakia
facility: Univeristy Hospital in Bratislava
city: Bratislava
country: Slovakia
facility: Inst. Exp. Endocrinology Slovak Acad Sci
Study officials:
affiliation: University Hospital Bratislava
name: Peter Valkovic, MD, PhD
role: STUDY_CHAIR
affiliation: University Hospital Bratislava
name: Stanislav Sutovsky, MD, PhD
role: STUDY_CHAIR
References:
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.