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

NCT ID: NCT02253732

Last Updated: 2018-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2018-03-31

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.

Conditions

Mild Cognitive Impairment; Alzheimer Disease; Parkinson Disease; Healthy Volunteers

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

'3 months exercise intervention program'

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

Group Type: EXPERIMENTAL

3 months exercise intervention program

Intervention Type: BEHAVIORAL

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

Interventions

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

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital Bratislava

OTHER

Sponsor Role: collaborator

Slovak Academy of Sciences

OTHER_GOV

Sponsor Role: lead

Responsible Party

Jozef Ukropec

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Peter Valkovic, MD, PhD

Role: STUDY_CHAIR

University Hospital Bratislava

Stanislav Sutovsky, MD, PhD

Role: STUDY_CHAIR

University Hospital Bratislava

Locations

Univeristy Hospital in Bratislava

Bratislava, , Slovakia

Inst. Exp. Endocrinology Slovak Acad Sci

Bratislava, , Slovakia

Countries

Slovakia

References

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.

Reference Type: DERIVED

PMID: 29312123 (View on PubMed)

Other Identifiers

UEE-SAS

Identifier Type: -

Identifier Source: org_study_id