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

Healthy Volunteers Clinical Trial

— Brain-Muscle  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02253732
• Other study ID #: UEE-SAS
• Status: Completed
• Phase: N/A
• First received: September 25, 2014
• Last updated: April 14, 2018
• Start date: September 2015
• Est. completion date: March 2018

Study information

• Verified date: April 2018
• Source: Slovak Academy of Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 2018
• Est. primary completion date: September 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognitive Dysfunction
• Healthy Volunteers
• Mild Cognitive Impairment
• Parkinson Disease

Intervention

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

Locations

Country	Name	City	State
Slovakia	Inst. Exp. Endocrinology Slovak Acad Sci	Bratislava
Slovakia	Univeristy Hospital in Bratislava	Bratislava

Sponsors (2)

Lead Sponsor	Collaborator
Slovak Academy of Sciences	University Hospital Bratislava

Country where clinical trial is conducted

Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	whole body energy metabolism	changes in whole body energy metabolism will be determined with indirect calorimetry. & oral glucose tolerance test	up to 24 months
Primary	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
Primary	motoric function	Proton (1H)-magnetic resonance spectroscopy - brain imaging and spectroscopy, motoric - balance testing	up to 30 months
Secondary	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