Mild Cognitive ImpairmentBrain-MuscleNCT02253732
Skeletal Muscle as a Mediator of Exercise Induced Effects on Metabolism & Cognitive Function: Role for Myokines & miRNAs
A study testing 3 months exercise intervention program in people with Mild Cognitive Impairment and Alzheimer Disease, run by Slovak Academy of Sciences at 2 sites in Slovakia.
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. Read more about this study
- Who is it for?
- Ages 60 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment, Alzheimer Disease, Parkinson Disease
- What is being tested?
- 3 months exercise intervention program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesSlovakia
- Study dates
- Sep 2015to Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Signed informed consent.
- Diagnosed with Parkinson disease
- Diagnosed with mild cognitive impairment (MCI) or Alzheimer disease (AD)
Who cannot join
- Serious systemic cardiovascular, hepatic, renal disease, cancer.
- Lack of compliance.
Trial locations and contacts
2 sites in 1 country.
Slovakia2 sites
Univeristy Hospital in Bratislava
Bratislava, 81369
Inst. Exp. Endocrinology Slovak Acad Sci
Bratislava, 83306
About this study
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.
Read the 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.
- Being tested
- 3 months exercise intervention program
- Keywords
- MicroRNAs, exercise, skeletal muscle, metabolism
- Medical subject headings
- Cognitive Dysfunction, Alzheimer Disease, Parkinson Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3 months exercise intervention programBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| '3 months exercise intervention program' | Experimental | all participants will be subjected to 3 months supervised exercise intervention programme Receives: Behavioral: 3 months exercise intervention program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 24 months
whole body energy metabolism
changes in whole body energy metabolism will be determined with indirect calorimetry. \& oral glucose tolerance test
Measured: 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
Measured: up to 24 months
motoric function
Proton (1H)-magnetic resonance spectroscopy - brain imaging and spectroscopy, motoric - balance testing
Measured: up to 30 months
Secondary outcomes (1)
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.
Measured: up to 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2014 (estimated)
- Study startSep 2015
- Primary completionSep 2017
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Slovak Academy of Sciences
- Sponsor type
- Other government
- Collaborators
- University Hospital Bratislava
- Responsible party
- Principal investigator, Jozef Ukropec, Slovak Academy of Sciences
- Investigators
- Peter Valkovic, MD, PhD, Study chair, University Hospital BratislavaStanislav Sutovsky, MD, PhD, Study chair, University Hospital Bratislava
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02253732
- Sponsor's protocol ID
- UEE-SAS
- Acronym
- Brain-Muscle
- Status last verified
- Apr 2018
- First submitted
- 25 Sep 2014
- Last updated
- 17 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 29312123
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skeletal Muscle as a Mediator of Exercise Induced Effects on Metabolism & Cognitive Function: Role for Myokines & miRNAs
- ClinicalTrials.gov ID
- NCT02253732
- Acronym / sponsor ID
- Brain-Muscle / UEE-SAS
- Keywords
- MicroRNAs, exercise, skeletal muscle, metabolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Slovak Academy of SciencesOther government
- Collaborators
- University Hospital Bratislava
- Study start
- Sep 2015 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 1 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| '3 months exercise intervention program' | Experimental | Behavioral: 3 months exercise intervention programall participants will be subjected to 3 months supervised exercise intervention programme |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Signed informed consent.
- Diagnosed with Parkinson disease
- Diagnosed with mild cognitive impairment (MCI) or Alzheimer disease (AD)
Key exclusion criteria (2 listed)
- Serious systemic cardiovascular, hepatic, renal disease, cancer.
- Lack of compliance.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3 months exercise intervention program3 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 | Behavioural | '3 months exercise intervention program' |
Primary outcome
muscle microRNAs and myokines
Time frame: up to 24 months
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
Time frame: up to 24 months
changes in whole body energy metabolism will be determined with indirect calorimetry. \& oral glucose tolerance test
cognitive function
Time frame: up to 24 months
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
Time frame: up to 30 months
Proton (1H)-magnetic resonance spectroscopy - brain imaging and spectroscopy, motoric - balance testing
1 secondary outcome
Muscle functional tests
Time frame: up to 30 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2018.
- Derived from this study: PubMed 29312123Krumpolec 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Valkovic, MD, PhD study chair
University Hospital Bratislava
Stanislav Sutovsky, MD, PhD study chair
University Hospital Bratislava
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3 months exercise intervention program in people with Mild Cognitive Impairment and Alzheimer Disease, run by Slovak Academy of Sciences at 2 sites in Slovakia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Slovakia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
muscle microRNAs and myokines (time frame: up to 24 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02253732, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2018.