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Trial record 74 of 1645 for:    Slovakia

Molecular Mediators of Physical Exercise and Carnosine Induced Effects in Patients With Preclinical and Early Stage Neurodegenerative Disease

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ClinicalTrials.gov Identifier: NCT03330470
Recruitment Status : Recruiting
First Posted : November 6, 2017
Last Update Posted : September 17, 2018
Sponsor:
Collaborators:
Comenius University
University Hospital Bratislava
National Cheng Kung University
Information provided by (Responsible Party):
Barbara Ukropcová, MD, PhD, Slovak Academy of Sciences

Brief Summary:
The purpose of this study is to investigate the beneficial effects of regular exercise and the impact of food supplement carnosine on cognitive, motoric and metabolic functions as well as on specific biologically active substances in volunteers with subjective (SCI) or mild (MCI) cognitive impairment, as well as in patients in early stages of Parkinson's disease. The investigators assume the immediate intervention-associated health benefit for volunteers.

Condition or disease Intervention/treatment Phase
Subjective Cognitive Impairment Mild Cognitive Impairment Parkinson Disease Healthy Volunteers Behavioral: exercise Dietary Supplement: carnosine supplementation Behavioral: stretching Dietary Supplement: supplementation with placebo Not Applicable

Detailed Description:

Standard Operating Procedures for patient recruitment, data collection, data management, data analysis routinely used in Biomedical Research Center, Slovak Academy of Sciences, University Hospital Bratislava and Comenius University, Bratislava will be employed.

Statistical analysis will be employed to address the primary and secondary objectives, as specified in the study protocol.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Molecular Mediators of Physical Exercise and Carnosine Induced Effects in Patients With Preclinical and Early Stage Neurodegenerative Disease
Actual Study Start Date : January 1, 2017
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: exercise and carnosine supplementation
exercise: participants will be subjected to 3 months supervised exercise intervention carnosine supplementation: participants will be instructed to take carnosine 2 times daily
Behavioral: exercise
participants will be subjected to 3 months supervised exercise intervention

Dietary Supplement: carnosine supplementation
participants will be instructed to take carnosine 2 times daily

Experimental: exercise and supplementation with placebo
exercise: participants will be subjected to 3 months supervised exercise intervention supplementation with placebo: participants will be instructed to take placebo 2 times daily
Behavioral: exercise
participants will be subjected to 3 months supervised exercise intervention

Dietary Supplement: supplementation with placebo
participants will be instructed to take placebo 2 times daily

Experimental: stretching controls and carnosine supplementation
stretching controls: participants will be subjected to 3 months supervised stretching program carnosine supplementation: participants will be instructed to take carnosine 2 times daily
Dietary Supplement: carnosine supplementation
participants will be instructed to take carnosine 2 times daily

Behavioral: stretching
participants will be subjected to 3 months supervised stretching program

Experimental: stretching controls and supplementation with placebo
stretching controls: participants will be subjected to 3 months supervised stretching program supplementation with placebo: participants will be instructed to take placebo 2 times daily
Behavioral: stretching
participants will be subjected to 3 months supervised stretching program

Dietary Supplement: supplementation with placebo
participants will be instructed to take placebo 2 times daily




Primary Outcome Measures :
  1. glucose tolerance [ Time Frame: up to 36 months ]
    changes in glucose tolerance will be determined with oral glucose tolerance test (2h glucose, mmol/l)

  2. learning/working memory [ Time Frame: up to 36 months ]
    exercise related changes in learning/working memory will be determined with the aid of Addenbrook's cognitive test (maximum test score 100)

  3. motoric functions - Berg Balance Scale [ Time Frame: up to 36 months ]
    exercise related changes in motoric functions will be determined with the aid of Berg Balance Scale (maximum score 56)


Secondary Outcome Measures :
  1. habitual physical activity [ Time Frame: up to 36 months ]
    Habitual physical activity will be determined with accelerometers

  2. physical fitness [ Time Frame: up to 36 months ]
    Submaximal aerobic capacity will be determined with one mile walk test



Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Signed informed consent
  • Age 55 - 80 years
  • Presence of Subjective Cognitive Impairment (SCI), Mild Cognitive Impairment (MCI) or early stage of Parkinson's Disease (Hoehn-Yahr 1st-2nd stage), assessed by experienced neurologist

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03330470


Contacts
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Contact: Barbara Ukropcová, Assoc. Prof., MD, PhD +421 2 32295 2261 barbara.ukropcova@savba.sk

Locations
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Slovakia
University Hospital Bratislava, Comenius University Active, not recruiting
Bratislava, Slovakia, 81369
Biomedical Research Center, Slovak Academy of Sciences Recruiting
Bratislava, Slovakia, 84505
Contact: Barbara Ukropcová, Assoc. Prof., MD, PhD    +421 2 32295 2261    barbara.ukropcova@savba.sk   
Principal Investigator: Jozef Ukropec, DrSC., PhD         
Sub-Investigator: Lucia Slobodová, Mgr.         
Sub-Investigator: Martin Schon, MD         
Taiwan
Laboratory of Cognitive Neurophysiology, Institute of Physical Education, Health & Leisure Studies, National Cheng Kung University Active, not recruiting
Tainan City, Tainan, Taiwan, 701
Sponsors and Collaborators
Slovak Academy of Sciences
Comenius University
University Hospital Bratislava
National Cheng Kung University
Investigators
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Principal Investigator: Peter Turčáni, Prof., MD, PhD University Hospital Bratislava, Comenius University, Bratislava,
Principal Investigator: Peter Valkovič, Prof., MD, PhD University Hospital Bratislava, Comenius University, Bratislava,
Principal Investigator: Barbara Ukropcová, Assoc. Prof., MD, PhD Biomedical Research Center, Slovak Academy of Sciences,
Principal Investigator: Jozef Ukropec, DrSc, PhD Biomedical Research Center, Slovak Academy of Sciences,

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Responsible Party: Barbara Ukropcová, MD, PhD, Assoc. Prof. MD, PhD, Slovak Academy of Sciences
ClinicalTrials.gov Identifier: NCT03330470     History of Changes
Other Study ID Numbers: 15-0253
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: September 17, 2018
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Parkinson Disease
Neurodegenerative Diseases
Cognitive Dysfunction
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Cognition Disorders
Neurocognitive Disorders
Mental Disorders