- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05232968
Ameliorating Effects of Aging by Physical Exercise (AMETHYST)
Ameliorating Effects of Aging by Physical Exercise: Molecular, Metabolic and Structural Adaptations, Multi-organ Integrative Approach
Study Overview
Status
Intervention / Treatment
Detailed Description
This interventional study will examine the effects of a comprehensive intervention associated with regular short-term (4 months) and long-term (≥2 years) exercise on the cognitive and motor functions of patients with mild cognitive impairment, as well as the effect of aging, physical activity profile and physical fitness on physiological functions (metabolism, motor skills, cognition) and bioactive molecules.
The study will be carried out in the Department of Internal Medicine and in the Center for Physical Activity Research of the Biomedical Center of the Slovak Academy of Sciences in Bratislava.
Recruitment and screening of seniors with MCI will be carried out by psychologists from the Memory Center in Bratislava (http://www.centrummemory.sk/) and neurologists from II. Department of Neurology LFUK and UNB. All volunteers will be informed in detail about the objectives of the study, the examinations and study protocol, the benefits as well as the potential risks associated with its completion and will sign an informed consent. The study protocol is approved by the ethics committee of the Bratislava.
The project aims to study the effects and mechanisms of the positive impact of regular physical activity and increased physical fitness on health and processes associated with aging, with emphasis on metabolic, cognitive and motor functions, physical fitness and bioactive molecules in the circulation and skeletal muscle. It therefore has real potential to reveal new physiologically important mechanisms, biomarkers or even potential molecular targets for the therapy of neurodegenerative and metabolic diseases. One of the important goals of the project is the implementation of the obtained results into clinical practice, in cooperation with clinicians, psychologists, trainers and special educators.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Barbora Ukropcova, Prof.
- Phone Number: +421911643630
- Email: barbara.ukropcova@sabva.sk
Study Locations
-
-
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Bratislava, Slovakia, 84505
- Recruiting
- Biomedical Research Center Slovak Academy of Sciences
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Contact:
- Barbara Ukropcova, Prof.
- Phone Number: +421911643630
- Email: barbara.ukropcova@savba.sk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 55-85 years of age,
- non-smokers
- complete vaccination against COVID19
- continuation in the supervised exercise program (for study of long-term effects of exercise experimental group)
- sedentary lifestyle ≥2 years prior this study (for group without intervention),
- mild cognitive impairment (for study of short-term effects of exercise experimental group)
- absence of any psychological, sociological or geographical factor that could jeopardize participation in the project.
Exclusion Criteria:
- any chronic disease (oncological, cardiovascular, neurological, liver, kidney or other diseases and its acute complications at the discretion of the doctor);
- no cooperation of probands;
- insufficient functional capacity - the presence comorbidities or disorders of the musculoskeletal system, which makes it impossible to complete the training program (assessment by cardiologist, or orthopedist or other specialist);
- smoking, alcohol or drugs abuse;
- non-compliance with epidemiological measures;
- absence of complete vaccination with SARS-CoV-2 vaccine;
- presence of a pacemaker or metal implants (contraindication for magnetic resonance imaging).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Elderly volunteers participating in the long-term exercise program
Elderly volunteers will be recruited from participants in the long-term exercise program (ongoing since 2017) at the Center of Physical Activity BMC SAS in Bratislava.
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Training intervention (aerobic-strength training) will combine a 1-hour aerobics training, which requires movement coordination, and two 1-hour lessons, combining strength load (25 minutes, 50-60% 1RM, which gradually increases in proportion to increasing strength, 8-12 repetitions, training all major muscle groups) and aerobic exercise (25 minutes of Nordic walking or stationary bike), with a short warm-up at the beginning and stretching at the end.
The individualized training program will be based on the determination of physical fitness (Rockport gait test) and muscle strength (dynamometry).
|
No Intervention: Elderly sedentary volunteers
Control population will be recruited from the sedentary elderly, who dropped out from the exercise program ≥2 years prior entering this study and do not exercise on regular basis.
|
|
Experimental: Elderly volunteers participating in the short-term exercise program
Elderly volunteers will follow 4-month of aerobic-strength training intervention and exercise induced effects on mild cognitive impairment will be determined afterwards.
|
Training intervention (aerobic-strength training) will combine a 1-hour aerobics training, which requires movement coordination, and two 1-hour lessons, combining strength load (25 minutes, 50-60% 1RM, which gradually increases in proportion to increasing strength, 8-12 repetitions, training all major muscle groups) and aerobic exercise (25 minutes of Nordic walking or stationary bike), with a short warm-up at the beginning and stretching at the end.
The individualized training program will be based on the determination of physical fitness (Rockport gait test) and muscle strength (dynamometry).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximal aerobic capacity
Time Frame: 4 months
|
Maximal aerobic capacity parameter of physical fitness will be determined by Rockport walking test (1609m).
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4 months
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Cognitive function testing
Time Frame: 4 months
|
All participants will receive extensive psychological testing (Montreal Cognitive Assessment), assessing cognitive domains: attention and concentration, executive functions, memory, language, visuo-constructional skills, conceptual thinking, calculations, and orientation.
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4 months
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Depressive symptoms
Time Frame: 4 months
|
All participants will receive Beck depression questionnaire to identify depressive symptoms.
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4 months
|
Olfactory function
Time Frame: 4 months
|
The sense of smell will be investigated using the extended "Sniffing' Sticks" test battery, standardized and reliable test used to measure odor thresholds, discrimination & identification.
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4 months
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Brain volumetry (MRI)
Time Frame: 4 months
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Brain MR scans will be performed at 3T PrismaFit scanner using a 64-channel head coil (Siemens Healthcare, Germany).
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4 months
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Molecular genetic analyses
Time Frame: 4 months
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Gene expression will be measured with the aid of qRT-PCR using TaqMan® Gene Expression Assays on the ABI 7900HT (Applied Biosystems, USA).
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4 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Barbora Ukropcova, Prof., Biomedical Research Center Slovak Academy of Sciences
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- APVV-20-0466
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- Study Protocol
- Clinical Study Report (CSR)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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