AgingAMETHYSTNCT05232968
Ameliorating Effects of Aging by Physical Exercise
A study testing Long-term exercise program and Short-term exercise program in people with Aging and Exercise, run by Slovak Academy of Sciences at 1 site in Slovakia.
Trial summary
With increasing longevity, a significant increase in the incidence of neurodegenerative diseases is expected. According to forecasts based on data from the World Health Organization and data from epidemiological studies, up to 106 million people will have Alzheimer's disease in 2050, it's 1 in 85 people living on the… Read more about this study
- Who is it for?
- Ages 55 to 85 yearsHealthy volunteers can take part
- What is being tested?
- Long-term exercise program and Short-term exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSlovakia
- Study dates
- 10 Jan 2022to Dec 2025
- 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 55 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Slovakia1 site, 1 recruiting
- Recruiting
Biomedical Research Center Slovak Academy of Sciences
Bratislava, 84505
Barbara Ukropcova, Prof., +421911643630, barbara.ukropcova@savba.sk
About this study
Official title: Ameliorating Effects of Aging by Physical Exercise: Molecular, Metabolic and Structural Adaptations, Multi-organ Integrative Approach
With increasing longevity, a significant increase in the incidence of neurodegenerative diseases is expected. According to forecasts based on data from the World Health Organization and data from epidemiological studies, up to 106 million people will have Alzheimer's disease in 2050, it's 1 in 85 people living on the planet. If it will be possible to manage to delay the onset or slow the progression of the disease by a single year, it will mean 9.2 million fewer patients worldwide. This leaves considerable scope for options to modify the onset and prevalence of the disease through lifestyle changes such as eating habits and exercise. It is known that the human brain retains a certain natural plasticity even in old age, which is a great advantage that allows it to adapt to physiological stimuli, such as regular exercise. The pleiotropic beneficial effects of exercise therefore have considerable potential to be used in the prevention and slowing of the progression of cognitive and motor function decline as well as in the prevention / treatment of metabolic dysregulation. This fact is supported by many epidemiological and interventional studies with exercise, emphasizing the importance of the global trend to use exercise as a standardized method of prevention and treatment of many chronic diseases and cognitive deficits.
Read the 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.
- Being tested
- Long-term exercise program, Short-term exercise program
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Long-term exercise programOther
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).
Short-term exercise programOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Elderly volunteers participating in the long-term exercise program | Experimental | 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. Receives: Other: Long-term exercise program |
| Elderly sedentary volunteers | No intervention | 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. |
| Elderly volunteers participating in the short-term exercise program | Experimental | Elderly volunteers will follow 4-month of aerobic-strength training intervention and exercise induced effects on mild cognitive impairment will be determined afterwards. Receives: Other: Short-term exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal aerobic capacity
Maximal aerobic capacity parameter of physical fitness will be determined by Rockport walking test (1609m).
Measured: 4 months
Cognitive function testing
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.
Measured: 4 months
Depressive symptoms
All participants will receive Beck depression questionnaire to identify depressive symptoms.
Measured: 4 months
Olfactory function
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.
Measured: 4 months
Brain volumetry (MRI)
Brain MR scans will be performed at 3T PrismaFit scanner using a 64-channel head coil (Siemens Healthcare, Germany).
Measured: 4 months
Molecular genetic analyses
Gene expression will be measured with the aid of qRT-PCR using TaqMan® Gene Expression Assays on the ABI 7900HT (Applied Biosystems, USA).
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2022
- Study start10 Jan 2022
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Slovak Academy of Sciences
- Sponsor type
- Other government
- Collaborators
- Medical University of Vienna
- Responsible party
- Principal investigator, Barbara Ukropcová, MD, PhD, Slovak Academy of Sciences
- Investigators
- Barbora Ukropcova, Prof., Principal investigator, Biomedical Research Center Slovak Academy of Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05232968
- Sponsor's protocol ID
- APVV-20-0466
- Acronym
- AMETHYST
- Status last verified
- Feb 2022
- First submitted
- 14 Jan 2022
- Last updated
- 10 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ameliorating Effects of Aging by Physical Exercise: Molecular, Metabolic and Structural Adaptations, Multi-organ Integrative Approach
- ClinicalTrials.gov ID
- NCT05232968
- Acronym / sponsor ID
- AMETHYST / APVV-20-0466
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Slovak Academy of SciencesOther government
- Collaborators
- Medical University of Vienna
- Study start
- 10 Jan 2022 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 10 Feb 2022 (actual)
- 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.
With increasing longevity, a significant increase in the incidence of neurodegenerative diseases is expected. According to forecasts based on data from the World Health Organization and data from epidemiological studies, up to 106 million people will have Alzheimer's disease in 2050, it's 1 in 85 people living on the planet. If it will be possible to manage to delay the onset or slow the progression of the disease by a single year, it will mean 9.2 million fewer patients worldwide. This leaves considerable scope for options to modify the onset and prevalence of the disease through lifestyle changes such as eating habits and exercise. It is known that the human brain retains a certain natural plasticity even in old age, which is a great advantage that allows it to adapt to physiological stimuli, such as regular exercise. The pleiotropic beneficial effects of exercise therefore have considerable potential to be used in the prevention and slowing of the progression of cognitive and motor function decline as well as in the prevention / treatment of metabolic dysregulation. This fact is supported by many epidemiological and interventional studies with exercise, emphasizing the importance of the global trend to use exercise as a standardized method of prevention and treatment of many chronic diseases and cognitive deficits.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Elderly volunteers participating in the long-term exercise program | Experimental | Other: Long-term exercise programElderly 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. |
| Elderly sedentary volunteers | No intervention | –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. |
| Elderly volunteers participating in the short-term exercise program | Experimental | Other: Short-term exercise programElderly volunteers will follow 4-month of aerobic-strength training intervention and exercise induced effects on mild cognitive impairment will be determined afterwards. |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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),
Key exclusion criteria (7 listed)
- 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;
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 |
|---|---|---|
| Long-term exercise programTraining 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). | Other | Elderly volunteers participating in the long-term exercise program |
| Short-term exercise programTraining 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). | Other | Elderly volunteers participating in the short-term exercise program |
Primary outcome
Maximal aerobic capacity
Time frame: 4 months
Maximal aerobic capacity parameter of physical fitness will be determined by Rockport walking test (1609m).
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.
Depressive symptoms
Time frame: 4 months
All participants will receive Beck depression questionnaire to identify depressive symptoms.
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.
Brain volumetry (MRI)
Time frame: 4 months
Brain MR scans will be performed at 3T PrismaFit scanner using a 64-channel head coil (Siemens Healthcare, Germany).
Molecular genetic analyses
Time frame: 4 months
Gene expression will be measured with the aid of qRT-PCR using TaqMan® Gene Expression Assays on the ABI 7900HT (Applied Biosystems, USA).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2022.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication
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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.
Barbora Ukropcova, Prof. principal investigator
Biomedical Research Center Slovak Academy of Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Long-term exercise program and Short-term exercise program in people with Aging and Exercise, run by Slovak Academy of Sciences at 1 site 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 7 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 10 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Barbora Ukropcova, Prof. (+421911643630, barbara.ukropcova@sabva.sk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal aerobic capacity (time frame: 4 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Feb 2022.