ClinicalTrials.gg
RecruitingNCT05232968AMETHYSTUpdated Feb 10, 2022

Ameliorating Effects of Aging by Physical Exercise

An interventional study of Long-term exercise program and Short-term exercise program in Aging and Exercise, sponsored by Slovak Academy of Sciences. Recruiting at 1 site in Slovakia. Open to participants aged 55 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-02-10.

Sponsored by Slovak Academy of Sciences · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Primary completion was expected by Dec 2025, 11 months ago, but the record still lists the study as recruiting.
  • Started Jan 2022; still recruiting 4 years 10 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
55 Years to 85 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 11 studies in Motor Activity with a site in Slovakia — 3 open to participants now, 3 under way, none of them phase 3. Motor Activity · Slovakia.

Planned enrollment
2nd of 10
120 · median 35
Started
2022
with 2 others
No phase
9 of 11
3 open now
Registered
6th of 11
by date
Lead sponsor
4 of 11
Slovak Academy of Sciences

Among the 11 studies in Motor Activity with a site in Slovakia, this one is the 2nd largest by planned enrollment of the 10 interventional ones, is one of 3 that started in 2022, is one of 9 with no phase, and was the 6th registered.

By phase

11 studies; the count open now beside each. This study's row is marked.

No phasethis study9 · 3 open
Observational1 · 0 open
Phase 21 · 0 open

By the year they started

First in 2015; this study’s year is marked. 3 started in 2022.

What they test

Size and results

Median enrollment 35 across the 10 interventional studies, 60 across the 1 observational. Of the 6 that completed or were terminated, 1 (17%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 11 studies in Motor Activity with a site in Slovakia, or all of them as a file.
02

Study 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 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.

03

Conditions studied

  • Aging
  • Exercise

Browse trials for

04

Who can participate

Ages eligible
55 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 ( for magnetic resonance imaging).
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
120 participants (estimated)

Study arms

  • 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.

    Other: Long-term exercise program

  • 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.

    Other: Short-term exercise program

Interventions

  • OtherLong-term exercise program

    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).

  • OtherShort-term exercise program

    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).

06

What researchers measure

Primary outcomes

  1. Maximal aerobic capacity

    Maximal aerobic capacity parameter of physical fitness will be determined by Rockport walking test (1609m).

    Time frame: 4 months

  2. 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.

    Time frame: 4 months

  3. Depressive symptoms

    All participants will receive Beck depression questionnaire to identify depressive symptoms.

    Time frame: 4 months

  4. 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.

    Time frame: 4 months

  5. Brain volumetry (MRI)

    Brain MR scans will be performed at 3T PrismaFit scanner using a 64-channel head coil (Siemens Healthcare, Germany).

    Time frame: 4 months

  6. 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).

    Time frame: 4 months

07

Study locations

1 of 1 sites recruiting
  • Biomedical Research Center Slovak Academy of Sciences
    Bratislava, 84505, Slovakia
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes — All IPD that underlie results in a publication

Supporting information: Study protocol, Clinical study report

Time frame: 31.12.2025 indefinitely

Access criteria: In principle to all researchers working in the area. Requests will be reviewed by Prof. Barbara Ukropcova.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2022 (actual). Primary completion is estimated for Dec 2025, 47 months after the start.

Of 5,147 non-industry interventional studies with no phase under Motor Activity, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 36. This study's planned 47 months is above that.

Counting every sponsor, half of 5,207 studies reached it within 17 months; a quarter within 7 and three quarters within 36.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 14, 2022
First posted
Feb 10, 2022
StartActual
Jan 10, 2022
Primary completionEst.
Dec 2025
CompletionEst.
Dec 2025
Last update
Feb 10, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 10, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05232968
Lead sponsor
Slovak Academy of Sciences
Responsible party
Barbara Ukropcová, MD, PhD (Professor, Slovak Academy of Sciences) — Principal investigator
First posted
Feb 10, 2022
Start date
Jan 10, 2022
Primary completion
Dec 2025 (estimated)
Completion
Dec 2025 (estimated)
Last update
Feb 10, 2022

Study contacts

Barbora Ukropcova, Prof.
Contact
barbara.ukropcova@sabva.sk
+421911643630
Barbora Ukropcova, Prof.
principal investigator · Biomedical Research Center Slovak Academy of Sciences

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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