AgingCAANCT05053282
Long-life Endurance Exercise and Healthy Aging
An observational study of Aging, run by Comenius University at 1 site in Slovakia.
Trial summary
The project aims to explore the mechanisms by which lifelong exercise can promote healthy aging and slow down the negative impact of aging on the muscular system, immunity and the circadian system. Read more about this study
- Who is it for?
- Ages 20 to 75 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- endurance running exercise
- How many people
- 60 participants
- Where
- 1 siteSlovakia
- Study dates
- 1 Sep 2020to 30 Sep 2022
- Phase
- Observational
- 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 20 to 75 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Inhabitants of Bratislava city (Slovakia) and those living within one hour drive by car from the laboratory (Faculty of Physical Education and Sport, Comenius University in Bratislava)
Who may be able to join
- for athletes' groups (master - 65 - 75 years old, and young athletes - 20 - 30 years old)
- more than 150 minutes of running activity which is by ACSM considered as vigorous intensity of endurance running for young athletes at least 3 years and for master athletes at least 15 years
- body mass index (BMI index) - range 18.5-30 kg/m2
- for groups less active than recommended (sedentary young and elderly)
- no history of regular physical activity training and no more practice than 150 minutes of moderate or 75 minutes of vigorous intensity per week
- body mass index (BMI index) - range 18.5-30 kg/m2
Who cannot join
- recent or current infection
- malignant disease
- uncontrolled hypertension (higher than 160 / 95mmHG)
- congestive heart failure (NYHA grade III and IV)
- unstable angina pectoris
- recent myocardial infarction (during the last 6 months)
Show all 19Show fewer
- severe cardiac arrhythmia (anamnestic)
- chronic obstructive pulmonary disease
- presence of severe pulmonary, pleural or pericardial disease
- severe asthma
- recent sudden stroke (during the last 6 months)
- epilepsy
- insulin-dependent diabetes mellitus
- unstable bone lesions with a high risk of fractures
- other chronic diseases, at the discretion of the responsible doctor
- states of mental incompetence (severe anxiety and depression, dementia, alcoholism , or other dependencies, mental retardation)
- conditions complicating regular physical activity (uncontrollable pain, severe arthritis, planned knee / hip endoprosthesis, pathological fractures (last 6 months), amputation, use of walker, wheelchair
- pharmacological interference (e.g., steroids, nonsteroidal anti-inflammatory agents, immunosuppressive and antineoplastic drugs, beta blockers, statins)
- the use of performance-enhancing drugs in the past and during the study period
Trial locations and contacts
1 site in 1 country.
Slovakia1 site, 1 recruiting
- Recruiting
Comenius University in Bratislava, Faculty of physical education and sport Bratislava, Slovakia
Bratislava, 814 99
Milan Sedliak, assoc. prof., +421907247021, milan.sedliak@uniba.sk
About this study
Official title: Active Aging: Effect of Life-long Endurance Exercises on the Circadian Regulation of Physiological Processes and Their Maintenance in Aging
The project aims to explore the mechanisms by which lifelong exercise can promote healthy aging and slow down the negative impact of aging on the muscular system, immunity and the circadian system. The main goal of the project is to investigate the effect of lifelong endurance exercise on physical fitness, body composition, bone density and selected hormonal, biochemical, histological and molecular indicators of metabolic health and circadian clock function based on blood, immune cell and skeletal muscle tissue analyses in volunteers differentiated by age and weekly volume of physical activity.
It is hypothesized that lifelong endurance exercise may have beneficial effects on the circadian system stability and many, but not all health outcomes. Osteopenia/osteoporosis and low-grade malnutrition may be more prevalent in the group of endurance-trained senior runners.
Read more
In order to achieve the above research aims, sixty male subjects in total will be recruited according to inclusion and exclusion criteria. Four groups of subjects will differ according to their age and physical activity levels:
- a group of endurance-trained seniors (age range 65 - 75 year old, n=15) ● a group of sedentary seniors (age range 65 - 75 year old, n=15)
- a group of well endurance-trained young men (age range 20 - 30 year old, n=15) ● a group of sedentary young men (age range 20 - 30 year old, n=15).
Subjects must meet the following inclusion criteria:
- for athletes' groups: defined as more than 150 minutes of running activity per week; for young athletes at least 3 years and for master athletes at least 15 years history of running.
- for groups less active than recommended: no history of regular physical activity training and no more practice than 150 minutes of moderate or 75 minutes of vigorous intensity per week.
The standard inclusion criterion for every group will be body mass index (range 18.5-30 kg/m2).
No experimental study has been published on the potential of life-long exercise to attenuate the aging-induced disorganization of the circadian system and thus to promote healthy aging. In this aspect, the proposed study is original and up-to-date. Moreover, also other aspects of the study, e.g. exercise and inflammaging or the risks (besides the benefits) of the long-life endurance training on bone tissue etc. have been studied only scarcely. Therefore, more scientific information is needed before it can be safely prescribed to the aging population
- Conditions
- Aging
- Being tested
- endurance running exercise
- Keywords
- aging, exercise, endurance running, circadian, inflammation, bone density
- Medical subject headings
- Motor Activity, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endurance running exerciseOther
regular competitive or non-competitive running of medium and/or high intensity with the duration at least 20 minutes per session
| Study group | Role | What they receive |
|---|---|---|
| master endurance athletes | men aged 65 to 75 with more than 150 minutes of running activity per week at least 15 years history of running Receives: Other: endurance running exercise | |
| elderly sedentary | men aged 65 to 75 with no history of regular physical activity training and no more practice than 150 minutes of moderate or 75 minutes of vigorous intensity per week according the ACSM recommendations | |
| young endurance athletes | men aged 20 to 30 with more than 150 minutes of running activity per week at least 3 years history of running Receives: Other: endurance running exercise | |
| young sedentary | men aged 20 to 30 with no history of regular physical activity training and no more practice than 150 minutes of moderate or 75 minutes of vigorous intensity per week according the ACSM recommendations |
What is being measured
The primary outcome is the main question the study is designed to answer.
maximal oxygen consumption
peak oxygen consumption normalised to body mass (mL/kg/min), measured through a graded cycling ergometry
Measured: cross-sectional, one-point assessment over 1 day
Secondary outcomes (8)
body composition
DXA method - fat mass (grams), lean mass (grams) and total mass (grams)
Measured: cross-sectional, one-point assessment over 1 day
bone mineral content
DXA method - BMC (grams)
Measured: cross-sectional, one-point assessment over 1 day
bone mineral density
DXA method - BMD (g/cm2)
Measured: cross-sectional, one-point assessment over 1 day
maximum isometric muscle strength
maximum voluntary contraction (Nm) of both isometric extension and flexion on knee dynamometer
Measured: cross-sectional, one-point assessment over 1 day
maximum isometric muscle torque development
rate of torque development (Nm/s) of both isometric extension and flexion on knee dynamometer
Measured: cross-sectional, one-point assessment over 1 day
Immunohistochemical analyses - skeletal muscle cell morphometry
cross-sectional area (um2) of myosin heavy chain I (BA-D5) positive fibers
Measured: cross-sectional, one-point assessment over 1 day
Immunohistochemical analyses - skeletal muscle tissue morphology
number of myonuclei, satellite cells, capillaries - counted per each fiber type nuclear number per fiber
Measured: cross-sectional, one-point assessment over 1 day
circadian system phase
CD14-positive monocytes (mRNA levels of selected clock and clock-controlled genes /alternatively microarray analysis in sub-sample of subjects from each group) blood count
Measured: cross-sectional, two-point assessment at morning and afternoon over 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2021
- Study start1 Sep 2020
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Sep 2022 (estimated)
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 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Comenius University
- Sponsor type
- University, hospital or other
- Collaborators
- Physiko- und Rheumatherapie Gesellschaft m.b.H., University of Padova, University of Roma La Sapienza, University of Primorska
- Responsible party
- Sponsor
- Investigators
- Ján Cvečka, PhD., Principal investigator, Comenius University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05053282
- Sponsor's protocol ID
- 305041X157
- Acronym
- CAA
- Status last verified
- Sep 2021
- First submitted
- 3 Aug 2021
- Last updated
- 22 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Matko S, Strasser B, Steinecker-Frohnwieser B, Stamm T, Kern H, Lofler S, Hochenwarter S, Prufer F, Unger A, Tirpakova V, Cvecka J, Sarabon N, Grote V. Multidomain changes in clinical outcomes after 12 weeks of resistance-based exercise training in healthy older adults: a four-domain framework for identifying non-responders. Eur Geriatr Med. 2026 Sep 22. doi: 10.1007/s41999-026-01614-8. Online ahead of print.
PubMed 42771097
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Active Aging: Effect of Life-long Endurance Exercises on the Circadian Regulation of Physiological Processes and Their Maintenance in Aging
- ClinicalTrials.gov ID
- NCT05053282
- Acronym / sponsor ID
- CAA / 305041X157
- Conditions
- Aging
- Keywords
- aging, exercise, endurance running, circadian, inflammation, bone density
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Comenius UniversityUniversity, hospital or other
- Collaborators
- Physiko- und Rheumatherapie Gesellschaft m.b.H., University of Padova, University of Roma La Sapienza, University of Primorska
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 22 Sep 2021 (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.
The project aims to explore the mechanisms by which lifelong exercise can promote healthy aging and slow down the negative impact of aging on the muscular system, immunity and the circadian system. The main goal of the project is to investigate the effect of lifelong endurance exercise on physical fitness, body composition, bone density and selected hormonal, biochemical, histological and molecular indicators of metabolic health and circadian clock function based on blood, immune cell and skeletal muscle tissue analyses in volunteers differentiated by age and weekly volume of physical activity.
It is hypothesized that lifelong endurance exercise may have beneficial effects on the circadian system stability and many, but not all health outcomes. Osteopenia/osteoporosis and low-grade malnutrition may be more prevalent in the group of endurance-trained senior runners.
In order to achieve the above research aims, sixty male subjects in total will be recruited according to inclusion and exclusion criteria. Four groups of subjects will differ according to their age and physical activity levels:
- a group of endurance-trained seniors (age range 65 - 75 year old, n=15) ● a group of sedentary seniors (age range 65 - 75 year old, n=15)
- a group of well endurance-trained young men (age range 20 - 30 year old, n=15) ● a group of sedentary young men (age range 20 - 30 year old, n=15).
Subjects must meet the following inclusion criteria:
- for athletes' groups: defined as more than 150 minutes of running activity per week; for young athletes at least 3 years and for master athletes at least 15 years history of running.
- for groups less active than recommended: no history of regular physical activity training and no more practice than 150 minutes of moderate or 75 minutes of vigorous intensity per week.
The standard inclusion criterion for every group will be body mass index (range 18.5-30 kg/m2).
No experimental study has been published on the potential of life-long exercise to attenuate the aging-induced disorganization of the circadian system and thus to promote healthy aging. In this aspect, the proposed study is original and up-to-date. Moreover, also other aspects of the study, e.g. exercise and inflammaging or the risks (besides the benefits) of the long-life endurance training on bone tissue etc. have been studied only scarcely. Therefore, more scientific information is needed before it can be safely prescribed to the aging population
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| master endurance athletes | – | Other: endurance running exercisemen aged 65 to 75 with more than 150 minutes of running activity per week at least 15 years history of running |
| elderly sedentary | – | –men aged 65 to 75 with no history of regular physical activity training and no more practice than 150 minutes of moderate or 75 minutes of vigorous intensity per week according the ACSM recommendations |
| young endurance athletes | – | Other: endurance running exercisemen aged 20 to 30 with more than 150 minutes of running activity per week at least 3 years history of running |
| young sedentary | – | –men aged 20 to 30 with no history of regular physical activity training and no more practice than 150 minutes of moderate or 75 minutes of vigorous intensity per week according the ACSM recommendations |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Inhabitants of Bratislava city (Slovakia) and those living within one hour drive by car from the laboratory (Faculty of Physical Education and Sport, Comenius University in Bratislava)
Key inclusion criteria (6 listed)
- for athletes' groups (master - 65 - 75 years old, and young athletes - 20 - 30 years old)
- more than 150 minutes of running activity which is by ACSM considered as vigorous intensity of endurance running for young athletes at least 3 years and for master athletes at least 15 years
- body mass index (BMI index) - range 18.5-30 kg/m2
- for groups less active than recommended (sedentary young and elderly)
- no history of regular physical activity training and no more practice than 150 minutes of moderate or 75 minutes of vigorous intensity per week
Key exclusion criteria (19 listed)
- recent or current infection
- malignant disease
- uncontrolled hypertension (higher than 160 / 95mmHG)
- congestive heart failure (NYHA grade III and IV)
- unstable angina pectoris
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 |
|---|---|---|
| endurance running exerciseregular competitive or non-competitive running of medium and/or high intensity with the duration at least 20 minutes per session | Other | master endurance athletes, young endurance athletes |
Primary outcome
maximal oxygen consumption
Time frame: cross-sectional, one-point assessment over 1 day
peak oxygen consumption normalised to body mass (mL/kg/min), measured through a graded cycling ergometry
8 secondary outcomes
body composition
Time frame: cross-sectional, one-point assessment over 1 day
bone mineral content
Time frame: cross-sectional, one-point assessment over 1 day
bone mineral density
Time frame: cross-sectional, one-point assessment over 1 day
maximum isometric muscle strength
Time frame: cross-sectional, one-point assessment over 1 day
maximum isometric muscle torque development
Time frame: cross-sectional, one-point assessment over 1 day
Immunohistochemical analyses - skeletal muscle cell morphometry
Time frame: cross-sectional, one-point assessment over 1 day
Immunohistochemical analyses - skeletal muscle tissue morphology
Time frame: cross-sectional, one-point assessment over 1 day
circadian system phase
Time frame: cross-sectional, two-point assessment at morning and afternoon over 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2021.
- Derived from this study: PubMed 42771097Matko S, Strasser B, Steinecker-Frohnwieser B, Stamm T, Kern H, Lofler S, Hochenwarter S, Prufer F, Unger A, Tirpakova V, Cvecka J, Sarabon N, Grote V. Multidomain changes in clinical outcomes after 12 weeks of resistance-based exercise training in healthy older adults: a four-domain framework for identifying non-responders. Eur Geriatr Med. 2026 Sep 22. doi: 10.1007/s41999-026-01614-8. Online ahead of print.
- Individual participant dataSharing planned: No
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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.
Ján Cvečka, PhD. principal investigator
Comenius University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aging, run by Comenius University 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 6 inclusion and 19 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 22 Sep 2021. 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 Milan Sedliak, assoc. prof. (+421907247021, milan.sedliak@uniba.sk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
maximal oxygen consumption (time frame: cross-sectional, one-point assessment over 1 day). 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 NCT05053282, 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 22 Sep 2021.