Age Over 50 YearsNCT07799103
The Impact of Exercise Intervention on Biological and Functional Aging Through the Lens of Epigenetic Clocks
A study testing Exercise - Relative High-Intensity Interval Training (HIIT) in people with Age Over 50 Years, run by Hungarian University of Sports Science at 1 site in Hungary.
Trial summary
This study investigated the effects of a structured 6-month high-intensity interval training (HIIT) program on blood DNA methylation-based measures of biological ageing, physical fitness, cardiovascular function, body composition, metabolic health, and the gut microbiome in adults aged 50-70 years. Read more about this study
- Who is it for?
- Ages 50 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Age Over 50 Years
- What is being tested?
- Exercise - Relative High-Intensity Interval Training (HIIT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteHungary
- Study dates
- 1 May 2022to 30 Jun 2024
- 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 50 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged 50-70 years
- Legal capacity to provide informed consent
- Successful completion of a questionnaire-based and instrumental medical screening, confirming eligibility for physical exercise
- Physical activity level between 1 and 5 METs/day, estimated based on a questionnaire
Who cannot join
- Cardiovascular diseases that contraindicate physical exercise, including the presence of a pacemaker
- Musculoskeletal conditions that contraindicate physical exercise
- Acute or chronic kidney disease
- Acute or chronic liver disease
- Acute or chronic gastrointestinal disease
- Acute or chronic infectious diseases or febrile conditions
Show all 14Show fewer
- Metabolic disorders or endocrine diseases
- Bleeding disorders or coagulation abnormalities
- Malignant diseases
- Autoimmune diseases
- Asthma
- Psychiatric or mental disorders
- Limited legal capacity or impaired ability to communicate
- Chronic alcohol consumption
Trial locations and contacts
1 site in 1 country.
Hungary1 site
Research Center for Molecular Exercise Science, Hungarian University of Sports Science, Alkotás st. 42-48
Budapest, Pest County, 1123
About this study
Official title: The Effects of Regular Exercise Training on Biological Aging in Older Adults: Investigation of Epigenetic and Functional Changes
This study investigated the effects of a structured 6-month high-intensity interval training (HIIT) program on blood DNA methylation-based measures of biological ageing, physical fitness, cardiovascular function, body composition, metabolic health, and the gut microbiome in adults aged 50-70 years.
Participants completed supervised exercise training three times per week for 6 months. Exercise intensity was individually prescribed based on estimated maximal heart rate (HRmax) and continuously monitored using Polar H10 heart-rate sensors. Perceived exertion was also assessed using the Borg Rating of Perceived Exertion scale to support safe and appropriate exercise intensity. The training program progressively increased the amount of high-intensity exercise over the intervention period. High-intensity intervals were performed above approximately 80% of estimated HRmax and were separated by 2-minute periods of active recovery.
Read more
Before and after the intervention, participants underwent physiological and functional assessments. Cardiovascular function was evaluated using echocardiography. Aerobic capacity was assessed using spiroergometry and the Chester Step Test for estimation of VO₂max. Muscular performance was evaluated using maximal vertical jump and handgrip strength tests. Exercise volume was quantified using oxygen-consumption and heart-rate data collected during exercise and expressed as MET-hours (MET-hrs), allowing the individual exercise dose accumulated during the intervention to be characterized.
Body composition was assessed using dual-energy X-ray absorptiometry (DEXA). Measurements included total and regional fat mass and fat-free mass, allowing changes in overall and regional body composition to be evaluated.
Blood samples were collected before and after the intervention, with participants refraining from exercise for 48 hours before blood collection. Samples were analyzed for selected metabolic and clinical biomarkers, including glucose, triglycerides, total cholesterol, HDL cholesterol, LDL cholesterol, and liver enzymes.
Blood samples were also used to assess blood DNA methylation-based measures of biological ageing. Genome-wide DNA methylation was measured using the Illumina Infinium MethylationEPIC BeadChip. Several DNA methylation-based ageing measures were calculated, including DNAmFitAge, DNAmPhenoAge, DNAmGrimAge, Hannum Age, DunedinPACE, and the Horvath Skin \& Blood and pan-tissue clocks. Changes in biological age acceleration were evaluated between baseline and post-intervention.
The gut microbiome was characterized using shotgun metagenomic sequencing to assess changes in microbial composition and functional potential following the exercise intervention.
The primary overall objective of the study was to determine whether the individual volume of exercise performed, quantified as MET-hours, was associated with changes in blood DNA methylation-based biological age acceleration following the 6-month intervention. The study also examined whether exercise volume and training-related changes were associated with changes in physical fitness, cardiovascular function, body composition, metabolic biomarkers, and gut microbiome characteristics. The results may contribute to understanding whether the amount of regular high-intensity exercise is related to biological ageing and other physiological adaptations in 50< years old adults.
- Conditions
- Age Over 50 Years
- Being tested
- Exercise - Relative High-Intensity Interval Training (HIIT)
- Keywords
- epigentic, biological aging, exersice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise - Relative High-Intensity Interval Training (HIIT)Other
Participants completed supervised high-intensity interval training (HIIT) 3 times weekly for 6 months. Exercise intensity was prescribed relative to estimated maximal heart rate (HRmax; Tanaka formula) and was monitored continuously using Polar H10 heart-rate sensors. Sessions included a progressive warm-up, repeated 2-minute high-intensity intervals performed above 80% of HRmax, and 2-minute active recovery periods. Perceived exertion was also monitored using the Borg 0-10 RPE scale, with an upper target of 8. The protocol progressively increased training load: sessions 1-25 included five high-intensity intervals, sessions 26-45 six intervals, and sessions 46 onward seven intervals. Session duration increased from 34 to 38 minutes in the final phase.
| Study group | Role | What they receive |
|---|---|---|
| Relative High Intensity Intervention Exercise Group for 6 month | Experimental | Individuals over 50 years of age will undergo regular exercise training three times per week for 40-45 minutes using a high-intensity interval training (HIIT) modality for a period of 6 months. Following health screening and a 2-3-week habituation period, exercise intensity will be monitored and prescribed using a chest-strap heart rate monitoring system. Before and after the intervention, blood samples will be collected, and physiological and functional assessments will be conducted. Receives: Other: Exercise - Relative High-Intensity Interval Training (HIIT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Epigenetic Age Accelration
Whole blood samples were collected and analyzed using the Illumina EPIC BeadChip assay to quantify DNA methylation at specific CpG sites. DNA methylation-based biological age estimators, including DNAmFitAge, DNAmPhenoAge, and DNAmGrimAge, were calculated from the methylation data. Age acceleration values were expressed in years, and changes in these measures were correlated with changes in other primary and secondary outcome measures.
Measured: Whole blood was collected within 2 weeks before the first exercise session as the baseline measurement. The second blood sample was collected at least 48 hours, but no more than 5 days, after the final exercise session.
Relative aerobic capaity spiroergometry: VO2 max measurement
Relative aerobic capacity was evaluated using cardiopulmonary exercise testing (spiroergometry) and expressed as ml/kg/min
Measured: Spiriergomerty was conducted within 2 weeks before the first exercise session as the baseline measurement and after at least 48 hours, but no more than 14 days, after the final exercise session.
Relative aerobic capacity esimation: Chester step test
The Chester Step Test was conducted to estimate changes in VO₂max during the 6-month intervention period. Heart rate responses recorded during each assessment were used to estimate relative aerobic capacity, expressed as mL/kg/min.
Measured: The Chester Step Test was performed at the first exercise session, which served as the baseline assessment, and was repeated monthly thereafter to monitor changes in aerobic capacity throughout the intervention period.
Exercise Volume: MET-hours
Exercise volume was calculated based on estimated VO₂max, average and resting heart rate during exercise, and exercise duration. Exercise volume was expressed as MET-hours.
Measured: Heart rate values and exercise duration were recorded during each exercise session throughout the 6-month intervention period.
Total body muscular power
Total body muscular strength was measured using a handheld dynamometer, and grip force was expressed in kilograms (kg).
Measured: Grip strength was measured within 2 weeks before the first exercise session as the baseline measurement. The second measurement was collected at least 48 hours, but no more than 14 days, after the final exercise session.
Echocardiographic measurements
Echocardiographic measurements included assessments of cardiac morphology and structure, as well as parameters of cardiac function. These measurements were used to characterize structural and functional cardiac adaptations and to evaluate changes in cardiovascular function over the course of the intervention.
Measured: Echocardiographic data was collected within 2 weeks before the first exercise session as the baseline measurement. The second second measurement was conducted at least 48 hours, but no more than 5 days, after the final exercise session.
Secondary outcomes (4)
Blood chemistry: LDL
Low-density lipoprotein cholesterol (LDL-C) was measured from venous blood reum samples as a marker of lipid metabolism and cardiovascular risk. LDL-C concentration was expressed in mmol/L.
Measured: Blood was collected within 2 weeks before the first exercise session as the baseline measurement. The second blood sample was collected at least 48 hours, but no more than 5 days, after the final exercise session.
Blood chemistry: HDL
High-density lipoprotein cholesterol (HDL) was measured from venous blood samples as a marker of lipid metabolism and cardiovascular health. HDL-C concentration was expressed in mmol/L.
Measured: Blood was collected within 2 weeks before the first exercise session as the baseline measurement. The second blood sample was collected at least 48 hours, but no more than 5 days, after the final exercise session.
Blood chemistry: Fastung glucose
Fasting blood glucose was measured from venous blood samples following an overnight fast as a marker of glucose metabolism. Glucose concentration was expressed in mmol/L.
Measured: Blood was collected within 2 weeks before the first exercise session as the baseline measurement. The second blood sample was collected at least 48 hours, but no more than 5 days, after the final exercise session.
Fecal microbial status
Gut microbiome composition and functional characteristics were assessed from fecal samples using shotgun metagenomic sequencing before and after the intervention. Microbiome composition was characterized at the species level, with individual taxa expressed as relative abundance.
Measured: Fecal samples were collected within 2 weeks before the first exercise session as the baseline measurement. The second fecal sample was collected at least 48 hours, but no more than 2 weeks, after the final exercise session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2026
- Study start1 May 2022
- Primary completion1 May 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age Over 50 YearsStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hungarian University of Sports Science
- Sponsor type
- University, hospital or other
- Collaborators
- Semmelweis University
- Responsible party
- Principal investigator, Ferenc Gergely Torma, Hungarian University of Sports Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07799103
- Sponsor's protocol ID
- NNGYK/14120-7/2025_FEP
- Other IDs
- 152986
- Status last verified
- Aug 2026
- First submitted
- 26 Aug 2026
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Regular Exercise Training on Biological Aging in Older Adults: Investigation of Epigenetic and Functional Changes
- ClinicalTrials.gov ID
- NCT07799103
- Acronym / sponsor ID
- NNGYK/14120-7/2025_FEP
- Conditions
- Age Over 50 Years
- Keywords
- epigentic, biological aging, exersice
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Hungarian University of Sports ScienceUniversity, hospital or other
- Collaborators
- Semmelweis University
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 2 Sep 2026 (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.
This study investigated the effects of a structured 6-month high-intensity interval training (HIIT) program on blood DNA methylation-based measures of biological ageing, physical fitness, cardiovascular function, body composition, metabolic health, and the gut microbiome in adults aged 50-70 years.
Participants completed supervised exercise training three times per week for 6 months. Exercise intensity was individually prescribed based on estimated maximal heart rate (HRmax) and continuously monitored using Polar H10 heart-rate sensors. Perceived exertion was also assessed using the Borg Rating of Perceived Exertion scale to support safe and appropriate exercise intensity. The training program progressively increased the amount of high-intensity exercise over the intervention period. High-intensity intervals were performed above approximately 80% of estimated HRmax and were separated by 2-minute periods of active recovery.
Before and after the intervention, participants underwent physiological and functional assessments. Cardiovascular function was evaluated using echocardiography. Aerobic capacity was assessed using spiroergometry and the Chester Step Test for estimation of VO₂max. Muscular performance was evaluated using maximal vertical jump and handgrip strength tests. Exercise volume was quantified using oxygen-consumption and heart-rate data collected during exercise and expressed as MET-hours (MET-hrs), allowing the individual exercise dose accumulated during the intervention to be characterized.
Body composition was assessed using dual-energy X-ray absorptiometry (DEXA). Measurements included total and regional fat mass and fat-free mass, allowing changes in overall and regional body composition to be evaluated.
Blood samples were collected before and after the intervention, with participants refraining from exercise for 48 hours before blood collection. Samples were analyzed for selected metabolic and clinical biomarkers, including glucose, triglycerides, total cholesterol, HDL cholesterol, LDL cholesterol, and liver enzymes.
Blood samples were also used to assess blood DNA methylation-based measures of biological ageing. Genome-wide DNA methylation was measured using the Illumina Infinium MethylationEPIC BeadChip. Several DNA methylation-based ageing measures were calculated, including DNAmFitAge, DNAmPhenoAge, DNAmGrimAge, Hannum Age, DunedinPACE, and the Horvath Skin \& Blood and pan-tissue clocks. Changes in biological age acceleration were evaluated between baseline and post-intervention.
The gut microbiome was characterized using shotgun metagenomic sequencing to assess changes in microbial composition and functional potential following the exercise intervention.
The primary overall objective of the study was to determine whether the individual volume of exercise performed, quantified as MET-hours, was associated with changes in blood DNA methylation-based biological age acceleration following the 6-month intervention. The study also examined whether exercise volume and training-related changes were associated with changes in physical fitness, cardiovascular function, body composition, metabolic biomarkers, and gut microbiome characteristics. The results may contribute to understanding whether the amount of regular high-intensity exercise is related to biological ageing and other physiological adaptations in 50< years old adults.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Relative High Intensity Intervention Exercise Group for 6 month | Experimental | Other: Exercise - Relative High-Intensity Interval Training (HIIT)Individuals over 50 years of age will undergo regular exercise training three times per week for 40-45 minutes using a high-intensity interval training (HIIT) modality for a period of 6 months. Following health screening and a 2-3-week habituation period, exercise intensity will be monitored and prescribed using a chest-strap heart rate monitoring system. Before and after the intervention, blood samples will be collected, and physiological and functional assessments will be conducted. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged 50-70 years
- Legal capacity to provide informed consent
- Successful completion of a questionnaire-based and instrumental medical screening, confirming eligibility for physical exercise
- Physical activity level between 1 and 5 METs/day, estimated based on a questionnaire
Key exclusion criteria (14 listed)
- Cardiovascular diseases that contraindicate physical exercise, including the presence of a pacemaker
- Musculoskeletal conditions that contraindicate physical exercise
- Acute or chronic kidney disease
- Acute or chronic liver disease
- Acute or chronic gastrointestinal disease
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 |
|---|---|---|
| Exercise - Relative High-Intensity Interval Training (HIIT)Participants completed supervised high-intensity interval training (HIIT) 3 times weekly for 6 months. Exercise intensity was prescribed relative to estimated maximal heart rate (HRmax; Tanaka formula) and was monitored continuously using Polar H10 heart-rate sensors. Sessions included a progressive warm-up, repeated 2-minute high-intensity intervals performed above 80% of HRmax, and 2-minute active recovery periods. Perceived exertion was also monitored using the Borg 0-10 RPE scale, with an upper target of 8. The protocol progressively increased training load: sessions 1-25 included five high-intensity intervals, sessions 26-45 six intervals, and sessions 46 onward seven intervals. Session duration increased from 34 to 38 minutes in the final phase. | Other | Relative High Intensity Intervention Exercise Group for 6 month |
Primary outcome
Epigenetic Age Accelration
Time frame: Whole blood was collected within 2 weeks before the first exercise session as the baseline measurement. The second blood sample was collected at least 48 hours, but no more than 5 days, after the final exercise session.
Whole blood samples were collected and analyzed using the Illumina EPIC BeadChip assay to quantify DNA methylation at specific CpG sites. DNA methylation-based biological age estimators, including DNAmFitAge, DNAmPhenoAge, and DNAmGrimAge, were calculated from the methylation data. Age acceleration values were expressed in years, and changes in these measures were correlated with changes in other primary and secondary outcome measures.
Relative aerobic capaity spiroergometry: VO2 max measurement
Time frame: Spiriergomerty was conducted within 2 weeks before the first exercise session as the baseline measurement and after at least 48 hours, but no more than 14 days, after the final exercise session.
Relative aerobic capacity was evaluated using cardiopulmonary exercise testing (spiroergometry) and expressed as ml/kg/min
Relative aerobic capacity esimation: Chester step test
Time frame: The Chester Step Test was performed at the first exercise session, which served as the baseline assessment, and was repeated monthly thereafter to monitor changes in aerobic capacity throughout the intervention period.
The Chester Step Test was conducted to estimate changes in VO₂max during the 6-month intervention period. Heart rate responses recorded during each assessment were used to estimate relative aerobic capacity, expressed as mL/kg/min.
Exercise Volume: MET-hours
Time frame: Heart rate values and exercise duration were recorded during each exercise session throughout the 6-month intervention period.
Exercise volume was calculated based on estimated VO₂max, average and resting heart rate during exercise, and exercise duration. Exercise volume was expressed as MET-hours.
Total body muscular power
Time frame: Grip strength was measured within 2 weeks before the first exercise session as the baseline measurement. The second measurement was collected at least 48 hours, but no more than 14 days, after the final exercise session.
Total body muscular strength was measured using a handheld dynamometer, and grip force was expressed in kilograms (kg).
Echocardiographic measurements
Time frame: Echocardiographic data was collected within 2 weeks before the first exercise session as the baseline measurement. The second second measurement was conducted at least 48 hours, but no more than 5 days, after the final exercise session.
Echocardiographic measurements included assessments of cardiac morphology and structure, as well as parameters of cardiac function. These measurements were used to characterize structural and functional cardiac adaptations and to evaluate changes in cardiovascular function over the course of the intervention.
4 secondary outcomes
Blood chemistry: LDL
Time frame: Blood was collected within 2 weeks before the first exercise session as the baseline measurement. The second blood sample was collected at least 48 hours, but no more than 5 days, after the final exercise session.
Blood chemistry: HDL
Time frame: Blood was collected within 2 weeks before the first exercise session as the baseline measurement. The second blood sample was collected at least 48 hours, but no more than 5 days, after the final exercise session.
Blood chemistry: Fastung glucose
Time frame: Blood was collected within 2 weeks before the first exercise session as the baseline measurement. The second blood sample was collected at least 48 hours, but no more than 5 days, after the final exercise session.
Fecal microbial status
Time frame: Fecal samples were collected within 2 weeks before the first exercise session as the baseline measurement. The second fecal sample was collected at least 48 hours, but no more than 2 weeks, after the final exercise session.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise - Relative High-Intensity Interval Training (HIIT) in people with Age Over 50 Years, run by Hungarian University of Sports Science at 1 site in Hungary.
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 4 inclusion and 14 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: finished, as of the sponsor's last update on 2 Sep 2026. 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 Hungary. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Epigenetic Age Accelration (time frame: Whole blood was collected within 2 weeks before the first exercise session as the baseline measurement. The second blood sample was collected at least 48 hours, but no more than 5 days, after the final exercise session.). 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 2 Sep 2026.