OsteopeniaCAExNCT06746649
Time-specific Exercise in Circadian Context
A study testing Combined training in people with Osteopenia and Osteoporosis, run by Comenius University at 1 site in Slovakia.
Trial summary
The project aims to explore the mechanisms, by which physical activity can support healthy ageing and decrease the negative impact of ageing on the circadian system, musculoskeletal system and immunity. Read more about this study
- Who is it for?
- Ages 65 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteopenia, Osteoporosis, Aging
- What is being tested?
- Combined training
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteSlovakia
- Study dates
- 1 Feb 2024to 30 Mar 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 to 80 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- no history of regular physical activity training and exercise of more than 150 minutes of moderate or 75 minutes of higher intensity per week.
- Body mass index (BMI) between 18.5 and 30 kg/m2 for all groups
Who cannot join
- Recent or current infection, physical disability,
- malignant, cardiovascular, metabolic, autoimmune diseases,
- Malnutrition and pharmacological interference (e.g., steroids, non-steroidal anti-inflammatory agents, immunosuppressive and antineoplastic drugs).
- Use of performance enhancing drugs in the past and during the study period will condition exclusion.
- recent or current infection, physical disabilities,
- malignant, cardiovascular, metabolic, autoimmune diseases,
- Malnutrition and pharmacological interference (e.g., steroids, nonsteroidal anti-inflammatory agents, immunosuppressive and antineoplastic drugs).
- Use of performance-enhancing drugs in the past and during the study period will condition exclusion.
Trial locations and contacts
1 site in 1 country.
Slovakia1 site
Comenius University in Bratislava, Faculty of physical education and sport Bratislava, Slovakia
Bratislava, 814 99
About this study
Official title: Healthy Aging: Effects of Time-specific Exercise on Functional, Structural, Metabolic and Immune Parameters in Circadian Context
The project aims to explore the mechanisms, by which physical activity can support healthy ageing and decrease the negative impact of ageing on the circadian system, musculoskeletal system and immunity.
Read the detailed description
The main aim of the project is to examine the effect of as well as of the three-month, timely specific training intervention on the functionality of circadian organization in elderly volunteers. The additive aim is to examine the effect of lifelong endurance physical activity, along with the experimental training intervention on the body composition, bone density, and selected hormonal, biochemical, histological and molecular indicators of metabolic health.
Partial aims are as follows:n to explore the effect of morning and afternoon training on the most significant parameters, identified by the previous cross-sectional study, in sedentary elderly. Furthermore, to clarify adaptation mechanisms of experimental training protocol on selected parameters, that may explain possible differences in mechanisms of active and passive aging.
- Conditions
- Osteopenia, Osteoporosis, Aging
- Being tested
- Combined training
- Keywords
- bone mineral density, circadian rhythm, elderly
- Medical subject headings
- Bone Diseases, Metabolic, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined trainingProcedure or surgery
12-week long time specific combined training 2 times a week
| Study group | Role | What they receive |
|---|---|---|
| Morning group | Experimental | The experimental factor will be applied in the morning (8:00-9:00). Receives: Procedure: Combined training |
| Afternoon group | Experimental | The experimental factor will be applied in the afternoon (16:00-17:00). Receives: Procedure: Combined training |
| Control group | No intervention | None expertimental factor will be aplied |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone mineral density
The proportion of total body fat mass, visceral fat mass, total body mass and bone density will be measured using Dual-energy X-ray Absorptiometry (DXA, hologic fan-beam bone densitometer Discovery QDR series). The DXA testing procedure will follow Kralik et al. (2019). All DXA procedures will be performed by a board-certified radiologist.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2024
- Study start1 Feb 2024
- Primary completion4 Jul 2024
- Study completion30 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteopeniaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In total, 34 previously untrained elderly subjects of both sexes, age range 65 - 80-year-old, will be recruited according to inclusion and exclusion criteria and will undergo the intervention. The subject will be randomly assigned to the three groups: a morning training group (n=14, 5 men, 9 women) an afternoon training group (n=14, 5 men, 9women) a control group (n=6, 6 women) Both men and women will be included to address the potential differences between sexes and to increase the clinical and practical relevance, since women make up more than 50 percent of clients visiting the Centre of Active Aging. The duration of the training intervention is 12 weeks with the frequency 2 times per week. The relative volume and intensity of the training for both training groups will be identical, except for timing of the training. The morning group and afternoon group will exercise exclusively between 08:00 - 09:00 h and 16:00 - 17:00 h, respectively.
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Comenius University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06746649
- Sponsor's protocol ID
- APVV-21-0164
- Acronym
- CAEx
- Status last verified
- Dec 2024
- First submitted
- 11 Jun 2024
- Last updated
- 24 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy Aging: Effects of Time-specific Exercise on Functional, Structural, Metabolic and Immune Parameters in Circadian Context
- ClinicalTrials.gov ID
- NCT06746649
- Acronym / sponsor ID
- CAEx / APVV-21-0164
- Conditions
- Osteopenia, Osteoporosis, Aging
- Keywords
- bone mineral density, circadian rhythm, elderly
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Comenius UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 4 Jul 2024 (actual)
- Study completion
- 30 Mar 2025 (estimated)
- First posted
- 24 Dec 2024 (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 physical activity can support healthy ageing and decrease the negative impact of ageing on the circadian system, musculoskeletal system and immunity.
Detailed description
The main aim of the project is to examine the effect of as well as of the three-month, timely specific training intervention on the functionality of circadian organization in elderly volunteers. The additive aim is to examine the effect of lifelong endurance physical activity, along with the experimental training intervention on the body composition, bone density, and selected hormonal, biochemical, histological and molecular indicators of metabolic health.
Partial aims are as follows:n to explore the effect of morning and afternoon training on the most significant parameters, identified by the previous cross-sectional study, in sedentary elderly. Furthermore, to clarify adaptation mechanisms of experimental training protocol on selected parameters, that may explain possible differences in mechanisms of active and passive aging.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- In total, 34 previously untrained elderly subjects of both sexes, age range 65 - 80-year-old, will be recruited according to inclusion and exclusion criteria and will undergo the intervention. The subject will be randomly assigned to the three groups: a morning training group (n=14, 5 men, 9 women) an afternoon training group (n=14, 5 men, 9women) a control group (n=6, 6 women) Both men and women will be included to address the potential differences between sexes and to increase the clinical and practical relevance, since women make up more than 50 percent of clients visiting the Centre of Active Aging. The duration of the training intervention is 12 weeks with the frequency 2 times per week. The relative volume and intensity of the training for both training groups will be identical, except for timing of the training. The morning group and afternoon group will exercise exclusively between 08:00 - 09:00 h and 16:00 - 17:00 h, respectively.
| Arm | Type | Receives |
|---|---|---|
| Morning group | Experimental | Procedure: Combined trainingThe experimental factor will be applied in the morning (8:00-9:00). |
| Afternoon group | Experimental | Procedure: Combined trainingThe experimental factor will be applied in the afternoon (16:00-17:00). |
| Control group | No intervention | –None expertimental factor will be aplied |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- no history of regular physical activity training and exercise of more than 150 minutes of moderate or 75 minutes of higher intensity per week.
- Body mass index (BMI) between 18.5 and 30 kg/m2 for all groups
Key exclusion criteria (8 listed)
- Recent or current infection, physical disability,
- malignant, cardiovascular, metabolic, autoimmune diseases,
- Malnutrition and pharmacological interference (e.g., steroids, non-steroidal anti-inflammatory agents, immunosuppressive and antineoplastic drugs).
- Use of performance enhancing drugs in the past and during the study period will condition exclusion.
- recent or current infection, physical disabilities,
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 |
|---|---|---|
| Combined training12-week long time specific combined training 2 times a week | Procedure or surgery | Afternoon group, Morning group |
Primary outcome
Bone mineral density
Time frame: 12 weeks
The proportion of total body fat mass, visceral fat mass, total body mass and bone density will be measured using Dual-energy X-ray Absorptiometry (DXA, hologic fan-beam bone densitometer Discovery QDR series). The DXA testing procedure will follow Kralik et al. (2019). All DXA procedures will be performed by a board-certified radiologist.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2024.
- Individual participant dataSharing planned: No
Related trials for Osteopenia
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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 Combined training in people with Osteopenia and Osteoporosis, 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 2 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 24 Dec 2024. 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?
This study is still under way. Results are not available in the source record yet.
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?
Bone mineral density (time frame: 12 weeks). 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 24 Dec 2024; AzTrials last refreshed its copy on 27 Oct 2026.