Physical FitnessOS&CYNCT07365228
Open Space and Closed Years
A study testing Physical exercising in people with Physical Fitness and Health Literacy, run by Goran Kuvacic.
Trial summary
The primary objective of this project is to examine the effects of a specific multicomponent physical activity program (MPAP), conducted in an outdoor setting, on the health and functional-motor status (HFMS) of women over the age of 60. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Physical Fitness, Health Literacy, Lipid Profile
- What is being tested?
- Physical exercising
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2026to 1 Jun 2029
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- physical fitness status which allows active participation in the physical exercising program organized as a tretment
Who cannot join
- health conditions not allowing the participation in treatment program
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: OPEN SPACE AND CLOSED YEARS
The primary objective of this project is to examine the effects of a specific multicomponent physical activity program (MPAP), conducted in an outdoor setting, on the health and functional-motor status (HFMS) of women over the age of 60. Additionally, the study will investigate the influence of sociodemographic factors (SDF), physical literacy (PL), and health literacy (HL) on the baseline HFMS and the subsequent changes resulting from the KTP.
Study Methodology
Read more
The program participants will consist of older women (>60 years; n=60) whose current HFMS allows for participation in the exercise protocol. They will be divided into two groups:
Experimental Group: Will participate in the MPAP.
Control Group: Will not participate in the MPAP.
The exercise intervention (MPAP) will include a combination of aerobic activities, strength exercises, balance, and flexibility. It will be conducted two to three times per week across two three-month cycles, separated by a three-month break.
Data Collection and Environment Assessments: Sociodemographic factors, physical literacy, and health literacy will be measured at the start of the study. A series of HFMS indicators will be recorded before and after each exercise cycle.
Setting: The MPAP will be performed outdoors in a public park.
Project Significance Beyond analyzing the direct effects of the exercise program and the correlations between the measured variables, this project will contribute to a deeper understanding of the importance of the natural environment in implementing goal-oriented physical activity for the elderly population.
Read the detailed description
The primary objective of this project is to examine the effects of a specific multicomponent physical activity program (MPAP), conducted in an outdoor setting, on the health and functional-motor status (HFMS) of women over the age of 60. Additionally, the study will investigate the influence of sociodemographic factors (SDF), physical literacy (PL), and health literacy (HL) on the baseline HFMS and the subsequent changes resulting from the KTP.
Study Methodology
The program participants will consist of older women (>60 years; n=60) whose current HFMS allows for participation in the exercise protocol. They will be divided into two groups:
Experimental Group: Will participate in the MPAP.
Control Group: Will not participate in the MPAP.
The exercise intervention (MPAP) will include a combination of aerobic activities, strength exercises, balance, and flexibility. It will be conducted two to three times per week across two three-month cycles, separated by a three-month break.
Data Collection and Environment Assessments: Sociodemographic factors, physical literacy, and health literacy will be measured at the start of the study. A series of HFMS indicators will be recorded before and after each exercise cycle.
Setting: The MPAP will be performed outdoors in a public park.
Project Significance Beyond analyzing the direct effects of the exercise program and the correlations between the measured variables, this project will contribute to a deeper understanding of the importance of the natural environment in implementing goal-oriented physical activity for the elderly population.
- Being tested
- Physical exercising
- Keywords
- physical fitness, health status, postmenopausal women
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical exercisingBehavioural
Participants will be involved in regular physical exercising in public space
| Study group | Role | What they receive |
|---|---|---|
| Evaluation | Experimental | Participants in the intervention Receives: Behavioral: Physical exercising |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fitness status - dynamic balance
Measured by Biodex balance system on the basis of standardized protocol
Measured: 3 months
Fitness status - static balance
Measured by Biodex balance system using the standardized protocol
Measured: 3 monts
Lipid profile
Tryglicerides, LDL Cholesterol, HDL Cholesterol, Total Cholesterol (measured by POC testing device)
Measured: 3 months
Health literacy
Health literacy evidenced via HLS19-Q12
Measured: 3 months
Secondary outcomes (2)
Body composition - skeletal muscle mass
Measured by Tanita measurement scale
Measured: 3 months
Body composition - body fat
Measured by Tanita scale
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start1 Jan 2026 (estimated)
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical FitnessStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Experimental (treatment group) vs. Control (non-treated group)
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Goran Kuvacic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Goran Kuvacic, University of Split
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07365228
- Sponsor's protocol ID
- Open space and closed years
- Other IDs
- IP-UNIST-23_OPZG
- Acronym
- OS&CY
- Status last verified
- Dec 2025
- First submitted
- 21 Dec 2025
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Anonymity issues
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OPEN SPACE AND CLOSED YEARS
- ClinicalTrials.gov ID
- NCT07365228
- Acronym / sponsor ID
- OS&CY / Open space and closed years
- Keywords
- physical fitness, health status, postmenopausal women
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Goran KuvacicUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Jun 2029 (estimated)
- First posted
- 26 Jan 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.
The primary objective of this project is to examine the effects of a specific multicomponent physical activity program (MPAP), conducted in an outdoor setting, on the health and functional-motor status (HFMS) of women over the age of 60. Additionally, the study will investigate the influence of sociodemographic factors (SDF), physical literacy (PL), and health literacy (HL) on the baseline HFMS and the subsequent changes resulting from the KTP.
Study Methodology
The program participants will consist of older women (>60 years; n=60) whose current HFMS allows for participation in the exercise protocol. They will be divided into two groups:
Experimental Group: Will participate in the MPAP.
Control Group: Will not participate in the MPAP.
The exercise intervention (MPAP) will include a combination of aerobic activities, strength exercises, balance, and flexibility. It will be conducted two to three times per week across two three-month cycles, separated by a three-month break.
Data Collection and Environment Assessments: Sociodemographic factors, physical literacy, and health literacy will be measured at the start of the study. A series of HFMS indicators will be recorded before and after each exercise cycle.
Setting: The MPAP will be performed outdoors in a public park.
Project Significance Beyond analyzing the direct effects of the exercise program and the correlations between the measured variables, this project will contribute to a deeper understanding of the importance of the natural environment in implementing goal-oriented physical activity for the elderly population.
Detailed description
The primary objective of this project is to examine the effects of a specific multicomponent physical activity program (MPAP), conducted in an outdoor setting, on the health and functional-motor status (HFMS) of women over the age of 60. Additionally, the study will investigate the influence of sociodemographic factors (SDF), physical literacy (PL), and health literacy (HL) on the baseline HFMS and the subsequent changes resulting from the KTP.
Study Methodology
The program participants will consist of older women (>60 years; n=60) whose current HFMS allows for participation in the exercise protocol. They will be divided into two groups:
Experimental Group: Will participate in the MPAP.
Control Group: Will not participate in the MPAP.
The exercise intervention (MPAP) will include a combination of aerobic activities, strength exercises, balance, and flexibility. It will be conducted two to three times per week across two three-month cycles, separated by a three-month break.
Data Collection and Environment Assessments: Sociodemographic factors, physical literacy, and health literacy will be measured at the start of the study. A series of HFMS indicators will be recorded before and after each exercise cycle.
Setting: The MPAP will be performed outdoors in a public park.
Project Significance Beyond analyzing the direct effects of the exercise program and the correlations between the measured variables, this project will contribute to a deeper understanding of the importance of the natural environment in implementing goal-oriented physical activity for the elderly population.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Experimental (treatment group) vs. Control (non-treated group)
| Arm | Type | Receives |
|---|---|---|
| Evaluation | Experimental | Behavioral: Physical exercisingParticipants in the intervention |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- physical fitness status which allows active participation in the physical exercising program organized as a tretment
Key exclusion criteria (1 listed)
- health conditions not allowing the participation in treatment program
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 |
|---|---|---|
| Physical exercisingParticipants will be involved in regular physical exercising in public space | Behavioural | Evaluation |
Primary outcome
Fitness status - dynamic balance
Time frame: 3 months
Measured by Biodex balance system on the basis of standardized protocol
Fitness status - static balance
Time frame: 3 monts
Measured by Biodex balance system using the standardized protocol
Lipid profile
Time frame: 3 months
Tryglicerides, LDL Cholesterol, HDL Cholesterol, Total Cholesterol (measured by POC testing device)
Health literacy
Time frame: 3 months
Health literacy evidenced via HLS19-Q12
2 secondary outcomes
Body composition - skeletal muscle mass
Time frame: 3 months
Body composition - body fat
Time frame: 3 months
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 26 Jan 2026.
- Individual participant dataSharing planned: Undecided. Anonymity issues
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Recruiting
The STRIVE Before Surgery Trial
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Physical exercising in people with Physical Fitness and Health Literacy, run by Goran Kuvacic.
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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Damir Sekulic, Professor (385912504664, damir.sekulic@kifst.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fitness status - dynamic balance (time frame: 3 months). The study lists 4 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 26 Jan 2026.