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NCT Number: NCT07365228

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

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.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • physical fitness status which allows active participation in the physical exercising program organized as a tretment

Exclusion criteria

  • health conditions not allowing the participation in treatment program

Treatment and study plan

Physical exercising

Behavioral

Participants will be involved in regular physical exercising in public space

Primary outcomes

  1. Fitness status - dynamic balance

    Time frame: 3 months

    Measured by Biodex balance system on the basis of standardized protocol

  2. Fitness status - static balance

    Time frame: 3 monts

    Measured by Biodex balance system using the standardized protocol

  3. Lipid profile

    Time frame: 3 months

    Tryglicerides, LDL Cholesterol, HDL Cholesterol, Total Cholesterol (measured by POC testing device)

  4. Health literacy

    Time frame: 3 months

    Health literacy evidenced via HLS19-Q12

Secondary outcomes

  1. Body composition - skeletal muscle mass

    Time frame: 3 months

    Measured by Tanita measurement scale

  2. Body composition - body fat

    Time frame: 3 months

    Measured by Tanita scale

Other outcomes

  1. Physical literacy

    Time frame: 3 months

    Evidenced by PPLQ

Study contacts

Contact information is provided by the study sponsor or research team.

Damir Sekulic, Professor

CONTACT

[email protected]

385912504664

Sponsors and collaborators

Lead sponsor

Goran Kuvacic

Other

Registry information

Acronym: OS&CY

Important dates

Study start
2026
Primary completion
2026
Study completion
2029
First posted
Jan 26, 2026
Registry last updated
Jan 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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