Open Space and Closed Years (OS&CY)

January 15, 2026 updated by: Goran Kuvacic

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Evaluation
Participants in the intervention
Behavioral: Physical exercising
Participants will be involved in regular physical exercising in public space

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fitness status - dynamic balance
Time Frame: 3 months
Measured by Biodex balance system on the basis of standardized protocol
3 months
Fitness status - static balance
Time Frame: 3 monts
Measured by Biodex balance system using the standardized protocol
3 monts
Lipid profile
Time Frame: 3 months
Tryglicerides, LDL Cholesterol, HDL Cholesterol, Total Cholesterol (measured by POC testing device)
3 months
Health literacy
Time Frame: 3 months
Health literacy evidenced via HLS19-Q12
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body composition - skeletal muscle mass
Time Frame: 3 months
Measured by Tanita measurement scale
3 months
Body composition - body fat
Time Frame: 3 months
Measured by Tanita scale
3 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical literacy
Time Frame: 3 months
Evidenced by PPLQ
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Goran Kuvacic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2026

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

June 1, 2029

Study Registration Dates

First Submitted

December 21, 2025

First Submitted That Met QC Criteria

January 15, 2026

First Posted (Actual)

January 26, 2026

Study Record Updates

Last Update Posted (Actual)

January 26, 2026

Last Update Submitted That Met QC Criteria

January 15, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Open space and closed years
  • IP-UNIST-23_OPZG (Other Grant/Funding Number: Ministry of Science, Education and Youth of the Republic of Croatia)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Anonymity issues

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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