NCT07365228

Brief 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. 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
38mo left

Started Jan 2026

Longer than P75 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress10%
Jan 2026Jun 2029

First Submitted

Initial submission to the registry

December 21, 2025

Completed
11 days until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
25 days until next milestone

First Posted

Study publicly available on registry

January 26, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2029

Expected
Last Updated

January 26, 2026

Status Verified

December 1, 2025

Enrollment Period

2 months

First QC Date

December 21, 2025

Last Update Submit

January 15, 2026

Conditions

Keywords

physical fitnesshealth statuspostmenopausal women

Outcome Measures

Primary Outcomes (4)

  • Fitness status - dynamic balance

    Measured by Biodex balance system on the basis of standardized protocol

    3 months

  • Fitness status - static balance

    Measured by Biodex balance system using the standardized protocol

    3 monts

  • Lipid profile

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

    3 months

  • Health literacy

    Health literacy evidenced via HLS19-Q12

    3 months

Secondary Outcomes (2)

  • Body composition - skeletal muscle mass

    3 months

  • Body composition - body fat

    3 months

Other Outcomes (1)

  • Physical literacy

    3 months

Study Arms (1)

Evaluation

EXPERIMENTAL

Participants in the intervention

Behavioral: Physical exercising

Interventions

Participants will be involved in regular physical exercising in public space

Evaluation

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • health conditions not allowing the participation in treatment program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Damir Sekulic, Professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: Experimental (treatment group) vs. Control (non-treated group)
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 21, 2025

First Posted

January 26, 2026

Study Start

January 1, 2026

Primary Completion

March 1, 2026

Study Completion (Estimated)

June 1, 2029

Last Updated

January 26, 2026

Record last verified: 2025-12