NCT07115888

Brief Summary

INTRODUCTION You are invited to take part in this academic study because you are 65 years or older and live independently in the community. Before participating, please read the following information carefully to understand the study's procedures. After reading, if you agree to join, you will be asked to complete some questionnaires and simple mobility tests. BACKGROUND Programs that promote health, physical activity, social interaction, and mental stimulation are becoming more important for older adults. However, there is no clear way to measure their effectiveness. Researchers from McGill, Exeter, Erasmus, and UT Health San Antonio universities are working together to better understand active aging. In earlier studies, over 200 people were interviewed to learn how older adults perceive active living. This study now aims to examine the physical and psychological functions associated with active living. PURPOSE OF THE STUDY This project aims to test the reliability of the HRQL-OPAL scale and assess the level of physical and psychological function related to active aging. STUDY PROCEDURES This research is conducted under the Department of Physiotherapy and Rehabilitation, Marmara University. If you agree to participate: You will first complete questionnaires (approx. 20 minutes). Then, you will perform mobility tests (approx. 20 minutes) such as walking and changing positions. A small sensor will be placed on your shoe to measure your steps and movements. You will not be asked to do anything unsafe or difficult, like jumping or standing on one leg. If you agree, you may be asked to complete the HRQL-OPAL scale again two weeks later. DURATION Total time for the first session is about 40 minutes. A second session, if agreed, will take about 20 minutes after two weeks. BENEFITS You may not receive direct personal benefit, but the results may help improve scientific knowledge and support better ways to measure quality of life in older adults. RISKS There are no known risks. Some questions may be sensitive, but you do not have to answer any that make you uncomfortable. All tests are widely used and supervised by trained professionals. VOLUNTARY PARTICIPATION AND WITHDRAWAL Your participation is voluntary. You may withdraw at any time without providing a reason and without any impact on your medical care. CONFIDENTIALITY All collected data will be coded and stored securely without using your name. Only the research team will access this information. Results may be shared in scientific reports, but your identity will remain confidential. Data will be stored for seven years by the lead researcher. ETHICAL REVIEW This study has been reviewed and approved by the Ethics Committee of Marmara University Faculty of Medicine. STUDY TITLE "Reliability and Validity Study of the Health-Related Quality of Life Scale Developed for Active Older Adults" NUMBER OF PARTICIPANTS At least 92 participants who meet the criteria are required for the study. PARTICIPANT STATEMENT I, the undersigned, confirm that I have received detailed information about this study from Physiotherapist Muhammed Furkan ORUÇ, and I have been invited to participate as a volunteer. I understand that all personal information will remain confidential, and the study will not affect my medical care. I am aware that I can withdraw at any time. If any health problems occur during the study, I can contact Fzt. Muhammed Furkan ORUÇ at 0534 421 52 94 or reach the institution at Küçük Çamlıca Mah. Çilehane Yolu Cad. No:51, 34696, Üsküdar/İstanbul, Prof. Dr. Fahrettin Kerim-Nilüfer Gökay Nursing Home Elderly Care and Rehabilitation Center. I voluntarily agree to participate in this research and will receive a signed copy of this form.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
92

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 4, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 11, 2025

Completed
Last Updated

August 14, 2025

Status Verified

August 1, 2025

Enrollment Period

5 months

First QC Date

August 4, 2025

Last Update Submit

August 9, 2025

Conditions

Keywords

Active AgingActive Older AdultsHealth Related Quality of LifeReliabilityValidityScale Development

Outcome Measures

Primary Outcomes (1)

  • Health Related Quality of Life - Older Persons of Active Living (HRQL-OPAL)

    The main finding of the study is the 17-item Health Related Quality of Life - Older Persons (HRQL-OPAL) measurement tool, which was developed in 2024 by Mayo et al. as a result of a multinational study based on self-report. The response options in this tool have linear characteristics, and the total score obtained from each item-assessed on a 4-point ordinal scale-reflects the overall scale score. The scale score ranges from 0 to 51, with higher scores indicating better health-related quality of life and active living.

    Day 1 and Day 15

Secondary Outcomes (13)

  • Short Form-36 Health Survey (SF-36)

    Day 1

  • EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L)

    Day 1

  • Lower Extremity Functional Scale (LEFS)

    Day 1

  • Apathy Evaluation Scale (AES)

    Day 1

  • Hand Grip Strength Test

    Day 1

  • +8 more secondary outcomes

Study Arms (1)

Active elderly individuals aged 65 and over

Active elderly people aged 65 and over, who have the ability to see, hear and see, and who do not go to a health center for any ongoing treatment.

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Individuals who reside in Istanbul, are over 65 years of age, are actively aging, and agree to participate in the study.

You may qualify if:

  • Volunteering,
  • Being 65 years of age or older,
  • Living independently in the community,
  • Being able to walk outdoors with or without a companion and with or without an assistive device,
  • Being able to see well with or without a visual aid,
  • Being able to hear well with or without a hearing aid,
  • Being approved for post-examination tests by Prof. Dr. Yaşar SERTBAŞ.

You may not qualify if:

  • Participants who: • Have a medical condition requiring ongoing hospitalization in a healthcare facility (e.g., malignant tumor, kidney or liver failure);
  • Are under 65 years of age;
  • Are unable to live independently in the community;
  • Are unable to see, hear, or walk properly, even with a device;
  • Are deemed unsuitable for post-examination testing by Prof. Dr. Yaşar SERTBAŞ; • Have severe cognitive impairment;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara University Health Sciences Institute

Istanbul, Kartal, 34865, Turkey (Türkiye)

Location

Study Officials

  • Eren Timurtaş, Assoc. Prof. Dr.

    Marmara University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist

Study Record Dates

First Submitted

August 4, 2025

First Posted

August 11, 2025

Study Start

February 1, 2025

Primary Completion

June 30, 2025

Study Completion

June 30, 2025

Last Updated

August 14, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

I have obligations regarding the confidentiality of participant data.

Locations