Reliability and Validity Assessment of the Health-Related Quality of Life Scale Developed for Active Older Adults

NCT ID: NCT07115888

Last Updated: 2025-08-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 92 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-02-01
• Study Completion Date: 2025-06-30

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.

Detailed Description

INTRODUCTION

As an individual aged 65 or over who is living independently in the community, you are invited to participate in this academic study.

Before participating in this study, we ask you to read the information in this form to understand the proposed procedures. The following information explains the background, objectives, procedures, benefits, and risks of this study. Please take time to read, understand, and carefully review this information. After reading the information, you will be asked a few questions about the study. If you understand the study well and agree to participate, you will be asked to complete some questionnaires and perform a few mobility tests.

BACKGROUND

Community programs that promote health, physical activity, socialization, and mental stimulation are gaining increasing importance for older adults. These programs support activities that elderly individuals consider important for active aging. However, there is currently no definitive way to measure the outcomes of these programs.

Researchers from McGill University, the University of Exeter, Erasmus University, and UT Health San Antonio have collaborated to understand how older adults maintain an active lifestyle. In these studies, more than 200 individuals were interviewed, and their perceptions of living actively were identified. The current study aims to understand the physical and psychological abilities and emotions associated with active living.

PURPOSE OF THE STUDY

This project aims to test the reliability of the HRQL-OPAL scale and measure the extent of physical and psychological function associated with how active a person is.

DESCRIPTION OF STUDY PROCEDURES

This research is conducted under the auspices of the Department of Physiotherapy and Rehabilitation at Marmara University Faculty of Health Sciences. Assessments of your physical and psychological health will be carried out at your place of residence or, if more convenient, in a specialized mobility laboratory. If you agree to participate, you will first be asked to complete some questionnaires, which will take approximately 20 minutes.

After completing the questionnaires, you will be asked to perform a simple mobility test, which will also take around 20 minutes. These tests include walking and transitioning from one position to another. While walking, a small sensor will be attached to your shoe. This sensor will count your steps and assess how well your foot moves while walking. You will not be asked to perform any test that you or the accompanying staff member thinks you are unable or should not perform - for example, jumping or standing on one leg.

If you agree, you will be asked to complete the HRQL-OPAL scale a second time, 2 weeks later.

DURATION OF THE STUDY

Completing the questionnaires will take about 20 minutes, and the mobility tests will take about 20 minutes. This will be done only once. If you agree to complete the HRQL-OPAL scale a second time, it will be conducted two weeks later.

BENEFITS OF THE STUDY

You may or may not receive personal benefits from participating in this research project. However, we hope that the results will contribute to the advancement of scientific knowledge in this area and help identify better ways to measure what matters most to older adults.

RISKS OF THE STUDY

There are no known risks associated with participating in this study. Some people may feel uncomfortable answering health-related questions, but you are not obligated to answer any question you do not wish to. The physical tests are commonly used for mobility assessment, and trained research assistants will assist you to ensure your safety during these tests.

VOLUNTARY PARTICIPATION AND RIGHT TO WITHDRAW

Your participation in this research project is entirely voluntary.

CONFIDENTIALITY

All information collected will be coded and stored without using your name. Only the research team will have access to the records.

All information collected in this study will be kept confidential and will not be shared with anyone outside the study except as required by law. Reports, publications, or presentations resulting from this study will maintain your anonymity.

During your participation, the principal investigator and the research team will collect and record only the information necessary to achieve the scientific objectives of the study. The data will be stored for 7 years after the final publication by the principal investigator. The data may be published or shared at scientific meetings; however, your identity will not be disclosed from this information.

ETHICAL OVERSIGHT OF THE STUDY

This study has been reviewed by the Ethics Committee of Marmara University Faculty of Medicine, which is responsible for the ongoing ethical oversight of the study.

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 eligibility criteria are required for the completion of the study.

PARTICIPANT'S STATEMENT

I have been informed by Physiotherapist Muhammed Furkan ORUÇ that a medical research study will be conducted at the Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Marmara University, and I have been provided with the above information regarding this research. Following this information, I have been invited to participate as a "participant" in this study.

I believe that the confidentiality of my personal information, which must remain private between me and my physician, will be respected and handled with great care during this study. I have been assured that my personal information will be protected with due diligence during the use of research results for educational and scientific purposes.

I am aware that I can withdraw from the study at any time for any reason. However, I understand it would be appropriate to inform the researchers beforehand to avoid causing any inconvenience. I also acknowledge that I may be removed from the study by the researcher to avoid any harm to my medical condition. I will not be held financially responsible for any expenses related to the study, nor will I receive any payment. I have been assured that any medical intervention required due to direct or indirect consequences of the study will be provided, and I will not incur any financial burden for these interventions.

In case of any health issue during the study, I know I can contact Physiotherapist 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 understand that I am not obligated to participate in this study, and I have not been subjected to any coercion. I know that if I choose not to participate, it will not negatively affect my medical care or relationship with my physician.

I fully understand all the explanations provided to me. After taking adequate time to consider independently, I have decided to participate in the aforementioned research project as a "participant" (subject). I accept this invitation with great satisfaction and willingness. A copy of this signed consent form will be provided to me.

Conditions

Active Aging Individuals Aged 65 and Over

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: OTHER

Study Groups

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.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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;

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Marmara University

OTHER

Sponsor Role: lead

Responsible Party

Muhammed Furkan Oruç

Physiotherapist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eren Timurtaş, Assoc. Prof. Dr.

Role: STUDY_DIRECTOR

Marmara University

Locations

Marmara University Health Sciences Institute

Istanbul, Kartal, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

09.2024.1584

Identifier Type: -

Identifier Source: org_study_id