EldrelyNCT05579457
Physical Performance Levels and Social Participation in Elderly Living In Urban and Rural Areas
An observational study of Eldrely, run by Suleyman Demirel University at 1 site in Turkey (Türkiye).
Trial summary
Purpose: This study aims to investigate the effect of physical performance levels of elderly living in rural and urban areas on social participation, social functioning, and quality of life. Read more about this study
- Who is it for?
- Ages 65 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Eldrely
- What is being tested?
- Short Physical Performance Battery
- How many people
- 418 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Mar 2019to 12 Mar 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 100 years
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: This study was carried out with the participation of elderly residing in the provinces of Isparta, Burdur, and Antalya in the Mediterranean region of Turkey
Who may be able to join
- individuals over the age of 65 years who received a score of ≥24 from the Mini-Mental State Examination were included in the study
Who cannot join
- elderly who were unable to communicate verbally, were unable to move independently, had undergone any operations in the last 6 months, had been diagnosed with cancer, or had severe vision loss, stroke, Parkinson's disease, multiple sclerosis, or other neurological diseases were excluded from the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Physical Performance Levels of Elderly Living In Urban and Rural Areas on Social Participation, Social Functioning, and Quality of Life
Purpose: This study aims to investigate the effect of physical performance levels of elderly living in rural and urban areas on social participation, social functioning, and quality of life.
Method: A total of 418 volunteer elderly aged 65 and over living in rural (42.3%) and urban (57.7%) areas participated in this study. The Mini-Mental State Examination, Short Physical Performance Battery, the World Health Organization Quality of Life Scale for Older Adults, Leisure Time subscale of the Social Functioning Scale and the Community Integration Questionnaire were applied to participants.
- Conditions
- Eldrely
- Being tested
- Short Physical Performance Battery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short Physical Performance BatteryOther
The SPPB was applied to determine the physical performance levels of the elderly. This test is a valid and reliable test that measures the performance of the lower extremities and can be applied for elderly. The SPPB included three sections: getting up from a chair, standing balance, and walking speed. At the end of these tests, the scores of the three sections were calculated and higher scores were evaluated as reflecting higher levels of physical performance
| Study group | Role | What they receive |
|---|---|---|
| elderly people living in rural areas | Not described Receives: Other: Short Physical Performance Battery | |
| elderly people living in urban areas | Not described Receives: Other: Short Physical Performance Battery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Community Integration Questionnaire
The questionnaire consists of a total of 18 questions and the highest total score attainable is 35. A total score of 0 is evaluated as no social participation and a total score of 35 is evaluated as full social participation, with an increase in the total score indicating an increase in social participation
Measured: 02.04.2021
Secondary outcomes (1)
Social Functioning Scale (
The SFS is a tool that evaluates the social role functions of individuals. It has been determined that the SFS is a valid and reliable scale for use in Turkish society
Measured: 02.04.2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2022
- Study start4 Mar 2019
- Primary completion7 May 2020
- Study completion12 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EldrelyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 418 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suleyman Demirel University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tahir Keskin , Pt, MSc, Suleyman Demirel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05579457
- Sponsor's protocol ID
- 72867572.050.01.04.2953
- Status last verified
- Oct 2022
- First submitted
- 11 Oct 2022
- Last updated
- 13 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Physical Performance Levels of Elderly Living In Urban and Rural Areas on Social Participation, Social Functioning, and Quality of Life
- ClinicalTrials.gov ID
- NCT05579457
- Acronym / sponsor ID
- 72867572.050.01.04.2953
- Conditions
- Eldrely
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 418 participants (actual)
- Lead sponsor
- Suleyman Demirel UniversityUniversity, hospital or other
- Study start
- 4 Mar 2019 (actual)
- Primary completion
- 7 May 2020 (actual)
- Study completion
- 12 Mar 2021 (actual)
- First posted
- 13 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Purpose: This study aims to investigate the effect of physical performance levels of elderly living in rural and urban areas on social participation, social functioning, and quality of life.
Method: A total of 418 volunteer elderly aged 65 and over living in rural (42.3%) and urban (57.7%) areas participated in this study. The Mini-Mental State Examination, Short Physical Performance Battery, the World Health Organization Quality of Life Scale for Older Adults, Leisure Time subscale of the Social Functioning Scale and the Community Integration Questionnaire were applied to participants.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| elderly people living in rural areas | – | Other: Short Physical Performance Battery |
| elderly people living in urban areas | – | Other: Short Physical Performance Battery |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- This study was carried out with the participation of elderly residing in the provinces of Isparta, Burdur, and Antalya in the Mediterranean region of Turkey
Key inclusion criteria (1 listed)
- individuals over the age of 65 years who received a score of ≥24 from the Mini-Mental State Examination were included in the study
Key exclusion criteria (1 listed)
- elderly who were unable to communicate verbally, were unable to move independently, had undergone any operations in the last 6 months, had been diagnosed with cancer, or had severe vision loss, stroke, Parkinson's disease, multiple sclerosis, or other neurological diseases were excluded from the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Short Physical Performance BatteryThe SPPB was applied to determine the physical performance levels of the elderly. This test is a valid and reliable test that measures the performance of the lower extremities and can be applied for elderly. The SPPB included three sections: getting up from a chair, standing balance, and walking speed. At the end of these tests, the scores of the three sections were calculated and higher scores were evaluated as reflecting higher levels of physical performance | Other | elderly people living in rural areas, elderly people living in urban areas |
Primary outcome
Community Integration Questionnaire
Time frame: 02.04.2021
The questionnaire consists of a total of 18 questions and the highest total score attainable is 35. A total score of 0 is evaluated as no social participation and a total score of 35 is evaluated as full social participation, with an increase in the total score indicating an increase in social participation
1 secondary outcome
Social Functioning Scale (
Time frame: 02.04.2021
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2022.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Eldrely, run by Suleyman Demirel University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Community Integration Questionnaire (time frame: 02.04.2021). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2022.