Aging DisorderNCT06267625
Physical Impairments in Elderly Individuals
An observational study of Aging Disorder, run by Izmir Democracy University at 1 site in Turkey (Türkiye).
Trial summary
There are no studies in the literature reporting the dyspnea, posture, strength, physical activity, functional mobility and balance in elderly individuals. The aims of this observational study are; 1) to evaluate dyspnea, posture, strength, physical activity, functional mobility and balance in elderly individuals, 2)… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging Disorder
- What is being tested?
- Physical Evaluations of individuals
- How many people
- 143 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2024to 1 Sep 2025
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: At least 50 individuals aged 65 and over will be included
Who may be able to join
- Being 65 years or older
- Volunteering to participate in the study
- Getting a score of 23 or higher on the Standardized Mini Mental State Test
Who cannot join
- The participant has a cognitive, neurological or orthopedic disease that would affect the participant's ability to move independently and understand the questions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of Dyspnea, Posture, Strength, Physical Activity, Functional Mobility and Balance in Elderly Individuals
There are no studies in the literature reporting the dyspnea, posture, strength, physical activity, functional mobility and balance in elderly individuals. The aims of this observational study are; 1) to evaluate dyspnea, posture, strength, physical activity, functional mobility and balance in elderly individuals, 2) to reveal the relationships between these parameters of research group.
Read the detailed description
The increase in the elderly population brings with it many health problems, especially in older ages. Rates of limitation and disability are increasing in elderly individuals due to chronic diseases. Many of these changes negatively affect their daily living activities. With aging, respiratory muscle strength and respiratory surface area decrease in the cardiopulmonary system. Respiration is negatively affected by the decrease in muscle strength. Postural correctness cannot be easily achieved in elderly individuals due to deterioration in bone, muscle and joint structures. Functional mobility and balance problems are observed with changes in postural control that occur with aging. There are not enough studies in the literature to clarify this issue that evalatues dyspnea, posture, strength, physical activity, functional mobility and balance in elderly individuals. Therefore, the aim of our study is to evaluate dyspnea, posture, strength, physical activity, functional mobility and balance in elderly individuals. Therefore, we aimed to clarify this gap.
- Conditions
- Aging Disorder
- Being tested
- Physical Evaluations of individuals
- Keywords
- elderly individuals, older adults, dyspnea, posture, functional mobility, balance, muscle strength
- Medical subject headings
- Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical Evaluations of individualsOther
Participants will be evaluated on posture, cough strength, functional mobility and hand grip strength.They will be asked to answer the Standardized Mini Mental Test, Modified Medical Research Council Scale, Physical Activity Scale for the Elderly, Berg Balance Scale. The data to be obtained from all these evaluations are planned to be collected face to face from the participants at once and within a maximum of 1 hour.
| Study group | Role | What they receive |
|---|---|---|
| Elderly Individuals | This group will consist of individuals aged 65 and over Receives: Other: Physical Evaluations of individuals |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dyspnea score
Dyspnea score will be obtained from the Modified Medical Research Council (MMRC) Scale. This scale is a five-item scale based on various physical activities that cause a feeling of shortness of breath (dyspnea). As the score an individual gets from the scale increases, the perception of shortness of breath also increases.
Measured: through study completion, an average of 1 year
Secondary outcomes (8)
Posture score
Posture deviation will be determined according to the deviation score in the joint centers obtained by photographing the posture of the individuals and uploading them to the system. Posture assessment will be made with a mobile application based on the concept of postural analysis with artificial intelligence.
Measured: through study completion, an average of 1 year
Cough strength
Cough strength will be evaluated using a PEFmeter.
Measured: through study completion, an average of 1 year
Handgrip strength
Hand grip strength will be measured using the Jamar hand dynamometer.
Measured: through study completion, an average of 1 year
Functional mobility score
Functional mobility will be evaluated with Chair Stand Test. Higher repetition numbers indicate better physical performance.
Measured: through study completion, an average of 1 year
Physical activity score
Physical activity will be assessed using the Physical Activity Scale for the Elderly. Participation in leisure activities, housework activities, and work-related activities are recorded. Higher score indicates better physical activity levels.
Measured: through study completion, an average of 1 year
Functional Mobility score
Functional mobility and balance will be evaluated with Time Up and Go test. The test measures speed during many functional maneuvers such as standing, walking, turning and sitting.
Measured: through study completion, an average of 1 year
Balance score
Balance will be assessed using Berg Balance Scale. The scale consists of 14 items. These items examine activities in which the support area gradually decreases and it becomes difficult to maintain the position.
Measured: through study completion, an average of 1 year
Cognitive function score
Cognitive function will be assessed using the Standardized Mini Mental State Test. The maximum score is 30 points. Scores of 23 and lower indicate cognitive dysfunction, scores of 24 and above indicate normal cognitive level.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start1 Jan 2024
- Primary completion15 Jun 2025
- Study completion1 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Aging DisorderStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Democracy University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gulsah Bargi, Izmir Democracy University
- Investigators
- GÜLŞAH BARĞI, Assoc.Dr, Study director, Izmir Democracy UniversityESRA SUDE AKIN, BSc, Principal investigator, Izmir Democracy UniversityÖZLEM ÇİNAR ÖZDEMİR, Assoc.Dr, Principal investigator, Izmir Democracy University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06267625
- Sponsor's protocol ID
- Elderly Individuals
- Status last verified
- Sep 2025
- First submitted
- 12 Feb 2024
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Silva CFR, Pegorari MS, Matos AP, Ohara DG. Dyspnea is associated with poor physical performance among community-dwelling older adults: a population-based cross-sectional study. Sao Paulo Med J. 2020 Mar;138(2):112-117. doi: 10.1590/1516-3180.2019.0428.R1.09122019. Epub 2020 Apr 9.
PubMed 32294715Dindorf C, Konradi J, Wolf C, Taetz B, Bleser G, Huthwelker J, Werthmann F, Bartaguiz E, Kniepert J, Drees P, Betz U, Frohlich M. Classification and Automated Interpretation of Spinal Posture Data Using a Pathology-Independent Classifier and Explainable Artificial Intelligence (XAI). Sensors (Basel). 2021 Sep 21;21(18):6323. doi: 10.3390/s21186323.
PubMed 34577530Kaulamo JT, Latti AM, Koskela HO. Recurrent Cough in the Elderly: A Forgotten Entity. Lung. 2023 Dec;201(6):545-553. doi: 10.1007/s00408-023-00654-2. Epub 2023 Nov 14.
PubMed 37964136
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Dyspnea, Posture, Strength, Physical Activity, Functional Mobility and Balance in Elderly Individuals
- ClinicalTrials.gov ID
- NCT06267625
- Acronym / sponsor ID
- Elderly Individuals
- Conditions
- Aging Disorder
- Keywords
- elderly individuals, older adults, dyspnea, posture, functional mobility, balance, muscle strength
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Izmir Democracy UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 15 Jun 2025 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 20 Feb 2024 (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.
There are no studies in the literature reporting the dyspnea, posture, strength, physical activity, functional mobility and balance in elderly individuals. The aims of this observational study are; 1) to evaluate dyspnea, posture, strength, physical activity, functional mobility and balance in elderly individuals, 2) to reveal the relationships between these parameters of research group.
Detailed description
The increase in the elderly population brings with it many health problems, especially in older ages. Rates of limitation and disability are increasing in elderly individuals due to chronic diseases. Many of these changes negatively affect their daily living activities. With aging, respiratory muscle strength and respiratory surface area decrease in the cardiopulmonary system. Respiration is negatively affected by the decrease in muscle strength. Postural correctness cannot be easily achieved in elderly individuals due to deterioration in bone, muscle and joint structures. Functional mobility and balance problems are observed with changes in postural control that occur with aging. There are not enough studies in the literature to clarify this issue that evalatues dyspnea, posture, strength, physical activity, functional mobility and balance in elderly individuals. Therefore, the aim of our study is to evaluate dyspnea, posture, strength, physical activity, functional mobility and balance in elderly individuals. Therefore, we aimed to clarify this gap.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elderly Individuals | – | Other: Physical Evaluations of individualsThis group will consist of individuals aged 65 and over |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- At least 50 individuals aged 65 and over will be included
Key inclusion criteria (3 listed)
- Being 65 years or older
- Volunteering to participate in the study
- Getting a score of 23 or higher on the Standardized Mini Mental State Test
Key exclusion criteria (1 listed)
- The participant has a cognitive, neurological or orthopedic disease that would affect the participant's ability to move independently and understand the questions.
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 |
|---|---|---|
| Physical Evaluations of individualsParticipants will be evaluated on posture, cough strength, functional mobility and hand grip strength.They will be asked to answer the Standardized Mini Mental Test, Modified Medical Research Council Scale, Physical Activity Scale for the Elderly, Berg Balance Scale. The data to be obtained from all these evaluations are planned to be collected face to face from the participants at once and within a maximum of 1 hour. | Other | Elderly Individuals |
Primary outcome
Dyspnea score
Time frame: through study completion, an average of 1 year
Dyspnea score will be obtained from the Modified Medical Research Council (MMRC) Scale. This scale is a five-item scale based on various physical activities that cause a feeling of shortness of breath (dyspnea). As the score an individual gets from the scale increases, the perception of shortness of breath also increases.
8 secondary outcomes
Posture score
Time frame: through study completion, an average of 1 year
Cough strength
Time frame: through study completion, an average of 1 year
Handgrip strength
Time frame: through study completion, an average of 1 year
Functional mobility score
Time frame: through study completion, an average of 1 year
Physical activity score
Time frame: through study completion, an average of 1 year
Functional Mobility score
Time frame: through study completion, an average of 1 year
Balance score
Time frame: through study completion, an average of 1 year
Cognitive function score
Time frame: through study completion, an average of 1 year
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 15 Sep 2025.
- Background: PubMed 32294715Silva CFR, Pegorari MS, Matos AP, Ohara DG. Dyspnea is associated with poor physical performance among community-dwelling older adults: a population-based cross-sectional study. Sao Paulo Med J. 2020 Mar;138(2):112-117. doi: 10.1590/1516-3180.2019.0428.R1.09122019. Epub 2020 Apr 9.
- Background: PubMed 34577530Dindorf C, Konradi J, Wolf C, Taetz B, Bleser G, Huthwelker J, Werthmann F, Bartaguiz E, Kniepert J, Drees P, Betz U, Frohlich M. Classification and Automated Interpretation of Spinal Posture Data Using a Pathology-Independent Classifier and Explainable Artificial Intelligence (XAI). Sensors (Basel). 2021 Sep 21;21(18):6323. doi: 10.3390/s21186323.
- Background: PubMed 37964136Kaulamo JT, Latti AM, Koskela HO. Recurrent Cough in the Elderly: A Forgotten Entity. Lung. 2023 Dec;201(6):545-553. doi: 10.1007/s00408-023-00654-2. Epub 2023 Nov 14.
- Individual participant dataSharing planned: No
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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.
GÜLŞAH BARĞI, Assoc.Dr study director
Izmir Democracy University
ESRA SUDE AKIN, BSc principal investigator
Izmir Democracy University
ÖZLEM ÇİNAR ÖZDEMİR, Assoc.Dr principal investigator
Izmir Democracy University
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 Aging Disorder, run by Izmir Democracy 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 3 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 15 Sep 2025. 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?
Dyspnea score (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06267625, which also lists 3 linked publications.
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 15 Sep 2025.