- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06267625
Physical Impairments in Elderly Individuals
February 12, 2024 updated by: Gulsah Bargi, Izmir Democracy University
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Estimated)
50
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: GÜLŞAH BARĞI, Assoc.Dr
- Phone Number: +90 232 299 0739
- Email: gulsahbargi35@gmail.com
Study Contact Backup
- Name: ESRA SUDE AKIN, BSc
- Phone Number: +90 543 581 4690
- Email: esrasudeakin@gmail.com
Study Locations
-
-
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İzmir, Turkey, 35140
- Izmir Democracy University
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Contact:
- ESRA SUDE AKIN, BSc
- Phone Number: +90 543 581 4690
- Email: esrasudeakin@gmail.com
-
Contact:
- GÜLŞAH BARĞI, Assoc.Dr.
- Phone Number: +90 531 793 8766
- Email: gulsahbargi35@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
At least 50 individuals aged 65 and over will be included
Description
Inclusion Criteria for Elderly Individuals
- 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
Exclusion Criteria for Elderly Individuals
- The participant has a cognitive, neurological or orthopedic disease that would affect the participant's ability to move independently and understand the questions.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Elderly Individuals
This group will consist of individuals aged 65 and over
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
through study completion, an average of 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Posture score
Time Frame: through study completion, an average of 1 year
|
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.
|
through study completion, an average of 1 year
|
Cough strength
Time Frame: through study completion, an average of 1 year
|
Cough strength will be evaluated using a PEFmeter.
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through study completion, an average of 1 year
|
Handgrip strength
Time Frame: through study completion, an average of 1 year
|
Hand grip strength will be measured using the Jamar hand dynamometer.
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through study completion, an average of 1 year
|
Functional mobility score
Time Frame: through study completion, an average of 1 year
|
Functional mobility will be evaluated with Chair Stand Test.
Higher repetition numbers indicate better physical performance.
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through study completion, an average of 1 year
|
Physical activity score
Time Frame: through study completion, an average of 1 year
|
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.
|
through study completion, an average of 1 year
|
Functional Mobility score
Time Frame: through study completion, an average of 1 year
|
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.
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through study completion, an average of 1 year
|
Balance score
Time Frame: through study completion, an average of 1 year
|
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.
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through study completion, an average of 1 year
|
Cognitive function score
Time Frame: through study completion, an average of 1 year
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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.
|
through study completion, an average of 1 year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: GÜLŞAH BARĞI, Assoc.Dr, Izmir Democracy University
- Principal Investigator: ESRA SUDE AKIN, BSc, Izmir Democracy University
- Principal Investigator: ÖZLEM ÇİNAR ÖZDEMİR, Assoc.Dr, Izmir Democracy University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Dindorf 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.
- Kaulamo 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
March 15, 2024
Primary Completion (Estimated)
March 15, 2026
Study Completion (Estimated)
December 15, 2026
Study Registration Dates
First Submitted
February 12, 2024
First Submitted That Met QC Criteria
February 12, 2024
First Posted (Actual)
February 20, 2024
Study Record Updates
Last Update Posted (Actual)
February 20, 2024
Last Update Submitted That Met QC Criteria
February 12, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Elderly Individuals
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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