AgedNCT06138366
Factors Affecting Kinesiophobia in the Elderly
An observational study of Aged, run by Bulent Ecevit University at 1 site in Turkey (Türkiye).
Trial summary
In epidemiological studies, the incidence of foot problems has been found to be high as a result of the increase in life expectancy. The changes that occur in the foot with advancing age are extremely important in that they affect how the foot functions and transfer these effects to other body systems while standing… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aged
- How many people
- 74 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jul 2024to 16 Sep 2024
- 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: Volunteer elderly individuals living in Zonguldak Center, Karadeniz Ereğli İzmirlioğlu and Çaycuma Nursing Homes affiliated with the Zonguldak Provincial Directorate of Family and Social Services and individuals who meet the inclusion criteria will participate in the research. In order to conduct the research, an application will be made to Zonguldak Provincial Directorate of Family and Social Services for the necessary permissions and permissions will be obtained. All individuals who volunteer to participate in the study will be given all necessary information about the purpose and procedure of the study before starting the study. All volunteers will then need to sign an informed consent form.
Who may be able to join
- Being 65 years of age and older
- Stay in a nursing home
- Getting a score of 24 or higher on the Standardized Mini Mental State Test
- Being able to walk with a cane or without a cane
- Know how to read and write
Who cannot join
- Being vision problem that cannot be corrected with glasses or lenses
- Being hear problem that cannot be corrected with hearing aids
- Being blood pressure unsafe for exercise (>180/100 or <100/60 mmHg at rest)
- Being severe respiratory and cardiac problems
- History of lower extremity surgery in the last six months
- Being severe orthopedic and neurological deficits that may affect walking
Show all 10Show fewer
- History of recurrent falls (more than one fall in the last year)
- Being do exercise more than 150 minutes a week
- Participating in any exercise program in the last six months
- Have received any foot health treatment in the last six months
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Zonguldak Center, Kdz. Ereğli İzmirlioğlu and Çaycuma Nursing Homes
Zonguldak, Center
About this study
Official title: The Effect of Foot-Ankle Characteristics, Lower Extremity Muscle Strength, Walking Speed and Functional Exercise Capacity on Kinesiophobia in Elderly Individuals: A Three-Center Observational Study
In epidemiological studies, the incidence of foot problems has been found to be high as a result of the increase in life expectancy. The changes that occur in the foot with advancing age are extremely important in that they affect how the foot functions and transfer these effects to other body systems while standing and walking. These changes can also cause foot pain, limit mobility, impair functional performance in activities where the foot bears weight, and increase the risk of falling. In recent years, the level of kinesiophobia in elderly individuals; It seems to attract attention in terms of its effects on balance, falling, risk of falling, fear of falling, depression, physical activity level and quality of life. However, in the elderly living in nursing homes; It is not yet known how ankle joint position sense, foot posture, pain, foot-ankle disability, activity limitation, lower extremity muscle strength, walking speed and functional exercise capacity affect kinesiophobia. By elucidating these relationships, it will be possible to develop intervention strategies aimed at increasing foot-ankle characteristics, lower extremity muscle strength, walking speed and functional capacity, which are modifiable risk factors. The aim of this study is to examine the relationship between kinesiophobia and foot-ankle characteristics, lower extremity muscle strength, walking speed and functional exercise capacity in elderly people living in nursing homes.
Read the detailed description
The research will be carried out in Zonguldak Center, Karadeniz Ereğli İzmirlioğlu and Çaycuma Nursing Homes affiliated with the Zonguldak Provincial Directorate of Family and Social Services. Among the elderly individuals staying here, those who are volunteers and meet the inclusion criteria will be included in the study.The study will begin after receiving ethics committee approval. After the ethics committee permission of the study is obtained by the researchers, the necessary permissions to conduct this study will be obtained by applying to the Zonguldak Provincial Directorate of Family and Social Services. Data collection by researchers will begin after receiving permission from the relevant units.Before starting the evaluations on elderly individuals within the scope of the study, all elderly individuals will be given all necessary information about the purpose and procedure of the study by the researchers and they will sign an informed consent form.Permission will be requested by the researchers from all test and scale owners for all tests and scales that the researchers will use in the study.
The study was planned as a cross-sectional observational study. In the study, the sample size was calculated with G-Power and a power analysis was performed.The sample size required for the study is 64, and the minimum number of people that will provide 80% test power and 95% confidence level is 64, with effect size = 0.3 for Pearson correlation analysis.This sample width also includes the sample widths required for other analysis methods to be used within the scope of the study. The relevant calculation was made in the G-Power 3.1.9.2 package program.In the study, the relationships between the kinesiophobia status of elderly individuals and the variables of foot-ankle characteristics, lower extremity muscle strength, walking speed and functional exercise capacity will be examined. In addition, according to the kinesiophobia levels of elderly individuals, the cut-off value is taken as 37 points and the score is; Those with a score below 37 points will be grouped as individuals with low kinesiophobia, and those with a score of 37 points and above will be grouped as individuals with high kinesiophobia, and the relationships between the variables will be analyzed.
The research is planned to be carried out by the researchers in Zonguldak Center, Kdz.Ereğli İzmirlioğlu and Çaycuma Nursing Homes between 9 December 2023 and 31 December 2024. As Evaluation Methods; For socio-demographic status, Demographic Information Form, for evaluation of foot deformities and problems; Foot deformity and problems evaluation form, for disease status, Charslon Comorbidity Score, for cognitive status; Standardized Mini Mental State Test, for fall risk and balance assessment; Timed Up and Go Test for walking speed; 10-meter Forward Walk Test, 3-meter Backward Walk Test for functional capacity evaluation; Six Minute Walk Test, for assessment of dyspnea and fatigue severity; Modified Borg Scale, for evaluation of foot-ankle characteristics; Ankle Joint Position Sense Assessment, Foot Posture Index, Foot Function Index, for lower extremity muscle strength; Sit-Stand Chair Test for fear of movement; Tampa Kinesiophobia Scale will be used. Within the scope of the study, participants' joint position sense will be evaluated with "Universal Goniometer", walking speed with "Digital Stopwatch" and blood pressure with "Sphygmomanometer (Omron M3 HEM-7155-E)".
- Conditions
- Aged
- Keywords
- Kinesophobia, Aged, Walking speed, foot
- Medical subject headings
- Kinesiophobia
What is being measured
The primary outcome is the main question the study is designed to answer.
Foot Posture
Foot Posture İndex: The test score is calculated by assigning values between -2 and +2 to the 6 criteria on the foot and summing the scores from all criteria.
A test score of 0 indicates that the foot is in a neutral position. A positive test score indicates standing pronation. A negative test score indicates standing supination.
Measured: Baseline
Foot Function
Foot Function İndex:The scale consists of three subscales: pain, disability, and activity limitation. There are 23 questions in total. The participants are asked to score all questions with a visual analog scale scaled between 0-10, taking into account their foot condition in the last week. To calculate the sub-scales and the total score, the score of each item is added, divided by the sum of the maximum scores of the items and multiplied by 100. Higher scores indicate more pain, disability, and activity limitation.
Measured: Baseline
Ankle Joint Position Sense
Individuals will be asked to bring their neutral feet to the desired target positions (10 degrees of dorsiflexion, 10 degrees of plantar flexion, 20 degrees of plantar flexion). Measurements will be repeated 3 times for each target angle. The absolute value of the deviations from the target angles will be recorded and the average of the deviations occurring during the 3 repetitions will be taken.
Measured: Baseline
Lower extremity muscle strength
Sit-Up Chair Test: The number of times the individual sits and stands in a chair during 30 seconds will be recorded as the individual's score.
Measured: Baseline
Forward Walking Speed
10 meters Forward Walk Test:The time it takes to cover the ten meters at the person's normal speed will be recorded. The test is performed twice, and the average value is recorded in meters/second with the stopwatch.
Measured: Baseline
Backward Walking Speed
3 meters Backward Walk Test:The time taken for the person to walk backwards as fast as possible will be recorded. The test is performed once and its duration is recorded in meters/second with a stopwatch.
Measured: Baseline
Kinesiophobia
Tampa Kinesiophobia Scale:Responses on the Tampa Kinesiophobia Scale are classified as strongly disagree, disagree, agree and strongly agree. There are two types of expressions (direct and inverse) in the scale. While these expressions are scored, those who get 1 point turn into 4, and those who get 4 points turn into 1.4-point answers in direct statements indicate a high level of kinesiophobia. In reversed expressions, answers with a value of 1 indicate a high level of kinesiophobia, and answers with a value of 4 indicate a low level of kinesiophobia. Scores from the scale range from 17 to 68. The score obtained from the scale constitutes the individual's score that should be interpreted at the level of kinesiophobia. A high score indicates a high level of kinesiophobia.
Measured: Baseline
Functional Exercise Capacity
Six-minute walk test: The distance traveled will be measured by walking in a straight 30-meter corridor for six minutes. More distance traveled indicates better functional capacity.
Measured: Baseline
Secondary outcomes (1)
Balance Performance
In the test, the person will be asked to get up from his chair, walk 3 meters at a safe and normal speed, turn, walk back and sit on the chair.
The time required by the individual to perform this movement will be recorded in seconds (sec). Three repetitions will be made, the average will be taken and the result will be recorded.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start15 Jul 2024
- Primary completion15 Sep 2024
- Study completion16 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgedStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bulent Ecevit University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayşe Toraman, Bulent Ecevit University
- Investigators
- AYŞE TORAMAN KARAGÜLMEZ, Principal investigator, Ankara Yildirim Beyazıt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06138366
- Sponsor's protocol ID
- AYSE TORAMAN KARAGULMEZ2
- Status last verified
- Feb 2025
- First submitted
- 12 Nov 2023
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Foot-Ankle Characteristics, Lower Extremity Muscle Strength, Walking Speed and Functional Exercise Capacity on Kinesiophobia in Elderly Individuals: A Three-Center Observational Study
- ClinicalTrials.gov ID
- NCT06138366
- Acronym / sponsor ID
- AYSE TORAMAN KARAGULMEZ2
- Conditions
- Aged
- Keywords
- Kinesophobia, Aged, Walking speed, foot
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Bulent Ecevit UniversityUniversity, hospital or other
- Study start
- 15 Jul 2024 (actual)
- Primary completion
- 15 Sep 2024 (actual)
- Study completion
- 16 Sep 2024 (actual)
- First posted
- 18 Nov 2023 (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.
In epidemiological studies, the incidence of foot problems has been found to be high as a result of the increase in life expectancy. The changes that occur in the foot with advancing age are extremely important in that they affect how the foot functions and transfer these effects to other body systems while standing and walking. These changes can also cause foot pain, limit mobility, impair functional performance in activities where the foot bears weight, and increase the risk of falling. In recent years, the level of kinesiophobia in elderly individuals; It seems to attract attention in terms of its effects on balance, falling, risk of falling, fear of falling, depression, physical activity level and quality of life. However, in the elderly living in nursing homes; It is not yet known how ankle joint position sense, foot posture, pain, foot-ankle disability, activity limitation, lower extremity muscle strength, walking speed and functional exercise capacity affect kinesiophobia. By elucidating these relationships, it will be possible to develop intervention strategies aimed at increasing foot-ankle characteristics, lower extremity muscle strength, walking speed and functional capacity, which are modifiable risk factors. The aim of this study is to examine the relationship between kinesiophobia and foot-ankle characteristics, lower extremity muscle strength, walking speed and functional exercise capacity in elderly people living in nursing homes.
Detailed description
The research will be carried out in Zonguldak Center, Karadeniz Ereğli İzmirlioğlu and Çaycuma Nursing Homes affiliated with the Zonguldak Provincial Directorate of Family and Social Services. Among the elderly individuals staying here, those who are volunteers and meet the inclusion criteria will be included in the study.The study will begin after receiving ethics committee approval. After the ethics committee permission of the study is obtained by the researchers, the necessary permissions to conduct this study will be obtained by applying to the Zonguldak Provincial Directorate of Family and Social Services. Data collection by researchers will begin after receiving permission from the relevant units.Before starting the evaluations on elderly individuals within the scope of the study, all elderly individuals will be given all necessary information about the purpose and procedure of the study by the researchers and they will sign an informed consent form.Permission will be requested by the researchers from all test and scale owners for all tests and scales that the researchers will use in the study.
The study was planned as a cross-sectional observational study. In the study, the sample size was calculated with G-Power and a power analysis was performed.The sample size required for the study is 64, and the minimum number of people that will provide 80% test power and 95% confidence level is 64, with effect size = 0.3 for Pearson correlation analysis.This sample width also includes the sample widths required for other analysis methods to be used within the scope of the study. The relevant calculation was made in the G-Power 3.1.9.2 package program.In the study, the relationships between the kinesiophobia status of elderly individuals and the variables of foot-ankle characteristics, lower extremity muscle strength, walking speed and functional exercise capacity will be examined. In addition, according to the kinesiophobia levels of elderly individuals, the cut-off value is taken as 37 points and the score is; Those with a score below 37 points will be grouped as individuals with low kinesiophobia, and those with a score of 37 points and above will be grouped as individuals with high kinesiophobia, and the relationships between the variables will be analyzed.
The research is planned to be carried out by the researchers in Zonguldak Center, Kdz.Ereğli İzmirlioğlu and Çaycuma Nursing Homes between 9 December 2023 and 31 December 2024. As Evaluation Methods; For socio-demographic status, Demographic Information Form, for evaluation of foot deformities and problems; Foot deformity and problems evaluation form, for disease status, Charslon Comorbidity Score, for cognitive status; Standardized Mini Mental State Test, for fall risk and balance assessment; Timed Up and Go Test for walking speed; 10-meter Forward Walk Test, 3-meter Backward Walk Test for functional capacity evaluation; Six Minute Walk Test, for assessment of dyspnea and fatigue severity; Modified Borg Scale, for evaluation of foot-ankle characteristics; Ankle Joint Position Sense Assessment, Foot Posture Index, Foot Function Index, for lower extremity muscle strength; Sit-Stand Chair Test for fear of movement; Tampa Kinesiophobia Scale will be used. Within the scope of the study, participants' joint position sense will be evaluated with "Universal Goniometer", walking speed with "Digital Stopwatch" and blood pressure with "Sphygmomanometer (Omron M3 HEM-7155-E)".
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Volunteer elderly individuals living in Zonguldak Center, Karadeniz Ereğli İzmirlioğlu and Çaycuma Nursing Homes affiliated with the Zonguldak Provincial Directorate of Family and Social Services and individuals who meet the inclusion criteria will participate in the research. In order to conduct the research, an application will be made to Zonguldak Provincial Directorate of Family and Social Services for the necessary permissions and permissions will be obtained. All individuals who volunteer to participate in the study will be given all necessary information about the purpose and procedure of the study before starting the study. All volunteers will then need to sign an informed consent form.
Key inclusion criteria (5 listed)
- Being 65 years of age and older
- Stay in a nursing home
- Getting a score of 24 or higher on the Standardized Mini Mental State Test
- Being able to walk with a cane or without a cane
- Know how to read and write
Key exclusion criteria (10 listed)
- Being vision problem that cannot be corrected with glasses or lenses
- Being hear problem that cannot be corrected with hearing aids
- Being blood pressure unsafe for exercise (>180/100 or <100/60 mmHg at rest)
- Being severe respiratory and cardiac problems
- History of lower extremity surgery in the last six months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Foot Posture
Time frame: Baseline
Foot Posture İndex: The test score is calculated by assigning values between -2 and +2 to the 6 criteria on the foot and summing the scores from all criteria. A test score of 0 indicates that the foot is in a neutral position. A positive test score indicates standing pronation. A negative test score indicates standing supination.
Foot Function
Time frame: Baseline
Foot Function İndex:The scale consists of three subscales: pain, disability, and activity limitation. There are 23 questions in total. The participants are asked to score all questions with a visual analog scale scaled between 0-10, taking into account their foot condition in the last week. To calculate the sub-scales and the total score, the score of each item is added, divided by the sum of the maximum scores of the items and multiplied by 100. Higher scores indicate more pain, disability, and activity limitation.
Ankle Joint Position Sense
Time frame: Baseline
Individuals will be asked to bring their neutral feet to the desired target positions (10 degrees of dorsiflexion, 10 degrees of plantar flexion, 20 degrees of plantar flexion). Measurements will be repeated 3 times for each target angle. The absolute value of the deviations from the target angles will be recorded and the average of the deviations occurring during the 3 repetitions will be taken.
Lower extremity muscle strength
Time frame: Baseline
Sit-Up Chair Test: The number of times the individual sits and stands in a chair during 30 seconds will be recorded as the individual's score.
Forward Walking Speed
Time frame: Baseline
10 meters Forward Walk Test:The time it takes to cover the ten meters at the person's normal speed will be recorded. The test is performed twice, and the average value is recorded in meters/second with the stopwatch.
Backward Walking Speed
Time frame: Baseline
3 meters Backward Walk Test:The time taken for the person to walk backwards as fast as possible will be recorded. The test is performed once and its duration is recorded in meters/second with a stopwatch.
Kinesiophobia
Time frame: Baseline
Tampa Kinesiophobia Scale:Responses on the Tampa Kinesiophobia Scale are classified as strongly disagree, disagree, agree and strongly agree. There are two types of expressions (direct and inverse) in the scale. While these expressions are scored, those who get 1 point turn into 4, and those who get 4 points turn into 1.4-point answers in direct statements indicate a high level of kinesiophobia. In reversed expressions, answers with a value of 1 indicate a high level of kinesiophobia, and answers with a value of 4 indicate a low level of kinesiophobia. Scores from the scale range from 17 to 68. The score obtained from the scale constitutes the individual's score that should be interpreted at the level of kinesiophobia. A high score indicates a high level of kinesiophobia.
Functional Exercise Capacity
Time frame: Baseline
Six-minute walk test: The distance traveled will be measured by walking in a straight 30-meter corridor for six minutes. More distance traveled indicates better functional capacity.
1 secondary outcome
Balance Performance
Time frame: Baseline
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 6 Feb 2025.
- 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.
AYŞE TORAMAN KARAGÜLMEZ principal investigator
Ankara Yildirim Beyazıt 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 Aged, run by Bulent Ecevit 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 5 inclusion and 10 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 6 Feb 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?
Foot Posture (time frame: Baseline). The study lists 8 primary outcomes in all. 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 6 Feb 2025.