Clinical trial NCT06138366: Factors Affecting Kinesiophobia in the Elderly
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aged
Keywords: Kinesophobia
Aged
Walking speed
foot
Lead sponsor: Bulent Ecevit University
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 74
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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 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)".

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Foot Posture
timeFrame: Baseline
measure: Foot Function
timeFrame: Baseline
measure: Ankle Joint Position Sense
timeFrame: Baseline
measure: Lower extremity muscle strength
timeFrame: Baseline
measure: Forward Walking Speed
timeFrame: Baseline
measure: Backward Walking Speed
timeFrame: Baseline
measure: Kinesiophobia
timeFrame: Baseline
measure: Functional Exercise Capacity
timeFrame: Baseline
Secondary outcomes:
measure: Balance Performance
timeFrame: Baseline
Other outcomes:
Locations:
city: Zonguldak
country: Turkey
facility: Zonguldak Center, Kdz. Ereğli İzmirlioğlu and Çaycuma Nursing Homes
state: Center
Study officials:
affiliation: Ankara Yildirim Beyazıt University
name: AYŞE TORAMAN KARAGÜLMEZ
role: PRINCIPAL_INVESTIGATOR
References: