NCT06138366

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 12, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 18, 2023

Completed
8 months until next milestone

Study Start

First participant enrolled

July 15, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2024

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 16, 2024

Completed
Last Updated

February 6, 2025

Status Verified

February 1, 2025

Enrollment Period

2 months

First QC Date

November 12, 2023

Last Update Submit

February 4, 2025

Conditions

Keywords

KinesophobiaAgedWalking speedfoot

Outcome Measures

Primary Outcomes (8)

  • 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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    Baseline

Secondary Outcomes (1)

  • Balance Performance

    Baseline

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zonguldak Center, Kdz. Ereğli İzmirlioğlu and Çaycuma Nursing Homes

Zonguldak, Center, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Kinesiophobia

Condition Hierarchy (Ancestors)

Phobic DisordersAnxiety DisordersMental Disorders

Study Officials

  • AYŞE TORAMAN KARAGÜLMEZ

    Ankara Yildirim Beyazıt University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

November 12, 2023

First Posted

November 18, 2023

Study Start

July 15, 2024

Primary Completion

September 15, 2024

Study Completion

September 16, 2024

Last Updated

February 6, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations