- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06300632
Geriatric Locomotive Syndrome and Related Factors in Older Adults
October 14, 2024 updated by: Ayşe Abit Kocaman, Kırıkkale University
Geriatric Locomotive Syndrome Kinesiophobia, Physical Activity Level, Physical Performance, Fatigue, Cognitive Functions in Older Adults
It has been stated that the results of physical function and physical performance affecting locomotive syndrome in elderly individuals are controversial and studies are still needed.
However, no studies have been found examining its relationship with the decrease in physical activity level, decline in cognitive functions, kinesiophobia (fear of movement) and fatigue seen in old age.
Early detection of locomotive syndrome risk factors in elderly individuals will help prevent this condition, detect the risk of falling in elderly individuals and increase their quality of life.
Based on these deficiencies, it is aimed to examine the relationship between locomotive syndrome and kinesiophobia, physical activity level, physical performance, fatigue and cognitive functions in elderly individuals.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
It has been reported that problems related to the musculoskeletal system, such as osteoarthritis, osteoporosis or spondylosis, increase with aging in elderly individuals.
The Japanese Orthopedic Association (JOA) has defined this condition as locomotive syndrome (LS) in elderly individuals, as a condition of decreased mobility due to deterioration of locomotive organs.
LS is a condition of reduced mobility due to deterioration of locomotive organs.
It has been stated that the results of physical function and physical performance affecting locomotive syndrome in elderly individuals are controversial and studies are still needed.
However, no studies have been found examining its relationship with the decrease in physical activity level, decline in cognitive functions, kinesiophobia (fear of movement) and fatigue seen in old age.
Early detection of locomotive syndrome risk factors in elderly individuals will help prevent this condition, detect the risk of falling in elderly individuals and increase their quality of life.
Based on these deficiencies, it is aimed to examine the relationship between locomotive syndrome and kinesiophobia, physical activity level, physical performance, fatigue and cognitive functions in elderly individuals.
Study Type
Observational
Enrollment (Actual)
97
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Kırıkkale, Turkey
- Ayşe Abit Kocaman
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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
No
Sampling Method
Non-Probability Sample
Study Population
At Kırıkkale University Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, all elderly individuals aged 65 and over who meet the inclusion and exclusion criteria and who volunteer to participate in the study will be collected by face-to-face interview using evaluation forms.
Description
Inclusion Criteria:
Individuals aged 65 and over, Volunteering to participate in research No cooperation and communication problems (Mini Mental State Test score above 24)
Exclusion Criteria:
Individuals with neurological and orthopedic problems
- Uncontrolled hypertension
- Those with cardiac disease
- Those with cooperation and communication problems
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 |
|---|---|
|
older adults
older adults Geriatric Locomotive Function Scale Tampa Kinesiophobia Scale Physical Activity Scale for the Elderly (PASE) Brief Physical Performance Battery Fatigue Severity Scale Montreal Cognitive Assessment Scale (MoCA)
|
Elderly individuals will be included in the study.
Before each elderly person starts the study, they will be informed about the content of the study and they will read and sign the consent form stating that they participate in the study voluntarily.
Socio-demographic data (age, body mass index, and family history, fall history, ) of all individuals participating in the study will be recorded.Within the scope of the evaluation, locomotive syndrome evaluation will be made through a survey.
Fear of movement will be evaluated with the Tampa kinesiophobia scale, your physical activity level with the physical activity scale for the elderly, your physical performance with the short physical performance battery, your fatigue level with the fatigue severity scale, and your cognitive functions with the Montreal Cognitive Assessment Scale.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Geriatric Locomotive Function Scale
Time Frame: Day 1
|
It consists of a survey of 25 items, and each item is rated between 0 and 4 points.
The total score is the result of the sum of all items ranging from 0 to 100; the higher the score, the greater the physical impairment of the elderly, and 16 points is the cutoff point for locomotive syndrome
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Day 1
|
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Two Step Test
Time Frame: Day 1
|
Two-step testing involves measuring step length for two steps.
Individuals are asked to take two steps as long as possible and the longest measurement is recorded
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Day 1
|
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Stand Up Test
Time Frame: Day 1
|
In the stand-up test, the height of the lowest stool at which the individual can stand up from a sitting position with both feet or one leg is recorded.
Stools of four heights are used: 40 cm, 30 cm, 20 cm and 10 cm.
If the individual manages to hold the final standing position for more than 3 seconds without needing to take any additional steps, they are judged to have completed the trial.
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Day 1
|
|
Tampa Kinesiophobia Scale
Time Frame: Day 1
|
Individuals' fear of movement (kinesiophobia) will be evaluated with the Tampa Kinesiophobia Scale, consisting of 17 items.People receive a total score between 17-68 points.
A high score on the scale indicates that the person has a high level of kinesiophobia, that is, the fear of movement.
|
Day 1
|
|
Physical Activity Scale for the Elderly (PASE)
Time Frame: Day 1
|
The PASE evaluates physical activity performed over a 1-week time frame.
Participation in leisure activities, including walking outside the home, light, moderate, and strenuous sport and recreation, and muscle strengthening were recorded as never, seldom (1-2 days/week), sometimes (3-4 days/week), and often (5-7 days/week) performed.
PASE score was stratifi ed in tertiles: 0 to 40 (sedentary), 41 to 90 (light physical activity) and more than 90 (moderate to intense activity).
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Day 1
|
|
Short Physical Performance Battery
Time Frame: Day 1
|
It consists of 3 objective tests that evaluate lower body function.
These; 2.44 meter walking, getting up from a chair and standing balance test
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Day 1
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Fatigue Severity Scale
Time Frame: Day 1
|
Fatigue Severity Scale (FSS) is a scale that evaluates fatigue and consists of 9 questions.
Each item is scored between 0 and 7.
|
Day 1
|
|
Montreal Cognitive Assessment Scale (MoCA)
Time Frame: Day 1
|
The scale includes items that evaluate attention and concentration, executive functions, memory, language, visual and spatial skills, abstract thinking, calculation and orientation dimensions.
The lowest score that can be obtained from the scale is 0 and the highest score is 30.
A low score indicates decreased cognitive functions
|
Day 1
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ayşe Abit Kocaman, Kırıkkale 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.
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 (Actual)
April 15, 2024
Primary Completion (Actual)
October 11, 2024
Study Completion (Actual)
October 11, 2024
Study Registration Dates
First Submitted
February 28, 2024
First Submitted That Met QC Criteria
March 2, 2024
First Posted (Actual)
March 8, 2024
Study Record Updates
Last Update Posted (Actual)
October 16, 2024
Last Update Submitted That Met QC Criteria
October 14, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Geriatric Locomotive Syndrome
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
product manufactured in and exported from the U.S.
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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