Locomotive SyndromeNCT06300632
Geriatric Locomotive Syndrome and Related Factors in Older Adults
An observational study of Locomotive Syndrome, run by Kırıkkale University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- Locomotive Syndrome
- What is being tested?
- geriatric locomotive syndrome
- How many people
- 97 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2024to 11 Oct 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 to 85 years
- All sexes
- No healthy volunteers
- Older adult
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.
Who may be able to join
- Individuals aged 65 and over, Volunteering to participate in research No cooperation and communication problems (Mini Mental State Test score above 24)
Who cannot join
- Individuals with neurological and orthopedic problems
- Uncontrolled hypertension
- Those with cardiac disease
- Those with cooperation and communication problems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Locomotive Syndrome
- Being tested
- geriatric locomotive syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
geriatric locomotive syndromeOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Other: geriatric locomotive syndrome |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geriatric Locomotive Function Scale
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
Measured: Day 1
Two Step Test
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
Measured: Day 1
Stand Up Test
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.
Measured: Day 1
Tampa Kinesiophobia Scale
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.
Measured: Day 1
Physical Activity Scale for the Elderly (PASE)
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).
Measured: Day 1
Short Physical Performance Battery
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
Measured: Day 1
Fatigue Severity Scale
Fatigue Severity Scale (FSS) is a scale that evaluates fatigue and consists of 9 questions. Each item is scored between 0 and 7.
Measured: Day 1
Montreal Cognitive Assessment Scale (MoCA)
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
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study start15 Apr 2024
- Primary completion11 Oct 2024
- Study completion11 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Locomotive SyndromeStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kırıkkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayşe Abit Kocaman, Kırıkkale University
- Investigators
- Ayşe Abit Kocaman, Principal investigator, Kırıkkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06300632
- Sponsor's protocol ID
- Geriatric Locomotive Syndrome
- Status last verified
- Apr 2024
- First submitted
- 28 Feb 2024
- Last updated
- 16 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Inanaga S, Hasegawa M, Kosuge M, Ichimura S, Morii T, Hosogane N. Relationship between the 25-question Geriatric Locomotive Function Scale and physical function in the elderly people. J Bone Miner Metab. 2023 Jul;41(4):550-556. doi: 10.1007/s00774-023-01427-w. Epub 2023 Apr 8.
PubMed 37029834
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Geriatric Locomotive Syndrome Kinesiophobia, Physical Activity Level, Physical Performance, Fatigue, Cognitive Functions in Older Adults
- ClinicalTrials.gov ID
- NCT06300632
- Acronym / sponsor ID
- Geriatric Locomotive Syndrome
- Conditions
- Locomotive Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Kırıkkale UniversityUniversity, hospital or other
- Study start
- 15 Apr 2024 (actual)
- Primary completion
- 11 Oct 2024 (actual)
- Study completion
- 11 Oct 2024 (actual)
- First posted
- 8 Mar 2024 (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.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| older adults | – | Other: geriatric locomotive syndromeolder 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) |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (1 listed)
- Individuals aged 65 and over, Volunteering to participate in research No cooperation and communication problems (Mini Mental State Test score above 24)
Key exclusion criteria (4 listed)
- Individuals with neurological and orthopedic problems
- Uncontrolled hypertension
- Those with cardiac disease
- Those with cooperation and communication problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| geriatric locomotive syndromeElderly 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. | Other | older adults |
Primary outcome
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
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
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.
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.
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).
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
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.
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
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 16 Oct 2024.
- Background: PubMed 37029834Inanaga S, Hasegawa M, Kosuge M, Ichimura S, Morii T, Hosogane N. Relationship between the 25-question Geriatric Locomotive Function Scale and physical function in the elderly people. J Bone Miner Metab. 2023 Jul;41(4):550-556. doi: 10.1007/s00774-023-01427-w. Epub 2023 Apr 8.
- Individual participant dataSharing planned: No
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 Abit Kocaman principal investigator
Kırıkkale 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 Locomotive Syndrome, run by Kırıkkale 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 1 inclusion and 4 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 16 Oct 2024. 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?
Geriatric Locomotive Function Scale (time frame: Day 1). 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?
On the ClinicalTrials.gov record for NCT06300632, which also lists 1 linked publication.
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 16 Oct 2024.