NCT06300632

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
97

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 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

February 28, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 8, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

April 15, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 11, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 11, 2024

Completed
Last Updated

October 16, 2024

Status Verified

April 1, 2024

Enrollment Period

6 months

First QC Date

February 28, 2024

Last Update Submit

October 14, 2024

Conditions

Outcome Measures

Primary Outcomes (8)

  • 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

    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

    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.

    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.

    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).

    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

    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.

    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

    Day 1

Study Arms (1)

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)

Other: geriatric locomotive syndrome

Interventions

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.

older adults

Eligibility Criteria

Age65 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Individuals aged 65 and over, Volunteering to participate in research No cooperation and communication problems (Mini Mental State Test score above 24)

You may not qualify if:

  • Individuals with neurological and orthopedic problems
  • Uncontrolled hypertension
  • Those with cardiac disease
  • Those with cooperation and communication problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ayşe Abit Kocaman

Kırıkkale, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

    PMID: 37029834BACKGROUND

Study Officials

  • Ayşe Abit Kocaman

    Kırıkkale University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 28, 2024

First Posted

March 8, 2024

Study Start

April 15, 2024

Primary Completion

October 11, 2024

Study Completion

October 11, 2024

Last Updated

October 16, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations