UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054911 |
|---|---|
| Receipt number | R000062698 |
| Scientific Title | Fear of falling and related factors in elderly patients with proximal femur fractures: a longitudinal study |
| Date of disclosure of the study information | 2024/07/15 |
| Last modified on | 2026/01/13 17:40:57 |
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Basic information
Public title
Fear of falling and related factors in elderly patients with proximal femur fractures: a longitudinal study
Acronym
Fear of falling and related factors in elderly patients with proximal femur fractures: a longitudinal study
Scientific Title
Fear of falling and related factors in elderly patients with proximal femur fractures: a longitudinal study
Scientific Title:Acronym
Fear of falling and related factors in elderly patients with proximal femur fractures: a longitudinal study
Region
| Japan |
Condition
Condition
Proximal thigh bone fracture
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Longitudinal assessment of fear of falling from the time of admission in patients with proximal femur fracture admitted to a recovery rehabilitation ward to clarify the relationship between the longitudinal course of fear of falling and physical function, physical activity, and level of independence in ADLs
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
fear of falling
Evaluation period: every week from the time of admission to the time of discharge
Key secondary outcomes
Physical activity, Functional Independence Measure (FIM), 10m walking speed, Berg Balance Scale (BBS), Numerical Rating Scale (NRS), Mini Mental State Examination (MMSE), 5 times stand-up test,
Functional Ambulation Categories (FAC), Number of days of ADL walking acquisition in the ward, 5-item Geriatric Depression Scale (GDS5), Vitality index (VI)
Evaluation period: at admission, one month after admission, and at discharge
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Inpatients with proximal femur fracture due to fall
Key exclusion criteria
Those with marked cognitive decline
Non-independent walking prior to admission
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | misato |
| Middle name | |
| Last name | torii |
Organization
KioUniversityGraduateSchool
Division name
Graduate School of Health Sciences
Zip code
635-0832
Address
4-2-2, Umaminaka, Hiroyo-cho, Kitakasegi-gun, Nara, Japan
TEL
0745-54-1601
f4956394@kio.ac.jp
Public contact
Name of contact person
| 1st name | misato |
| Middle name | |
| Last name | torii |
Organization
KioUniversityGraduateSchool
Division name
Graduate School of Health Sciences
Zip code
635-0832
Address
4-2-2, Umaminaka, Hiroyo-cho, Kitakasegi-gun, Nara, Japan
TEL
0745-54-1601
Homepage URL
f4956394@kio.ac.jp
Sponsor or person
Institute
KioUniversity
Institute
Department
Personal name
Funding Source
Organization
KioUniversity
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
KioUniversity
Address
4-2-2, Umaminaka, Hiroyo-cho, Kitakasegi-gun, Nara, Japan
Tel
0745-54-1601
f4956394@kio.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 07 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2024 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 27 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
prospective cohort study
Patients admitted to our facility between August 2024 and August 2025 with a proximal femur fracture due to a fall
Basic information will be obtained from the medical record at admission, and physical activity and other assessments will be made at admission, one month after admission, and at discharge. Fear of falling will be assessed every week. Fear of falling and physical activity will be interviewed one month after discharge
Management information
Registered date
| 2024 | Year | 07 | Month | 08 | Day |
Last modified on
| 2026 | Year | 01 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062698
