UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055027 |
|---|---|
| Receipt number | R000061790 |
| Scientific Title | Effects of an intervention strategy for fall prevention in community-dwelling older people with musculoskeletal pain |
| Date of disclosure of the study information | 2024/08/01 |
| Last modified on | 2025/01/20 09:43:49 |
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Basic information
Public title
Effects of an intervention program for fall prevention in community-dwelling older people with pain
Acronym
Effects of an intervention program for fall prevention in community-dwelling older people with pain
Scientific Title
Effects of an intervention strategy for fall prevention in community-dwelling older people with musculoskeletal pain
Scientific Title:Acronym
Effects of an intervention strategy for fall prevention in community-dwelling older people with musculoskeletal pain
Region
| Japan |
Condition
Condition
musculoskeletal pain
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This randomized controlled trial examine whether balance training using a foam rubber pad combined with psychosocial intervention prevent falls via improvements in reactive balance recovery reduce falls in community-dwelling older people with musculoskeletal pain.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
reactive balance
Key secondary outcomes
the number of falls, pain, physical function, cognitive function, psychological status, physical activity levels
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
balance training using a foam rubber pad combined with psychosocial intervention
Interventions/Control_2
control
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The eligibility criteria are as follows: 65 years and older, living at home, musculoskeletal pain lasting longer than 4 weeks, able to walk outdoors without an assistive device, able to engage independently in activities of daily living, and not exercise at least four times during the month before the initial interview.
Key exclusion criteria
Individuals who had cognitive impairment or who had undergone orthopedic surgery, and patients with neurological, musculoskeletal, or cardiovascular impairments, including dementia, stroke, and Parkinson's disease.
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | Tatsuya |
| Middle name | |
| Last name | Hirase |
Organization
Kanagawa University of Human Services
Division name
Division of Physical Therapy Science, Graduate Course of Health and Social Work
Zip code
238-8522
Address
1-10-1, Heisei-cho, Yokosuka, Kanagawa, Japan
TEL
046-828-2730
hirase-rx7@kuhs.ac.jp
Public contact
Name of contact person
| 1st name | Tatsuya |
| Middle name | |
| Last name | Hirase |
Organization
Kanagawa University of Human Services
Division name
Division of Physical Therapy Science, Graduate Course of Health and Social Work
Zip code
238-8522
Address
1-10-1, Heisei-cho, Yokosuka, Kanagawa, Japan
TEL
046-828-2730
Homepage URL
hirase-rx7@kuhs.ac.jp
Sponsor or person
Institute
Kanagawa University of Human Services
Institute
Department
Personal name
Funding Source
Organization
Ministry of education
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kanagawa University of Human Services
Address
1-10-1, Heisei-cho, Yokosuka, Kanagawa, Japan
Tel
046-828-2530
kenkyuurinri@kuhs.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 | 08 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 19 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 07 | Month | 20 | Day |
Last modified on
| 2025 | Year | 01 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061790
| Research Plan | |
|---|---|
| Registered date | File name |
| 2025/07/22 | 2．研究計画書R3.pdf |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2025/07/22 | 2．研究計画書R3.pdf |
| Research case data | |
|---|---|
| Registered date | File name |
| 2025/07/22 | データ入力フォーマット_20250722_UMIN.xlsx |
Single case data URL
Value
https://center6.umin.ac.jp/ice/61790
