UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057790 |
|---|---|
| Receipt number | R000066047 |
| Scientific Title | Multifactorial intervention program for fall prevention among community-dwelling older adults with disabilities |
| Date of disclosure of the study information | 2025/05/08 |
| Last modified on | 2025/05/07 17:12:01 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Multifactorial intervention program for fall prevention among community-dwelling older adults with disabilities
Acronym
Fall prevention program for older adults with disabilities
Scientific Title
Multifactorial intervention program for fall prevention among community-dwelling older adults with disabilities
Scientific Title:Acronym
Fall prevention program for older adults with disabilities
Region
| Japan |
Condition
Condition
older adults with disabilities in community
Classification by specialty
| Geriatrics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify the effectiveness of a multifactorial intervention program consisting of exercise, nutrition, and sleep guidance for fall prevention among community-dwelling older adults with disabilities.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fall rate (average number of falls)
Key secondary outcomes
Short Physical Performance Battery, Timed Up and Go Test, One-leg Standing Time, Sit-to-Stand Five Test, Mini Mental State Examination, Japanese Version of the Geriatric Depression Scale-15, Chronic Pain, Mini Nutritional Assessment-Short Form, Japanese Version of the Pittsburgh Sleep Quality Index
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom | Maneuver |
Interventions/Control_1
Exercise instruction consists of home-based exercises comprising strength training, balance training, and walking exercises, performed independently by participants within their pain tolerance range for 40 minutes per session, three times per week. Home-based exercises are selected from the Otago Exercise Program, which has demonstrated effectiveness in preventing falls and improving safety among community-dwelling older adults. Physical therapists select several exercises appropriate for each participant and conduct the exercises with their consent.
Nutrition counseling is provided by a registered dietitian, focusing on energy, protein, vitamin D, and calcium intake, through a combination of face-to-face counseling and remote counseling using information and communication technology, once every 3 weeks for 20 minutes per session. In addition to counseling, subjects in the intervention group will be asked to consume a nutritional supplement. The nutritional supplement is a 125 ml Rehab Days (Otsuka Pharmaceutical Factory Co., Ltd.) beverage that is fortified with leucine, an essential amino acid that is believed to be useful for skeletal muscle synthesis.
Sleep guidance is provided by clinical psychologists, nurses, physical therapists, and occupational therapists using stimulus control therapy and sleep hygiene guidance, with counseling sessions lasting 30 minutes once every three weeks.
Interventions/Control_2
Provide health information only.
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
| 110 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Inclusion criteria were: ability to walk at least 10 m, Mini Mental State Examination score of 24 or higher, history of falls in the past year, no serious osteoarticular disease, renal failure, or heart failure requiring exercise or dietary restrictions, no dysphagia, and subjects with consent for the study. The subjects are those who have given consent for the study.
Key exclusion criteria
Exclusion criteria were subjects who offered to withdraw from the study.
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | Yoshinobu |
| Middle name | |
| Last name | Yoshimoto |
Organization
Seirei Christopher University
Division name
Department of Physical Therapy, School of Rehabilitation Sciences
Zip code
433-8558
Address
3453 Mikatahara, Chuo-ku, Hamamatsu, Shizuoka
TEL
053-439-1400
yoshinobu-y@seirei.ac.jp
Public contact
Name of contact person
| 1st name | Yoshinobu |
| Middle name | |
| Last name | Yoshimoto |
Organization
Seirei Christopher University
Division name
Department of Physical Therapy, School of Rehabilitation Sciences
Zip code
433-8558
Address
3453 Mikatahara, Chuo-ku, Hamamatsu, Shizuoka
TEL
053-439-1400
Homepage URL
yoshinobu-y@seirei.ac.jp
Sponsor or person
Institute
Seirei Christopher University
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
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
Seirei Christopher University
Address
3453 Mikatahara, Chuo-ku, Hamamatsu, Shizuoka
Tel
053-439-1400
yoshinobu-y@seirei.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
| 2025 | Year | 05 | Month | 08 | 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
| 2023 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 19 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 14 | Day |
Last follow-up date
| 2027 | 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
| 2025 | Year | 05 | Month | 07 | Day |
Last modified on
| 2025 | Year | 05 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066047
