UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051416 |
|---|---|
| Receipt number | R000058615 |
| Scientific Title | Effects of Upper Extremity Resistance Exercise on Cognitive Function and BPSD |
| Date of disclosure of the study information | 2023/06/22 |
| Last modified on | 2024/02/02 15:18:15 |
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Basic information
Public title
Effects of Upper Extremity Resistance Exercise on Cognitive Function and BPSD
Acronym
Effects of Upper Extremity Resistance Exercise on Cognitive Function and BPSD
Scientific Title
Effects of Upper Extremity Resistance Exercise on Cognitive Function and BPSD
Scientific Title:Acronym
Effects of Upper Extremity Resistance Exercise on Cognitive Function and BPSD
Region
| Japan |
Condition
Condition
Dementia with BPSD
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of upper extremity resistance exercise on cognitive function and BPSD.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
NPI-Q Score
Key secondary outcomes
Mini Mental State Examination (MMSE)
N Mental State Scale for the Elderly (NM Scale)
time spent away from bed
Sleep time
Grip strength
Japanese version of the Apathy Evaluation Scale Caregiver Evaluation (AES-I-J)
Glasgow Coma Scale (GCS)
Functional Independence Measure (FIM)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Upper extremity resistance exercise
Interventions/Control_2
Usual exercise
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
Institutionalized in a long-term care ward
Able to stay away from bed
Rank A or B based on the "Independence degree of daily living for older adults with disability"
Dementia defined as Mini-Mental State Examination (MMSE) score of 23 points or lower
A severity score of 2 or higher on any item on the Neuropsychiatric Inventory-Brief Questionnaire Form (NPI-Q)
Key exclusion criteria
Expected to deteriorate health status by the intervention
Difficult to perform moderate to heavy load exercise
Unable to comprehend instructions and perform exercise due to severe cognitive decline or higher brain dysfunction
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Ichiro |
| Middle name | |
| Last name | Murayama |
Organization
Medical Corporation Awaji Heiseikai Higashiura Heisei Hospital
Division name
Department of Rehabilitation
Zip code
656-2311
Address
1867,Kuruma,Awaji,Hyogo,Japan
TEL
0799-74-0503
research_umin-ml@hmw.gr.jp
Public contact
Name of contact person
| 1st name | Ichiro |
| Middle name | |
| Last name | Murayama |
Organization
Medical Corporation Awaji Heiseikai Higashiura Heisei Hospital
Division name
Department of Rehabilitation
Zip code
656-2311
Address
1867,Kuruma,Awaji,Hyogo,Japan
TEL
0799-74-0503
Homepage URL
research_umin-ml@hmw.gr.jp
Sponsor or person
Institute
Medical Corporation Awaji Heiseikai Higashiura Heisei Hospital
Institute
Department
Personal name
Funding Source
Organization
Heisei Medical Welfare Group Research Institute
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
Heisei Medical Welfare Group Research Institute
Address
1-3-1,Yoyogi,Shibuya-ku,Tokyo,Japan
Tel
03-6712-6401
info.research@hmw.gr.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
| 2023 | Year | 06 | Month | 22 | 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
| 2023 | Year | 05 | Month | 16 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 31 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 22 | Day |
Last follow-up date
| 2025 | 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
| 2023 | Year | 06 | Month | 22 | Day |
Last modified on
| 2024 | Year | 02 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058615
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
