UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051284 |
|---|---|
| Receipt number | R000058021 |
| Scientific Title | Effectiveness of Multifactorial Exercise in Older Adults After Femoral Neck Fracture Surgery |
| Date of disclosure of the study information | 2023/07/01 |
| Last modified on | 2024/06/07 20:03:12 |
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Basic information
Public title
Effectiveness of Multifactorial Exercise in Older Adults After Femoral Neck Fracture Surgery
Acronym
Effectiveness of Multifactorial Exercise in Older Adults After Femoral Neck Fracture Surgery
Scientific Title
Effectiveness of Multifactorial Exercise in Older Adults After Femoral Neck Fracture Surgery
Scientific Title:Acronym
Effectiveness of Multifactorial Exercise in Older Adults After Femoral Neck Fracture Surgery
Region
| Japan |
Condition
Condition
femoral neck fracture
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of multifactorial exercises in home work in older patients with a femoral neck fracture
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Total body muscle mass
Grip strength
Key secondary outcomes
Functional Independence Assessment
Berg Balance Scale
walking speed
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Two months of multi-factor exercises
Interventions/Control_2
Groups that have taught exercises in the past
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Admitted to Heisei Medical & Welfare Group's convalescent rehabilitation ward.
Patient presents with a fracture of the femoral neck, which can be judged as sarcopenia
65 years old and over
Level of Independence in Daily Living for the Disabled Elderly B
Physical ability to perform multifactorial exercises
No contractures that interfere with daily activities
Able to transfer to a chair by himself/herself and maintain sitting position independently
Cognitive ability to perform multifactorial exercises
MMSE: 22 points or higher and able to communicate in conversation
Key exclusion criteria
Japan Coma Scale(II- III digit)
Persons in poor general condition
Persons with intravenous infusion
Those on oxygen therapy.
Obvious onset of respiratory impairment
Malignant tumors undergoing chemotherapy
Persons who are deemed by their physician to be unsuitable to perform the exercises in view of
No history of cerebrovascular or neurological disorders in the past
Those scheduled to be discharged within 2 months
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Ryosuke |
| Middle name | |
| Last name | Kakureda |
Organization
Medical Corporation Koseikai Toyonaka Heisei Hospital
Division name
Department of Rehabilitation
Zip code
561-0807
Address
1-16-18 Haradanaka, Toyonaka City, Osaka, Japan
TEL
06-6841-3262
research_umin-ml@hmw.gr.jp
Public contact
Name of contact person
| 1st name | Ryosuke |
| Middle name | |
| Last name | Kakureda |
Organization
Medical Corporation Koseikai Toyonaka Heisei Hospital
Division name
Department of Rehabilitation
Zip code
561-0807
Address
1-16-18 Haradanaka, Toyonaka City, Osaka, Japan
TEL
06-6841-3262
Homepage URL
research_umin-ml@hmw.gr.jp
Sponsor or person
Institute
Medical Corporation Koseikai Toyonaka 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
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 | 07 | 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
3
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
Completed
Date of protocol fixation
| 2023 | Year | 05 | Month | 04 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 16 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 05 | 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 | 07 | Day |
Last modified on
| 2024 | Year | 06 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058021
