UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038145 |
|---|---|
| Receipt number | R000043479 |
| Scientific Title | Verification of relationship between muscle strength and postoperative Activity of Daily Living and nutritional status in patients with hip fractures. |
| Date of disclosure of the study information | 2019/09/29 |
| Last modified on | 2019/09/29 08:02:18 |
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Basic information
Public title
Verification of relationship between muscle strength and postoperative Activity of Daily Living and nutritional status in patients with hip fractures.
Acronym
Verification of relationship between muscle strength and postoperative Activity of Daily Living and nutritional status in patients with hip fractures.
Scientific Title
Verification of relationship between muscle strength and postoperative Activity of Daily Living and nutritional status in patients with hip fractures.
Scientific Title:Acronym
Verification of relationship between muscle strength and postoperative Activity of Daily Living and nutritional status in patients with hip fractures.
Region
| Japan |
Condition
Condition
Hip fractures
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Nutritional assessment using the Geriatric Nutrition Risk Index (GNRI) was conducted in patients with proximal femoral fracture to investigate the relationship between muscle strength and ADL of these patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Barthel Index at discharge
Key secondary outcomes
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
| 65 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients aged 65 years or older who were hospitalized in our hospital for proximal femoral fracture and underwent surgery and postoperative rehabilitation between June 1 and April 30, 2019, 2018
Key exclusion criteria
Cases of abasia and death due to serious complications before injury
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Takako |
| Middle name | |
| Last name | Nagai |
Organization
Nihon University
Division name
Orthopedic surgery
Zip code
101-8309
Address
101-8309 1-6, Kandasurugadai, Chiyoda-ku, Tokyo
TEL
0332931711
ntnyf092@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Takako |
| Middle name | |
| Last name | Nagai |
Organization
Nihon University Hospital
Division name
Orthopedic surgery
Zip code
101-8309
Address
1-6, Kandasurugadai, Chiyoda-ku, Tokyo
TEL
0332931711
Homepage URL
ntnyf092@yahoo.co.jp
Sponsor or person
Institute
Nihon University Hospital
Institute
Department
Personal name
Funding Source
Organization
Nihon University Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
N
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nihon University Hospital
Address
1-6, Kandasurugadai, Chiyoda-ku, Tokyo
Tel
0332931711
ntnyf092@yahoo.co.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
| 2019 | Year | 09 | Month | 29 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
40
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
Main results already published
Date of protocol fixation
| 2018 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 12 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2019 | Year | 09 | Month | 01 | Day |
Other
Other related information
About 60% of patients with hip fractures are malnourished, contributing to postoperative complications and increased mortality. Then, the relation between nutritional evaluation and Activity of Daily Living of the hip fracture patient was verified. It was shown that the patient with the nutritional state risk tended to be inferior in muscle force and Activity of Daily Living in comparison with the patient without the risk. The possibility of improving the functional prognosis was shown by carrying out the appropriate nutritional administration in parallel with exercise therapy, when there is a nutritional state risk.
Management information
Registered date
| 2019 | Year | 09 | Month | 29 | Day |
Last modified on
| 2019 | Year | 09 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043479
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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