UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039888 |
|---|---|
| Receipt number | R000045491 |
| Scientific Title | Impact of sacopenia and activities of daily living in patients with hip fractures |
| Date of disclosure of the study information | 2020/03/20 |
| Last modified on | 2020/03/20 11:26:16 |
* 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
Impact of sacopenia and activities of daily living in patients with hip fractures
Acronym
Impact of sacopenia and ADL in patients with hip fractures
Scientific Title
Impact of sacopenia and activities of daily living in patients with hip fractures
Scientific Title:Acronym
Impact of sacopenia and activities of ADL in patients with hip fractures
Region
| Japan |
Condition
Condition
femoral neck fracture
Classification by specialty
| Orthopedics | Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the relationship between the actual condition of sarcopenia and ADL at discharge in patients with proximal femoral fracture.
Basic objectives2
Others
Basic objectives -Others
Sarcopenia accounts for approximately 20 ~ 50% of proximal femoral fractures and is associated with a high risk of QOL deterioration and frailty. Therefore, rehabilitation requires not only measures against functional impairment but also measures against sarcopenia.
However, the status of sarcopenia in the perioperative period and the relationship between sarcopenia and rehabilitation outcome are unclear. In this study, we investigated the actual condition of sarcopenia and factors affecting ADL in patients with proximal femoral fracture.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Barthel index efficacy
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 undergoing surgery and postoperative rehabilitation at our hospital for proximal femoral fracture
Key exclusion criteria
Patients with serious complications who were unable to walk or died before the injury
Target sample size
42
Research contact person
Name of lead principal investigator
| 1st name | Takako |
| Middle name | |
| Last name | Nagai |
Organization
Nihon university hospital
Division name
Orthpedic surgery
Zip code
101-8309
Address
1-6, kanda surugadai, Chiyoda-ku,Tokyo
TEL
03-3293-1711
ntnyf092@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Takako |
| Middle name | |
| Last name | Nagai |
Organization
Nihon University hospital
Division name
Orthpedic surgery
Zip code
101-8309
Address
1-6, kanda surugadai, Chiyoda-ku,Tokyo
TEL
03-3293-1711
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
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nihon University hospital
Address
1-6, kanda surugadai, Chiyoda-ku,Tokyo
Tel
03-3293-1711
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
| 2020 | Year | 03 | Month | 20 | 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
42
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 | 12 | Month | 12 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
There were 28 patients in the sarcopenia group and 14 patients in the non-sarcopenia group. Univariate analysis revealed significant differences in age, body weight, body mass index (BMI), and dementia. In the correlation between BI gain and each value in Spearman's rank correlation coefficient, GNRI and BI at discharge showed positive correlation, and negative correlation in age, sarcopenia, CCI, PIMs, and cognitive function. Multiple regression analysis using BI at discharge as the dependent variable revealed that age and PIMs were significant associated factors.
Management information
Registered date
| 2020 | Year | 03 | Month | 20 | Day |
Last modified on
| 2020 | Year | 03 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045491
