UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054602 |
|---|---|
| Receipt number | R000062362 |
| Scientific Title | Early intensive in-hospital rehabilitation after hip fracture surgery in patients with and without dementia: Emulating a randomized control trial using medical claims data |
| Date of disclosure of the study information | 2024/06/07 |
| Last modified on | 2024/12/06 09:15:33 |
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Basic information
Public title
Early intensive in-hospital rehabilitation after hip fracture surgery in patients with and without dementia: Emulating a randomized control trial using medical claims data
Acronym
Early intensive in-hospital rehabilitation after hip fracture surgery in patients with and without dementia: Emulating a randomized control trial using medical claims data
Scientific Title
Early intensive in-hospital rehabilitation after hip fracture surgery in patients with and without dementia: Emulating a randomized control trial using medical claims data
Scientific Title:Acronym
Early intensive in-hospital rehabilitation after hip fracture surgery in patients with and without dementia: Emulating a randomized control trial using medical claims data
Region
| Japan |
Condition
Condition
hip fracture
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Early rehabilitation following hip fracture surgery is commonly practiced, but the dose response relationship of the therapy remains uncertain. This study will be conducted to investigate the impact of early intensive rehabilitation, initiated within 2 days of surgery and lasting up to 7 days, on activity of daily living recovery in patients with and without dementia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The Barthel Index (BI) scores at 14 days post-surgery will be the main outcome.
Key secondary outcomes
The Barthel Index (BI) scores at 30 days post-surgery will be the main outcome.
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
| 50 | years-old | <= |
Age-upper limit
| 120 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who (1) had hip fractures (ICD 10 codes S720 and S721) and underwent surgery (sliding hip screws, intramedullary nails, or hemiarthroplasty) within 2 days after admission; (2) were aged 50 years and older; and (3) underwent rehabilitation by a physiotherapist or occupational therapist within 2 days postoperatively.
Key exclusion criteria
Without dementia cohort: Patients who (1) were admitted from nursing homes or other hospitals; (2) used home health care services prior to admission; (3) had dementia; or (4) had bilateral hip fracture or multiple injuries.
With dementia cohort: Patients who (1) were admitted from other hospitals; (2) did not have dementia; or (3) had bilateral hip fracture or multiple injuries.
Target sample size
25000
Research contact person
Name of lead principal investigator
| 1st name | Takaaki |
| Middle name | |
| Last name | Ikeda |
Organization
Yamagata University
Division name
Department of Health Policy Science
Zip code
9909585
Address
2-2-2, Iidanishi, Yamagata City, Yamagata
TEL
0236285932
tikeda@med.id.yamagata-u.ac.jp
Public contact
Name of contact person
| 1st name | Takaaki |
| Middle name | |
| Last name | Ikeda |
Organization
Yamagata University
Division name
Department of Health Policy Science
Zip code
9909585
Address
2-2-2 Iidanishi, Yamagata, Yamagata
TEL
0236285932
Homepage URL
tikeda@med.id.yamagata-u.ac.jp
Sponsor or person
Institute
Yamagata University
Institute
Department
Personal name
Takaaki Ikeda
Funding Source
Organization
This work was supported by the Japan Society for the Promotion of Science (JSPS) KAKENHI Grant Number (22K17648).
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Occupational and Environmental Health
Address
1-1, Iseigaoka, Yahatanishi-ku Kitakyushu-shi, Fukuoka
Tel
0936917205
daigakurinri@mbox.pub.uoeh-u.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
| 2024 | Year | 06 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://linkinghub.elsevier.com/retrieve/pii/S0895-4356(24)00306-8
Number of participants that the trial has enrolled
25763
Results
Among patients without dementia (N = 11,461), no significant differences in Barthel Index (BI) scores were observed at 14 days postoperatively across regimens. At 30 days postoperatively, significant differences in BI scores were noted between highest- and low-intensity regimens and between gradually increasing intensity and low-intensity regimens.
Results date posted
| 2024 | Year | 12 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2024 | Year | 10 | Month | 05 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2024 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 11 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 02 | Day |
Last follow-up date
| 2024 | Year | 04 | Month | 03 | Day |
Date of closure to data entry
| 2024 | Year | 09 | Month | 01 | Day |
Date trial data considered complete
| 2024 | Year | 09 | Month | 02 | Day |
Date analysis concluded
| 2024 | Year | 09 | Month | 02 | Day |
Other
Other related information
This is a longitudinal study conducted using Diagnosis Procedure Combination data.Patients discharged between April 1, 2018 and December 31, 2019, who were diagnosed with a femoral neck fracture and underwent surgery (by sliding hip screw Fusion, intramedullary nail fixation, and arthroplasty) within 2 days of admission will be included in the analysis. Exposure will be low intensity early inpatient rehabilitation (20 minutes of rehabilitation from postoperative day 2 to day 7), high intensity early inpatient rehabilitation (60 minutes or more of rehabilitation from the day after surgery to day 7), and graduated intensity early inpatient rehabilitation (20 minutes the day after surgery, 40 minutes from day 2 to day 4, and 60 minutes from day 5 to day 7). Outcome will be Barthel Index score at 14 days postoperatively.
Management information
Registered date
| 2024 | Year | 06 | Month | 07 | Day |
Last modified on
| 2024 | Year | 12 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062362
