UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050278 |
|---|---|
| Receipt number | R000057251 |
| Scientific Title | Changes in activity level during hospitalization in patients with stroke and post-fracture: A prospective longitudinal study. |
| Date of disclosure of the study information | 2023/02/09 |
| Last modified on | 2024/01/18 17:33:00 |
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Basic information
Public title
Changes in activity level during hospitalization in patients with stroke and post-fracture: A prospective longitudinal study.
Acronym
Changes in activity level during hospitalization in patients with stroke and post-fracture
Scientific Title
Changes in activity level during hospitalization in patients with stroke and post-fracture: A prospective longitudinal study.
Scientific Title:Acronym
Changes in activity level during hospitalization in patients with stroke and post-fracture
Region
| Japan |
Condition
Condition
Patients with stroke and post-fracture admitted to rehabilitation hospital
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aims were to examine whether physical activity changes between admission and discharge and whether there are differences in physical activity between patients with stroke and post-fracture.
Basic objectives2
Others
Basic objectives -Others
The aims were to examine whether physical activity changes between admission and discharge and whether there are differences in physical activity between patients with stroke and post-fracture.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Physical activity(Sedentary behavior, light-intensity physical activity, moderate to vigorous physical activity)
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
admission with stroke, lower extremity fracture, pelvis of spine fracture.
able to manage an accelerometer during the day.
Key exclusion criteria
unstable conditions requiring medical treatment.
complications or past histories that affect ambulation.
hospital discharge within a week.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Sota |
| Middle name | |
| Last name | Kobayashi |
Organization
Public Nanokaichi hospital, Gunma university graduate school of health science
Division name
Department of Rehabilitation
Zip code
370-2343
Address
643, Nanokaichi, Tomioka, Gunma
TEL
0274-62-7100
h181c003@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Sota |
| Middle name | |
| Last name | \Kobayashi |
Organization
Public Nanokaichi hospital, Gunma university graduate school of health science
Division name
Department of Rehabilitation
Zip code
370-2343
Address
643, Nanokaichi, Tomioka, Gunma
TEL
0274-62-7100
Homepage URL
h181c003@gunma-u.ac.jp
Sponsor or person
Institute
Public Nanokaichi Hospital
Institute
Department
Personal name
Sota Kobayashi
Funding Source
Organization
Public Nanokaichi Hospital
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Public Nanokaichi Hospital
Address
643, Nanokaichi, Tomioka, Gunma
Tel
0274625100
h181c003@gunma-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
| 2023 | Year | 02 | Month | 09 | Day |
Related information
URL releasing protocol
https://www.jstage.jst.go.jp/article/jpts/36/1/36_2023-111/_pdf/-char/ja
Publication of results
Published
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/jpts/36/1/36_2023-111/_pdf/-char/ja
Number of participants that the trial has enrolled
77
Results
The median LIPA time in patients after stroke and fracture increased from 107.5 and 106.7 minutes on admission to 122.0 and 127.3 minutes at discharge, and the median MVPA time increased from 2.7 and 0.7 minutes on admission to 4.2 and 2.7 minutes at discharge, respectively. In particular, LIPA in non-therapy time increased for patients both after stroke and fracture. No differences in characteristics were observed between with or without changes in SB regardless of differences in diagnoses.
Results date posted
| 2024 | Year | 01 | Month | 18 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients admitted from March 2021 to August 2022 were followed until discharge.
The inclusion criteria were as follows: 1) admission with stroke or fracture (lower extremity, pelvis, or vertebra); and 2)ability to manage an accelerometer during the day. The exclusion criteria were: 1) an unstable condition requiring medical treatment; 2) complications or a past history affecting ambulation; and 3) hospital discharge within 1 week of admission
Participant flow
A total of 337 patients were admitted to the hospital during the recruitment period. Among these patients, 163 were eligible for inclusion (Fig. 1), of whom 77 (36 with stroke, 41 with fracture) participated in this study.
Adverse events
None
Outcome measures
Sedentary behavior time, light intensity physical activity time, and moderate to vigorous physical activity time during day-time, therapy time, and non-therapy time.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2020 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 09 | Day |
Anticipated trial start date
| 2020 | Year | 03 | Month | 29 | Day |
Last follow-up date
| 2022 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Main results published
Management information
Registered date
| 2023 | Year | 02 | Month | 09 | Day |
Last modified on
| 2024 | Year | 01 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057251
