UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048354 |
|---|---|
| Receipt number | R000055071 |
| Scientific Title | Changes and related factors in the circadian activity rhythm and temperature rhythm after discharge from rehabilitation facility |
| Date of disclosure of the study information | 2022/07/20 |
| Last modified on | 2022/07/12 15:23:44 |
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Basic information
Public title
Changes and related factors in the circadian activity rhythm and temperature rhythm after discharge from rehabilitation facility
Acronym
Changes and related factors in the circadian activity rhythm and temperature rhythm after discharge
Scientific Title
Changes and related factors in the circadian activity rhythm and temperature rhythm after discharge from rehabilitation facility
Scientific Title:Acronym
Changes and related factors in the circadian activity rhythm and temperature rhythm after discharge
Region
| Japan |
Condition
Condition
stroke, motor diseases
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the circadian activity rhythm and temperature rhythm of patients during hospitalization and after discharge
Basic objectives2
Others
Basic objectives -Others
prevention
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Patients were evaluated one week after admission.
Primary outcomes were the amount of activity and temperature of inpatient.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patients were treated at the rehabilitation facility in Japan
2. Sixty-five years of age or more
3. Diagnosed to have stroke or motor diseases
4.No signs of cognitive decline, as determined by the Mini-Mental State Examination, which had a cut-off value of >23
Key exclusion criteria
1.Patients not permitted to participate in the study by their doctors due to risks associated with assessing mental and physical function
2.With severe memory impairment or aphasia
3.Diagnosed with arteriosclerosis obliterans
4. have a metal allergy
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yuki |
| Middle name | |
| Last name | Nakagawa |
Organization
(1)Osaka University of Human Sciences, Japan
(2)Graduate School of Health Sciences, Kobe University, Kobe, Japan
Division name
(1)Faculty of Health Sciences(2)Department of Rehabilitation Science
Zip code
566-8501
Address
(1)1-4-1 Shojaku, Settsu-shi, Osaka (2)7-10-2 Tomogaoka Suma-ku, Kobe-shi, Hyogo-ken, Japan
TEL
06-6383-6441
yuki-nakagawa@kun.ohs.ac.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Nakagawa |
Organization
Osaka University of Human Sciences, Japan
Division name
Faculty of Health Sciences
Zip code
566-8501
Address
1-4-1 Shojaku, Settsu-shi, Osaka
TEL
06-6383-6441
Homepage URL
yuki-nakagawa@kun.ohs.ac.jp
Sponsor or person
Institute
Osaka University of Human Sciences
Institute
Department
Personal name
Funding Source
Organization
Graduate School of Health Sciences, Kobe University, Kobe, Japan
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Senri-chuo Hospital, Japan
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the ethics committee of Senri-chuo Hospital
Address
1-4-3 Sinsenrihigashi-machi, Toyonaka-shi, Osakahu, Japan
Tel
06-6834-1100
naritomi@kyowakai.com
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
| 2022 | Year | 07 | Month | 20 | 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
34
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
I will submit the results to a paper. Therefore, I can not publish the results.
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
| 2019 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 05 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Inpatients admitted to the rehabilitation unit in A hospital who met the inclusion criteria were selected.
Management information
Registered date
| 2022 | Year | 07 | Month | 12 | Day |
Last modified on
| 2022 | Year | 07 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055071
