UMIN-CTR Clinical Trial

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
Email	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
Email	yuki-nakagawa@kun.ohs.ac.jp

Sponsor
Institute	Osaka University of Human Sciences
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055071