UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055092 |
|---|---|
| Receipt number | R000062836 |
| Scientific Title | The impact of sleep quality on the activities of daily living in patients in a convalescent rehabilitation ward |
| Date of disclosure of the study information | 2024/07/28 |
| Last modified on | 2024/07/28 09:25:09 |
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Basic information
Public title
The impact of sleep quality on the activities of daily living in patients in a convalescent rehabilitation ward
Acronym
The impact of sleep quality on the activities of daily living in patients in a convalescent rehabilitation ward
Scientific Title
The impact of sleep quality on the activities of daily living in patients in a convalescent rehabilitation ward
Scientific Title:Acronym
The impact of sleep quality on the activities of daily living in patients in a convalescent rehabilitation ward
Region
| Japan |
Condition
Condition
Patients admitted to a convalescent rehabilitation ward
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim is to clarify the relationship between the quality of sleep and the improvement in activity of daily living by measuring the non-REM sleep duration of patients admitted to a convalescent rehabilitation ward.
Basic objectives2
Others
Basic objectives -Others
The quality of sleep and activity of daily living at the time of admission and discharge in a convalescent rehabilitation ward will be investigated to clarify the relationship between the improvement in sleep quality and daily living functions.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Functional Independence Measure (FIM) effectiveness (at admission and discharge)
Key secondary outcomes
Quality of sleep, Body composition, Grip strength, Quadriceps muscle strength, Balance ability
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Persons aged 18 and older
2.Persons with a pre-onset or pre-injury FIM mobility score of 6 or higher
Key exclusion criteria
1.Persons whose mode of mobility prior to onset or injury was other than walking
2.Persons with severe dementia or higher brain dysfunction making participation in the study difficult
3.Persons using a pacemaker
4.Persons for whom wearing a smartwatch on the arm is difficult due to skin conditions or polyurethane allergies
5.Other persons deemed unsuitable by the attending physician due to complications or treatment course
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Fumihiko |
| Middle name | |
| Last name | Miura |
Organization
Saiseikai Otaru Hospital
Division name
Department of Rehabilitation
Zip code
061-0293
Address
10-1, Chikko, Otaru, Hokkaido, Japan
TEL
0134-25-4321
f.with.k.0616@gmail.com
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Sawada |
Organization
Health Sciences University of Hokkaido
Division name
Department of Physical Therapy, School of Rehabilitation Sciences
Zip code
061-0293
Address
1757, Kanazawa, Tobetsu, Hokkaido, Japan
TEL
0133-23-1219
Homepage URL
as-51@hoku-iryo-u.ac.jp
Sponsor or person
Institute
Health Sciences University of Hokkaido
Institute
Department
Personal name
Atsushi Sawada
Funding Source
Organization
Health Sciences University of Hokkaido
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Saiseikai Otaru Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saiseikai Otaru Hospital Ethics Committee
Address
10-1, Chikko, Otaru, Hokkaido, Japan
Tel
0134-25-4321
saise4@saiseikai-otaru.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
北海道済生会小樽病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 07 | Month | 28 | 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
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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 06 | Month | 25 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 16 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 29 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
All patients admitted to the convalescent rehabilitation ward of Hokkaido Saiseikai Otaru Hospital on or after July 29, 2024, who meet the selection criteria, will be included in the study.
Management information
Registered date
| 2024 | Year | 07 | Month | 28 | Day |
Last modified on
| 2024 | Year | 07 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062836
