UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061681 |
|---|---|
| Receipt number | R000070570 |
| Scientific Title | A clinical study of physical activity and sleep-disordered breathing among stroke patients |
| Date of disclosure of the study information | 2026/05/26 |
| Last modified on | 2026/05/25 16:52:23 |
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Basic information
Public title
A clinical study of physical activity and sleep-disordered breathing among stroke patients
Acronym
A clinical study of physical activity and sleep-disordered breathing among stroke patients
Scientific Title
A clinical study of physical activity and sleep-disordered breathing among stroke patients
Scientific Title:Acronym
A clinical study of physical activity and sleep-disordered breathing among stroke patients
Region
| Japan |
Condition
Condition
cerebral infarction, cerebral hemorrhage, stroke
Classification by specialty
| Rehabilitation medicine | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to examine the impact of daytime physical activity on sleep-disordered breathing and to identify associated risk factors among stroke patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Apnea-Hypopnea Index
Key secondary outcomes
Physical activity (Steps per day and METs)
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Participants diagnosed with cerebral infarction or cerebral hemorrhage, and more than 10 days post-onset
Participants who are capable of communicating in Japanese
Participants who have received sufficient explanation about the study, understand its content, and provide voluntary informed consent
Participants whose general condition is stable and whose physician that participation is feasible
Key exclusion criteria
Participants requiring respiratory therapy, such as mechanical ventilation, continuous positive airway pressure, or oxygen therapy
Participants who were already diagnosed as sleep-disordered breathing and treated
Participants with hemodialysis
Participants with persistent atrial fibrillation
Participants with a cardiac pacemaker
Participants with aphasia
Participants deemed unsuitable for enrollment in this study by the investigator for any other reason
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Hanako |
| Middle name | |
| Last name | Misao |
Organization
University of Shizuoka
Division name
Graduate School of Nursing
Zip code
422-8021
Address
2-2-1, Oshika, Suruga-ku, Shizuoka
TEL
054-202-2050
misahana@u-shizuoka-ken.ac.jp
Public contact
Name of contact person
| 1st name | Ayami |
| Middle name | |
| Last name | Suzuki |
Organization
University of Shizuoka
Division name
School of Nursing
Zip code
422-8021
Address
2-2-1, Oshika, Suruga-ku, Shizuoka
TEL
0542022050
Homepage URL
ayasuzuki@u-shizuoka-ken.ac.jp
Sponsor or person
Institute
University of Shizuoka
Institute
Department
Personal name
Funding Source
Organization
Grants-in-aid for Scientific Research
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board, University of Shizuoka
Address
52-1 Yada, Suruga-ku, Shizuoka
Tel
054-264-5102
koho1@u-shizuoka-ken.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
静清リハビリテーション病院（静岡県）/Hospitality Care Garden Seisei Rehabilitation Hospital
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 05 | Month | 26 | 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
| 2025 | Year | 10 | Month | 28 | Day |
Date of IRB
| 2025 | Year | 10 | Month | 28 | Day |
Anticipated trial start date
| 2026 | Year | 01 | Month | 26 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To examine the association between daytime physical activity and sleep-disordered breathing.
Management information
Registered date
| 2026 | Year | 05 | Month | 25 | Day |
Last modified on
| 2026 | Year | 05 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070570
