UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035327 |
|---|---|
| Receipt number | R000040051 |
| Scientific Title | Relationship between post-stroke fatigue and autonomic nerve function: a fundamental research to develop an effective treatment for post-stroke fatigue |
| Date of disclosure of the study information | 2018/12/21 |
| Last modified on | 2021/12/22 09:44:16 |
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Basic information
Public title
Relationship between post-stroke fatigue and autonomic nerve function: a fundamental research to develop an effective treatment for post-stroke fatigue
Acronym
Autonomic nerve function in individuals with post-stroke fatigue
Scientific Title
Relationship between post-stroke fatigue and autonomic nerve function: a fundamental research to develop an effective treatment for post-stroke fatigue
Scientific Title:Acronym
Autonomic nerve function in individuals with post-stroke fatigue
Region
| Japan |
Condition
Condition
stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the relationship between post-stroke fatigue and autonomic nerve function in individuals with subacute stroke.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Heart rate variability
Key secondary outcomes
The number of postural orthostatic tachycardia syndrome
The number of orthostatic hypotension
The number of neurally mediated hypotension
Changes in heart rate during a conventional active standing test
Changes in blood pressure during a conventional active standing test
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. First-ever stroke
2. Stroke within 1 to 6 months
3. Unilateral hemiparetic stroke
4. No severe cognitive impairment (a Mini-mental State Examination score of 24 or more)
5. Age between 40 and 80 years
6. Able to stand up without manual assistance
7. Consent to participate in this study
Key exclusion criteria
1. Arrhythmia such as atrial fibrillation
2. Cognitive impairment leading to inability to cooperate
3. Using a cardiac pacemaker
4. A heart rate of more than 120 bpm or a systolic blood pressure of less than 90 mmHg during supine at rest
5. Other neurologic conditions in addition to stroke
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kazuaki |
| Middle name | |
| Last name | Oyake |
Organization
Shinshu University
Division name
Department of Physical Therapy
Zip code
390-8621
Address
3-1-1 Asahi, Matsumoto, Nagano
TEL
0263-37-2413
oyake.kazuaki@hotmail.co.jp
Public contact
Name of contact person
| 1st name | Keita |
| Middle name | |
| Last name | Sue |
Organization
Kakeyu-Misayama rehabilitation center
Division name
Department of Physical Therapy
Zip code
386-0396
Address
1308 Kakeyuonsen, Ueda-city, Nagano
TEL
0268-44-2111
Homepage URL
keitasue@live.jp
Sponsor or person
Institute
Kakeyu-Misayama rehabilitation center
Institute
Department
Personal name
Funding Source
Organization
Grant-in Aid for Young Scientists
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Shinshu University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kakeyu-Misayama rehabilitation center
Address
1308 Kakeyuonsen, Ueda-city, Nagano
Tel
0268-44-2111
pt-b@kakeyu-hp.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
鹿教湯三才山リハビリテーションセンター
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 12 | Month | 21 | 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
42
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
Completed
Date of protocol fixation
| 2018 | Year | 12 | Month | 20 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 08 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To investigate the relationship between post-stroke fatigue and autonomic nerve function in a cross-sectional design.
To examine whether reducing post-stroke fatigue is related to improving autonomic nerve function.
Management information
Registered date
| 2018 | Year | 12 | Month | 20 | Day |
Last modified on
| 2021 | Year | 12 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040051
