UMIN-CTR Clinical Trial

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
Email	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
Email	keitasue@live.jp

Sponsor
Institute	Kakeyu-Misayama rehabilitation center
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000040051