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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000029953
Receipt No. R000034124
Scientific Title Physiological mechanisms associated with fatigue in individuals with stroke
Date of disclosure of the study information 2017/11/30
Last modified on 2019/06/24

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Basic information
Public title Physiological mechanisms associated with fatigue in individuals with stroke
Acronym Relationship between post-stroke fatigue and cardiorespiratory fitness
Scientific Title Physiological mechanisms associated with fatigue in individuals with stroke
Scientific Title:Acronym Relationship between post-stroke fatigue and cardiorespiratory fitness
Region
Japan

Condition
Condition Stroke
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the relationship between post-stroke fatigue and cardiorespiratory fitness.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Fatigue severity scale
Key secondary outcomes Oxygen consumption
Minute ventilation
Respiratory rate
Tidal volume
Cardiac output
Heart rate
Stroke volume
Arteriovenous oxygen difference

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 maintain a target cadence of 50 rpm during leg cycle exercise
7. At least 1 week at admission in convalescent rehabilitation ward
8. Consent to participate in this study
Key exclusion criteria 1. Restriction of physical activity due to unstable medical conditions
2. Resting hypertension with systolic or diastolic blood pressures of 200/110 mmHg or more
3. Taking beta-blockers
4. Limited range of motion and/or pain that affect exercise test
5. Other neurologic conditions in addition to stroke
6. Mental impairment leading to inability to cooperate
7. Inappropriate patients due to other reasons
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Kazuaki
Middle name
Last name Oyake
Organization Shinshu University
Division name Division 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 Yasuto
Middle name
Last name Baba
Organization Tokyo Bay Rehabilitation Hospital
Division name Division of Rehabilitation
Zip code 275-0026
Address 4-1-1 Yatsu, Narashino-city, Chiba
TEL 047-453-9000
Homepage URL
Email pt-tbr@wanreha.net

Sponsor
Institute Tokyo Bay Rehabilitation Hospital
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 Department of Physical Therapy, Shinshu University School of Health Sciences
Name of secondary funder(s)

IRB Contact (For public release)
Organization Tokyo Bay Rehabilitation Hospital
Address 4-1-1 Yatsu, Narashino, Chiba
Tel 047-453-9000
Email shinsakai@wanreha.net

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
2017 Year 11 Month 30 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
2017 Year 09 Month 05 Day
Date of IRB
2017 Year 09 Month 05 Day
Anticipated trial start date
2017 Year 11 Month 01 Day
Last follow-up date
2020 Year 05 Month 22 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 cardiorespiratory fitness in a cross-sectional design.
To examine whether improving post-stroke fatigue is related to increasing cardiorespiratory fitness.

Management information
Registered date
2017 Year 11 Month 13 Day
Last modified on
2019 Year 06 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034124

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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