UMIN-CTR Clinical Trial

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	Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled	23
Results	A higher Fatigue Severity Scale (FSS) score was significantly associated with a delayed increase in oxygen uptake at the onset of exercise (rho = 0.530; p = 0.009), but not oxygen uptake at peak exercise (rho = -0.264; p = 0.224). In addition, a higher FSS score was correlated with a delayed increase in cardiac output at the onset of exercise (rho = 0.476, p = 0.022).
Results date posted	2021 Year 05 Month 17 Day
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	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.

Management information
Registered date	2017 Year 11 Month 13 Day
Last modified on	2021 Year 05 Month 17 Day

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