UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029953 |
|---|---|
| Receipt number | 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 | 2021/05/17 09:54:39 |
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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
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
pt-tbr@wanreha.net
Sponsor or person
Institute
Tokyo Bay Rehabilitation Hospital
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
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034124
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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