UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014733 |
|---|---|
| Receipt number | R000017095 |
| Scientific Title | Cardiorespiratory fitness in patients with stroke |
| Date of disclosure of the study information | 2014/08/01 |
| Last modified on | 2017/08/03 09:21:02 |
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Basic information
Public title
Cardiorespiratory fitness in patients with stroke
Acronym
Cardiorespiratory fitness in patients with stroke
Scientific Title
Cardiorespiratory fitness in patients with stroke
Scientific Title:Acronym
Cardiorespiratory fitness in patients with stroke
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess exercise capacity in patients with stroke by using arm and leg exercise testing.
Basic objectives2
Others
Basic objectives -Others
Relevancy
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Peak oxygen uptake
Key secondary outcomes
Ventilatory threshold
Heart rate-oxygen coefficient
Peak heart rate
Peak work rate
Borg's ratings of perceived exertion scale
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 (Mini-Mental State Examination >= 22)
5. Age between 40 and 80 years
6. Independent in sitting
7. At least 1 week after admission
8. Consent to participate in this study
Key exclusion criteria
1. Restriction of physical activity due to uncorrected medical conditions
2. Resting hypertension with systolic or diastolic blood pressures >= 200/110 mmHg
3. Taking beta-blocker
4. Thrombosis of lower extremities
5. Musculoskeletal impairment and pain that compromises exercise performance
6. Other neurologic conditions in addition to stroke
7. Mental impairment leading to inability to cooperate
8. Inappropriate patients due to other reasons
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuaki Oyake |
Organization
Tokyo Bay Rehabilitation Hospital
Division name
Division of physical therapy
Zip code
Address
4-1-1 Yatsu, Narashino-shi, Chiba
TEL
047-453-9010
oyake.kazuaki@hotmail.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuaki Oyake |
Organization
Tokyo Bay Rehabilitation Hospital
Division name
Division of physical therapy
Zip code
Address
4-1-1 Yatsu, Narashino-shi, Chiba
TEL
047-453-9010
Homepage URL
oyake.kazuaki@hotmail.co.jp
Sponsor or person
Institute
Tokyo Bay Rehabilitation Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Shinshu University
Graduate School of Medicine
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
東京湾岸リハビリテーション病院(千葉県)
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 08 | Month | 01 | 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
Completed
Date of protocol fixation
| 2014 | Year | 04 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 08 | Month | 05 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To investigate relations between cardiorespiratory fitness and characteristics (motor function, performance, ADL, etc.) in patients with stroke.
To compare outcomes by arm and leg exercise testing.
Management information
Registered date
| 2014 | Year | 08 | Month | 01 | Day |
Last modified on
| 2017 | Year | 08 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017095
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
