UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014733
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email oyake.kazuaki@hotmail.co.jp

Sponsor
Institute Tokyo Bay Rehabilitation Hospital
Institute
Department

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
Email

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
URL(English) https://upload.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
Registered date File name


Contact us.