UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Cardiorespiratory fitness in patients with stroke
Title of the study (Brief title)	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	Kazuaki Oyake
Organization	Tokyo Bay Rehabilitation Hospital
Division name	Division of physical therapy
Address	4-1-1 Yatsu, Narashino-shi, Chiba
TEL	047-453-9010
Email	oyake.kazuaki@hotmail.co.jp

Public contact
Name of contact person	Kazuaki Oyake
Organization	Tokyo Bay Rehabilitation Hospital
Division name	Division of physical therapy
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 04 Month 23 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000017095