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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000036818
Receipt No. R000041945
Scientific Title Cardiovascular physiotherapy for acute heart failure patients in the Tokyo metropolitan area study
Date of disclosure of the study information 2019/05/22
Last modified on 2019/05/22

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Basic information
Public title Cardiovascular physiotherapy for acute heart failure patients in the Tokyo metropolitan area study
Acronym CRAFTMAN study
Scientific Title Cardiovascular physiotherapy for acute heart failure patients in the Tokyo metropolitan area study
Scientific Title:Acronym CRAFTMAN study
Region
Japan

Condition
Condition heart failure
Classification by specialty
Cardiology Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We examined the acute phase of physiotherapy, trajectory of functional status, activities of daily living, and evaluate the impact of these variate in outcome in patients diagnosed with acute heart failure.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Mortality
Key secondary outcomes readmission due to heart failure

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Acute heart failure patients received acute phase of physiotherapy during hospitalization
Key exclusion criteria Patient death in hospital
Target sample size 2500

Research contact person
Name of lead principal investigator
1st name Saitoh
Middle name
Last name Masakazu
Organization Sakakibara Heart Institute
Division name Department of Rehabilitation
Zip code 1830003
Address 3-16-1, Asahi-cho, Fuchu 1830003, Tokyo
TEL 042-314-3111
Email msaitoh@shi.heart.or.jp

Public contact
Name of contact person
1st name Masakazu
Middle name
Last name Saitoh
Organization Sakakibara Heart Institute
Division name Department of Rehabilitation
Zip code 1830003
Address 3-16-1, Asahi-cho, Fuchu 1830003, Tokyo
TEL 042-314-3111
Homepage URL
Email msaitoh@shi.heart.or.jp

Sponsor
Institute Sakakibara Heart Institute
Institute
Department

Funding Source
Organization Sakakibara Heat Institute
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Sakakibara Heart Institute
Address 3-16-1, Asahi-cho, Fuchu 1830003, Tokyo
Tel 042-314-3111
Email kenkyu@shi.heart.or.jp

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 東京都

Other administrative information
Date of disclosure of the study information
2019 Year 05 Month 22 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 2500
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 No longer recruiting
Date of protocol fixation
2018 Year 05 Month 28 Day
Date of IRB
2018 Year 05 Month 28 Day
Anticipated trial start date
2018 Year 06 Month 01 Day
Last follow-up date
2019 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information we evaluated the outcome in patients enrolled ouor cohort study between April 2014 and March 2018

Management information
Registered date
2019 Year 05 Month 22 Day
Last modified on
2019 Year 05 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041945

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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