UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038373 |
|---|---|
| Receipt number | R000043732 |
| Scientific Title | Validity of Assessment in Early-phase Rehabilitation in Patients with Cardiovascular Diseases: A prospective observational study |
| Date of disclosure of the study information | 2019/12/01 |
| Last modified on | 2025/04/27 10:25:13 |
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Basic information
Public title
Assessment in Early-phase Rehabilitation for Patients with Cardiovascular Diseases
Acronym
Assessment in Early-phase Rehabilitation for Patients with Cardiovascular Diseases
Scientific Title
Validity of Assessment in Early-phase Rehabilitation in Patients with Cardiovascular Diseases: A prospective observational study
Scientific Title:Acronym
Validity of Assessment in Early-phase Rehabilitation in Patients with Cardiovascular Diseases: A prospective observational study
Region
| Japan |
Condition
Condition
Cardiovascular disease
Classification by specialty
| Cardiology | Vascular surgery | Intensive care medicine |
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate prospectively the influence of parameter in acute-phase rehabilitation on patient physical function, activities of daily living, and prognosis after hospital discharge
Basic objectives2
Others
Basic objectives -Others
Validity
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Assessment
Primary outcomes
All-cause mortality at 1-, 2-, 3-, and 5-year after hospital discharge
Key secondary outcomes
Rehospitalization for cardiovascular disease
Physical function at 5 months after hospital discharge
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
Cardiovascular disease patients who admitted to Kitasato University Hospital cardiovascular centre
Key exclusion criteria
Myocardial ischemia induced by low intensity exercise
Untreated severe arrhythmia
Supported with circulatory devices
Estimated prognosis of less than 1 year
Pregnant women, lactating women, patients who may be pregnant
Not given consent
Target sample size
6000
Research contact person
Name of lead principal investigator
| 1st name | Nobuaki |
| Middle name | |
| Last name | Hamazaki |
Organization
Kitasato University Hospital
Division name
Department of Rehabilitation
Zip code
252-0375
Address
1-15-1, Kitasato, Minami-ku, Sagamihara-city, Japan
TEL
0427788413
hamanobu0317@gmail.com
Public contact
Name of contact person
| 1st name | Nobuaki |
| Middle name | |
| Last name | Hamazaki |
Organization
Kitasato University Hospital
Division name
Department of Rehabilitation
Zip code
252-0375
Address
1-15-1, Kitasato, Minami-ku, Sagamihara-city, Japan
TEL
0427788413
Homepage URL
hamanobu0317@gmail.com
Sponsor or person
Institute
Kitasato University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Kitasato Institute Clinical Research Review Board
Address
1-15-1, Kitasato, Minami-ku, Sagamihara-city, Japan
Tel
0427788111
rinri@med.kitasato-u.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
KMEO B18-083
Org. issuing International ID_1
Kitasato Institute Clinical Research Review Board
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
北里大学病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 12 | 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
Enrolling by invitation
Date of protocol fixation
| 2018 | Year | 09 | Month | 04 | Day |
Date of IRB
| 2018 | Year | 09 | Month | 04 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 04 | Day |
Last follow-up date
| 2030 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2019 | Year | 10 | Month | 23 | Day |
Last modified on
| 2025 | Year | 04 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043732
