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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000885
Receipt No. R000001067
Scientific Title Exercise and Life Functioning in Patients with Congestive Heart Failure ; A Rehabilitation Cohort Study.
Date of disclosure of the study information 2007/12/01
Last modified on 2013/05/14

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Basic information
Public title Exercise and Life Functioning in Patients with Congestive Heart Failure
; A Rehabilitation Cohort Study.
Acronym Exercise and Life Functioning in Patients with Congestive Heart Failure
; A Rehabilitation Cohort Study.
Scientific Title Exercise and Life Functioning in Patients with Congestive Heart Failure
; A Rehabilitation Cohort Study.
Scientific Title:Acronym Exercise and Life Functioning in Patients with Congestive Heart Failure
; A Rehabilitation Cohort Study.
Region
Japan

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

Objectives
Narrative objectives1 To clarify the time course of life functioning and the relationship of the exercise and life functioning in patients with congestive heart failure.
Basic objectives2 Others
Basic objectives -Others To clarify: 1)the time course of life functioning; 2) the relationship between exercise and the life functioning; 3)the relationship between the life functioning and readmission or death; and 4) the onset of depressive symptoms in patients with congestive heart failure.
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Life functioning measure
Key secondary outcomes Readmission or death
Depressive symptoms

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

Not applicable
Gender Male and Female
Key inclusion criteria CHF patients with NYHA classification II to III who hospitalized due
to acute exacerbation with ischemic heart diesase, cardiomyopathy,
hypertension, valvular disease and arrhythmia, and an left ventricular
ejection fraction 40% or less or B-type natriuretic peptide (BNP) levels more than 80pg/ml.
Key exclusion criteria No.1-7 apply to all participants and No.1-18 apply to exercise group.
The patient who;
1. underwent cardiac surgery during hospitalization.
2. can not walk over 50 meters.
3. has congnitive dysfunction(Mini Mental State Examination<18points).
4. has chronic obstructive pulmonary disease.
5. has psychiatry disorder.
6. has other disease that require hospitalization.
7. does not agree to participate in this study.
8. has severe renal dysfunction(Cr>2.3mg/dl,BUN>50mg/dl).
9. has anemia (Hb<9.0g/dl).
10. has uncontrolled rapid ventricular tachycardia (>180bpm,ICD firing>1/month).
11. has uncontrolled diabetes mellitus (HbA1c>9%).
12. has low blood pressure (SBP<80mmHg or proportional pulse pressure<20% of SBP).
13. has uncontrolled blood presure (SBP>160mmHg or DBP>100mmHg)
14. has HR<50bpm or HR>100bpm.
15. has anginal symptom.
16. has new atrial fibrilation.
17. has moderate to sever aortic valvular stenosis, or sever mitral valve regurgitation.
18. has hypertrophic obstructive cardiomyopathy.
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name YAMADA SUMIO
Organization Nagoya University
Division name School of Health Sciences
Zip code
Address Daikou minami 1-1-20, Higashi-ku, Nagoya sity, Aichi
TEL 052-917-1346
Email

Public contact
Name of contact person
1st name
Middle name
Last name YAMADA SUMIO
Organization Nagoya University
Division name Yamada Labolatory
Zip code
Address
TEL 052-719-1346
Homepage URL
Email

Sponsor
Institute Nagoya University School of Health Sciences
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information
2007 Year 12 Month 01 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2008 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2008 Year 05 Month 01 Day
Last follow-up date
2011 Year 05 Month 01 Day
Date of closure to data entry
2011 Year 12 Month 01 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information Functional limitation is closely related to cardiac hospitalization in patients with chronic heart failure.

Management information
Registered date
2007 Year 11 Month 12 Day
Last modified on
2013 Year 05 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001067

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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