UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000885 |
|---|---|
| Receipt number | 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 13:41:45 |
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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
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
Sponsor or person
Institute
Nagoya University School of Health Sciences
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001067
