UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040062 |
|---|---|
| Receipt number | R000045679 |
| Scientific Title | Impact of cardiac rehabilitation interruption in elderly patients with chronic heart failure |
| Date of disclosure of the study information | 2020/04/13 |
| Last modified on | 2023/04/09 23:17:56 |
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Basic information
Public title
Impact of cardiac rehabilitation interruption in elderly patients with chronic heart failure
Acronym
Interruption of cardiac rehabilitation in patients with heart failure
Scientific Title
Impact of cardiac rehabilitation interruption in elderly patients with chronic heart failure
Scientific Title:Acronym
Interruption of cardiac rehabilitation in patients with heart failure
Region
| Japan |
Condition
Condition
Chronic heart failure
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of interruption of cardiac rehabilitation on heart failure in the elderly.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cardiopulmonary exercise test after interruption of cardiac rehabilitation
Key secondary outcomes
Stress echocardiography
Biochemical test
Adverse event
Echocardiography
Dynamometry
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
One month suspension of cardiac rehabilitation
Interventions/Control_2
One month of cardiac rehabilitation
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
A patient who was hospitalized for heart failure, underwent acute cardiac rehabilitation, and transitioned to outpatient cardiac rehabilitation.
Key exclusion criteria
none
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Masaru |
| Middle name | |
| Last name | Araki |
Organization
University of Occupational and Environmental Health
Division name
Second department of internal medicine
Zip code
8078556
Address
1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu, Fukuoka, Japan
TEL
093-603-1611
maraki@med.uoeh-u.ac.jp
Public contact
Name of contact person
| 1st name | Masaru |
| Middle name | |
| Last name | Araki |
Organization
University of Occupational and Environmental Health
Division name
Second department of internal medicine
Zip code
8078556
Address
1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu, Fukuoka, Japan
TEL
093-603-1611
Homepage URL
maraki@med.uoeh-u.ac.jp
Sponsor or person
Institute
University of Occupational and Environmental Health
Institute
Department
Personal name
Funding Source
Organization
JSPS KAKENHI
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Occupational and Environmental Health Ethics Committee
Address
1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu, Fukuoka, Japan
Tel
093-691-7205
Daigakukanri@mbox.pub.uoeh-u.ac.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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 04 | Month | 13 | 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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 03 | Month | 18 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 18 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 13 | Day |
Last follow-up date
| 2026 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 04 | Month | 05 | Day |
Last modified on
| 2023 | Year | 04 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045679
