UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017341 |
|---|---|
| Receipt number | R000019838 |
| Scientific Title | Effectiveness of chest mobilization in patients with heart failure ; pilot study |
| Date of disclosure of the study information | 2015/05/01 |
| Last modified on | 2019/11/02 09:35:24 |
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Basic information
Public title
Effectiveness of chest mobilization in patients with heart failure ; pilot study
Acronym
Effectiveness of chest mobilization in patients with heart failure ; pilot study
Scientific Title
Effectiveness of chest mobilization in patients with heart failure ; pilot study
Scientific Title:Acronym
Effectiveness of chest mobilization in patients with heart failure ; pilot study
Region
| Japan |
Condition
Condition
chronic heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
efficacy of chest mobilization in patients with chronic heart failure
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
rehopitalization of heart failure
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
chest mobilization
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Chronic heart failure patients in our hospital with heart failure history
Key exclusion criteria
1) Patient who received a diagnosis of acute disease.
2) Patient who is impossible to walk alone in activities of daily living,
3) Patient who has advanced anemia (Hgb (Hb)<8mg / dL).
4) Patinet who has severe liver disease (AST (GOT) or ALT (GPT) >100 IU / L).
5) Patient who has severe renal disease (BUN>25 mg / dL or serum creatinine>2.0 mg / dL).
6) Patient who is possibility of lactating or pregnant or has a positive result of pregnancy test within 14 days prior to the procedure
7) Pateint whom investigator determined to be inappropriate as a subject.
8) Patient who participate other clinical trial or study
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Shimozato |
Organization
Nagoya Tokushukai General Hospital
Division name
Department of cardiology
Zip code
Address
2-52 Kouzoujicho-kita Kasugai city Aich
TEL
0568-51-8711
t2simozato@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Shimozato |
Organization
Nagoya Tokushukai General Hospital
Division name
Department of cardiology
Zip code
Address
2-52 Kouzoujicho-kita Kasugai city Aich
TEL
0568-51-8711
Homepage URL
t2simozato@gmail.com
Sponsor or person
Institute
Nagoya Tokushukai General Hospital
Institute
Department
Personal name
Funding Source
Organization
Nagoya Tokushukai General Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
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
| 2015 | Year | 05 | 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
Completed
Date of protocol fixation
| 2015 | Year | 03 | Month | 18 | Day |
Date of IRB
| 2015 | Year | 03 | Month | 30 | Day |
Anticipated trial start date
| 2015 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 04 | Month | 30 | Day |
Last modified on
| 2019 | Year | 11 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019838
