UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041811 |
|---|---|
| Receipt number | R000047694 |
| Scientific Title | Effect of physical therapy on activity of daily living at discharge in patient with acute heart failure. |
| Date of disclosure of the study information | 2020/09/20 |
| Last modified on | 2021/03/18 15:43:24 |
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Basic information
Public title
Effect of physical therapy on activity of daily living at discharge in patient with acute heart failure.
Acronym
Effect of physical therapy on activity of daily living at discharge in patient with acute heart failure.
Scientific Title
Effect of physical therapy on activity of daily living at discharge in patient with acute heart failure.
Scientific Title:Acronym
Effect of physical therapy on activity of daily living at discharge in patient with acute heart failure.
Region
| Japan |
Condition
Condition
Heart failure
Classification by specialty
| Cardiology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The present study aimed to examine the effects of physical therapy on activity of daily living at discharge in patients with acute heart failure.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Functional Independence Measure (FIM) at discharge
Key secondary outcomes
Short Physical Performance Battery (SPPB) at discharge
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Intervention: Endurance training, Resistance training, Physical therapy.
The intervention period is daily from the start of intervention to discharge. (Excluding weekends)
Interventions/Control_2
Control: Endurance training, Resistance training.
The intervention period is daily from the start of intervention to discharge. (Excluding weekends)
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
Patients with acute heart failure underwent cardiac rehabilitation in hospitals.
Key exclusion criteria
It took more than 4 days to start walking
New York Heart Association functional classification IV
Serious arrhythmia at rest
unstable angina
severe aortic stenosis
Severe dementia (MMSE less than 18 points)
Cannot answer the questionnaire in writing
Cannot walk 50m independently before hospitalization
No deterioration in balance function and activity of daily living at the start of research
Target sample size
44
Research contact person
Name of lead principal investigator
| 1st name | Norio |
| Middle name | |
| Last name | Suzuki |
Organization
St. Marianna University School of Medicine Hospital
Division name
Division of Cardiology, Department of Internal Medicine
Zip code
216-8511
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki
TEL
044-977-8111
noriwosuzuki@gmail.com
Public contact
Name of contact person
| 1st name | Shinji |
| Middle name | |
| Last name | Nemoto |
Organization
St. Marianna University School of Medicine Yokohama City Seib hospital
Division name
Department of Rehabilitation Medicine
Zip code
241-0811
Address
1197-1 Yasashi-cho, Asahi-ku, Yokohama-shi, Kanagawa
TEL
045-366-1111
Homepage URL
shinji4df@marianna-u.ac.jp
Sponsor or person
Institute
Division of Cardiology, Department of Internal Medicine, St. Marianna University School of Medicine Hospital
Institute
Department
Personal name
Funding Source
Organization
St. Marianna University School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kawasaki Municipal Tama Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
St. Marianna University School of Medicine
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki
Tel
044-977-8111
k-sienbu.mail@marianna-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 | 09 | Month | 20 | 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
Terminated
Date of protocol fixation
| 2020 | Year | 09 | Month | 16 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 06 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
| 2021 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 09 | Month | 16 | Day |
Last modified on
| 2021 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047694
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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