UMIN-CTR Clinical Trial

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
Email	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
Email	shinji4df@marianna-u.ac.jp

Sponsor
Institute	Division of Cardiology, Department of Internal Medicine, St. Marianna University School of Medicine Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000047694