UMIN-CTR Clinical Trial

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
Email	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
Email	t2simozato@gmail.com

Sponsor
Institute	Nagoya Tokushukai General Hospital
Institute
Department

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
Email

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000019838