UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation test about safety and efficacy of the respiratory muscle training therapy by abdominal respiratory weight exercises in chronic cardiovascular disease patients
Acronym	Respiratory muscle training therapy in chronic cardiovascular diseases
Scientific Title	Evaluation test about safety and efficacy of the respiratory muscle training therapy by abdominal respiratory weight exercises in chronic cardiovascular disease patients
Scientific Title:Acronym	Respiratory muscle training therapy in chronic cardiovascular diseases
Region	Japan

Condition
Condition	Chronic cardiovascular disease
Classification by specialty	Medicine in general Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the safety and efficacy of the respiratory physical therapy by abdominal respiratory muscle training method in the chronic cardiovascular disease patients
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	Improvement of cardiac function
Key secondary outcomes	Improvement of respiratory function Improvement of exercise capacity Relief of symptoms Autonomic function Body composition Physical function Carbohydrate metabolism Lipid metabolism

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	YES
Institution consideration
Blocking
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Maneuver
Interventions/Control_1	The respiratory muscle training therapy is performed in addition to performing conventional cardiac rehabilitation. The respiratory muscle training therapy is abdominal muscle training method. Intervention period is 6 months
Interventions/Control_2	Conventional cardiac rehabilitation ,such as aerobic exercise and lower extremity strength training , is performed. Intervention period is 6 months.
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	20 years-old <=
Age-upper limit	90 years-old >
Gender	Male and Female
Key inclusion criteria	Patients with chronic cardiovascular disease in outpatient or in hospital of Kurume University hospital Patients with informed consent Patients with chronic cardiovascular disease shown in the following Ischemic heart disease Valvular heart disease Hypertensive heart disease Cardiomyopathy Arrhythmia Adult congenital heart disease Pulmonary hypertension
Key exclusion criteria	Patients with obstructive respiratory disease Patients with the device planted Patients with difficult musculoskeletal disease Patients with symptoms at rest Patients with pulmonary hypertension of the WHO classification 3 more Patients with hypoxemia in spite of the use of breathing ancillary equipment Patients with uncontrolled high blood pressure Patients with poor control of arrhythmia, such as adverse effects on hemodynamics Patients that may be in or pregnancy Others, patients who are judged that this study is unsuitable by physician
Target sample size	90

Research contact person
Name of lead principal investigator	1st name Middle name Last name Miki Biwa
Organization	Kurume University School of Medicine
Division name	Division of Cardio-Vascular Medicine, Department of Internal Medicine
Zip code
Address	The Cardiovascular Research Institute, Kurume University,67 Asahi-machi, Kurume, Fukuoka, 830-0011, Japan
TEL	0942-31-7580
Email	biwa_miki@med.kurume-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Miki Biwa
Organization	Kurume University School of Medicine
Division name	Division of Cardio-Vascular Medicine, Department of Internal Medicine
Zip code
Address	The Cardiovascular Research Institute, Kurume University,67 Asahi-machi, Kurume, Fukuoka, Japan
TEL	0942-31-7580
Homepage URL
Email	biwa_miki@med.kurume-u.ac.jp

Sponsor
Institute	Kurume University School of Medicine
Institute
Department

Funding Source
Organization	None
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	2016 Year 04 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	Enrolling by invitation
Date of protocol fixation	2016 Year 03 Month 16 Day
Date of IRB
Anticipated trial start date	2016 Year 04 Month 04 Day
Last follow-up date	2017 Year 02 Month 23 Day
Date of closure to data entry	2017 Year 02 Month 28 Day
Date trial data considered complete	2017 Year 02 Month 28 Day
Date analysis concluded	2017 Year 03 Month 28 Day

Other
Other related information

Management information
Registered date	2016 Year 03 Month 29 Day
Last modified on	2017 Year 03 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024944

Research Plan
Registered date	File name

Research case data specifications
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Research case data
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