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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000021661
Receipt No. R000024944
Scientific Title Evaluation test about safety and efficacy of the respiratory muscle training therapy by abdominal respiratory weight exercises in chronic cardiovascular disease patients
Date of disclosure of the study information 2016/04/01
Last modified on 2017/03/24

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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
Registered date File name

Research case data
Registered date File name


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