UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021661 |
|---|---|
| Receipt number | 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 20:06:39 |
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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
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
biwa_miki@med.kurume-u.ac.jp
Sponsor or person
Institute
Kurume University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024944
