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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | |||
Condition | Chronic cardiovascular disease | ||
Classification by specialty |
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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 |
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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 |
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Interventions/Control_2 | Conventional cardiac rehabilitation ,such as aerobic exercise and lower extremity strength training , is performed.
Intervention period is 6 months. |
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Interventions/Control_3 | ||
Interventions/Control_4 | ||
Interventions/Control_5 | ||
Interventions/Control_6 | ||
Interventions/Control_7 | ||
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Interventions/Control_9 | ||
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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 |
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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 |
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Target sample size | 90 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
Institute | Kurume University School of Medicine |
Institute | |
Department |
Funding Source | |
Organization | None |
Organization | |
Division | |
Category of Funding Organization | Self funding |
Nationality of Funding Organization |
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IRB Contact (For public release) | |
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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 |
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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 | |
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Outcome measures | |
Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Enrolling by invitation | ||||||
Date of protocol fixation |
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Anticipated trial start date |
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Last follow-up date |
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Date trial data considered complete |
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Date analysis concluded |
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Other | |
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Management information | |||||||
Registered date |
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Last modified on |
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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 |