UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039164 |
|---|---|
| Receipt number | R000044665 |
| Scientific Title | Usefulness of yoga as cardiac rehabilitation in patients with heart failure |
| Date of disclosure of the study information | 2020/01/15 |
| Last modified on | 2020/05/19 09:37:00 |
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Basic information
Public title
Usefulness of yoga as cardiac rehabilitation in patients with heart failure
Acronym
Usefulness of yoga as cardiac rehabilitation in patients with heart failure
Scientific Title
Usefulness of yoga as cardiac rehabilitation in patients with heart failure
Scientific Title:Acronym
Usefulness of yoga as cardiac rehabilitation in patients with heart failure
Region
| Japan |
Condition
Condition
Heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examine whether enhance parasympathetic activity by suppressing acceleration of sympathetic nerve activity by carrying out yoga which can be carried out by sitting on a chair against a heart failure.
The autonomic nervous activity is measured by an autonomic nervous function measuring device. Inspection items: CVRR, HF, LF/HF, BP, HR, etc.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Autonomic function
Key secondary outcomes
Heart rate
Blood pressure
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Maneuver |
Interventions/Control_1
Sitting on a chair,three kinds of yoga of asana,pranayama and meditation on were carried out of a total of about 20 minutes.
Analysis of electrocardiogram at resting position,standing upright,standing position and sitting before and after yoga practice.
Measure electrocardiogram for 6 minutes before and after yoga.
Coefficient of Variation on R-R interval(CVRR)is analyzed by RR spectrum and the parasympathetic activity index(HF) and the sympathetic activity index(LF/HF),which are autonomic indexes, are measured.
Interventions/Control_2
Sitting on a chair,watch DVD about 20 minutes.
Analysis of electrocardiogram at resting position,standing upright,standing position and sitting before and after watch DVD.
Measure electrocardiogram for 6 minutes before and after yoga.
Coefficient of Variation on R-R interval(CVRR)is analyzed by RR spectrum and the parasympathetic activity index(HF) and the sympathetic activity index(LF/HF),which are autonomic indexes, are measured.
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Heart failure
Key exclusion criteria
Patients with absolute contraindications to exercise therapy for chronic heart failure, those with arrhythmia such as pacemaker implantation or atrial fibrillation, those who cannot maintain a stable standing for 5 minutes, those who are judged inappropriate by the attending physician, written studies Those who did not give consent to participate.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Watanabe |
Organization
Kagoshima City Hospital
Division name
Department of Rehabilitation
Zip code
890-8760
Address
37-1 Uearata-Cho,Kagoshima-City,Kagoshima 890-8760,Japan
TEL
099-230-7000
rptnabe3@gmail.com
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Watanabe |
Organization
Kagoshima City Hospital
Division name
Department of Rehabilitation
Zip code
890-8760
Address
37-1 Uearata-Cho,Kagoshima-City,Kagoshima 890-8760,Japan
TEL
099-230-7000
Homepage URL
rptnabe3@gmail.com
Sponsor or person
Institute
Kagoshima City Hospital
Institute
Department
Personal name
Funding Source
Organization
Kagoshima University Graduate school of Medical and Dental Sciences
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kagoshima City Hospital
Address
37-1 Uearata-Cho,Kagoshima-City,Kagoshima 890-8760,Japan
Tel
099-230-7000
kch-kenkyu@kch.kagoshima.jp
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
| 2020 | Year | 01 | Month | 15 | 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
10
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
| 2019 | Year | 01 | Month | 10 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 10 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 10 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 01 | Month | 15 | Day |
Last modified on
| 2020 | Year | 05 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044665
