UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041349 |
|---|---|
| Receipt number | R000047191 |
| Scientific Title | Effect of High intensity interval training on Heart rate recovery among Heart Failure patients in Myanmar: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2021/04/06 |
| Last modified on | 2020/08/07 17:23:15 |
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Basic information
Public title
Effect of High intensity interval training on Heart rate recovery among Heart Failure patients in Myanmar
Acronym
Effect of HIIT on HRR in HF patients in Myanmar
Scientific Title
Effect of High intensity interval training on Heart rate recovery among Heart Failure patients in Myanmar: A Randomized Controlled Trial
Scientific Title:Acronym
Effect of HIIT on HRR among HF patients in Myanmar: A RCT
Region
| Asia(except Japan) |
Condition
Condition
PhD
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study was to determine the effect of high interval interval training on heart rate recovery among heart failure patients in Myanmar. These findings will be useful evidences to adopt cardiac rehabilitation protocol for HF patients in our country.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Heart rate recovery (beats/minute) after six weeks of high intensity interval training
Key secondary outcomes
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
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Intervention group receive high intensity interval training 3 sessions per week for 6 weeks in addition to standard medical treatment
Interventions/Control_2
Control group receive standard medical treatment only
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
| 40 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Heart failure patients with NYHA class II and III, Ejection fraction < 40%
Key exclusion criteria
Heart failure patients with documented history of congenital heart disease and chronic obstructive pulmonary disease
Target sample size
66
Research contact person
Name of lead principal investigator
| 1st name | Khin |
| Middle name | Palae |
| Last name | Swe |
Organization
University of Medicine, Mandalay
Division name
Department of Physical Medicine and Rehabilitation, Mandalay General Hospital
Zip code
959
Address
21 street, between 87 and 88 streets, Aung Myay Tharsan Township, Mandalay
TEL
2032720
khinpalaeswe@ummdy.edu.mm
Public contact
Name of contact person
| 1st name | Khin |
| Middle name | Palae |
| Last name | Swe |
Organization
University of Medicine, Mandalay
Division name
Department of Physical Medicine and Rehabilitation, Mandalay General Hospital
Zip code
959
Address
21 street, between 87 and 88 streets, Aung Myay Tharsan Township, Mandalay
TEL
2032720
Homepage URL
khinpalaeswe@ummdy.edu.mm
Sponsor or person
Institute
Department of Physical Medicine and Rehabilitation, Mandalay General Hospital, University of Medicine, Mandalay
Institute
Department
Personal name
Funding Source
Organization
Department of Physical Medicine and Rehabilitation, Mandalay General Hospital,University of Medicine, Mandalay
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
University of Medicine, Mandalay
Address
30th street, between 73rd and 74th streets, Chan Aye Tharsan township, Mandalay
Tel
95-9-2017508
hlamoe.physio@ummedu.com
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
University of Medicine, Mandalay, Mandalay General Hospital
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 04 | Month | 06 | 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
46
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
Open public recruiting
Date of protocol fixation
| 2019 | Year | 02 | Month | 14 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 14 | Day |
Anticipated trial start date
| 2019 | Year | 02 | Month | 15 | Day |
Last follow-up date
| 2020 | Year | 07 | Month | 06 | 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 | 08 | Month | 07 | Day |
Last modified on
| 2020 | Year | 08 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047191
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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