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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Open public recruiting |
Unique ID issued by UMIN | UMIN000041349 |
Receipt No. | 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 |
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 |
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Condition | ||
Condition | PhD | |
Classification by specialty |
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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 |
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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 | ||
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Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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 |
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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 |
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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 | |
Institute | Department of Physical Medicine and Rehabilitation, Mandalay General Hospital, University of Medicine, Mandalay |
Institute | |
Department |
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 |
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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 | 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 |
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Date of IRB |
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Anticipated trial start date |
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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=R000047191 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |