UMIN-CTR Clinical Trial

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
Email	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
Email	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
Email	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
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

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