High Intensity Interval Training in Heart Failure
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|ClinicalTrials.gov Identifier: NCT03032081|
Recruitment Status : Withdrawn (PI relocated, unable to complete the study. No replacement PI identified.)
First Posted : January 26, 2017
Last Update Posted : August 23, 2017
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure Physical Activity||Other: High intensity exercise Other: Moderate intensity exercise||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||High Intensity Interval Training in Heart Failure: The Gold Standard of Future Patient Care|
|Actual Study Start Date :||March 2, 2017|
|Estimated Primary Completion Date :||July 1, 2018|
|Estimated Study Completion Date :||July 1, 2018|
Experimental: High Intensity Group
3 set of 4 minutes of cycling intense exercise, 4 days per week, for 8 weeks at about 80% to 90% of heart rate reserve
Other: High intensity exercise
High intensity exercise, defined as an exercise intensity of > 80% of heart rate reserve. Heart rate reserve is the maximum measured heart rate minus the measured resting heart rate.
Active Comparator: Moderate Intensity Group
40 to 47 minutes of continuous cycling exercise at 50% to 60% of heart rate reserve, 4 days per week, for 8 weeks.
Other: Moderate intensity exercise
Moderate intensity exercise, defined as 50 to 60% of heart rate reserve for 40 to 47 minutes per day, 4 days per week, for 8 weeks. Heart rate reserve is the maximum measured heart rate minus the measured resting heart rate.
- Cardiac output [ Time Frame: 8 weeks ]Measures how much blood is ejected from the left ventricle of the heart per minute (L/min). We will look at this at rest and at peak exercise.
- Ejection fraction [ Time Frame: 8 weeks ]Measures the fraction of blood ejected from the left ventricle at every heart beat (%). We will look at this at rest and at peak exercise.
- Pulmonary diffusing capacity [ Time Frame: 8 Weeks ]Measures gas transfer at the lung in mL/min/mmHg. We will look at this at rest and at peak exercise.
- Global longitudinal strain [ Time Frame: 8 Weeks ]Measures measuring regional or global deformation of the heart measure in (number/s) at rest.
- Heart rate variability [ Time Frame: 8 weeks ]A measurement of either increased sympathetic or reduced vagal activity
- Number of arrhythmic events [ Time Frame: over a 24 hr period, before 8 weeks of training and after 8 weeks of training ]We are examining the number of times there is a recorded irregularity in the force or rhythm of the heartbeat.
- Quality of Life [ Time Frame: 8 weeks ]The MacNew Quality of Life questionnaire will be used to assess the emotional, physical, and social domains
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03032081
|United States, Georgia|
|Grady Memorial Hospital|
|Atlanta, Georgia, United States, 30303|
|Principal Investigator:||Gerald S Zavorsky, PhD||Georgia State University|