High Intensity Interval Training in Heart Failure
Primary Purpose
Heart Failure, Physical Activity
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
High intensity exercise
Moderate intensity exercise
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure
Eligibility Criteria
Inclusion Criteria:
- Stable, chronic heart failure with a left ventricular ejection fraction of 20 to 40%.
- New York Heart Association (NYHA) class I to III symptoms with treatment that includes beta-blocker and angiotensin-converting enzyme (ACE) inhibitor and angiotensin receptor blocker (ARB) Therapy for at least eight weeks prior to exercise training if ejection fraction is < 35%.
- No recent major cardiovascular hospitalizations or procedures within the previous three months.
- Age 40-65 years
- Aerobic capacity ≥ 12 mL/kg/min.
- Subjects with an implantable cardioverter defibrillator (ICD) are also included.
- Subjects with right ventricular systolic pressure ≤ 60 mmHg at rest.
Exclusion Criteria:
- Inability to exercise (orthopedic or neurological problems).
- History of seizure disorders.
- History of atrial fibrillation or ventricular tachycardia in the past 3 months.
- Implantable cardioverter defibrillator shocks due to atrial fibrillation or ventricular fibrillation within the past 3 months.
- Presence of pacemaker.
- Uncontrolled diabetes mellitus.
- Diabetic insulin pump.
- Uncontrolled hypertension.
- Renal insufficiency (creatinine: > 2.5 mg/dl).
- Severe left ventricular hypertrophy (> 1.8 cm wall thickness) or dynamic left ventricular outflow tract obstruction.
- Greater than mild degree of valve stenosis or presence of an artificial heart valve.
- Drug addiction.
- Not being able to read and understand the consent form.
- Signs of unreliableness.
Sites / Locations
- Grady Memorial Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
High Intensity Group
Moderate Intensity Group
Arm Description
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
40 to 47 minutes of continuous cycling exercise at 50% to 60% of heart rate reserve, 4 days per week, for 8 weeks.
Outcomes
Primary Outcome Measures
Cardiac output
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
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
Measures gas transfer at the lung in mL/min/mmHg. We will look at this at rest and at peak exercise.
Secondary Outcome Measures
Global longitudinal strain
Measures measuring regional or global deformation of the heart measure in (number/s) at rest.
Heart rate variability
A measurement of either increased sympathetic or reduced vagal activity
Number of arrhythmic events
We are examining the number of times there is a recorded irregularity in the force or rhythm of the heartbeat.
Quality of Life
The MacNew Quality of Life questionnaire will be used to assess the emotional, physical, and social domains
Full Information
NCT ID
NCT03032081
First Posted
January 24, 2017
Last Updated
August 21, 2017
Sponsor
Georgia State University
Collaborators
Emory University
1. Study Identification
Unique Protocol Identification Number
NCT03032081
Brief Title
High Intensity Interval Training in Heart Failure
Official Title
High Intensity Interval Training in Heart Failure: The Gold Standard of Future Patient Care
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Withdrawn
Why Stopped
PI relocated, unable to complete the study. No replacement PI identified.
Study Start Date
March 2, 2017 (Actual)
Primary Completion Date
July 1, 2018 (Anticipated)
Study Completion Date
July 1, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Georgia State University
Collaborators
Emory University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The investigators will assess the efficacy and safety of utilizing high-intensity interval training in stable heart failure patients on functional outcomes. Specifically, an assessment of baseline peak oxygen uptake and peak cardiac output will be assessed before and 8 weeks after intense interval training. Measurements of quality of life will be assessed before and after training as well as the number of arrhythmic events before and after training. The control group will be a group that will follow a moderate exercise training protocol over a similar period.
Detailed Description
Aerobic exercise training of moderate intensity is recommended as safe and effective for all stable outpatients with chronic heart failure who are able to participate in improving physical conditioning. Emerging data suggest that high-intensity exercise training in select heart failure patients may achieve even greater improvement in functional capacity than moderate intensity training leading to a better quality of life. In the few studies to date, aerobic capacity, heart function is increased to a better extent in heart failure patients that undergo an eight-week high-intensity exercise program (32 exercise sessions) compared to the standard of care. The goal of this pilot study is to collect data on safety and efficacy of high-intensity interval training in stable heart failure patients to demonstrate better physiological and clinical outcomes with fewer long-term health care costs compared to the standard of care. Twenty participants with stable heart failure (age range = 40 to 65 years of age) will be randomized into two different groups: the standard of care group, in which subjects will exercise for 40 minutes at 40 to 60 % of heart rate reserve (HRR) for eight weeks (32 sessions); and the high-intensity interval training group, in which subjects will perform four sets of 4-minutes at > 85% of HRR, with three minutes of active rest between intervals, for six weeks (32 sessions). The functional outcomes measured will be cardiac function (i.e. stroke volume, cardiac output, ejection fraction), pulmonary function (diffusing capacity, lung volumes, spirometry), exercise capacity (peak oxygen uptake) at rest and during exercise before and after eight weeks of exercise training (32 sessions). Adverse events related to each exercise training session (i.e. cardiac arrest, myocardial infarction during exercise, or within the first hour afterward) as well as arrhythmias will be recorded via Holter monitoring 24-hrs post-exercise. Quality of life will also be measured. The exercise training will be supervised at Grady Hospital. This novel approach has the chance to become impactful to these patients and will challenge the current negative perception of high-intensity exercise training in this patient population. The investigators anticipate this study will help reform the current exercise guidelines in these participants.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Physical Activity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High Intensity Group
Arm Type
Experimental
Arm Description
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
Arm Title
Moderate Intensity Group
Arm Type
Active Comparator
Arm Description
40 to 47 minutes of continuous cycling exercise at 50% to 60% of heart rate reserve, 4 days per week, for 8 weeks.
Intervention Type
Other
Intervention Name(s)
High intensity exercise
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Moderate intensity exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cardiac output
Description
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.
Time Frame
8 weeks
Title
Ejection fraction
Description
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.
Time Frame
8 weeks
Title
Pulmonary diffusing capacity
Description
Measures gas transfer at the lung in mL/min/mmHg. We will look at this at rest and at peak exercise.
Time Frame
8 Weeks
Secondary Outcome Measure Information:
Title
Global longitudinal strain
Description
Measures measuring regional or global deformation of the heart measure in (number/s) at rest.
Time Frame
8 Weeks
Title
Heart rate variability
Description
A measurement of either increased sympathetic or reduced vagal activity
Time Frame
8 weeks
Title
Number of arrhythmic events
Description
We are examining the number of times there is a recorded irregularity in the force or rhythm of the heartbeat.
Time Frame
over a 24 hr period, before 8 weeks of training and after 8 weeks of training
Title
Quality of Life
Description
The MacNew Quality of Life questionnaire will be used to assess the emotional, physical, and social domains
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Stable, chronic heart failure with a left ventricular ejection fraction of 20 to 40%.
New York Heart Association (NYHA) class I to III symptoms with treatment that includes beta-blocker and angiotensin-converting enzyme (ACE) inhibitor and angiotensin receptor blocker (ARB) Therapy for at least eight weeks prior to exercise training if ejection fraction is < 35%.
No recent major cardiovascular hospitalizations or procedures within the previous three months.
Age 40-65 years
Aerobic capacity ≥ 12 mL/kg/min.
Subjects with an implantable cardioverter defibrillator (ICD) are also included.
Subjects with right ventricular systolic pressure ≤ 60 mmHg at rest.
Exclusion Criteria:
Inability to exercise (orthopedic or neurological problems).
History of seizure disorders.
History of atrial fibrillation or ventricular tachycardia in the past 3 months.
Implantable cardioverter defibrillator shocks due to atrial fibrillation or ventricular fibrillation within the past 3 months.
Presence of pacemaker.
Uncontrolled diabetes mellitus.
Diabetic insulin pump.
Uncontrolled hypertension.
Renal insufficiency (creatinine: > 2.5 mg/dl).
Severe left ventricular hypertrophy (> 1.8 cm wall thickness) or dynamic left ventricular outflow tract obstruction.
Greater than mild degree of valve stenosis or presence of an artificial heart valve.
Drug addiction.
Not being able to read and understand the consent form.
Signs of unreliableness.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerald S Zavorsky, PhD
Organizational Affiliation
Georgia State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Grady Memorial Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
17548726
Citation
Wisloff U, Stoylen A, Loennechen JP, Bruvold M, Rognmo O, Haram PM, Tjonna AE, Helgerud J, Slordahl SA, Lee SJ, Videm V, Bye A, Smith GL, Najjar SM, Ellingsen O, Skjaerpe T. Superior cardiovascular effect of aerobic interval training versus moderate continuous training in heart failure patients: a randomized study. Circulation. 2007 Jun 19;115(24):3086-94. doi: 10.1161/CIRCULATIONAHA.106.675041. Epub 2007 Jun 4.
Results Reference
background
PubMed Identifier
23397179
Citation
Meyer P, Gayda M, Juneau M, Nigam A. High-intensity aerobic interval exercise in chronic heart failure. Curr Heart Fail Rep. 2013 Jun;10(2):130-8. doi: 10.1007/s11897-013-0130-3.
Results Reference
background
PubMed Identifier
19351942
Citation
Flynn KE, Pina IL, Whellan DJ, Lin L, Blumenthal JA, Ellis SJ, Fine LJ, Howlett JG, Keteyian SJ, Kitzman DW, Kraus WE, Miller NH, Schulman KA, Spertus JA, O'Connor CM, Weinfurt KP; HF-ACTION Investigators. Effects of exercise training on health status in patients with chronic heart failure: HF-ACTION randomized controlled trial. JAMA. 2009 Apr 8;301(14):1451-9. doi: 10.1001/jama.2009.457. Erratum In: JAMA. 2009 Dec 2;302(21):2322.
Results Reference
background
PubMed Identifier
23591293
Citation
Guiraud T, Labrunee M, Gaucher-Cazalis K, Despas F, Meyer P, Bosquet L, Gales C, Vaccaro A, Bousquet M, Galinier M, Senard JM, Pathak A. High-intensity interval exercise improves vagal tone and decreases arrhythmias in chronic heart failure. Med Sci Sports Exerc. 2013 Oct;45(10):1861-7. doi: 10.1249/MSS.0b013e3182967559.
Results Reference
background
PubMed Identifier
22446291
Citation
Freyssin C, Verkindt C, Prieur F, Benaich P, Maunier S, Blanc P. Cardiac rehabilitation in chronic heart failure: effect of an 8-week, high-intensity interval training versus continuous training. Arch Phys Med Rehabil. 2012 Aug;93(8):1359-64. doi: 10.1016/j.apmr.2012.03.007. Epub 2012 Mar 21.
Results Reference
background
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High Intensity Interval Training in Heart Failure
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