High Intensity Interval Training in Heart Failure

Heart Failure Clinical Trial

Official title:

High Intensity Interval Training in Heart Failure: The Gold Standard of Future Patient Care

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03032081
• Other study ID #: UL1TR000454
• Secondary ID: CRN 00091835
• Status: Withdrawn
• Phase: N/A
• First received: January 24, 2017
• Last updated: August 21, 2017
• Start date: March 2, 2017
• Est. completion date: July 1, 2018

Study information

• Verified date: August 2017
• Source: Georgia State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 1, 2018
• Est. primary completion date: July 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Stable, chronic heart failure with a left ventricular ejection fraction of 20 to 40%.

2. 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%.

3. No recent major cardiovascular hospitalizations or procedures within the previous three months.

4. Age 40-65 years

5. Aerobic capacity = 12 mL/kg/min.

6. Subjects with an implantable cardioverter defibrillator (ICD) are also included.

7. Subjects with right ventricular systolic pressure = 60 mmHg at rest.

Exclusion Criteria:

1. Inability to exercise (orthopedic or neurological problems).

2. History of seizure disorders.

3. History of atrial fibrillation or ventricular tachycardia in the past 3 months.

4. Implantable cardioverter defibrillator shocks due to atrial fibrillation or ventricular fibrillation within the past 3 months.

5. Presence of pacemaker.

6. Uncontrolled diabetes mellitus.

7. Diabetic insulin pump.

8. Uncontrolled hypertension.

9. Renal insufficiency (creatinine: > 2.5 mg/dl).

10. Severe left ventricular hypertrophy (> 1.8 cm wall thickness) or dynamic left ventricular outflow tract obstruction.

11. Greater than mild degree of valve stenosis or presence of an artificial heart valve.

12. Drug addiction.

13. Not being able to read and understand the consent form.

14. Signs of unreliableness.

Related Conditions & MeSH terms

• Heart Failure
• Physical Activity

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Grady Memorial Hospital	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Georgia State University	Emory University

Country where clinical trial is conducted

United States, 

References & Publications (5)

Flynn KE, Piña 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. — View 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. — View Citation

Guiraud T, Labrunee M, Gaucher-Cazalis K, Despas F, Meyer P, Bosquet L, Gales C, Vaccaro A, Bousquet M, Galinier M, Sénard 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. — View 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. Review. — View Citation

Wisløff U, Støylen A, Loennechen JP, Bruvold M, Rognmo Ø, Haram PM, Tjønna AE, Helgerud J, Slørdahl SA, Lee SJ, Videm V, Bye A, Smith GL, Najjar SM, Ellingsen Ø, 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. Epub 2007 Jun 4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	8 weeks
Primary	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.	8 weeks
Primary	Pulmonary diffusing capacity	Measures gas transfer at the lung in mL/min/mmHg. We will look at this at rest and at peak exercise.	8 Weeks
Secondary	Global longitudinal strain	Measures measuring regional or global deformation of the heart measure in (number/s) at rest.	8 Weeks
Secondary	Heart rate variability	A measurement of either increased sympathetic or reduced vagal activity	8 weeks
Secondary	Number of arrhythmic events	We are examining the number of times there is a recorded irregularity in the force or rhythm of the heartbeat.	over a 24 hr period, before 8 weeks of training and after 8 weeks of training
Secondary	Quality of Life	The MacNew Quality of Life questionnaire will be used to assess the emotional, physical, and social domains	8 weeks