NCT03032081

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2017

Shorter than P25 for not_applicable heart-failure

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 24, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 26, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

March 2, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

August 23, 2017

Status Verified

August 1, 2017

Enrollment Period

1.3 years

First QC Date

January 24, 2017

Last Update Submit

August 21, 2017

Conditions

Heart FailurePhysical Activity

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (4)

  • Global longitudinal strain

    8 Weeks

  • Heart rate variability

    8 weeks

  • Number of arrhythmic events

    over a 24 hr period, before 8 weeks of training and after 8 weeks of training

  • Quality of Life

    8 weeks

Study Arms (2)

High Intensity Group

EXPERIMENTAL

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

Moderate Intensity Group

ACTIVE COMPARATOR

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

Interventions

High intensity exerciseOTHER

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.

High Intensity Group
Moderate intensity exerciseOTHER

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.

Moderate Intensity Group

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Grady Memorial Hospital

Atlanta, Georgia, 30303, United States

Location

Related Publications (5)

  • 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.

    PMID: 17548726BACKGROUND

  • 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.

    PMID: 23397179BACKGROUND

  • 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.

    PMID: 19351942BACKGROUND

  • 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.

    PMID: 23591293BACKGROUND

  • 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.

    PMID: 22446291BACKGROUND

MeSH Terms

Conditions

Heart FailureMotor Activity

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesBehavior

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Gerald S Zavorsky, PhD

    Georgia State University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2017

First Posted

January 26, 2017

Study Start

March 2, 2017

Primary Completion

July 1, 2018

Study Completion

July 1, 2018

Last Updated

August 23, 2017

Record last verified: 2017-08

Locations

US(1)