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Trial record 26 of 45945 for:    intensity

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Recruitment Status : Withdrawn (PI relocated, unable to complete the study.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
Sponsor:
Collaborator:
Emory University
Information provided by (Responsible Party):
Georgia State University

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.

Condition or disease Intervention/treatment Phase
Heart Failure Physical Activity Other: High intensity exercise Other: Moderate intensity exercise Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. Global longitudinal strain [ Time Frame: 8 Weeks ]
    Measures measuring regional or global deformation of the heart measure in (number/s) at rest.

  2. Heart rate variability [ Time Frame: 8 weeks ]
    A measurement of either increased sympathetic or reduced vagal activity

  3. 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.

  4. Quality of Life [ Time Frame: 8 weeks ]
    The MacNew Quality of Life questionnaire will be used to assess the emotional, physical, and social domains



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Locations
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United States, Georgia
Grady Memorial Hospital
Atlanta, Georgia, United States, 30303
Sponsors and Collaborators
Georgia State University
Emory University
Investigators
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Principal Investigator: Gerald S Zavorsky, PhD Georgia State University

Publications:

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Responsible Party: Georgia State University
ClinicalTrials.gov Identifier: NCT03032081     History of Changes
Other Study ID Numbers: UL1TR000454 ( U.S. NIH Grant/Contract )
CRN 00091835 ( Other Identifier: Atlanta Clinical and Translational Science Institute )
First Posted: January 26, 2017    Key Record Dates
Last Update Posted: August 23, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases