Heart FailureNCT03032081
High Intensity Interval Training in Heart Failure
A study testing High intensity exercise and Moderate intensity exercise in people with Heart Failure and Physical Activity, run by Georgia State University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Heart Failure, Physical Activity
- What is being tested?
- High intensity exercise and Moderate intensity exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Mar 2017to 1 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: High Intensity Interval Training in Heart Failure: The Gold Standard of Future Patient Care
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.
Read the 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.
- Conditions
- Heart Failure, Physical Activity
- Being tested
- High intensity exercise, Moderate intensity exercise
- Medical subject headings
- Heart Failure, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Other: Moderate intensity exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 8 Weeks
Secondary outcomes (4)
Global longitudinal strain
Measures measuring regional or global deformation of the heart measure in (number/s) at rest.
Measured: 8 Weeks
Heart rate variability
A measurement of either increased sympathetic or reduced vagal activity
Measured: 8 weeks
Number of arrhythmic events
We are examining the number of times there is a recorded irregularity in the force or rhythm of the heartbeat.
Measured: over a 24 hr period, before 8 weeks of training and after 8 weeks of training
Quality of Life
The MacNew Quality of Life questionnaire will be used to assess the emotional, physical, and social domains
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2017 (estimated)
- Study start2 Mar 2017
- Primary completion1 Jul 2018 (estimated)
- Study completion1 Jul 2018 (estimated)
Why it stopped: PI relocated, unable to complete the study. No replacement PI identified.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Georgia State University
- Sponsor type
- University, hospital or other
- Collaborators
- Emory University
- Responsible party
- Sponsor
- Investigators
- Gerald S Zavorsky, PhD, Principal investigator, Georgia State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03032081
- Sponsor's protocol ID
- UL1TR000454
- Other IDs
- CRN 00091835
- Status last verified
- Aug 2017
- First submitted
- 24 Jan 2017
- Last updated
- 23 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 17548726Meyer 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.
PubMed 23397179Flynn 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.
PubMed 19351942Guiraud 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.
PubMed 23591293Freyssin 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.
PubMed 22446291
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Intensity Interval Training in Heart Failure: The Gold Standard of Future Patient Care
- ClinicalTrials.gov ID
- NCT03032081
- Acronym / sponsor ID
- UL1TR000454
- Conditions
- Heart Failure, Physical Activity
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI relocated, unable to complete the study. No replacement PI identified.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Georgia State UniversityUniversity, hospital or other
- Collaborators
- Emory University
- Study start
- 2 Mar 2017 (actual)
- Primary completion
- 1 Jul 2018 (estimated)
- Study completion
- 1 Jul 2018 (estimated)
- First posted
- 26 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Intensity Group | Experimental | Other: High intensity exercise3 set of 4 minutes of cycling intense exercise, 4 days per week, for 8 weeks at about 80% to 90% of heart rate reserve |
| Moderate Intensity Group | Active comparator | Other: Moderate intensity exercise40 to 47 minutes of continuous cycling exercise at 50% to 60% of heart rate reserve, 4 days per week, for 8 weeks. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High intensity exerciseHigh 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. | Other | High Intensity Group |
| Moderate intensity exerciseModerate 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. | Other | Moderate Intensity Group |
Primary outcome
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.
4 secondary outcomes
Global longitudinal strain
Time frame: 8 Weeks
Heart rate variability
Time frame: 8 weeks
Number of arrhythmic events
Time frame: over a 24 hr period, before 8 weeks of training and after 8 weeks of training
Quality of Life
Time frame: 8 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2017.
- Background: PubMed 17548726Wisloff 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.
- Background: PubMed 23397179Meyer 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.
- Background: PubMed 19351942Flynn 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.
- Background: PubMed 23591293Guiraud 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.
- Background: PubMed 22446291Freyssin 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gerald S Zavorsky, PhD principal investigator
Georgia State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High intensity exercise and Moderate intensity exercise in people with Heart Failure and Physical Activity, run by Georgia State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 23 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac output (time frame: 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03032081, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2017.