Cardiomyopathy, Hypertrophic
Conditions
Keywords
Hypertrophic Cardiomyopathy, Exercise, Oxygen consumption
Brief summary
The investigators propose a pilot randomized controlled trial to determine the safety and potential benefits of moderate intensity exercise in patients with hypertrophic cardiomyopathy. The investigators hypotheses are that exercise parameters derived from a baseline cardiopulmonary exercise test will target an appropriately safe level of exercise intensity that will not cause significant arrhythmias or exacerbate symptoms and that exercise training for 4 months will result in significant improvements in peak oxygen consumption (peak VO2) and quality of life, with neutral effects on the clinical characteristics.
Detailed description
The goal of this randomized clinical pilot trial is to establish the safety profile and potential benefits of moderate intensity exercise in patients with hypertrophic cardiomyopathy (HCM). Participation in competitive athletics is associated with an increased risk of sudden cardiac death (SCD) in individuals with structural heart disease, including HCM. This has appropriately led to the establishment of national guidelines based on expert opinion that discourage participation in high intensity competitive sports, burst exertion (e.g., sprinting), or isometric exercise (e.g., heavy lifting). Non-competitive, low to moderate intensity exercise is allowable, although many physicians and HCM patients are still understandably apprehensive. Data on the safety of a recreational exercise program, and how to gauge appropriate intensity level, are desperately needed so that HCM patients can reap the well established health benefits of regular physical activity. Limited, but compelling animal data suggest that moderate intensity exercise is not only safe, but may also prevent or even reverse cardiac hypertrophy, fibrosis, myocellular disarray, and apoptosis associated with HCM. There are no published studies on exercise in patients with HCM, although large clinical trials in heart failure have shown exercise training to be safe, to improve peak VO2 and quality of life, and to lower cardiovascular mortality. The pilot randomized control trial proposed here is the first to determine the safety of moderate intensity exercise training and explore its potential benefits in patients with HCM.
Interventions
BEHAVIORALExercise training
4 months of exercise training that is custom-designed based on individual cardiopulmonary stress test data. Regimen starts at low intensity (60% of heart rate reserve) and frequency (20 minutes, 3 days per week) and increases with a goal of 70% of heart rate reserve and exercising 60 minutes 4-7 days per week.
Sponsors
Stanford University
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Masking description
Investigator who randomized participants was blinded to participant PHI. Investigators who interpreted all data and assessed outcomes were masked to randomization status.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years and ≤ 80. * Diagnosis of HCM, defined by the presence of unexplained left-ventricular hypertrophy \> 13 mm in any wall segment. * Agreement to be a participant in the study protocol and willing/able to return for follow-up.
Exclusion criteria
* History of exercise-induced syncope or arrhythmias (ventricular tachycardia or non-sustained ventricular tachycardia). * Medically refractory left ventricular outflow tract obstruction being evaluated for septal reduction therapy. * Less than 3 months post septal reduction therapy (surgery or catheter based intervention). * Hypotensive response to exercise (\> 20 mm Hg drop in systolic blood pressure from peak blood pressure to post exercise blood pressure). * Pregnancy. * Implantable Cardioverter-Defibrillator (ICD) placement in last 3 months or scheduled. * Left ventricular systolic dysfunction (left ventricular ejection fraction \< 55% by echocardiography). * Worsening clinical status in the last 3 months, advanced heart failure (New York Heart Association class IV symptoms) or angina (Canadian Cardiovascular Society class IV symptoms). * Life expectancy less than 12 months. * Inability to exercise due to orthopedic or other non-cardiovascular limitations. * Unwillingness to refrain from competitive sports, burst activity, or heavy isometric exercise for the duration of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Peak Oxygen Consumption (Peak VO2) | At study Enrollment and 4 months later | Cardiopulmonary exercise testing was performed at study enrollment and termination (4 months apart). Peak VO2 was measured at each time point in each subject and change in peak VO2 over time was calculated. The change in Peak VO2 was compared between the study arms. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Concentration of Brain Natriuretic Peptide (BNP) | At study enrollment and 4 months later | Blood will be drawn to evaluate BNP at study enrollment and termination (4 months later). Change over time was compared between study arms. |
| Change in Scar Volume | At study enrollment and 4 months later | Cardiac MRI was performed in all patients without implantable devices/claustrophobia requiring sedation at study enrollment and termination (4 months later). Scar volume was calculated as total delayed gadolinium enhancement mass at each time interval. Change over time was compared between study arms. |
| Change in Systolic Function as Measured by Left Ventricular Ejection Fraction. | At study enrollment and 4 months later | Echocardiography was performed at study enrollment and termination. Left ventricular ejection fraction was visually estimated on each echocardiogram. Change over time was compared by study arm assignment. |
| Change in Degree of Left Ventricular Outflow (LVOT) Obstruction. | At study enrollment and 4 months later | Cardiopulmonary exercise testing in combination with echocardiography was performed at study enrollment and termination (4 months). Peak left ventricular outflow gradients were obtained at rest, with Valsalva and after exercise at each time point. The change over time was compared by study arm assignment. |
| Change in Maximal Left Ventricle Wall Thickness | At study enrollment and 4 months later | Magnitude or distribution of cardiac hypertrophy or left ventricular dimensions were a pre-specified outcome. Maximal left ventricle (LV) wall thickness (mm) was measured by cardiac MRI performed at study enrollment and termination (4 months later) and change over time was compared between study arms. Cardiac MRI was only be performed in those who do not have implantable devices or claustrophobia significant enough to require sedation. |
| Change in Quality of Life | At study enrollment and 4 months later | Quality of life (QOL) questionnaires (Minnesota Living With Heart Failure Questionnaire, MLHF; Quick Inventory of Depressive Symptomatology-Self Report, QIDS-SR16; and the 36-Item Short-Form Health Survey Version 2, SF-36v2) were administered at study enrollment and termination (4 months later). Change over time was compared between study arms. MLHF: range, 0-105; higher scores indicate worse QOL QIDS-SR16: range, 0-27; higher scores indicate more severe depression SF-36v2: 8 subscales and 2 component summary scores; range, 1-100; lower scores indicate more disability; minimal clinically important difference, 3 to 5 points |
| Change in Left Ventricular Mass Index | At study enrollment and 4 months later | Magnitude or distribution of cardiac hypertrophy or left ventricular dimensions were a pre-specified outcome. Left ventricular mass index was measured by cardiac MRI at study enrollment and termination (4 months later) and change over time was compared between study arms. Cardiac MRI was only be performed in those who do not have implantable devices or claustrophobia significant enough to require sedation. |
| Change in Left Ventricular End Diastolic Volume Index | At study enrollment and 4 months later | Magnitude or distribution of cardiac hypertrophy or left ventricular dimensions were a pre-specified outcome. Left ventricular end diastolic volume index was measured by cardiac MRI at study enrollment and termination (4 months later) and change over time was compared between study arms. Cardiac MRI was only be performed in those who do not have implantable devices or claustrophobia significant enough to require sedation. |
| Change in Left Ventricular End Systolic Volume Index | At study enrollment and 4 months later | Magnitude or distribution of cardiac hypertrophy or left ventricular dimensions were a pre-specified outcome. Left ventricular end systolic index was measured by cardiac MRI at study enrollment and termination (4 months later) and change over time was compared between study arms. Cardiac MRI was only be performed in those who do not have implantable devices or claustrophobia significant enough to require sedation. |
| Change in Left Atrial Size | At study enrollment and 4 months later | Magnitude or distribution of cardiac hypertrophy or left ventricular dimensions were a pre-specified outcome. Left atrial size was measured by echocardiography at study enrollment and termination (4 months later) and change over time was compared between study arms. |
| Change in Left Atrial Volume Index | At study enrollment and 4 months later | Magnitude or distribution of cardiac hypertrophy or left ventricular dimensions were a pre-specified outcome. Left atrial volume index was measured by echocardiography at study enrollment and termination (4 months later) and change over time was compared between study arms. |
| Change in Diastolic Function | At study Enrollment and 4 months later | Diastolic function was assessed at each time point and categorized as indeterminate diastolic function, grade I diastolic dysfunction and grade II-III diastolic dysfunction, according to American Society of Echocardiography criteria. Number of participants whose findings fell into each category was calculated and % change over time was compared between study arms. Indeterminate indicates diastolic function could not be accurately categorized. Grade I diastolic dysfunction indicates least severe in terms of outcome measure and Grade III, most severe. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Exercise Training Participants in the exercise group will be follow an individualized moderate-intensity exercise prescription (designed in consultation with an exercise physiologist based on data from the initial cardiopulmonary stress test). Exercise regimen will begin at a low level of intensity (3 sessions per week, 20 minutes per session, at a heart rate corresponding to 60% of heart rate reserve), then increase in duration and training intensity to a goal of up to 60 minutes per session, 4 to 7 sessions per week, at 70% of the heart rate reserve during the 1st month of the study protocol with maintenance of the program thereafter. No strength training or burst activity will be prescribed and all activities will fall well within the recommended national guidelines for recreational exercise. | 67 |
| Usual Activity Participants in this group are not restricted in their activities. They simply are not guided in their physical activities by the study team. At the end of the 4-month study period, they will also receive an individualized exercise prescription for personal use. | 69 |
| Total | 136 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 7 | 10 |
| Overall Study | Physician Decision | 3 | 3 |
Baseline characteristics
| Characteristic | Usual Activity | Total | Exercise Training |
|---|---|---|---|
| Age, Continuous | 50.0 years STANDARD_DEVIATION 13.5 | 50.4 years STANDARD_DEVIATION 13.3 | 50.5 years STANDARD_DEVIATION 13.2 |
| Beta-blocker use | 51 Participants | 92 Participants | 41 Participants |
| B-type natriuretic peptide | 83 pg/mL | 79 pg/mL | 79 pg/mL |
| Calcium channel blocker use | 14 Participants | 29 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 6 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 67 Participants | 130 Participants | 63 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| History of atrial fibrillation or flutter | 8 Participants | 22 Participants | 14 Participants |
| History of hypertension | 16 Participants | 30 Participants | 14 Participants |
| History of implantable cardioverter defibrillator | 21 Participants | 46 Participants | 25 Participants |
| History of nonsustained ventricular tachycardia | 10 Participants | 19 Participants | 9 Participants |
| History of septal reduction procedure | 15 Participants | 35 Participants | 20 Participants |
| History of ventricular tachycardia, ventricular fibrillation, or sudden cardiac death | 2 Participants | 5 Participants | 3 Participants |
| Left atrial volume index | 46.1 mL/m2 STANDARD_DEVIATION 14.3 | 46.7 mL/m2 STANDARD_DEVIATION 14.9 | 47.4 mL/m2 STANDARD_DEVIATION 15.6 |
| Left ventricular ejection fraction | 70.8 % STANDARD_DEVIATION 4.3 | 70.7 % STANDARD_DEVIATION 4.1 | 70.6 % STANDARD_DEVIATION 4 |
| Left ventricular outflow tract obstruction at rest | 12 Participants | 23 Participants | 11 Participants |
| Maximal left ventricular wall thickness | 21 mm STANDARD_DEVIATION 6 | 21 mm STANDARD_DEVIATION 5.9 | 21 mm STANDARD_DEVIATION 5 |
| New York Heart Association Class II-III | 23 Participants | 46 Participants | 23 Participants |
| Peak left ventricular outflow gradient after exercise | 57.0 mm Hg STANDARD_DEVIATION 51.9 | 52.6 mm Hg STANDARD_DEVIATION 47.4 | 48.1 mm Hg STANDARD_DEVIATION 43.5 |
| Peak left ventricular outflow gradient with Valsalva maneuver | 31.8 mm Hg STANDARD_DEVIATION 37.3 | 27.7 mm Hg STANDARD_DEVIATION 31.7 | 23.6 mm Hg STANDARD_DEVIATION 24.6 |
| Peak left ventricular pressure gradient at rest | 20.7 mm Hg STANDARD_DEVIATION 27.2 | 18.0 mm Hg STANDARD_DEVIATION 21.8 | 15.2 mm Hg STANDARD_DEVIATION 14 |
| Peak oxygen consumption (VO2), Continuous | 22.5 mL/kg/min STANDARD_DEVIATION 7.2 | 21.9 mL/kg/min STANDARD_DEVIATION 6.8 | 21.3 mL/kg/min STANDARD_DEVIATION 6.3 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 5 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 9 Participants | 5 Participants |
| Race (NIH/OMB) White | 63 Participants | 119 Participants | 56 Participants |
| Region of Enrollment United States | 69 participants | 136 participants | 67 participants |
| Sarcomere mutation Negative | 37 Participants | 58 Participants | 21 Participants |
| Sarcomere mutation No testing | 1 Participants | 6 Participants | 5 Participants |
| Sarcomere mutation Pathogenic | 25 Participants | 58 Participants | 33 Participants |
| Sarcomere mutation Variant of uncertain significance | 6 Participants | 14 Participants | 8 Participants |
| Sex: Female, Male Female | 28 Participants | 57 Participants | 29 Participants |
| Sex: Female, Male Male | 41 Participants | 79 Participants | 38 Participants |
| Total delayed gadolinium enhancement mass | 4.9 g STANDARD_DEVIATION 10.3 | 4.8 g STANDARD_DEVIATION 8.7 | 4.7 g STANDARD_DEVIATION 6.7 |
| Weight, Continous | 92.6 kg STANDARD_DEVIATION 15.7 | 91.6 kg STANDARD_DEVIATION 17 | 90.5 kg STANDARD_DEVIATION 18.3 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 67 | 0 / 69 |
| other Total, other adverse events | 34 / 67 | 38 / 69 |
| serious Total, serious adverse events | 0 / 67 | 0 / 69 |
Outcome results
Primary
Change in Peak Oxygen Consumption (Peak VO2)
Cardiopulmonary exercise testing was performed at study enrollment and termination (4 months apart). Peak VO2 was measured at each time point in each subject and change in peak VO2 over time was calculated. The change in Peak VO2 was compared between the study arms.
Time frame: At study Enrollment and 4 months later
Population: These numbers reflect the attrition rates seen in the study.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Exercise Training | Change in Peak Oxygen Consumption (Peak VO2) | 1.35 mL/kg/min |
| Usual Activity | Change in Peak Oxygen Consumption (Peak VO2) | 0.08 mL/kg/min |
Other Pre-specified
Change in Concentration of Brain Natriuretic Peptide (BNP)
Blood will be drawn to evaluate BNP at study enrollment and termination (4 months later). Change over time was compared between study arms.
Time frame: At study enrollment and 4 months later
Population: These numbers reflect attrition rates in the study, as well as, whether data was obtained at each time point.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Exercise Training | Change in Concentration of Brain Natriuretic Peptide (BNP) | 5 pg/mL |
| Usual Activity | Change in Concentration of Brain Natriuretic Peptide (BNP) | 9 pg/mL |
Other Pre-specified
Change in Degree of Left Ventricular Outflow (LVOT) Obstruction.
Cardiopulmonary exercise testing in combination with echocardiography was performed at study enrollment and termination (4 months). Peak left ventricular outflow gradients were obtained at rest, with Valsalva and after exercise at each time point. The change over time was compared by study arm assignment.
Time frame: At study enrollment and 4 months later
Population: These numbers reflect the rate of attrition in the study, as well as, whether data was reliably obtained at each time point.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Exercise Training | Change in Degree of Left Ventricular Outflow (LVOT) Obstruction. | Change in peak LVOT gradient with Valsalva | 9.6 mm Hg |
| Exercise Training | Change in Degree of Left Ventricular Outflow (LVOT) Obstruction. | Change in peak LVOT gradient at rest | 4.2 mm Hg |
| Exercise Training | Change in Degree of Left Ventricular Outflow (LVOT) Obstruction. | Change in peak LVOT gradient after exercise | 3.3 mm Hg |
| Usual Activity | Change in Degree of Left Ventricular Outflow (LVOT) Obstruction. | Change in peak LVOT gradient at rest | -3.8 mm Hg |
| Usual Activity | Change in Degree of Left Ventricular Outflow (LVOT) Obstruction. | Change in peak LVOT gradient with Valsalva | -3.0 mm Hg |
| Usual Activity | Change in Degree of Left Ventricular Outflow (LVOT) Obstruction. | Change in peak LVOT gradient after exercise | -4.2 mm Hg |
Other Pre-specified
Change in Diastolic Function
Diastolic function was assessed at each time point and categorized as indeterminate diastolic function, grade I diastolic dysfunction and grade II-III diastolic dysfunction, according to American Society of Echocardiography criteria. Number of participants whose findings fell into each category was calculated and % change over time was compared between study arms. Indeterminate indicates diastolic function could not be accurately categorized. Grade I diastolic dysfunction indicates least severe in terms of outcome measure and Grade III, most severe.
Time frame: At study Enrollment and 4 months later
Population: These numbers reflect attrition rates in the study, as well as, whether data was reliably obtained at each time point.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Exercise Training | Change in Diastolic Function | Change in % Indeterminate diastolic dysfunction | 16.4 % of participants |
| Exercise Training | Change in Diastolic Function | Change in % Grade I diastolic dysfunction | -11.9 % of participants |
| Exercise Training | Change in Diastolic Function | Cahnge in % Grade II-III diastolic dysfunction | 0 % of participants |
| Usual Activity | Change in Diastolic Function | Change in % Indeterminate diastolic dysfunction | 15.9 % of participants |
| Usual Activity | Change in Diastolic Function | Change in % Grade I diastolic dysfunction | -13.0 % of participants |
| Usual Activity | Change in Diastolic Function | Cahnge in % Grade II-III diastolic dysfunction | 1.7 % of participants |
Other Pre-specified
Change in Left Atrial Size
Magnitude or distribution of cardiac hypertrophy or left ventricular dimensions were a pre-specified outcome. Left atrial size was measured by echocardiography at study enrollment and termination (4 months later) and change over time was compared between study arms.
Time frame: At study enrollment and 4 months later
Population: These numbers reflect the attrition rates in the study as well as ability to accurately obtain the data given image quality.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Exercise Training | Change in Left Atrial Size | 0.9 mm |
| Usual Activity | Change in Left Atrial Size | -0.1 mm |
Other Pre-specified
Change in Left Atrial Volume Index
Magnitude or distribution of cardiac hypertrophy or left ventricular dimensions were a pre-specified outcome. Left atrial volume index was measured by echocardiography at study enrollment and termination (4 months later) and change over time was compared between study arms.
Time frame: At study enrollment and 4 months later
Population: These numbers reflect the attrition rates in the study as well as ability to accurately obtain the data given image quality.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Exercise Training | Change in Left Atrial Volume Index | -1.0 mL/m2 |
| Usual Activity | Change in Left Atrial Volume Index | 0.7 mL/m2 |
Other Pre-specified
Change in Left Ventricular End Diastolic Volume Index
Magnitude or distribution of cardiac hypertrophy or left ventricular dimensions were a pre-specified outcome. Left ventricular end diastolic volume index was measured by cardiac MRI at study enrollment and termination (4 months later) and change over time was compared between study arms. Cardiac MRI was only be performed in those who do not have implantable devices or claustrophobia significant enough to require sedation.
Time frame: At study enrollment and 4 months later
Population: These numbers reflect the number of participants who were able to undergo cardiac MRI and attrition rates in the study.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Exercise Training | Change in Left Ventricular End Diastolic Volume Index | 1.1 mL/m2 |
| Usual Activity | Change in Left Ventricular End Diastolic Volume Index | 0.5 mL/m2 |
Other Pre-specified
Change in Left Ventricular End Systolic Volume Index
Magnitude or distribution of cardiac hypertrophy or left ventricular dimensions were a pre-specified outcome. Left ventricular end systolic index was measured by cardiac MRI at study enrollment and termination (4 months later) and change over time was compared between study arms. Cardiac MRI was only be performed in those who do not have implantable devices or claustrophobia significant enough to require sedation.
Time frame: At study enrollment and 4 months later
Population: These numbers reflect number of participants who were able to undergo cardiac MRI and attrition rates in the study.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Exercise Training | Change in Left Ventricular End Systolic Volume Index | 0.4 mL/m2 |
| Usual Activity | Change in Left Ventricular End Systolic Volume Index | -0.1 mL/m2 |
Other Pre-specified
Change in Left Ventricular Mass Index
Magnitude or distribution of cardiac hypertrophy or left ventricular dimensions were a pre-specified outcome. Left ventricular mass index was measured by cardiac MRI at study enrollment and termination (4 months later) and change over time was compared between study arms. Cardiac MRI was only be performed in those who do not have implantable devices or claustrophobia significant enough to require sedation.
Time frame: At study enrollment and 4 months later
Population: These numbers reflect the number of participants who were able to undergo cardiac MRI and attrition rates in the study.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Exercise Training | Change in Left Ventricular Mass Index | 2.8 g/m2 |
| Usual Activity | Change in Left Ventricular Mass Index | 0.7 g/m2 |
Other Pre-specified
Change in Maximal Left Ventricle Wall Thickness
Magnitude or distribution of cardiac hypertrophy or left ventricular dimensions were a pre-specified outcome. Maximal left ventricle (LV) wall thickness (mm) was measured by cardiac MRI performed at study enrollment and termination (4 months later) and change over time was compared between study arms. Cardiac MRI was only be performed in those who do not have implantable devices or claustrophobia significant enough to require sedation.
Time frame: At study enrollment and 4 months later
Population: These numbers reflect the number of participants that underwent cardiac MRI and attrition rates in the study.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Exercise Training | Change in Maximal Left Ventricle Wall Thickness | -0.3 mm |
| Usual Activity | Change in Maximal Left Ventricle Wall Thickness | -0.6 mm |
Other Pre-specified
Change in Quality of Life
Quality of life (QOL) questionnaires (Minnesota Living With Heart Failure Questionnaire, MLHF; Quick Inventory of Depressive Symptomatology-Self Report, QIDS-SR16; and the 36-Item Short-Form Health Survey Version 2, SF-36v2) were administered at study enrollment and termination (4 months later). Change over time was compared between study arms. MLHF: range, 0-105; higher scores indicate worse QOL QIDS-SR16: range, 0-27; higher scores indicate more severe depression SF-36v2: 8 subscales and 2 component summary scores; range, 1-100; lower scores indicate more disability; minimal clinically important difference, 3 to 5 points
Time frame: At study enrollment and 4 months later
Population: These numbers reflect attrition rates in the study.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Exercise Training | Change in Quality of Life | Change in Physical Functioning Scale, SF-36v2 | 5.7 units on a scale |
| Exercise Training | Change in Quality of Life | Change in Role Physical Scale, SF-36v2 | 0.1 units on a scale |
| Exercise Training | Change in Quality of Life | Change in Bodily Pain Scale, SF-36v2 | 1.1 units on a scale |
| Exercise Training | Change in Quality of Life | Change in General Health Perception Scale, SF-36v2 | 4.1 units on a scale |
| Exercise Training | Change in Quality of Life | Change in Energy/Fatigue Scale, SF-36v2 | 3.5 units on a scale |
| Exercise Training | Change in Quality of Life | Change in Social Functioning Scale, SF-36v2 | 1.0 units on a scale |
| Exercise Training | Change in Quality of Life | Change in Role Emotional Scale, SF-36v2 | 0 units on a scale |
| Exercise Training | Change in Quality of Life | Change in Emotional Well-Being Scale, SF-36v2 | 2.8 units on a scale |
| Exercise Training | Change in Quality of Life | Change in Physical Component Summary, SF-36v2 | 1.3 units on a scale |
| Exercise Training | Change in Quality of Life | Change in Mental Component Summary, SF-36v2 | 1.3 units on a scale |
| Exercise Training | Change in Quality of Life | Change in QIDS-SR16 | -0.9 units on a scale |
| Exercise Training | Change in Quality of Life | Change in MLHF Total Score | -3.4 units on a scale |
| Exercise Training | Change in Quality of Life | Change in Physical Dimension, MLHF | -1.1 units on a scale |
| Exercise Training | Change in Quality of Life | Change in Emotional Dimension, MLHF | -0.9 units on a scale |
| Usual Activity | Change in Quality of Life | Change in QIDS-SR16 | -0.8 units on a scale |
| Usual Activity | Change in Quality of Life | Change in Physical Functioning Scale, SF-36v2 | -2.5 units on a scale |
| Usual Activity | Change in Quality of Life | Change in Emotional Well-Being Scale, SF-36v2 | 4.5 units on a scale |
| Usual Activity | Change in Quality of Life | Change in Role Physical Scale, SF-36v2 | -0.04 units on a scale |
| Usual Activity | Change in Quality of Life | Change in Physical Dimension, MLHF | -0.2 units on a scale |
| Usual Activity | Change in Quality of Life | Change in Bodily Pain Scale, SF-36v2 | -2.2 units on a scale |
| Usual Activity | Change in Quality of Life | Change in Physical Component Summary, SF-36v2 | -0.1 units on a scale |
| Usual Activity | Change in Quality of Life | Change in General Health Perception Scale, SF-36v2 | 0.2 units on a scale |
| Usual Activity | Change in Quality of Life | Change in MLHF Total Score | -2.4 units on a scale |
| Usual Activity | Change in Quality of Life | Change in Energy/Fatigue Scale, SF-36v2 | 6.0 units on a scale |
| Usual Activity | Change in Quality of Life | Change in Mental Component Summary, SF-36v2 | 1.9 units on a scale |
| Usual Activity | Change in Quality of Life | Change in Social Functioning Scale, SF-36v2 | 3.0 units on a scale |
| Usual Activity | Change in Quality of Life | Change in Emotional Dimension, MLHF | -2.1 units on a scale |
| Usual Activity | Change in Quality of Life | Change in Role Emotional Scale, SF-36v2 | 0.5 units on a scale |
Other Pre-specified
Change in Scar Volume
Cardiac MRI was performed in all patients without implantable devices/claustrophobia requiring sedation at study enrollment and termination (4 months later). Scar volume was calculated as total delayed gadolinium enhancement mass at each time interval. Change over time was compared between study arms.
Time frame: At study enrollment and 4 months later
Population: These numbers reflect attrition rates in the study, as well as, whether cardiac MRI was performed.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Exercise Training | Change in Scar Volume | 0.35 g |
| Usual Activity | Change in Scar Volume | -0.03 g |
Other Pre-specified
Change in Systolic Function as Measured by Left Ventricular Ejection Fraction.
Echocardiography was performed at study enrollment and termination. Left ventricular ejection fraction was visually estimated on each echocardiogram. Change over time was compared by study arm assignment.
Time frame: At study enrollment and 4 months later
Population: These numbers reflect attrition rates in the study, as well as, whether data was reliably obtained at each time point.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Exercise Training | Change in Systolic Function as Measured by Left Ventricular Ejection Fraction. | -0.2 percentage of ventricular blood |
| Usual Activity | Change in Systolic Function as Measured by Left Ventricular Ejection Fraction. | -0.2 percentage of ventricular blood |