Trial Outcomes & Findings for Study of Exercise Training in Hypertrophic Cardiomyopathy (NCT NCT01127061)
NCT ID: NCT01127061
Last Updated: 2019-02-15
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
136 participants
Primary outcome timeframe
At study Enrollment and 4 months later
Results posted on
2019-02-15
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
67
|
69
|
|
Overall Study
COMPLETED
|
57
|
56
|
|
Overall Study
NOT COMPLETED
|
10
|
13
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
7
|
10
|
|
Overall Study
Physician Decision
|
3
|
3
|
Baseline Characteristics
Data was not obtained or was not reliably measured in every study participant.
Baseline characteristics by cohort
| Measure |
Exercise Training
n=67 Participants
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.
|
Usual Activity
n=69 Participants
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.
|
Total
n=136 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50.5 years
STANDARD_DEVIATION 13.2 • n=67 Participants
|
50.0 years
STANDARD_DEVIATION 13.5 • n=69 Participants
|
50.4 years
STANDARD_DEVIATION 13.3 • n=136 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=67 Participants
|
28 Participants
n=69 Participants
|
57 Participants
n=136 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=67 Participants
|
41 Participants
n=69 Participants
|
79 Participants
n=136 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=67 Participants
|
2 Participants
n=69 Participants
|
6 Participants
n=136 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
63 Participants
n=67 Participants
|
67 Participants
n=69 Participants
|
130 Participants
n=136 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=67 Participants
|
0 Participants
n=69 Participants
|
0 Participants
n=136 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=67 Participants
|
0 Participants
n=69 Participants
|
0 Participants
n=136 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=67 Participants
|
0 Participants
n=69 Participants
|
3 Participants
n=136 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=67 Participants
|
0 Participants
n=69 Participants
|
0 Participants
n=136 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=67 Participants
|
2 Participants
n=69 Participants
|
5 Participants
n=136 Participants
|
|
Race (NIH/OMB)
White
|
56 Participants
n=67 Participants
|
63 Participants
n=69 Participants
|
119 Participants
n=136 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=67 Participants
|
0 Participants
n=69 Participants
|
0 Participants
n=136 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=67 Participants
|
4 Participants
n=69 Participants
|
9 Participants
n=136 Participants
|
|
Region of Enrollment
United States
|
67 participants
n=67 Participants
|
69 participants
n=69 Participants
|
136 participants
n=136 Participants
|
|
Weight, Continous
|
90.5 kg
STANDARD_DEVIATION 18.3 • n=67 Participants
|
92.6 kg
STANDARD_DEVIATION 15.7 • n=69 Participants
|
91.6 kg
STANDARD_DEVIATION 17.0 • n=136 Participants
|
|
Peak oxygen consumption (VO2), Continuous
|
21.3 mL/kg/min
STANDARD_DEVIATION 6.3 • n=67 Participants
|
22.5 mL/kg/min
STANDARD_DEVIATION 7.2 • n=69 Participants
|
21.9 mL/kg/min
STANDARD_DEVIATION 6.8 • n=136 Participants
|
|
Maximal left ventricular wall thickness
|
21 mm
STANDARD_DEVIATION 5 • n=67 Participants
|
21 mm
STANDARD_DEVIATION 6 • n=69 Participants
|
21 mm
STANDARD_DEVIATION 5.9 • n=136 Participants
|
|
Left ventricular outflow tract obstruction at rest
|
11 Participants
n=67 Participants
|
12 Participants
n=69 Participants
|
23 Participants
n=136 Participants
|
|
Peak left ventricular pressure gradient at rest
|
15.2 mm Hg
STANDARD_DEVIATION 14 • n=67 Participants
|
20.7 mm Hg
STANDARD_DEVIATION 27.2 • n=69 Participants
|
18.0 mm Hg
STANDARD_DEVIATION 21.8 • n=136 Participants
|
|
Peak left ventricular outflow gradient with Valsalva maneuver
|
23.6 mm Hg
STANDARD_DEVIATION 24.6 • n=60 Participants • Data was not obtained or was not reliably measured in every study participant.
|
31.8 mm Hg
STANDARD_DEVIATION 37.3 • n=60 Participants • Data was not obtained or was not reliably measured in every study participant.
|
27.7 mm Hg
STANDARD_DEVIATION 31.7 • n=120 Participants • Data was not obtained or was not reliably measured in every study participant.
|
|
Peak left ventricular outflow gradient after exercise
|
48.1 mm Hg
STANDARD_DEVIATION 43.5 • n=66 Participants • Data was not obtained or was not reliably measured in every study participant.
|
57.0 mm Hg
STANDARD_DEVIATION 51.9 • n=68 Participants • Data was not obtained or was not reliably measured in every study participant.
|
52.6 mm Hg
STANDARD_DEVIATION 47.4 • n=134 Participants • Data was not obtained or was not reliably measured in every study participant.
|
|
Left atrial volume index
|
47.4 mL/m2
STANDARD_DEVIATION 15.6 • n=67 Participants
|
46.1 mL/m2
STANDARD_DEVIATION 14.3 • n=69 Participants
|
46.7 mL/m2
STANDARD_DEVIATION 14.9 • n=136 Participants
|
|
Left ventricular ejection fraction
|
70.6 %
STANDARD_DEVIATION 4.0 • n=67 Participants
|
70.8 %
STANDARD_DEVIATION 4.3 • n=69 Participants
|
70.7 %
STANDARD_DEVIATION 4.1 • n=136 Participants
|
|
Total delayed gadolinium enhancement mass
|
4.7 g
STANDARD_DEVIATION 6.7 • n=28 Participants • Cardiac magnetic resonance imaging was not obtained in every participant due to presence of implantable cardioverter-defibrillator, permanent pacemaker, or claustrophobia.
|
4.9 g
STANDARD_DEVIATION 10.3 • n=30 Participants • Cardiac magnetic resonance imaging was not obtained in every participant due to presence of implantable cardioverter-defibrillator, permanent pacemaker, or claustrophobia.
|
4.8 g
STANDARD_DEVIATION 8.7 • n=58 Participants • Cardiac magnetic resonance imaging was not obtained in every participant due to presence of implantable cardioverter-defibrillator, permanent pacemaker, or claustrophobia.
|
|
New York Heart Association Class II-III
|
23 Participants
n=67 Participants
|
23 Participants
n=69 Participants
|
46 Participants
n=136 Participants
|
|
B-type natriuretic peptide
|
79 pg/mL
n=67 Participants
|
83 pg/mL
n=69 Participants
|
79 pg/mL
n=136 Participants
|
|
History of implantable cardioverter defibrillator
|
25 Participants
n=67 Participants
|
21 Participants
n=69 Participants
|
46 Participants
n=136 Participants
|
|
History of ventricular tachycardia, ventricular fibrillation, or sudden cardiac death
|
3 Participants
n=67 Participants
|
2 Participants
n=69 Participants
|
5 Participants
n=136 Participants
|
|
History of nonsustained ventricular tachycardia
|
9 Participants
n=67 Participants
|
10 Participants
n=69 Participants
|
19 Participants
n=136 Participants
|
|
History of atrial fibrillation or flutter
|
14 Participants
n=67 Participants
|
8 Participants
n=69 Participants
|
22 Participants
n=136 Participants
|
|
History of septal reduction procedure
|
20 Participants
n=67 Participants
|
15 Participants
n=69 Participants
|
35 Participants
n=136 Participants
|
|
History of hypertension
|
14 Participants
n=67 Participants
|
16 Participants
n=69 Participants
|
30 Participants
n=136 Participants
|
|
Beta-blocker use
|
41 Participants
n=67 Participants
|
51 Participants
n=69 Participants
|
92 Participants
n=136 Participants
|
|
Calcium channel blocker use
|
15 Participants
n=67 Participants
|
14 Participants
n=69 Participants
|
29 Participants
n=136 Participants
|
|
Sarcomere mutation
No testing
|
5 Participants
n=67 Participants
|
1 Participants
n=69 Participants
|
6 Participants
n=136 Participants
|
|
Sarcomere mutation
Pathogenic
|
33 Participants
n=67 Participants
|
25 Participants
n=69 Participants
|
58 Participants
n=136 Participants
|
|
Sarcomere mutation
Variant of uncertain significance
|
8 Participants
n=67 Participants
|
6 Participants
n=69 Participants
|
14 Participants
n=136 Participants
|
|
Sarcomere mutation
Negative
|
21 Participants
n=67 Participants
|
37 Participants
n=69 Participants
|
58 Participants
n=136 Participants
|
PRIMARY outcome
Timeframe: At study Enrollment and 4 months laterPopulation: These numbers reflect the attrition rates seen in the study.
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.
Outcome measures
| Measure |
Usual Activity
n=56 Participants
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.
|
Exercise Training
n=57 Participants
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.
|
|---|---|---|
|
Change in Peak Oxygen Consumption (Peak VO2)
|
0.08 mL/kg/min
Interval -0.62 to 0.79
|
1.35 mL/kg/min
Interval 0.5 to 2.21
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At study enrollment and 4 months laterPopulation: These numbers reflect attrition rates in the study.
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
Outcome measures
| Measure |
Usual Activity
n=56 Participants
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.
|
Exercise Training
n=57 Participants
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.
|
|---|---|---|
|
Change in Quality of Life
Change in Physical Functioning Scale, SF-36v2
|
-2.5 units on a scale
Interval -6.2 to 1.3
|
5.7 units on a scale
Interval 1.6 to 9.8
|
|
Change in Quality of Life
Change in Role Physical Scale, SF-36v2
|
-0.04 units on a scale
Interval -1.7 to 1.6
|
0.1 units on a scale
Interval -0.5 to 0.8
|
|
Change in Quality of Life
Change in Bodily Pain Scale, SF-36v2
|
-2.2 units on a scale
Interval -8.3 to 3.9
|
1.1 units on a scale
Interval -3.4 to 5.8
|
|
Change in Quality of Life
Change in General Health Perception Scale, SF-36v2
|
0.2 units on a scale
Interval -4.3 to 4.6
|
4.1 units on a scale
Interval 0.03 to 8.2
|
|
Change in Quality of Life
Change in Energy/Fatigue Scale, SF-36v2
|
6.0 units on a scale
Interval 1.5 to 10.5
|
3.5 units on a scale
Interval -0.9 to 7.9
|
|
Change in Quality of Life
Change in Social Functioning Scale, SF-36v2
|
3.0 units on a scale
Interval -3.0 to 8.9
|
1.0 units on a scale
Interval -3.3 to 5.3
|
|
Change in Quality of Life
Change in Role Emotional Scale, SF-36v2
|
0.5 units on a scale
Interval -0.1 to 1.1
|
0 units on a scale
Interval 0.0 to 0.0
|
|
Change in Quality of Life
Change in Emotional Well-Being Scale, SF-36v2
|
4.5 units on a scale
Interval 0.7 to 8.3
|
2.8 units on a scale
Interval -1.5 to 7.0
|
|
Change in Quality of Life
Change in Physical Component Summary, SF-36v2
|
-0.1 units on a scale
Interval -1.4 to 1.2
|
1.3 units on a scale
Interval 0.2 to 2.3
|
|
Change in Quality of Life
Change in Mental Component Summary, SF-36v2
|
1.9 units on a scale
Interval 0.4 to 3.4
|
1.3 units on a scale
Interval -0.3 to 2.8
|
|
Change in Quality of Life
Change in QIDS-SR16
|
-0.8 units on a scale
Interval -1.7 to 0.1
|
-0.9 units on a scale
Interval -1.7 to -0.1
|
|
Change in Quality of Life
Change in MLHF Total Score
|
-2.4 units on a scale
Interval -6.1 to 1.4
|
-3.4 units on a scale
Interval -6.6 to -0.2
|
|
Change in Quality of Life
Change in Physical Dimension, MLHF
|
-0.2 units on a scale
Interval -1.8 to 1.3
|
-1.1 units on a scale
Interval -2.8 to 0.7
|
|
Change in Quality of Life
Change in Emotional Dimension, MLHF
|
-2.1 units on a scale
Interval -3.5 to -0.6
|
-0.9 units on a scale
Interval -2.0 to 0.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At study enrollment and 4 months laterPopulation: These numbers reflect attrition rates in the study, as well as, whether data was obtained at each time point.
Blood will be drawn to evaluate BNP at study enrollment and termination (4 months later). Change over time was compared between study arms.
Outcome measures
| Measure |
Usual Activity
n=44 Participants
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.
|
Exercise Training
n=44 Participants
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.
|
|---|---|---|
|
Change in Concentration of Brain Natriuretic Peptide (BNP)
|
9 pg/mL
Interval -14.0 to 40.0
|
5 pg/mL
Interval -10.0 to 27.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At study enrollment and 4 months laterPopulation: These numbers reflect attrition rates in the study, as well as, whether cardiac MRI was performed.
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.
Outcome measures
| Measure |
Usual Activity
n=30 Participants
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.
|
Exercise Training
n=29 Participants
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.
|
|---|---|---|
|
Change in Scar Volume
|
-0.03 g
Interval -0.7 to 0.7
|
0.35 g
Interval -0.2 to 0.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At study enrollment and 4 months laterPopulation: These numbers reflect attrition rates in the study, as well as, whether data was reliably obtained at each time point.
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.
Outcome measures
| Measure |
Usual Activity
n=58 Participants
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.
|
Exercise Training
n=55 Participants
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.
|
|---|---|---|
|
Change in Systolic Function as Measured by Left Ventricular Ejection Fraction.
|
-0.2 percentage of ventricular blood
Interval -1.3 to 1.0
|
-0.2 percentage of ventricular blood
Interval -0.9 to 0.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At study enrollment and 4 months laterPopulation: These numbers reflect the rate of attrition in the study, as well as, whether data was reliably obtained at each time point.
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.
Outcome measures
| Measure |
Usual Activity
n=58 Participants
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.
|
Exercise Training
n=55 Participants
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.
|
|---|---|---|
|
Change in Degree of Left Ventricular Outflow (LVOT) Obstruction.
Change in peak LVOT gradient at rest
|
-3.8 mm Hg
Interval -9.2 to 1.5
|
4.2 mm Hg
Interval -1.5 to 9.9
|
|
Change in Degree of Left Ventricular Outflow (LVOT) Obstruction.
Change in peak LVOT gradient with Valsalva
|
-3.0 mm Hg
Interval -13.0 to 7.0
|
9.6 mm Hg
Interval -1.5 to 9.9
|
|
Change in Degree of Left Ventricular Outflow (LVOT) Obstruction.
Change in peak LVOT gradient after exercise
|
-4.2 mm Hg
Interval -13.9 to 5.5
|
3.3 mm Hg
Interval -4.8 to 11.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At study enrollment and 4 months laterPopulation: These numbers reflect the number of participants that underwent cardiac MRI and attrition rates in the study.
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.
Outcome measures
| Measure |
Usual Activity
n=31 Participants
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.
|
Exercise Training
n=30 Participants
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.
|
|---|---|---|
|
Change in Maximal Left Ventricle Wall Thickness
|
-0.6 mm
Interval -1.1 to -0.1
|
-0.3 mm
Interval -0.9 to 0.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At study Enrollment and 4 months laterPopulation: These numbers reflect attrition rates in the study, as well as, whether data was reliably obtained at each time point.
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.
Outcome measures
| Measure |
Usual Activity
n=58 Participants
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.
|
Exercise Training
n=54 Participants
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.
|
|---|---|---|
|
Change in Diastolic Function
Change in % Indeterminate diastolic dysfunction
|
15.9 % of participants
Interval 7.1 to 24.8
|
16.4 % of participants
Interval 6.4 to 26.5
|
|
Change in Diastolic Function
Change in % Grade I diastolic dysfunction
|
-13.0 % of participants
Interval -26.0 to -0.1
|
-11.9 % of participants
Interval -24.3 to 0.5
|
|
Change in Diastolic Function
Cahnge in % Grade II-III diastolic dysfunction
|
1.7 % of participants
Interval -10.8 to 14.3
|
0 % of participants
Interval -11.9 to 11.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At study enrollment and 4 months laterPopulation: These numbers reflect the number of participants who were able to undergo cardiac MRI and attrition rates in the study.
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.
Outcome measures
| Measure |
Usual Activity
n=29 Participants
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.
|
Exercise Training
n=28 Participants
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.
|
|---|---|---|
|
Change in Left Ventricular Mass Index
|
0.7 g/m2
Interval -1.4 to 2.9
|
2.8 g/m2
Interval -0.8 to 6.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At study enrollment and 4 months laterPopulation: These numbers reflect the number of participants who were able to undergo cardiac MRI and attrition rates in the study.
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.
Outcome measures
| Measure |
Usual Activity
n=30 Participants
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.
|
Exercise Training
n=28 Participants
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.
|
|---|---|---|
|
Change in Left Ventricular End Diastolic Volume Index
|
0.5 mL/m2
Interval -2.1 to 3.2
|
1.1 mL/m2
Interval -2.3 to 4.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At study enrollment and 4 months laterPopulation: These numbers reflect number of participants who were able to undergo cardiac MRI and attrition rates in the study.
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.
Outcome measures
| Measure |
Usual Activity
n=30 Participants
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.
|
Exercise Training
n=28 Participants
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.
|
|---|---|---|
|
Change in Left Ventricular End Systolic Volume Index
|
-0.1 mL/m2
Interval -2.4 to 2.1
|
0.4 mL/m2
Interval -1.4 to 2.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At study enrollment and 4 months laterPopulation: These numbers reflect the attrition rates in the study as well as ability to accurately obtain the data given image quality.
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.
Outcome measures
| Measure |
Usual Activity
n=58 Participants
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.
|
Exercise Training
n=54 Participants
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.
|
|---|---|---|
|
Change in Left Atrial Size
|
-0.1 mm
Interval -0.9 to 0.8
|
0.9 mm
Interval -0.7 to 2.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At study enrollment and 4 months laterPopulation: These numbers reflect the attrition rates in the study as well as ability to accurately obtain the data given image quality.
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.
Outcome measures
| Measure |
Usual Activity
n=55 Participants
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.
|
Exercise Training
n=55 Participants
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.
|
|---|---|---|
|
Change in Left Atrial Volume Index
|
0.7 mL/m2
Interval -2.9 to 4.3
|
-1.0 mL/m2
Interval -4.1 to 2.0
|
Adverse Events
Exercise Training
Serious events: 0 serious events
Other events: 34 other events
Deaths: 0 deaths
Usual Activity
Serious events: 0 serious events
Other events: 38 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Exercise Training
n=67 participants at risk
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.
|
Usual Activity
n=69 participants at risk
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.
|
|---|---|---|
|
Cardiac disorders
Nonsustained ventricular tachycardia
|
28.4%
19/67
|
21.7%
15/69
|
|
Cardiac disorders
Atrial fibrillation
|
7.5%
5/67
|
10.1%
7/69
|
|
Cardiac disorders
Supraventricular tachycardia
|
34.3%
23/67
|
42.0%
29/69
|
|
Cardiac disorders
Syncope
|
0.00%
0/67
|
2.9%
2/69
|
|
Musculoskeletal and connective tissue disorders
Major musculoskeletal injury
|
4.5%
3/67
|
2.9%
2/69
|
|
Metabolism and nutrition disorders
Minor musculoskeletal injury
|
0.00%
0/67
|
1.4%
1/69
|
Additional Information
Dr. Sara Saberi, MD, MS
University of Michigan School of Medicine
Phone: 734-764-4500
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place