Trial Outcomes & Findings for High Intensity Interval Exercise in Diastolic Heart Failure (NCT NCT02147613)
NCT ID: NCT02147613
Last Updated: 2019-04-12
Results Overview
Measured using left ventricular echocardiography. Diastolic dysfunction is graded as: normal, grade 1, grade 2, grade 3, grade 4. Increasing grade is indicative of worsening LV dysfunction and worse outcomes. Improvement in LV grade is associated with better long term outcomes.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
19 participants
Primary outcome timeframe
Before and after the 1 month exercise intervention
Results posted on
2019-04-12
Participant Flow
Participant milestones
| Measure |
High Intensity Interval Training
High intensity interval training - 3 days per week at 85-90% peak heart rate (4x4 bouts) for 1 month (12 sessions of exercise)
High intensity interval training: 3 days per week at 85-90% peak heart rate (4x4 bouts) for 1 month (12 sessions of exercise)
|
Moderate Intensity Exercise Training
3 days/week, 30 mins at 70% Peak heart rate for 1 month (12 sessions of exercise)
Moderate intensity exercise training: 3 days/week, 30 mins at 70% Peak heart rate for 1 month (12 sessions of exercise)
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
9
|
|
Overall Study
COMPLETED
|
9
|
6
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Subjects who completed
Baseline characteristics by cohort
| Measure |
High Intensity Interval Training
n=10 Participants
High intensity interval training - 3 days per week at 85-90% peak heart rate (4x4 bouts) for 1 month (12 sessions of exercise)
High intensity interval training: 3 days per week at 85-90% peak heart rate (4x4 bouts) for 1 month (12 sessions of exercise)
|
Moderate Intensity Exercise Training
n=9 Participants
3 days/week, 30 mins at 70% Peak heart rate for 1 month (12 sessions of exercise)
Moderate intensity exercise training: 3 days/week, 30 mins at 70% Peak heart rate for 1 month (12 sessions of exercise)
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=9 Participants • Subjects who completed
|
0 Participants
n=6 Participants • Subjects who completed
|
0 Participants
n=15 Participants • Subjects who completed
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=9 Participants • Subjects who completed
|
1 Participants
n=6 Participants • Subjects who completed
|
3 Participants
n=15 Participants • Subjects who completed
|
|
Age, Categorical
>=65 years
|
7 Participants
n=9 Participants • Subjects who completed
|
5 Participants
n=6 Participants • Subjects who completed
|
12 Participants
n=15 Participants • Subjects who completed
|
|
Age, Continuous
Mean age of completers
|
69 years
STANDARD_DEVIATION 6.1 • n=9 Participants • Mean age of participants that completed the study
|
71.5 years
STANDARD_DEVIATION 11.7 • n=6 Participants • Mean age of participants that completed the study
|
69.9 years
STANDARD_DEVIATION 8.3 • n=15 Participants • Mean age of participants that completed the study
|
|
Sex: Female, Male
Female
|
1 Participants
n=9 Participants • Composition of participants that completed
|
2 Participants
n=6 Participants • Composition of participants that completed
|
3 Participants
n=15 Participants • Composition of participants that completed
|
|
Sex: Female, Male
Male
|
8 Participants
n=9 Participants • Composition of participants that completed
|
4 Participants
n=6 Participants • Composition of participants that completed
|
12 Participants
n=15 Participants • Composition of participants that completed
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
10 participants
n=10 Participants
|
9 participants
n=9 Participants
|
19 participants
n=19 Participants
|
PRIMARY outcome
Timeframe: Before and after the 1 month exercise interventionMeasured using left ventricular echocardiography. Diastolic dysfunction is graded as: normal, grade 1, grade 2, grade 3, grade 4. Increasing grade is indicative of worsening LV dysfunction and worse outcomes. Improvement in LV grade is associated with better long term outcomes.
Outcome measures
| Measure |
High Intensity Interval Training
n=9 Participants
High intensity interval training - 3 days per week at 85-90% peak heart rate (4x4 bouts) for 1 month (12 sessions of exercise)
High intensity interval training: 3 days per week at 85-90% peak heart rate (4x4 bouts) for 1 month (12 sessions of exercise)
|
Moderate Intensity Exercise Training
n=6 Participants
3 days/week, 30 mins at 70% Peak heart rate for 1 month (12 sessions of exercise)
Moderate intensity exercise training: 3 days/week, 30 mins at 70% Peak heart rate for 1 month (12 sessions of exercise)
|
|---|---|---|
|
Left Ventricular Diastolic Dysfunction
Post
|
1.3 DD grade
Standard Deviation 0.7
|
2.2 DD grade
Standard Deviation 0.8
|
|
Left Ventricular Diastolic Dysfunction
Pre
|
2.1 DD grade
Standard Deviation 0.3
|
2 DD grade
Standard Deviation 0.6
|
SECONDARY outcome
Timeframe: Test carried out before and after the 1 month long exercise intervention.Measured using a graded exercise test (modified Bruce protocol) with 12-lead EKG monitoring and ventilatory gas exchange analysis.
Outcome measures
| Measure |
High Intensity Interval Training
n=9 Participants
High intensity interval training - 3 days per week at 85-90% peak heart rate (4x4 bouts) for 1 month (12 sessions of exercise)
High intensity interval training: 3 days per week at 85-90% peak heart rate (4x4 bouts) for 1 month (12 sessions of exercise)
|
Moderate Intensity Exercise Training
n=6 Participants
3 days/week, 30 mins at 70% Peak heart rate for 1 month (12 sessions of exercise)
Moderate intensity exercise training: 3 days/week, 30 mins at 70% Peak heart rate for 1 month (12 sessions of exercise)
|
|---|---|---|
|
VO2peak
Pre
|
19.2 ml/kg/min
Standard Deviation 5.2
|
16.9 ml/kg/min
Standard Deviation 3
|
|
VO2peak
Post
|
21 ml/kg/min
Standard Deviation 5.2
|
16.8 ml/kg/min
Standard Deviation 4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Before and after 1-month exercise interventionReactive hyperemia mediated brachial artery dilation will be measured after 5 minutes of ischemia with forearm cuff occlusion. Artery will be continuously monitored using B-mode ultrasound.
Outcome measures
| Measure |
High Intensity Interval Training
n=9 Participants
High intensity interval training - 3 days per week at 85-90% peak heart rate (4x4 bouts) for 1 month (12 sessions of exercise)
High intensity interval training: 3 days per week at 85-90% peak heart rate (4x4 bouts) for 1 month (12 sessions of exercise)
|
Moderate Intensity Exercise Training
n=6 Participants
3 days/week, 30 mins at 70% Peak heart rate for 1 month (12 sessions of exercise)
Moderate intensity exercise training: 3 days/week, 30 mins at 70% Peak heart rate for 1 month (12 sessions of exercise)
|
|---|---|---|
|
Brachial Artery Flow-mediated Dilation
Pre
|
6.9 percentage of FMD
Standard Deviation 3.7
|
8.1 percentage of FMD
Standard Deviation 4.1
|
|
Brachial Artery Flow-mediated Dilation
Post
|
7 percentage of FMD
Standard Deviation 4.2
|
3.4 percentage of FMD
Standard Deviation 3.6
|
Adverse Events
High Intensity Interval Training
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Moderate Intensity Exercise Training
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Siddhartha S. Angadi, PhD., FACSM
Arizona State University - Downtown Phoenix Campus
Phone: 6028272254
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place