Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

High Intensity Interval Exercise in Diastolic Heart Failure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02147613
Recruitment Status : Completed
First Posted : May 28, 2014
Results First Posted : April 12, 2019
Last Update Posted : April 12, 2019
Sponsor:
Collaborators:
Mayo Clinic
University of Alberta
Information provided by (Responsible Party):
Arizona State University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Diastolic Heart Failure
Interventions Other: High intensity interval training
Other: Moderate intensity exercise training
Enrollment 19
Recruitment Details  
Pre-assignment Details  
Arm/Group Title High Intensity Interval Training Moderate Intensity Exercise Training
Hide Arm/Group Description

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)

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)

Period Title: Overall Study
Started 10 9
Completed 9 6
Not Completed 1 3
Arm/Group Title High Intensity Interval Training Moderate Intensity Exercise Training Total
Hide Arm/Group Description

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)

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 of all reporting groups
Overall Number of Baseline Participants 10 9 19
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 6 participants 15 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
2
  22.2%
1
  16.7%
3
  20.0%
>=65 years
7
  77.8%
5
  83.3%
12
  80.0%
[1]
Measure Analysis Population Description: Subjects who completed
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Mean age of completers Number Analyzed 9 participants 6 participants 15 participants
69  (6.1) 71.5  (11.7) 69.9  (8.3)
[1]
Measure Analysis Population Description: Mean age of participants that completed the study
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 6 participants 15 participants
Female
1
  11.1%
2
  33.3%
3
  20.0%
Male
8
  88.9%
4
  66.7%
12
  80.0%
[1]
Measure Analysis Population Description: Composition of participants that completed
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants 9 participants 19 participants
10 9 19
1.Primary Outcome
Title Left Ventricular Diastolic Dysfunction
Hide Description 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.
Time Frame Before and after the 1 month exercise intervention
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High Intensity Interval Training Moderate Intensity Exercise Training
Hide Arm/Group Description:

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)

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 Number of Participants Analyzed 9 6
Mean (Standard Deviation)
Unit of Measure: DD grade
Pre 2.1  (0.3) 2  (0.6)
Post 1.3  (0.7) 2.2  (0.8)
2.Secondary Outcome
Title VO2peak
Hide Description Measured using a graded exercise test (modified Bruce protocol) with 12-lead EKG monitoring and ventilatory gas exchange analysis.
Time Frame Test carried out before and after the 1 month long exercise intervention.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High Intensity Interval Training Moderate Intensity Exercise Training
Hide Arm/Group Description:

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)

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 Number of Participants Analyzed 9 6
Mean (Standard Deviation)
Unit of Measure: ml/kg/min
Pre 19.2  (5.2) 16.9  (3)
Post 21  (5.2) 16.8  (4)
3.Other Pre-specified Outcome
Title Brachial Artery Flow-mediated Dilation
Hide Description Reactive 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.
Time Frame Before and after 1-month exercise intervention
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High Intensity Interval Training Moderate Intensity Exercise Training
Hide Arm/Group Description:

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)

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 Number of Participants Analyzed 9 6
Mean (Standard Deviation)
Unit of Measure: percentage of FMD
Pre 6.9  (3.7) 8.1  (4.1)
Post 7  (4.2) 3.4  (3.6)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title High Intensity Interval Training Moderate Intensity Exercise Training
Hide Arm/Group Description

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)

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)

All-Cause Mortality
High Intensity Interval Training Moderate Intensity Exercise Training
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/9 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
High Intensity Interval Training Moderate Intensity Exercise Training
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/9 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
High Intensity Interval Training Moderate Intensity Exercise Training
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/9 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Siddhartha S. Angadi, PhD., FACSM
Organization: Arizona State University - Downtown Phoenix Campus
Phone: 6028272254
Responsible Party: Arizona State University
ClinicalTrials.gov Identifier: NCT02147613     History of Changes
Other Study ID Numbers: Mayo-ArizonaSU Seed 93016001
First Submitted: May 21, 2014
First Posted: May 28, 2014
Results First Submitted: October 5, 2017
Results First Posted: April 12, 2019
Last Update Posted: April 12, 2019