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High Intensity Interval Training in Chronic Stroke (HIT)

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ClinicalTrials.gov Identifier: NCT01958606
Recruitment Status : Completed
First Posted : October 9, 2013
Results First Posted : March 29, 2017
Last Update Posted : May 15, 2017
Sponsor:
Collaborators:
American Physical Therapy Association
Children's Hospital Medical Center, Cincinnati
Information provided by (Responsible Party):
Brett Kissela, University of Cincinnati

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Stroke
Interventions Other: High-intensity interval training (HIT)
Other: Traditional Aerobic Training
Enrollment 18
Recruitment Details  
Pre-assignment Details  
Arm/Group Title High-intensity Interval Training (HIT) Traditional Aerobic Training
Hide Arm/Group Description

Treadmill exercise using bursts of concentrated effort alternated with recovery periods

High-intensity interval training (HIT): Treadmill exercise using bursts of concentrated effort alternated with recovery periods

Moderate intensity continuous aerobic exercise on a treadmill

Traditional Aerobic Training: Moderate intensity continuous aerobic exercise on a treadmill

Period Title: Overall Study
Started 13 5
Completed 11 5
Not Completed 2 0
Arm/Group Title High-intensity Interval Training (HIT) Traditional Aerobic Training Total
Hide Arm/Group Description

Treadmill exercise using bursts of concentrated effort alternated with recovery periods

High-intensity interval training (HIT): Treadmill exercise using bursts of concentrated effort alternated with recovery periods

Moderate intensity continuous aerobic exercise on a treadmill

Traditional Aerobic Training: Moderate intensity continuous aerobic exercise on a treadmill

Total of all reporting groups
Overall Number of Baseline Participants 11 5 16
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 11 participants 5 participants 16 participants
59  (9) 57  (12) 58  (10)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 5 participants 16 participants
Female
4
  36.4%
3
  60.0%
7
  43.8%
Male
7
  63.6%
2
  40.0%
9
  56.3%
Comfortable gait speed, m/s  
Mean (Standard Deviation)
Unit of measure:  M/s
Number Analyzed 11 participants 5 participants 16 participants
0.63  (0.48) 0.76  (0.36) 0.67  (0.44)
Peak oxygen consumption rate, ml/kg/min  
Mean (Standard Deviation)
Unit of measure:  Ml/kg/min
Number Analyzed 11 participants 5 participants 16 participants
16.0  (4.0) 21.6  (4.0) 17.7  (4.7)
1.Primary Outcome
Title Change in Peak Aerobic Capacity (VO2-peak)
Hide Description [Not Specified]
Time Frame Baseline and 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
on treatment analysis
Arm/Group Title High-intensity Interval Training (HIT) Traditional Aerobic Training
Hide Arm/Group Description:

Treadmill exercise using bursts of concentrated effort alternated with recovery periods

High-intensity interval training (HIT): Treadmill exercise using bursts of concentrated effort alternated with recovery periods

Moderate intensity continuous aerobic exercise on a treadmill

Traditional Aerobic Training: Moderate intensity continuous aerobic exercise on a treadmill

Overall Number of Participants Analyzed 11 5
Least Squares Mean (95% Confidence Interval)
Unit of Measure: ml/kg/min
2.2
(-0.05 to 4.5)
-1.3
(-4.7 to 2.1)
2.Secondary Outcome
Title Change in Submaximal Aerobic Capacity (VO2 at Ventilatory Threshold)
Hide Description [Not Specified]
Time Frame Baseline and 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ventilatory threshold was not identifiable for one participant
Arm/Group Title High-intensity Interval Training (HIT) Traditional Aerobic Training
Hide Arm/Group Description:

Treadmill exercise using bursts of concentrated effort alternated with recovery periods

High-intensity interval training (HIT): Treadmill exercise using bursts of concentrated effort alternated with recovery periods

Moderate intensity continuous aerobic exercise on a treadmill

Traditional Aerobic Training: Moderate intensity continuous aerobic exercise on a treadmill

Overall Number of Participants Analyzed 10 5
Least Squares Mean (95% Confidence Interval)
Unit of Measure: ml/kg/min
4.4
(3.1 to 5.7)
0.6
(-1.3 to 2.5)
3.Secondary Outcome
Title Change in Gait Velocity (10 Meter Walk Test)
Hide Description [Not Specified]
Time Frame Baseline and 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High-intensity Interval Training (HIT) Traditional Aerobic Training
Hide Arm/Group Description:

Treadmill exercise using bursts of concentrated effort alternated with recovery periods

High-intensity interval training (HIT): Treadmill exercise using bursts of concentrated effort alternated with recovery periods

Moderate intensity continuous aerobic exercise on a treadmill

Traditional Aerobic Training: Moderate intensity continuous aerobic exercise on a treadmill

Overall Number of Participants Analyzed 11 5
Least Squares Mean (95% Confidence Interval)
Unit of Measure: m/s
0.10
(0.06 to 0.14)
0.02
(-0.03 to 0.08)
4.Secondary Outcome
Title Change in 6-Minute Walk Test
Hide Description distance walked in 6 minutes
Time Frame Baseline and 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High-intensity Interval Training (HIT) Traditional Aerobic Training
Hide Arm/Group Description:

Treadmill exercise using bursts of concentrated effort alternated with recovery periods

High-intensity interval training (HIT): Treadmill exercise using bursts of concentrated effort alternated with recovery periods

Moderate intensity continuous aerobic exercise on a treadmill

Traditional Aerobic Training: Moderate intensity continuous aerobic exercise on a treadmill

Overall Number of Participants Analyzed 11 5
Mean (95% Confidence Interval)
Unit of Measure: meters
15
(1 to 29)
15
(-6 to 36)
5.Secondary Outcome
Title Change in Gait Economy (Mean Oxygen Uptake at Comfortable Walking Speed)
Hide Description mean oxygen uptake at comfortable walking speed reported in units mLO2 per kilogram body weight per meter
Time Frame Baseline and 4 weeks
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Hide Analysis Population Description
Subjects with available data
Arm/Group Title High-intensity Interval Training (HIT) Traditional Aerobic Training
Hide Arm/Group Description:

Treadmill exercise using bursts of concentrated effort alternated with recovery periods

High-intensity interval training (HIT): Treadmill exercise using bursts of concentrated effort alternated with recovery periods

Moderate intensity continuous aerobic exercise on a treadmill

Traditional Aerobic Training: Moderate intensity continuous aerobic exercise on a treadmill

Overall Number of Participants Analyzed 9 5
Mean (95% Confidence Interval)
Unit of Measure: mLO2/kg/m
-0.10
(-0.17 to -0.03)
-0.01
(-0.10 to 0.09)
6.Secondary Outcome
Title Change in Fastest Treadmill Speed (Steep Ramp Test)
Hide Description fastest safe treadmill walking speed
Time Frame Baseline and 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High-intensity Interval Training (HIT) Traditional Aerobic Training
Hide Arm/Group Description:

Treadmill exercise using bursts of concentrated effort alternated with recovery periods

High-intensity interval training (HIT): Treadmill exercise using bursts of concentrated effort alternated with recovery periods

Moderate intensity continuous aerobic exercise on a treadmill

Traditional Aerobic Training: Moderate intensity continuous aerobic exercise on a treadmill

Overall Number of Participants Analyzed 11 5
Mean (95% Confidence Interval)
Unit of Measure: meters per second
0.36
(0.25 to 0.47)
0.07
(-0.10 to 0.24)
7.Secondary Outcome
Title Change in Fractional Utilization
Hide Description Metabolic cost of gait as a percentage of aerobic capacity
Time Frame Baseline and 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects with available data
Arm/Group Title High-intensity Interval Training (HIT) Traditional Aerobic Training
Hide Arm/Group Description:

Treadmill exercise using bursts of concentrated effort alternated with recovery periods

High-intensity interval training (HIT): Treadmill exercise using bursts of concentrated effort alternated with recovery periods

Moderate intensity continuous aerobic exercise on a treadmill

Traditional Aerobic Training: Moderate intensity continuous aerobic exercise on a treadmill

Overall Number of Participants Analyzed 8 5
Mean (95% Confidence Interval)
Unit of Measure: percentage of aerobic capacity
-36.8
(-49.3 to -24.3)
-8.8
(-24.7 to -7.0)
8.Other Pre-specified Outcome
Title Change in Self-Efficacy and Outcome Expectations for Exercise Scale
Hide Description [Not Specified]
Time Frame Baseline and 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Outcome measure not used
Arm/Group Title High-intensity Interval Training (HIT) Traditional Aerobic Training
Hide Arm/Group Description:

Treadmill exercise using bursts of concentrated effort alternated with recovery periods

High-intensity interval training (HIT): Treadmill exercise using bursts of concentrated effort alternated with recovery periods

Moderate intensity continuous aerobic exercise on a treadmill

Traditional Aerobic Training: Moderate intensity continuous aerobic exercise on a treadmill

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
9.Other Pre-specified Outcome
Title Change in Montreal Cognitive Assessment
Hide Description [Not Specified]
Time Frame Baseline and 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Measure not used
Arm/Group Title High-intensity Interval Training (HIT) Traditional Aerobic Training
Hide Arm/Group Description:

Treadmill exercise using bursts of concentrated effort alternated with recovery periods

High-intensity interval training (HIT): Treadmill exercise using bursts of concentrated effort alternated with recovery periods

Moderate intensity continuous aerobic exercise on a treadmill

Traditional Aerobic Training: Moderate intensity continuous aerobic exercise on a treadmill

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
10.Other Pre-specified Outcome
Title Change in Gait Kinematics/Kinetics From Baseline to 4 Weeks
Hide Description 3D motion capture and force plates
Time Frame Baseline and 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Measure not used
Arm/Group Title High-intensity Interval Training (HIT) Traditional Aerobic Training
Hide Arm/Group Description:

Treadmill exercise using bursts of concentrated effort alternated with recovery periods

High-intensity interval training (HIT): Treadmill exercise using bursts of concentrated effort alternated with recovery periods

Moderate intensity continuous aerobic exercise on a treadmill

Traditional Aerobic Training: Moderate intensity continuous aerobic exercise on a treadmill

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
11.Other Pre-specified Outcome
Title Change in Gait Kinematics/Kinetics From Baseline to Post Session 1
Hide Description 3D motion capture and force plates
Time Frame Baseline and after session 1
Hide Outcome Measure Data
Hide Analysis Population Description
measure not used
Arm/Group Title High-intensity Interval Training (HIT) Traditional Aerobic Training
Hide Arm/Group Description:

Treadmill exercise using bursts of concentrated effort alternated with recovery periods

High-intensity interval training (HIT): Treadmill exercise using bursts of concentrated effort alternated with recovery periods

Moderate intensity continuous aerobic exercise on a treadmill

Traditional Aerobic Training: Moderate intensity continuous aerobic exercise on a treadmill

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
12.Other Pre-specified Outcome
Title Change in Gait Kinematics/Kinetics During Session 1
Hide Description 3D motion capture and force plates
Time Frame During session 1
Hide Outcome Measure Data
Hide Analysis Population Description
measure not used
Arm/Group Title High-intensity Interval Training (HIT) Traditional Aerobic Training
Hide Arm/Group Description:

Treadmill exercise using bursts of concentrated effort alternated with recovery periods

High-intensity interval training (HIT): Treadmill exercise using bursts of concentrated effort alternated with recovery periods

Moderate intensity continuous aerobic exercise on a treadmill

Traditional Aerobic Training: Moderate intensity continuous aerobic exercise on a treadmill

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
13.Other Pre-specified Outcome
Title Change in Transcranial Magnetic Stimulation (TMS) Responses From Baseline to 4 Weeks
Hide Description Primary variable is motor threshold (MT). Secondary variables include: motor evoked potential amplitude/latency, corticomotor map size and volume and intracortical inhibition
Time Frame Baseline and 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
measure not used
Arm/Group Title High-intensity Interval Training (HIT) Traditional Aerobic Training
Hide Arm/Group Description:

Treadmill exercise using bursts of concentrated effort alternated with recovery periods

High-intensity interval training (HIT): Treadmill exercise using bursts of concentrated effort alternated with recovery periods

Moderate intensity continuous aerobic exercise on a treadmill

Traditional Aerobic Training: Moderate intensity continuous aerobic exercise on a treadmill

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
14.Other Pre-specified Outcome
Title Change in Transcranial Magnetic Stimulation (TMS) Responses Associated With Training Session 2
Hide Description Primary variable is motor threshold (MT). Secondary variables include: motor evoked potential amplitude/latency and intracortical inhibition
Time Frame Before and after training session 2
Hide Outcome Measure Data
Hide Analysis Population Description
measure not used
Arm/Group Title High-intensity Interval Training (HIT) Traditional Aerobic Training
Hide Arm/Group Description:

Treadmill exercise using bursts of concentrated effort alternated with recovery periods

High-intensity interval training (HIT): Treadmill exercise using bursts of concentrated effort alternated with recovery periods

Moderate intensity continuous aerobic exercise on a treadmill

Traditional Aerobic Training: Moderate intensity continuous aerobic exercise on a treadmill

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
15.Other Pre-specified Outcome
Title Change in Transcranial Magnetic Stimulation (TMS) Responses Associated With Training Session 12
Hide Description Primary variable is motor threshold (MT). Secondary variables include: motor evoked potential amplitude/latency and intracortical inhibition
Time Frame Before and after training session 12
Hide Outcome Measure Data
Hide Analysis Population Description
measure not used
Arm/Group Title High-intensity Interval Training (HIT) Traditional Aerobic Training
Hide Arm/Group Description:

Treadmill exercise using bursts of concentrated effort alternated with recovery periods

High-intensity interval training (HIT): Treadmill exercise using bursts of concentrated effort alternated with recovery periods

Moderate intensity continuous aerobic exercise on a treadmill

Traditional Aerobic Training: Moderate intensity continuous aerobic exercise on a treadmill

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
16.Other Pre-specified Outcome
Title Change in Daily Physical Activity (Activity Monitor)
Hide Description [Not Specified]
Time Frame Baseline and 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
measure not used
Arm/Group Title High-intensity Interval Training (HIT) Traditional Aerobic Training
Hide Arm/Group Description:

Treadmill exercise using bursts of concentrated effort alternated with recovery periods

High-intensity interval training (HIT): Treadmill exercise using bursts of concentrated effort alternated with recovery periods

Moderate intensity continuous aerobic exercise on a treadmill

Traditional Aerobic Training: Moderate intensity continuous aerobic exercise on a treadmill

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
17.Other Pre-specified Outcome
Title Change in Stroke Impact Scale
Hide Description Cognition Domain Score of Stroke Impact Scale. Scores range from 0 to 100 (higher is better) and represent a sum of scores from multiple questions related to cognition.
Time Frame Baseline and 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High-intensity Interval Training (HIT) Traditional Aerobic Training
Hide Arm/Group Description:

Treadmill exercise using bursts of concentrated effort alternated with recovery periods

High-intensity interval training (HIT): Treadmill exercise using bursts of concentrated effort alternated with recovery periods

Moderate intensity continuous aerobic exercise on a treadmill

Traditional Aerobic Training: Moderate intensity continuous aerobic exercise on a treadmill

Overall Number of Participants Analyzed 11 5
Mean (Standard Deviation)
Unit of Measure: units on a scale from 0-100
9.4  (15) 0.7  (5.9)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title High-intensity Interval Training (HIT) Traditional Aerobic Training
Hide Arm/Group Description

Treadmill exercise using bursts of concentrated effort alternated with recovery periods

High-intensity interval training (HIT): Treadmill exercise using bursts of concentrated effort alternated with recovery periods

Moderate intensity continuous aerobic exercise on a treadmill

Traditional Aerobic Training: Moderate intensity continuous aerobic exercise on a treadmill

All-Cause Mortality
High-intensity Interval Training (HIT) Traditional Aerobic Training
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
High-intensity Interval Training (HIT) Traditional Aerobic Training
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/13 (0.00%)      0/5 (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 (HIT) Traditional Aerobic Training
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/13 (69.23%)      4/5 (80.00%)    
Cardiac disorders     
Atrial fibrillation   1/13 (7.69%)  2 0/5 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Joint/muscle soreness   7/13 (53.85%)  10 2/5 (40.00%)  6
Fatigue   4/13 (30.77%)  4 0/5 (0.00%)  0
Fall   1/13 (7.69%)  1 2/5 (40.00%)  2
Other injury   1/13 (7.69%)  1 0/5 (0.00%)  0
Vascular disorders     
Light-headedness   2/13 (15.38%)  3 0/5 (0.00%)  0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Pierce Boyne
Organization: University of Cincinnati
Phone: 513-558-7499
Responsible Party: Brett Kissela, University of Cincinnati
ClinicalTrials.gov Identifier: NCT01958606     History of Changes
Other Study ID Numbers: HIT in chronic stroke
First Submitted: October 7, 2013
First Posted: October 9, 2013
Results First Submitted: February 12, 2017
Results First Posted: March 29, 2017
Last Update Posted: May 15, 2017