HIT: High Intensity Interval Training in Chronic Stroke

• Sponsor: University of Cincinnati (Other)
• Overall Status: Completed
• CT.gov ID: NCT01958606
• Collaborator: American Physical Therapy Association (Other), Children's Hospital Medical Center, Cincinnati (Other)
• Enrollment: 18
• Location: 1
• Arms: 2
• Duration (Months): 10
• Patients Per Site Per Month: 1.8

Study Details

Study Description

Brief Summary

The objective of this study was to compare the effectiveness of high intensity interval training (HIT) and traditional aerobic training for persons with stroke.

Condition or Disease	Intervention/Treatment	Phase
Stroke	Other: High-intensity interval training (HIT); Other: Traditional Aerobic Training	N/A

Detailed Description

Participants were randomized to either HIT or traditional aerobic training; each 25 minutes, 3 times per week for 4 weeks. Outcomes were measured before and after training by a blinded rater.

Study Design

• Study Type: Interventional
• Actual Enrollment: 18 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: High Intensity Interval Training in Chronic Stroke
• Study Start Date: Oct 1, 2013
• Actual Primary Completion Date: Aug 1, 2014
• Actual Study Completion Date: Aug 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: High-intensity interval training (HIT) Treadmill exercise using bursts of concentrated effort alternated with recovery periods	Other: High-intensity interval training (HIT); Treadmill exercise using bursts of concentrated effort alternated with recovery periods
Active Comparator: Traditional aerobic training Moderate intensity continuous aerobic exercise on a treadmill	Other: Traditional Aerobic Training; Moderate intensity continuous aerobic exercise on a treadmill

Outcome Measures

Primary Outcome Measures

1. Change in Peak Aerobic Capacity (VO2-peak) [Baseline and 4 weeks]

Secondary Outcome Measures

1. Change in Submaximal Aerobic Capacity (VO2 at Ventilatory Threshold) [Baseline and 4 weeks]

2. Change in Gait Velocity (10 Meter Walk Test) [Baseline and 4 weeks]

3. Change in 6-Minute Walk Test [Baseline and 4 weeks]

   distance walked in 6 minutes

4. Change in Gait Economy (Mean Oxygen Uptake at Comfortable Walking Speed) [Baseline and 4 weeks]

   mean oxygen uptake at comfortable walking speed reported in units mLO2 per kilogram body weight per meter

5. Change in Fastest Treadmill Speed (Steep Ramp Test) [Baseline and 4 weeks]

   fastest safe treadmill walking speed

6. Change in Fractional Utilization [Baseline and 4 weeks]

   Metabolic cost of gait as a percentage of aerobic capacity

Other Outcome Measures

1. Change in Self-Efficacy and Outcome Expectations for Exercise Scale [Baseline and 4 weeks]

2. Change in Montreal Cognitive Assessment [Baseline and 4 weeks]

3. Change in Gait Kinematics/Kinetics From Baseline to 4 Weeks [Baseline and 4 weeks]

   3D motion capture and force plates

4. Change in Gait Kinematics/Kinetics From Baseline to Post Session 1 [Baseline and after session 1]

   3D motion capture and force plates

5. Change in Gait Kinematics/Kinetics During Session 1 [During session 1]

   3D motion capture and force plates

6. Change in Transcranial Magnetic Stimulation (TMS) Responses From Baseline to 4 Weeks [Baseline and 4 weeks]

   Primary variable is motor threshold (MT). Secondary variables include: motor evoked potential amplitude/latency, corticomotor map size and volume and intracortical inhibition

7. Change in Transcranial Magnetic Stimulation (TMS) Responses Associated With Training Session 2 [Before and after training session 2]

   Primary variable is motor threshold (MT). Secondary variables include: motor evoked potential amplitude/latency and intracortical inhibition

8. Change in Transcranial Magnetic Stimulation (TMS) Responses Associated With Training Session 12 [Before and after training session 12]

   Primary variable is motor threshold (MT). Secondary variables include: motor evoked potential amplitude/latency and intracortical inhibition

9. Change in Daily Physical Activity (Activity Monitor) [Baseline and 4 weeks]

10. Change in Stroke Impact Scale [Baseline and 4 weeks]

    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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 35 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 1. age 35-90 years
• 1. unilateral stroke experienced >6 months prior to enrollment
• 1. able to walk 10m overground with assistive devices as needed and no physical assistance
• 1. able to walk 3 minutes on the treadmill at >.13m/s (0.3mph) with no aerobic exercise contraindications
• 1. stable cardiovascular condition (American Heart Association class B, allowing for aerobic capacity <6 metabolic equivalents)
• 1. discharged from formal rehabilitation

Exclusion Criteria:

• 1. significant resting ECG abnormalities
• 1. evidence of significant arrhythmia or myocardial ischemia on treadmill ECG stress test
• 1. hospitalization for cardiac or pulmonary disease within 3 months
• 1. pacemaker or implanted defibrillator
• 1. lower extremity claudication
• 1. unable to communicate with investigators or correctly answer consent comprehension questions
• 1. severe lower extremity spasticity (Ashworth >2)
• 1. lower extremity weight bearing pain >4/10 on visual analogue scale

For the transcranial magnetic stimulation substudy, additional exclusions will also be applied. These include large cerebral infarcts or other structural defects with the potential to increase seizure risk, uncontrolled seizures, metal implants and previous craniotomy.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Cincinnati	Cincinnati	Ohio	United States	45267

Sponsors and Collaborators

• University of Cincinnati
• American Physical Therapy Association
• Children's Hospital Medical Center, Cincinnati

Investigators

• Principal Investigator: Brett Kissela, MD, University of Cincinnati
• Principal Investigator: Kari Dunning, PhD, PT, University of Cincinnati

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Brett Kissela, Principal Investigator, University of Cincinnati
• ClinicalTrials.gov Identifier: NCT01958606
• Other Study ID Numbers: HIT in chronic stroke
• First Posted: Oct 9, 2013
• Last Update Posted: May 15, 2017
• Last Verified: Apr 1, 2017

• Keywords provided by Brett Kissela, Principal Investigator, University of Cincinnati: Stroke; Rehabilitation; Exercise; Intensity; Gait
• Additional relevant MeSH terms: Stroke

Study Results

Participant Flow

Arm/Group Title	High-intensity Interval Training (HIT)	Traditional Aerobic Training
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

Baseline Characteristics

Arm/Group Title	High-intensity Interval Training (HIT)	Traditional Aerobic Training	Total
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 Participants	11	5	16
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	59 (9)	57 (12)	58 (10)
Sex: Female, Male (Count of Participants)
Female	4 36.4%	3 60%	7 43.8%
Male	7 63.6%	2 40%	9 56.3%
Comfortable gait speed, m/s (m/s) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [m/s]	0.63 (0.48)	0.76 (0.36)	0.67 (0.44)
Peak oxygen consumption rate, ml/kg/min (ml/kg/min) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [ml/kg/min]	16.0 (4.0)	21.6 (4.0)	17.7 (4.7)

Outcome Measures

1. Primary Outcome

Title	Change in Peak Aerobic Capacity (VO2-peak)
Time Frame	Baseline and 4 weeks

Outcome Measure Data

Analysis Population Description

on treatment analysis

Arm/Group Title	High-intensity Interval Training (HIT)	Traditional Aerobic Training
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
Measure Participants	11	5
Least Squares Mean (95% Confidence Interval) [ml/kg/min]	2.2	-1.3

2. Secondary Outcome

Title	Change in Submaximal Aerobic Capacity (VO2 at Ventilatory Threshold)
Time Frame	Baseline and 4 weeks

Outcome Measure Data

Analysis Population Description

ventilatory threshold was not identifiable for one participant

Arm/Group Title	High-intensity Interval Training (HIT)	Traditional Aerobic Training
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
Measure Participants	10	5
Least Squares Mean (95% Confidence Interval) [ml/kg/min]	4.4	0.6

3. Secondary Outcome

Title	Change in Gait Velocity (10 Meter Walk Test)
Time Frame	Baseline and 4 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	High-intensity Interval Training (HIT)	Traditional Aerobic Training
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
Measure Participants	11	5
Least Squares Mean (95% Confidence Interval) [m/s]	0.10	0.02

4. Secondary Outcome

Title	Change in 6-Minute Walk Test
Description	distance walked in 6 minutes
Time Frame	Baseline and 4 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	High-intensity Interval Training (HIT)	Traditional Aerobic Training
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
Measure Participants	11	5
Mean (95% Confidence Interval) [meters]	15	15

5. Secondary Outcome

Title	Change in Gait Economy (Mean Oxygen Uptake at Comfortable Walking Speed)
Description	mean oxygen uptake at comfortable walking speed reported in units mLO2 per kilogram body weight per meter
Time Frame	Baseline and 4 weeks

Outcome Measure Data

Analysis Population Description

Subjects with available data

Arm/Group Title	High-intensity Interval Training (HIT)	Traditional Aerobic Training
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
Measure Participants	9	5
Mean (95% Confidence Interval) [mLO2/kg/m]	-0.10	-0.01

6. Secondary Outcome

Title	Change in Fastest Treadmill Speed (Steep Ramp Test)
Description	fastest safe treadmill walking speed
Time Frame	Baseline and 4 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	High-intensity Interval Training (HIT)	Traditional Aerobic Training
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
Measure Participants	11	5
Mean (95% Confidence Interval) [meters per second]	0.36	0.07

7. Secondary Outcome

Title	Change in Fractional Utilization
Description	Metabolic cost of gait as a percentage of aerobic capacity
Time Frame	Baseline and 4 weeks

Outcome Measure Data

Analysis Population Description

Subjects with available data

Arm/Group Title	High-intensity Interval Training (HIT)	Traditional Aerobic Training
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
Measure Participants	8	5
Mean (95% Confidence Interval) [percentage of aerobic capacity]	-36.8	-8.8

8. Other Pre-specified Outcome

Title	Change in Self-Efficacy and Outcome Expectations for Exercise Scale
Time Frame	Baseline and 4 weeks

Outcome Measure Data

Analysis Population Description

Outcome measure not used

Arm/Group Title	High-intensity Interval Training (HIT)	Traditional Aerobic Training
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
Measure Participants	0	0

9. Other Pre-specified Outcome

Title	Change in Montreal Cognitive Assessment
Time Frame	Baseline and 4 weeks

Outcome Measure Data

Analysis Population Description

Measure not used

Arm/Group Title	High-intensity Interval Training (HIT)	Traditional Aerobic Training
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
Measure Participants	0	0

10. Other Pre-specified Outcome

Title	Change in Gait Kinematics/Kinetics From Baseline to 4 Weeks
Description	3D motion capture and force plates
Time Frame	Baseline and 4 weeks

Outcome Measure Data

Analysis Population Description

Measure not used

Arm/Group Title	High-intensity Interval Training (HIT)	Traditional Aerobic Training
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
Measure Participants	0	0

11. Other Pre-specified Outcome

Title	Change in Gait Kinematics/Kinetics From Baseline to Post Session 1
Description	3D motion capture and force plates
Time Frame	Baseline and after session 1

Outcome Measure Data

Analysis Population Description

measure not used

Arm/Group Title	High-intensity Interval Training (HIT)	Traditional Aerobic Training
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
Measure Participants	0	0

12. Other Pre-specified Outcome

Title	Change in Gait Kinematics/Kinetics During Session 1
Description	3D motion capture and force plates
Time Frame	During session 1

Outcome Measure Data

Analysis Population Description

measure not used

Arm/Group Title	High-intensity Interval Training (HIT)	Traditional Aerobic Training
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
Measure Participants	0	0

13. Other Pre-specified Outcome

Title	Change in Transcranial Magnetic Stimulation (TMS) Responses From Baseline to 4 Weeks
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

Outcome Measure Data

Analysis Population Description

measure not used

Arm/Group Title	High-intensity Interval Training (HIT)	Traditional Aerobic Training
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
Measure Participants	0	0

14. Other Pre-specified Outcome

Title	Change in Transcranial Magnetic Stimulation (TMS) Responses Associated With Training Session 2
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

Outcome Measure Data

Analysis Population Description

measure not used

Arm/Group Title	High-intensity Interval Training (HIT)	Traditional Aerobic Training
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
Measure Participants	0	0

15. Other Pre-specified Outcome

Title	Change in Transcranial Magnetic Stimulation (TMS) Responses Associated With Training Session 12
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

Outcome Measure Data

Analysis Population Description

measure not used

Arm/Group Title	High-intensity Interval Training (HIT)	Traditional Aerobic Training
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
Measure Participants	0	0

16. Other Pre-specified Outcome

Title	Change in Daily Physical Activity (Activity Monitor)
Time Frame	Baseline and 4 weeks

Outcome Measure Data

Analysis Population Description

measure not used

Arm/Group Title	High-intensity Interval Training (HIT)	Traditional Aerobic Training
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
Measure Participants	0	0

17. Other Pre-specified Outcome

Title	Change in Stroke Impact Scale
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	High-intensity Interval Training (HIT)	Traditional Aerobic Training
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
Measure Participants	11	5
Mean (Standard Deviation) [units on a scale from 0-100]	9.4 (15)	0.7 (5.9)

Adverse Events

Arm/Group Title	High-intensity Interval Training (HIT)		Traditional Aerobic Training
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 (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	High-intensity Interval Training (HIT)		Traditional Aerobic Training
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/13 (0%)		0/5 (0%)
Other (Not Including Serious) Adverse Events
	High-intensity Interval Training (HIT)		Traditional Aerobic Training
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	9/13 (69.2%)		4/5 (80%)
Cardiac disorders
Atrial fibrillation	1/13 (7.7%)	2	0/5 (0%)	0
Musculoskeletal and connective tissue disorders
Joint/muscle soreness	7/13 (53.8%)	10	2/5 (40%)	6
Fatigue	4/13 (30.8%)	4	0/5 (0%)	0
Fall	1/13 (7.7%)	1	2/5 (40%)	2
Other injury	1/13 (7.7%)	1	0/5 (0%)	0
Vascular disorders
Light-headedness	2/13 (15.4%)	3	0/5 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

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.