High Intensity Interval Training in Chronic Stroke

Stroke Clinical Trial

— HIT  

Official title:

High Intensity Interval Training in Chronic Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01958606
• Other study ID #: HIT in chronic stroke
• Status: Completed
• Phase: N/A
• First received: October 7, 2013
• Last updated: April 29, 2015
• Start date: October 2013
• Est. completion date: August 2014

Study information

• Verified date: April 2015
• Source: University of Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 90 Years

Eligibility

Inclusion Criteria:

• 1) age 35-90 years

• 2) unilateral stroke experienced >6 months prior to enrollment

• 3) able to walk 10m overground with assistive devices as needed and no physical assistance

• 4) able to walk 3 minutes on the treadmill at >.13m/s (0.3mph) with no aerobic exercise contraindications

• 5) stable cardiovascular condition (American Heart Association class B, allowing for aerobic capacity <6 metabolic equivalents)

• 6) discharged from formal rehabilitation

Exclusion Criteria:

• 1) significant resting ECG abnormalities

• 2) evidence of significant arrhythmia or myocardial ischemia on treadmill ECG stress test

• 3) hospitalization for cardiac or pulmonary disease within 3 months

• 4) pacemaker or implanted defibrillator

• 5) lower extremity claudication

• 6) unable to communicate with investigators or correctly answer consent comprehension questions

• 7) severe lower extremity spasticity (Ashworth >2)

• 8) 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• High-intensity interval training (HIT)
Treadmill exercise using bursts of concentrated effort alternated with recovery periods
• Traditional Aerobic Training
Moderate intensity continuous aerobic exercise on a treadmill

Locations

Country	Name	City	State
United States	University of Cincinnati	Cincinnati	Ohio

Sponsors (3)

Lead Sponsor	Collaborator
University of Cincinnati	American Physical Therapy Association, Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Self-Efficacy and Outcome Expectations for Exercise Scale		Baseline and 4 weeks	No
Other	Change in Montreal Cognitive Assessment		Baseline and 4 weeks	No
Other	Change in gait kinematics/kinetics from baseline to 4 weeks	3D motion capture and force plates	Baseline and 4 weeks	No
Other	Change in gait kinematics/kinetics from baseline to POST session 1	3D motion capture and force plates	Baseline and after session 1	No
Other	Change in gait kinematics/kinetics during session 1	3D motion capture and force plates	During session 1	No
Other	Change in transcranial magnetic stimulation (TMS) responses from baseline to 4 weeks	Primary variable is motor threshold (MT). Secondary variables include: motor evoked potential amplitude/latency, corticomotor map size and volume and intracortical inhibition	Baseline and 4 weeks	No
Other	Change in transcranial magnetic stimulation (TMS) responses associated with training session 2	Primary variable is motor threshold (MT). Secondary variables include: motor evoked potential amplitude/latency and intracortical inhibition	Before and after training session 2	No
Other	Change in transcranial magnetic stimulation (TMS) responses associated with training session 12	Primary variable is motor threshold (MT). Secondary variables include: motor evoked potential amplitude/latency and intracortical inhibition	Before and after training session 12	No
Other	Change in daily physical activity (activity monitor)		Baseline and 4 weeks	No
Other	Change in Stroke Impact Scale		Baseline and 4 weeks	No
Primary	Change in peak aerobic capacity (VO2-peak)		Baseline and 4 weeks	No
Secondary	Change in submaximal aerobic capacity (VO2 at ventilatory threshold)		Baseline and 4 weeks	No
Secondary	Change in gait velocity (10 meter walk test)		Baseline and 4 weeks	No
Secondary	Change in 6-Minute Walk Test		Baseline and 4 weeks	No
Secondary	Change in gait economy (mean oxygen uptake at comfortable walking speed)		Baseline and 4 weeks	No
Secondary	Change in fastest treadmill speed (steep ramp test)		Baseline and 4 weeks	No
Secondary	Change in fractional utilization		Baseline and 4 weeks	No