Stroke
Conditions
Keywords
Stroke, Rehabilitation, Exercise, Intensity, Gait
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.
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.
Interventions
Treadmill exercise using bursts of concentrated effort alternated with recovery periods
Moderate intensity continuous aerobic exercise on a treadmill
Sponsors
American Physical Therapy Association
Children's Hospital Medical Center, Cincinnati
University of Cincinnati
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
35 Years to 90 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Peak Aerobic Capacity (VO2-peak) | Baseline and 4 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Gait Velocity (10 Meter Walk Test) | Baseline and 4 weeks | — |
| Change in 6-Minute Walk Test | Baseline and 4 weeks | distance walked in 6 minutes |
| Change in Submaximal Aerobic Capacity (VO2 at Ventilatory Threshold) | Baseline and 4 weeks | — |
| Change in Fastest Treadmill Speed (Steep Ramp Test) | Baseline and 4 weeks | fastest safe treadmill walking speed |
| Change in Fractional Utilization | Baseline and 4 weeks | Metabolic cost of gait as a percentage of aerobic capacity |
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Change in Self-Efficacy and Outcome Expectations for Exercise Scale | Baseline and 4 weeks | — |
| 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. |
| Change in Daily Physical Activity (Activity Monitor) | Baseline and 4 weeks | — |
| Change in Montreal Cognitive Assessment | Baseline and 4 weeks | — |
| Change in Gait Kinematics/Kinetics From Baseline to 4 Weeks | Baseline and 4 weeks | 3D motion capture and force plates |
| Change in Gait Kinematics/Kinetics From Baseline to Post Session 1 | Baseline and after session 1 | 3D motion capture and force plates |
| Change in Gait Kinematics/Kinetics During Session 1 | During session 1 | 3D motion capture and force plates |
| 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 |
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| High-intensity Interval Training (HIT) 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 | 11 |
| Traditional Aerobic Training Moderate intensity continuous aerobic exercise on a treadmill
Traditional Aerobic Training: Moderate intensity continuous aerobic exercise on a treadmill | 5 |
| Total | 16 |
Baseline characteristics
| Characteristic | Traditional Aerobic Training | Total | High-intensity Interval Training (HIT) |
|---|---|---|---|
| Age, Continuous | 57 years STANDARD_DEVIATION 12 | 58 years STANDARD_DEVIATION 10 | 59 years STANDARD_DEVIATION 9 |
| Comfortable gait speed, m/s | 0.76 m/s STANDARD_DEVIATION 0.36 | 0.67 m/s STANDARD_DEVIATION 0.44 | 0.63 m/s STANDARD_DEVIATION 0.48 |
| Peak oxygen consumption rate, ml/kg/min | 21.6 ml/kg/min STANDARD_DEVIATION 4 | 17.7 ml/kg/min STANDARD_DEVIATION 4.7 | 16.0 ml/kg/min STANDARD_DEVIATION 4 |
| Sex: Female, Male Female | 3 Participants | 7 Participants | 4 Participants |
| Sex: Female, Male Male | 2 Participants | 9 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 9 / 13 | 4 / 5 |
| serious Total, serious adverse events | 0 / 13 | 0 / 5 |
Outcome results
Primary
Change in Peak Aerobic Capacity (VO2-peak)
Time frame: Baseline and 4 weeks
Population: on treatment analysis
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| High-intensity Interval Training (HIT) | Change in Peak Aerobic Capacity (VO2-peak) | 2.2 ml/kg/min |
| Traditional Aerobic Training | Change in Peak Aerobic Capacity (VO2-peak) | -1.3 ml/kg/min |
Secondary
Change in 6-Minute Walk Test
distance walked in 6 minutes
Time frame: Baseline and 4 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| High-intensity Interval Training (HIT) | Change in 6-Minute Walk Test | 15 meters |
| Traditional Aerobic Training | Change in 6-Minute Walk Test | 15 meters |
Secondary
Change in Fastest Treadmill Speed (Steep Ramp Test)
fastest safe treadmill walking speed
Time frame: Baseline and 4 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| High-intensity Interval Training (HIT) | Change in Fastest Treadmill Speed (Steep Ramp Test) | 0.36 meters per second |
| Traditional Aerobic Training | Change in Fastest Treadmill Speed (Steep Ramp Test) | 0.07 meters per second |
Secondary
Change in Fractional Utilization
Metabolic cost of gait as a percentage of aerobic capacity
Time frame: Baseline and 4 weeks
Population: Subjects with available data
| Arm | Measure | Value (MEAN) |
|---|---|---|
| High-intensity Interval Training (HIT) | Change in Fractional Utilization | -36.8 percentage of aerobic capacity |
| Traditional Aerobic Training | Change in Fractional Utilization | -8.8 percentage of aerobic capacity |
Secondary
Change in Gait Economy (Mean Oxygen Uptake at Comfortable Walking Speed)
mean oxygen uptake at comfortable walking speed reported in units mLO2 per kilogram body weight per meter
Time frame: Baseline and 4 weeks
Population: Subjects with available data
| Arm | Measure | Value (MEAN) |
|---|---|---|
| High-intensity Interval Training (HIT) | Change in Gait Economy (Mean Oxygen Uptake at Comfortable Walking Speed) | -0.10 mLO2/kg/m |
| Traditional Aerobic Training | Change in Gait Economy (Mean Oxygen Uptake at Comfortable Walking Speed) | -0.01 mLO2/kg/m |
Secondary
Change in Gait Velocity (10 Meter Walk Test)
Time frame: Baseline and 4 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| High-intensity Interval Training (HIT) | Change in Gait Velocity (10 Meter Walk Test) | 0.10 m/s |
| Traditional Aerobic Training | Change in Gait Velocity (10 Meter Walk Test) | 0.02 m/s |
Secondary
Change in Submaximal Aerobic Capacity (VO2 at Ventilatory Threshold)
Time frame: Baseline and 4 weeks
Population: ventilatory threshold was not identifiable for one participant
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| High-intensity Interval Training (HIT) | Change in Submaximal Aerobic Capacity (VO2 at Ventilatory Threshold) | 4.4 ml/kg/min |
| Traditional Aerobic Training | Change in Submaximal Aerobic Capacity (VO2 at Ventilatory Threshold) | 0.6 ml/kg/min |
Other Pre-specified
Change in Daily Physical Activity (Activity Monitor)
Time frame: Baseline and 4 weeks
Population: measure not used
Other Pre-specified
Change in Gait Kinematics/Kinetics During Session 1
3D motion capture and force plates
Time frame: During session 1
Population: measure not used
Other Pre-specified
Change in Gait Kinematics/Kinetics From Baseline to 4 Weeks
3D motion capture and force plates
Time frame: Baseline and 4 weeks
Population: Measure not used
Other Pre-specified
Change in Gait Kinematics/Kinetics From Baseline to Post Session 1
3D motion capture and force plates
Time frame: Baseline and after session 1
Population: measure not used
Other Pre-specified
Change in Montreal Cognitive Assessment
Time frame: Baseline and 4 weeks
Population: Measure not used
Other Pre-specified
Change in Self-Efficacy and Outcome Expectations for Exercise Scale
Time frame: Baseline and 4 weeks
Population: Outcome measure not used
Other Pre-specified
Change in Stroke Impact Scale
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High-intensity Interval Training (HIT) | Change in Stroke Impact Scale | 9.4 units on a scale from 0-100 | Standard Deviation 15 |
| Traditional Aerobic Training | Change in Stroke Impact Scale | 0.7 units on a scale from 0-100 | Standard Deviation 5.9 |
Other Pre-specified
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
Time frame: Before and after training session 12
Population: measure not used
Other Pre-specified
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
Time frame: Before and after training session 2
Population: measure not used
Other Pre-specified
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
Time frame: Baseline and 4 weeks
Population: measure not used