StrokeHITNCT01958606
High Intensity Interval Training in Chronic Stroke
A study testing High-intensity interval training (HIT) and Traditional Aerobic Training in people with Stroke, run by University of Cincinnati at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 35 to 90 years
- Conditions the study is for
- Stroke
- What is being tested?
- High-intensity interval training (HIT) and Traditional Aerobic Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Aug 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this study was to compare the effectiveness of high intensity interval training (HIT) and traditional aerobic training for persons with stroke.
Read the 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.
- Conditions
- Stroke
- Being tested
- High-intensity interval training (HIT), Traditional Aerobic Training
- Keywords
- Stroke, Rehabilitation, Exercise, Intensity, Gait
- Medical subject headings
- Stroke, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-intensity interval training (HIT)Other
Treadmill exercise using bursts of concentrated effort alternated with recovery periods
Traditional Aerobic TrainingOther
Moderate intensity continuous aerobic exercise on a treadmill
| Study group | Role | What they receive |
|---|---|---|
| High-intensity interval training (HIT) | Experimental | Treadmill exercise using bursts of concentrated effort alternated with recovery periods Receives: Other: High-intensity interval training (HIT) |
| Traditional aerobic training | Active comparator | Moderate intensity continuous aerobic exercise on a treadmill Receives: Other: Traditional Aerobic Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Peak Aerobic Capacity (VO2-peak)
Measured: Baseline and 4 weeks
Secondary outcomes (6)
Change in Submaximal Aerobic Capacity (VO2 at Ventilatory Threshold)
Measured: Baseline and 4 weeks
Change in Gait Velocity (10 Meter Walk Test)
Measured: Baseline and 4 weeks
Change in 6-Minute Walk Test
distance walked in 6 minutes
Measured: Baseline and 4 weeks
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
Measured: Baseline and 4 weeks
Change in Fastest Treadmill Speed (Steep Ramp Test)
fastest safe treadmill walking speed
Measured: Baseline and 4 weeks
Change in Fractional Utilization
Metabolic cost of gait as a percentage of aerobic capacity
Measured: Baseline and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- American Physical Therapy Association, Children's Hospital Medical Center, Cincinnati
- Responsible party
- Principal investigator, Brett Kissela, University of Cincinnati
- Investigators
- Brett Kissela, MD, Principal investigator, University of CincinnatiKari Dunning, PhD, PT, Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01958606
- Sponsor's protocol ID
- HIT in chronic stroke
- Acronym
- HIT
- Status last verified
- Apr 2017
- First submitted
- 7 Oct 2013
- Last updated
- 15 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Intensity Interval Training in Chronic Stroke
- ClinicalTrials.gov ID
- NCT01958606
- Acronym / sponsor ID
- HIT / HIT in chronic stroke
- Conditions
- Stroke
- Keywords
- Stroke, Rehabilitation, Exercise, Intensity, Gait
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Collaborators
- American Physical Therapy Association, Children's Hospital Medical Center, Cincinnati
- Study start
- Oct 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 9 Oct 2013 (estimated)
- Results
- Posted 29 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-intensity interval training (HIT) | Experimental | Other: High-intensity interval training (HIT)Treadmill exercise using bursts of concentrated effort alternated with recovery periods |
| Traditional aerobic training | Active comparator | Other: Traditional Aerobic TrainingModerate intensity continuous aerobic exercise on a treadmill |
Who may qualify
- Ages
- 35 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-intensity interval training (HIT)Treadmill exercise using bursts of concentrated effort alternated with recovery periods | Other | High-intensity interval training (HIT) |
| Traditional Aerobic TrainingModerate intensity continuous aerobic exercise on a treadmill | Other | Traditional aerobic training |
Primary outcome
Change in Peak Aerobic Capacity (VO2-peak)
Time frame: Baseline and 4 weeks
6 secondary outcomes
Change in Submaximal Aerobic Capacity (VO2 at Ventilatory Threshold)
Time frame: Baseline and 4 weeks
Change in Gait Velocity (10 Meter Walk Test)
Time frame: Baseline and 4 weeks
Change in 6-Minute Walk Test
Time frame: Baseline and 4 weeks
Change in Gait Economy (Mean Oxygen Uptake at Comfortable Walking Speed)
Time frame: Baseline and 4 weeks
Change in Fastest Treadmill Speed (Steep Ramp Test)
Time frame: Baseline and 4 weeks
Change in Fractional Utilization
Time frame: Baseline and 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brett Kissela, MD principal investigator
University of Cincinnati
Kari Dunning, PhD, PT principal investigator
University of Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-intensity interval training (HIT) and Traditional Aerobic Training in people with Stroke, run by University of Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Peak Aerobic Capacity (VO2-peak) (time frame: Baseline and 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2017.