StrokeNCT02550015
High Intensity Interval Training After Stroke
A study testing High intensity interval training and General information in people with Stroke, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
The purpose of this study is to examine if high intensity interval training after stroke is more effective than standard care to increase maximal oxygen uptake, reduce known risk factors for recurrent stroke and improve function. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stroke
- What is being tested?
- High intensity interval training and General information
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteNorway
- Study dates
- Sep 2015to 2 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Approved informed consent
- Independent walking > 2 minutes
- First episode of stroke (ischemic or hemorrhagic)
- Minimum 3 months post-stroke
- Living in the community and able to travel to assessment and training site
- Approval to participate from the study's responsible medical doctor
- Modified Rankin Scale 0-3
Who cannot join
- Impaired cognitive function to give valid informed consent to participate
- Instability of cardiac conditions (ie. serious rhythm disorder, valve malfunction)
- Other conditions where test of maximal oxygen uptake is contraindicated
- Poorly controlled hypertension (>180/100), measured at rest
- > 5 years post stroke
- Subarachnoid hemorrhage
- Participating in other ongoing intervention study
- Other serious illness influencing testing of cardiorespiratory fitness and function at 1 year follow-up
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of High Intensity Interval Training on Maximal Oxygen Uptake and Risk Factors for Recurrent Stroke
The purpose of this study is to examine if high intensity interval training after stroke is more effective than standard care to increase maximal oxygen uptake, reduce known risk factors for recurrent stroke and improve function.
Read the detailed description
Stroke is a leading cause of adult disability. Well designed studies have shown that the majority of the stroke population have low aerobic capacity and many are inactive. This is negative for their health and well-being. Physical inactivity may increase their risk of having recurrent stroke.
The optimal training mode and intensity to improve aerobic capacity after stroke are not clear. High intensity interval training (ie. 90-95% of peak heart rate) has been proven to be more beneficial than moderate and low intensity exercise in order to improve maximal oxygen uptake in patients with cardiac disease. The response from this training on aerobic capacity and physical function in the stroke population are not known.
- Conditions
- Stroke
- Being tested
- High intensity interval training, General information
- Keywords
- Exercise training, Oxygen consumption
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High intensity interval trainingBehavioural
Uphill treadmill walking
General informationBehavioural
Standard care
| Study group | Role | What they receive |
|---|---|---|
| Training | Experimental | Supervised high intensity interval training (uphill treadmill walking 4 x 4 min at 90-95% of peak heart rate) 3 times weekly for 8 weeks Receives: Behavioral: High intensity interval training |
| standard care | Other | Standard clinical follow-up care, including general information about importance of physical activity as part of a healthy lifestyle Receives: Behavioral: General information |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal Oxygen Uptake
A graded treadmill test of maximal oxygen uptake using a breath by breath ergospirometer
Measured: 1 year after inclusion
Secondary outcomes (9)
Change in blood pressure (systolic and diastolic)
Blood pressure will be measured at rest
Measured: 8 weeks and 12 months after inclusion
Walking speed
Walking speed (in minutes:seconds) will be measured with the 10 meter walk test and the Timed Up and Go test.
Measured: 8 weeks and 12 months after inclusion
Leisure time activity and inactive time
Using the ActivePal monitor attached to the participants non-affected leg information on position, walking and inactive time will be measured during 3 whole consecutive days.
Measured: 8 weeks and 12 months after inclusion
Balance tested with the Bergs Balance Test
Measured: 8 weeks and 12 months after inclusion
Change in Blood tests
The following blood tests will be taken: Hemoglobin, HDL, LDL, Cholesterol, Total Cholesterol, C peptides, Triglycerides and HbA1c
Measured: 8 weeks and 12 months after inclusion
Independence assessed by Functional Independence Measure (FIM)
Measured: 8 weeks and 12 months after inclusion
Self reported physical activity level assessed by International Physical Activity Questionnaire
Measured: 8 weeks and 12 months after inclusion
Cognitive function assessed by Montreal Cognitive Assessment and Trail Making A and B
Measured: 8 weeks and 12 months after inclusion
Walking distance
Walking distance (in meters) will be measured with the 6 minute walk test.
Measured: 8 weeks and 12 months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2015 (estimated)
- Study startSep 2015
- Primary completion2 Dec 2018
- Study completion2 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Torunn Askim, phd, Study director, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02550015
- Sponsor's protocol ID
- 2015/563
- Status last verified
- Mar 2020
- First submitted
- 8 Sep 2015
- Last updated
- 10 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gjellesvik TI, Becker F, Tjonna AE, Indredavik B, Nilsen H, Brurok B, Torhaug T, Busuladzic M, Lydersen S, Askim T. Effects of High-Intensity Interval Training After Stroke (the HIIT-Stroke Study): A Multicenter Randomized Controlled Trial. Arch Phys Med Rehabil. 2020 Jun;101(6):939-947. doi: 10.1016/j.apmr.2020.02.006. Epub 2020 Mar 4.
PubMed 32145280
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of High Intensity Interval Training on Maximal Oxygen Uptake and Risk Factors for Recurrent Stroke
- ClinicalTrials.gov ID
- NCT02550015
- Acronym / sponsor ID
- 2015/563
- Conditions
- Stroke
- Keywords
- Exercise training, Oxygen consumption
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Study start
- Sep 2015 (actual)
- Primary completion
- 2 Dec 2018 (actual)
- Study completion
- 2 Dec 2018 (actual)
- First posted
- 15 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examine if high intensity interval training after stroke is more effective than standard care to increase maximal oxygen uptake, reduce known risk factors for recurrent stroke and improve function.
Detailed description
Stroke is a leading cause of adult disability. Well designed studies have shown that the majority of the stroke population have low aerobic capacity and many are inactive. This is negative for their health and well-being. Physical inactivity may increase their risk of having recurrent stroke.
The optimal training mode and intensity to improve aerobic capacity after stroke are not clear. High intensity interval training (ie. 90-95% of peak heart rate) has been proven to be more beneficial than moderate and low intensity exercise in order to improve maximal oxygen uptake in patients with cardiac disease. The response from this training on aerobic capacity and physical function in the stroke population are not known.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training | Experimental | Behavioral: High intensity interval trainingSupervised high intensity interval training (uphill treadmill walking 4 x 4 min at 90-95% of peak heart rate) 3 times weekly for 8 weeks |
| standard care | Other | Behavioral: General informationStandard clinical follow-up care, including general information about importance of physical activity as part of a healthy lifestyle |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Approved informed consent
- Independent walking > 2 minutes
- First episode of stroke (ischemic or hemorrhagic)
- Minimum 3 months post-stroke
- Living in the community and able to travel to assessment and training site
Key exclusion criteria (8 listed)
- Impaired cognitive function to give valid informed consent to participate
- Instability of cardiac conditions (ie. serious rhythm disorder, valve malfunction)
- Other conditions where test of maximal oxygen uptake is contraindicated
- Poorly controlled hypertension (>180/100), measured at rest
- > 5 years post stroke
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 trainingUphill treadmill walking | Behavioural | Training |
| General informationStandard care | Behavioural | standard care |
Primary outcome
Maximal Oxygen Uptake
Time frame: 1 year after inclusion
A graded treadmill test of maximal oxygen uptake using a breath by breath ergospirometer
9 secondary outcomes
Change in blood pressure (systolic and diastolic)
Time frame: 8 weeks and 12 months after inclusion
Walking speed
Time frame: 8 weeks and 12 months after inclusion
Leisure time activity and inactive time
Time frame: 8 weeks and 12 months after inclusion
Balance tested with the Bergs Balance Test
Time frame: 8 weeks and 12 months after inclusion
Change in Blood tests
Time frame: 8 weeks and 12 months after inclusion
Independence assessed by Functional Independence Measure (FIM)
Time frame: 8 weeks and 12 months after inclusion
Self reported physical activity level assessed by International Physical Activity Questionnaire
Time frame: 8 weeks and 12 months after inclusion
Cognitive function assessed by Montreal Cognitive Assessment and Trail Making A and B
Time frame: 8 weeks and 12 months after inclusion
Walking distance
Time frame: 8 weeks and 12 months after inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2020.
- Results publication: PubMed 32145280Gjellesvik TI, Becker F, Tjonna AE, Indredavik B, Nilsen H, Brurok B, Torhaug T, Busuladzic M, Lydersen S, Askim T. Effects of High-Intensity Interval Training After Stroke (the HIIT-Stroke Study): A Multicenter Randomized Controlled Trial. Arch Phys Med Rehabil. 2020 Jun;101(6):939-947. doi: 10.1016/j.apmr.2020.02.006. Epub 2020 Mar 4.
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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.
Torunn Askim, phd study director
Norwegian University of Science and Technology
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 and General information in people with Stroke, run by Norwegian University of Science and Technology at 1 site in Norway.
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 7 inclusion and 8 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 10 Mar 2020. 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 Norway. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Maximal Oxygen Uptake (time frame: 1 year after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02550015, which also lists 1 linked publication.
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 10 Mar 2020.