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Stroke, IschemicNCT03942588

High-intensity Interval Training After Stroke

A study testing High-intensity interval training in people with Stroke, Ischemic and Stroke Hemorrhagic, run by Northern Arizona University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Aerobic conditioning is very important after stroke as it may reduce the risk of subsequent stroke and overall mortality. High-intensity interval training (HIIT), in which aerobic training workload is varied between lower and higher intensity bouts within a training session, is known to be effective for maximizing… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stroke, Ischemic, Stroke Hemorrhagic
What is being tested?
High-intensity interval training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
17 participants
Where
No sites listed yet
Study dates
24 Sep 2014to 8 Jun 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male and female adults 18 years of age or older who had a unilateral stroke at least 6 months prior to enrollment
  • Ability to provide informed consent and follow instructions to participate
  • Medically stable
  • Must be able to walk with no more than contact guard assistance on level surfaces
  • Must be willing to walk on a treadmill with a support harness and handrail

Who cannot join

  • Cerebellar stroke
  • Medical instability
  • Implanted pacemaker or defibrillator
  • Inability to walk on a treadmill with a support harness and use of handrail for at least 5 minutes
  • Absence of walking impairments
  • Abnormal resting heart rate, blood pressure or ECG
  • Abnormal ECG during graded exercise test

About this study

Official title: High-intensity Interval Training for Adults With Chronic Stroke Impairments: A Pilot Feasibility Study

Aerobic conditioning is very important after stroke as it may reduce the risk of subsequent stroke and overall mortality. High-intensity interval training (HIIT), in which aerobic training workload is varied between lower and higher intensity bouts within a training session, is known to be effective for maximizing aerobic capacity in healthy individuals and those with cardiac disease. HIIT has not been studied extensively in adults with stroke, but it could be an efficient way to maximize aerobic capacity in this population. Furthermore, using heart rate response to establish training intensity may lead to underestimation of target intensity after stroke because blood pressure medications may blunt the heart rate response. Ventilatory threshold is an alternate method of establishing training intensity and is derived independently of heart rate response. The investigators hypothesized that a 10-week program of treadmill HIIT with intensity based on ventilatory threshold would be feasible in adults at least 6 months post-stroke, and would increase aerobic capacity.

Read the detailed description

Stroke is the main cause of serious, long-term disability among Americans. The effects of a stroke make it difficult to participate in routine, daily activities so people become seriously deconditioned after a stroke. This increases the chances of having another stroke and it also increases the risk of death. Even a small increase in aerobic capacity reduces these risks, making aerobic training an important component of post-stroke management.

Twenty to 60 minutes of moderate-intensity exercise on most days of the week is recommended for people with cardiovascular disease, but this is not very practical for many people after a stroke, who need to practice functional tasks like using the impaired arm and improving walking and balance. Another problem is that even when people do participate in aerobic training after a stroke, the improvements in aerobic capacity are sometimes surprisingly small. It is possible that the intensity of the training program was inadequate to improve aerobic capacity in some interventions. High-intensity interval training, in which people alternate between short, intense bouts of exercise and recovery bouts within the session, may be a way to improve aerobic capacity after a stroke with a more feasible training schedule that leaves time to practice functional skills too. High-intensity interval training on a treadmill might be appropriate to improve aerobic capacity and walking ability.

This non-randomized, non-blinded pilot study was designed to assess the feasibility of ten weeks of high-intensity interval training (HIIT) using treadmill training for adults with impaired walking who were at least 6 months post-stroke.

A secondary objective was to measure change in aerobic capacity, and a tertiary objective was to measure functional change in self-selected walking speed and leg strength as a result of the intervention.

10 participants completed HIIT intervention while 5 participants served as controls and received no intervention, but completed both baseline and post-testing sessions.

HIIT participants completed twice-weekly, 35-minute training sessions in a research laboratory for 10 consecutive weeks. At baseline and 12 weeks, all participants completed a graded exercise test, 10-meter walk test at self-selected and fastest, safe overground walking speeds, and a 30-second sit-to-stand test.

Being tested
High-intensity interval training
Medical subject headings
Ischemic Stroke, Hemorrhagic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • High-intensity interval trainingBehavioural

Study groups in NCT03942588
Study groupRoleWhat they receive
High-intensity interval trainingExperimentalTwice-weekly supervised high-intensity interval treadmill training in a laboratory setting for 10 weeks.
Receives: Behavioral: High-intensity interval training
ControlNo interventionUsual activities for 10 weeks

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Aerobic Capacity

    Whole-body oxygen consumption measured via a graded exercise test

    Measured: Baseline and 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 May 2019
  2. Study start24 Sep 2014
  3. Primary completion8 Jun 2018
  4. Study completion8 Jun 2018

Resources

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
Non-randomised
Intervention model
Parallel groups
Model description
Exercise Intervention group and Usual Activity Control group
Masking
None (open label)
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03942588
Sponsor's protocol ID
1002492
Status last verified
May 2019
First submitted
14 Feb 2019
Last updated
9 May 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bosch PR, Holzapfel S, Traustadottir T. Feasibility of Measuring Ventilatory Threshold in Adults With Stroke-Induced Hemiparesis: Implications for Exercise Prescription. Arch Phys Med Rehabil. 2015 Oct;96(10):1779-84. doi: 10.1016/j.apmr.2015.04.023. Epub 2015 May 12.

    PubMed 25979162

  • Benjamin EJ, Blaha MJ, Chiuve SE, Cushman M, Das SR, Deo R, de Ferranti SD, Floyd J, Fornage M, Gillespie C, Isasi CR, Jimenez MC, Jordan LC, Judd SE, Lackland D, Lichtman JH, Lisabeth L, Liu S, Longenecker CT, Mackey RH, Matsushita K, Mozaffarian D, Mussolino ME, Nasir K, Neumar RW, Palaniappan L, Pandey DK, Thiagarajan RR, Reeves MJ, Ritchey M, Rodriguez CJ, Roth GA, Rosamond WD, Sasson C, Towfighi A, Tsao CW, Turner MB, Virani SS, Voeks JH, Willey JZ, Wilkins JT, Wu JH, Alger HM, Wong SS, Muntner P; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2017 Update: A Report From the American Heart Association. Circulation. 2017 Mar 7;135(10):e146-e603. doi: 10.1161/CIR.0000000000000485. Epub 2017 Jan 25. No abstract available.

    PubMed 28122885

  • Tang A, Marzolini S, Oh P, McIlroy WE, Brooks D. Factors associated with change in aerobic capacity following an exercise program for individuals with stroke. J Rehabil Med. 2013 Jan;45(1):32-7. doi: 10.2340/16501977-1053.

    PubMed 23150062

  • Moholdt TT, Amundsen BH, Rustad LA, Wahba A, Lovo KT, Gullikstad LR, Bye A, Skogvoll E, Wisloff U, Slordahl SA. Aerobic interval training versus continuous moderate exercise after coronary artery bypass surgery: a randomized study of cardiovascular effects and quality of life. Am Heart J. 2009 Dec;158(6):1031-7. doi: 10.1016/j.ahj.2009.10.003.

    PubMed 19958872

  • Calmels P, Degache F, Courbon A, Roche F, Ramas J, Fayolle-Minon I, Devillard X. The feasibility and the effects of cycloergometer interval-training on aerobic capacity and walking performance after stroke. Preliminary study. Ann Phys Rehabil Med. 2011 Feb;54(1):3-15. doi: 10.1016/j.rehab.2010.09.009. Epub 2010 Nov 18. English, French.

    PubMed 21131249

Questions about this trial

What is this clinical trial studying?

A study testing High-intensity interval training in people with Stroke, Ischemic and Stroke Hemorrhagic, run by Northern Arizona University.

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 5 inclusion and 7 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 9 May 2019. Status can change between updates, so confirm with the study contact before making plans.

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?

Change in Aerobic Capacity (time frame: Baseline and 12 weeks). 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 NCT03942588, which also lists 5 linked publications.

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 9 May 2019.

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