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High-intensity Interval Training After Stroke

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ClinicalTrials.gov Identifier: NCT03942588
Recruitment Status : Completed
First Posted : May 8, 2019
Last Update Posted : May 9, 2019
Sponsor:
Collaborator:
Arizona State University
Information provided by (Responsible Party):
Pamela Rogers Bosch, Northern Arizona University

Study Description
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Brief 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 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.

Condition or disease Intervention/treatment Phase
Stroke, Ischemic Stroke Hemorrhagic Behavioral: High-intensity interval training Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Exercise Intervention group and Usual Activity Control group
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: High-intensity Interval Training for Adults With Chronic Stroke Impairments: A Pilot Feasibility Study
Actual Study Start Date : September 24, 2014
Actual Primary Completion Date : June 8, 2018
Actual Study Completion Date : June 8, 2018
Arms and Interventions
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Arm Intervention/treatment
Experimental: High-intensity interval training
Twice-weekly supervised high-intensity interval treadmill training in a laboratory setting for 10 weeks.
 Behavioral: High-intensity interval training
No Intervention: Control
Usual activities for 10 weeks


Outcome Measures
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Primary Outcome Measures :
  1. Change in Aerobic Capacity [ Time Frame: Baseline and 12 weeks ]
    Whole-body oxygen consumption measured via a graded exercise test


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03942588


Sponsors and Collaborators
Northern Arizona University
Arizona State University
Investigators
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Principal Investigator: Pamela R Bosch, PhD Northern Arizona University
More Information
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Additional Information:

Publications:
Benjamin EJ, Blaha MJ, Chiuve SE, Cushman M, Das SR, Deo R, de Ferranti SD, Floyd J, Fornage M, Gillespie C, Isasi CR, Jiménez 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. Review. Erratum in: Circulation. 2017 Mar 7;135(10 ):e646. Circulation. 2017 Sep 5;136(10 ):e196.

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Responsible Party: Pamela Rogers Bosch, Associate Professor, Northern Arizona University
ClinicalTrials.gov Identifier: NCT03942588    
Other Study ID Numbers: 1002492
First Posted: May 8, 2019    Key Record Dates
Last Update Posted: May 9, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stroke
Ischemic Stroke
Hemorrhagic Stroke
Cerebrovascular Disorders
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases