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High-intensity Interval Training After Stroke

Primary Purpose

Stroke, Ischemic, Stroke Hemorrhagic

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
High-intensity interval training
Sponsored by
Northern Arizona University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke, Ischemic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    High-intensity interval training

    Control

    Arm Description

    Twice-weekly supervised high-intensity interval treadmill training in a laboratory setting for 10 weeks.

    Usual activities for 10 weeks

    Outcomes

    Primary Outcome Measures

    Change in Aerobic Capacity
    Whole-body oxygen consumption measured via a graded exercise test

    Secondary Outcome Measures

    Full Information

    First Posted
    February 14, 2019
    Last Updated
    May 7, 2019
    Sponsor
    Northern Arizona University
    Collaborators
    Arizona State University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03942588
    Brief Title
    High-intensity Interval Training After Stroke
    Official Title
    High-intensity Interval Training for Adults With Chronic Stroke Impairments: A Pilot Feasibility Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    September 24, 2014 (Actual)
    Primary Completion Date
    June 8, 2018 (Actual)
    Study Completion Date
    June 8, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Northern Arizona University
    Collaborators
    Arizona State University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stroke, Ischemic, Stroke Hemorrhagic

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Exercise Intervention group and Usual Activity Control group
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    17 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    High-intensity interval training
    Arm Type
    Experimental
    Arm Description
    Twice-weekly supervised high-intensity interval treadmill training in a laboratory setting for 10 weeks.
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    Usual activities for 10 weeks
    Intervention Type
    Behavioral
    Intervention Name(s)
    High-intensity interval training
    Primary Outcome Measure Information:
    Title
    Change in Aerobic Capacity
    Description
    Whole-body oxygen consumption measured via a graded exercise test
    Time Frame
    Baseline and 12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Pamela R Bosch, PhD
    Organizational Affiliation
    Northern Arizona University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    25979162
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    28122885
    Citation
    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. Erratum In: Circulation. 2017 Mar 7;135(10 ):e646. Circulation. 2017 Sep 5;136(10 ):e196.
    Results Reference
    background
    PubMed Identifier
    23150062
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    19958872
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    21131249
    Citation
    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.
    Results Reference
    background
    Links:
    URL
    https://doi.org/10.1016/j.apmr.2017.08.022
    Description
    Conference Abstract

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    High-intensity Interval Training After Stroke

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