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
About this trial
This is an interventional treatment trial for Stroke, Ischemic
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
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
NCT ID
NCT03942588
First Posted
February 14, 2019
Last Updated
May 7, 2019
Sponsor
Northern Arizona University
Collaborators
Arizona State University
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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