High-intensity Interval Training After Stroke

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

Tracking Information

• First Submitted Date: February 14, 2019
• First Posted Date: May 8, 2019
• Last Update Posted Date: May 9, 2019
• Actual Study Start Date: September 24, 2014
• Actual Primary Completion Date: June 8, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 6, 2019)

Change in Aerobic Capacity [ Time Frame: Baseline and 12 weeks ]

Whole-body oxygen consumption measured via a graded exercise test

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: High-intensity Interval Training After Stroke
• Official Title: High-intensity Interval Training for Adults With Chronic Stroke Impairments: A Pilot Feasibility Study
• 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.

• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

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

Condition

• Stroke, Ischemic
• Stroke Hemorrhagic

• Intervention: Behavioral: High-intensity interval training

Study Arms

• Experimental: High-intensity interval training
  Twice-weekly supervised high-intensity interval treadmill training in a laboratory setting for 10 weeks.
  Intervention: Behavioral: High-intensity interval training
• No Intervention: Control
  Usual activities for 10 weeks

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.
• 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.
• 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.
• Moholdt TT, Amundsen BH, Rustad LA, Wahba A, Løvø KT, Gullikstad LR, Bye A, Skogvoll E, Wisløff U, Slørdahl 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.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 6, 2019): 17
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: June 8, 2018
• Actual Primary Completion Date: June 8, 2018 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT03942588
• Other Study ID Numbers: 1002492
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Pamela Rogers Bosch, Northern Arizona University
• Study Sponsor: Northern Arizona University
• Collaborators: Arizona State University

Investigators

• Principal Investigator: Pamela R Bosch, PhD; Northern Arizona University

• PRS Account: Northern Arizona University
• Verification Date: May 2019