NCT03942588

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2014

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 24, 2014

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 8, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 8, 2018

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 14, 2019

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 8, 2019

Completed
Last Updated

May 9, 2019

Status Verified

May 1, 2019

Enrollment Period

3.7 years

First QC Date

February 14, 2019

Last Update Submit

May 7, 2019

Conditions

Stroke, IschemicStroke Hemorrhagic

Outcome Measures

Primary Outcomes (1)

  • Change in Aerobic Capacity

    Whole-body oxygen consumption measured via a graded exercise test

    Baseline and 12 weeks

Study Arms (2)

High-intensity interval training

EXPERIMENTAL

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

Behavioral: High-intensity interval training

Control

NO INTERVENTION

Usual activities for 10 weeks

Interventions

High-intensity interval trainingBEHAVIORAL
High-intensity interval training

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • 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.

    PMID: 25979162BACKGROUND

  • 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. doi: 10.1161/CIR.0000000000000491. Circulation. 2017 Sep 5;136(10):e196. doi: 10.1161/CIR.0000000000000530.

    PMID: 28122885BACKGROUND

  • 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.

    PMID: 23150062BACKGROUND

  • 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.

    PMID: 19958872BACKGROUND

  • 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.

    PMID: 21131249BACKGROUND

Related Links

MeSH Terms

Conditions

Ischemic StrokeHemorrhagic Stroke

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Pamela R Bosch, PhD

    Northern Arizona University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Exercise Intervention group and Usual Activity Control group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 14, 2019

First Posted

May 8, 2019

Study Start

September 24, 2014

Primary Completion

June 8, 2018

Study Completion

June 8, 2018

Last Updated

May 9, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share