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Clinical Trials/NCT02550015
NCT02550015CompletedNot Applicable

The Effect of High Intensity Interval Training on Maximal Oxygen Uptake and Risk Factors for Recurrent Stroke

Norwegian University of Science and Technology1 site in 1 country70 target enrollmentStarted: September 2015Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
70
Locations
1
Primary Endpoint
Maximal Oxygen Uptake

Study Overview

Brief Summary

The purpose of this study is to examine if high intensity interval training after stroke is more effective than standard care to increase maximal oxygen uptake, reduce known risk factors for recurrent stroke and improve function.

Detailed Description

Stroke is a leading cause of adult disability. Well designed studies have shown that the majority of the stroke population have low aerobic capacity and many are inactive. This is negative for their health and well-being. Physical inactivity may increase their risk of having recurrent stroke.

The optimal training mode and intensity to improve aerobic capacity after stroke are not clear. High intensity interval training (ie. 90-95% of peak heart rate) has been proven to be more beneficial than moderate and low intensity exercise in order to improve maximal oxygen uptake in patients with cardiac disease. The response from this training on aerobic capacity and physical function in the stroke population are not known.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Approved informed consent
  • Independent walking > 2 minutes
  • First episode of stroke (ischemic or hemorrhagic)
  • Minimum 3 months post-stroke
  • Living in the community and able to travel to assessment and training site
  • Approval to participate from the study's responsible medical doctor
  • Modified Rankin Scale 0-3

Exclusion Criteria

  • Impaired cognitive function to give valid informed consent to participate
  • Instability of cardiac conditions (ie. serious rhythm disorder, valve malfunction)
  • Other conditions where test of maximal oxygen uptake is contraindicated
  • Poorly controlled hypertension (>180/100), measured at rest
  • > 5 years post stroke
  • Subarachnoid hemorrhage
  • Participating in other ongoing intervention study
  • Other serious illness influencing testing of cardiorespiratory fitness and function at 1 year follow-up

Outcomes

Primary Outcomes

Maximal Oxygen Uptake

Time Frame: 1 year after inclusion

A graded treadmill test of maximal oxygen uptake using a breath by breath ergospirometer

Secondary Outcomes

  • Walking speed(8 weeks and 12 months after inclusion)
  • Independence assessed by Functional Independence Measure (FIM)(8 weeks and 12 months after inclusion)
  • Cognitive function assessed by Montreal Cognitive Assessment and Trail Making A and B(8 weeks and 12 months after inclusion)
  • Walking distance(8 weeks and 12 months after inclusion)
  • Leisure time activity and inactive time(8 weeks and 12 months after inclusion)
  • Balance tested with the Bergs Balance Test(8 weeks and 12 months after inclusion)
  • Change in Blood tests(8 weeks and 12 months after inclusion)
  • Change in blood pressure (systolic and diastolic)(8 weeks and 12 months after inclusion)
  • Self reported physical activity level assessed by International Physical Activity Questionnaire(8 weeks and 12 months after inclusion)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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