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Completed

NCT Number: NCT02550015

High Intensity Interval Training After Stroke

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Neuroscience

Trondheim, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High Intensity Interval Training

Behavioral

Uphill treadmill walking

General information

Behavioral

Standard care

Primary outcomes

  1. 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

  1. Change in blood pressure (systolic and diastolic)

    Time frame: 8 weeks and 12 months after inclusion

    Blood pressure will be measured at rest

  2. Walking speed

    Time frame: 8 weeks and 12 months after inclusion

    Walking speed (in minutes:seconds) will be measured with the 10 meter walk test and the Timed Up and Go test.

  3. Leisure time activity and inactive time

    Time frame: 8 weeks and 12 months after inclusion

    Using the ActivePal monitor attached to the participants non-affected leg information on position, walking and inactive time will be measured during 3 whole consecutive days.

  4. Balance tested with the Bergs Balance Test

    Time frame: 8 weeks and 12 months after inclusion

  5. Change in Blood tests

    Time frame: 8 weeks and 12 months after inclusion

    The following blood tests will be taken: Hemoglobin, HDL, LDL, Cholesterol, Total Cholesterol, C peptides, Triglycerides and HbA1c

  6. Independence assessed by Functional Independence Measure (FIM)

    Time frame: 8 weeks and 12 months after inclusion

  7. Self reported physical activity level assessed by International Physical Activity Questionnaire

    Time frame: 8 weeks and 12 months after inclusion

  8. Cognitive function assessed by Montreal Cognitive Assessment and Trail Making A and B

    Time frame: 8 weeks and 12 months after inclusion

  9. Walking distance

    Time frame: 8 weeks and 12 months after inclusion

    Walking distance (in meters) will be measured with the 6 minute walk test.

Other outcomes

  1. New cardiovascular or cerebrovascular incidents

    Time frame: 8 weeks and 12 months after inclusion

    Gathered from the participants and their electronic journal system

  2. Severity of stroke

    Time frame: 8 weeks and 12 months after inclusion

    The Stroke Impact Scale will be used to evaluate how the stroke has affected the participants' health and life in addition to the National Institute of Health Stroke scale

  3. Anxiety and depression after stroke

    Time frame: 8 weeks and 12 months after inclusion

    Hospital and Anxiety and Depression Scale will be used to get information about the participants level of anxiety and depression

  4. Degree of disability and dependence

    Time frame: 8 weeks and 12 months after inclusion

    Modified Rankin Scale (mRS)

  5. Health status assessed by The Norwegian version of EQ-5D-5L questionnaire

    Time frame: 8 weeks and 12 months after inclusion

  6. Submaximal oxygen consumption during treadmill walking

    Time frame: 8 weeks and 12 months after inclusion

    Oxygen consumption will be measured at a standardized speed and inclination.

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Sep 15, 2015
Registry last updated
Mar 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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