High Intensity Interval Training After Stroke

March 9, 2020 updated by: Norwegian University of Science and Technology

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Trondheim, Norway
        • Department of Neuroscience

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Training
Supervised high intensity interval training (uphill treadmill walking 4 x 4 min at 90-95% of peak heart rate) 3 times weekly for 8 weeks
Behavioral: High intensity interval training
Uphill treadmill walking
Other: standard care
Standard clinical follow-up care, including general information about importance of physical activity as part of a healthy lifestyle
Behavioral: General information
Standard care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximal Oxygen Uptake
Time Frame: 1 year after inclusion
A graded treadmill test of maximal oxygen uptake using a breath by breath ergospirometer
1 year after inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in blood pressure (systolic and diastolic)
Time Frame: 8 weeks and 12 months after inclusion
Blood pressure will be measured at rest
8 weeks and 12 months after inclusion
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.
8 weeks and 12 months after inclusion
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.
8 weeks and 12 months after inclusion
Balance tested with the Bergs Balance Test
Time Frame: 8 weeks and 12 months after inclusion
8 weeks and 12 months after inclusion
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
8 weeks and 12 months after inclusion
Independence assessed by Functional Independence Measure (FIM)
Time Frame: 8 weeks and 12 months after inclusion
8 weeks and 12 months after inclusion
Self reported physical activity level assessed by International Physical Activity Questionnaire
Time Frame: 8 weeks and 12 months after inclusion
8 weeks and 12 months after inclusion
Cognitive function assessed by Montreal Cognitive Assessment and Trail Making A and B
Time Frame: 8 weeks and 12 months after inclusion
8 weeks and 12 months after inclusion
Walking distance
Time Frame: 8 weeks and 12 months after inclusion
Walking distance (in meters) will be measured with the 6 minute walk test.
8 weeks and 12 months after inclusion

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
New cardiovascular or cerebrovascular incidents
Time Frame: 8 weeks and 12 months after inclusion
Gathered from the participants and their electronic journal system
8 weeks and 12 months after inclusion
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
8 weeks and 12 months after inclusion
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
8 weeks and 12 months after inclusion
Degree of disability and dependence
Time Frame: 8 weeks and 12 months after inclusion
Modified Rankin Scale (mRS)
8 weeks and 12 months after inclusion
Health status assessed by The Norwegian version of EQ-5D-5L questionnaire
Time Frame: 8 weeks and 12 months after inclusion
8 weeks and 12 months after inclusion
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.
8 weeks and 12 months after inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Norwegian University of Science and Technology

Investigators

  • Study Director: Torunn Askim, phd, Norwegian University of Science and Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2015

Primary Completion (Actual)

December 2, 2018

Study Completion (Actual)

December 2, 2018

Study Registration Dates

First Submitted

September 8, 2015

First Submitted That Met QC Criteria

September 14, 2015

First Posted (Estimate)

September 15, 2015

Study Record Updates

Last Update Posted (Actual)

March 10, 2020

Last Update Submitted That Met QC Criteria

March 9, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015/563

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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