Back to resultsHigh Intensity Interval Training After Stroke
Primary Purpose
Stroke
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
High intensity interval training
General information
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring Exercise training, Oxygen consumption
Eligibility Criteria
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
Sites / Locations
- Department of Neuroscience
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Training
standard care
Arm Description
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
Standard clinical follow-up care, including general information about importance of physical activity as part of a healthy lifestyle
Outcomes
Primary Outcome Measures
Maximal Oxygen Uptake
A graded treadmill test of maximal oxygen uptake using a breath by breath ergospirometer
Secondary Outcome Measures
Change in blood pressure (systolic and diastolic)
Blood pressure will be measured at rest
Walking speed
Walking speed (in minutes:seconds) will be measured with the 10 meter walk test and the Timed Up and Go test.
Leisure time activity and inactive time
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.
Balance tested with the Bergs Balance Test
Change in Blood tests
The following blood tests will be taken: Hemoglobin, HDL, LDL, Cholesterol, Total Cholesterol, C peptides, Triglycerides and HbA1c
Independence assessed by Functional Independence Measure (FIM)
Self reported physical activity level assessed by International Physical Activity Questionnaire
Cognitive function assessed by Montreal Cognitive Assessment and Trail Making A and B
Walking distance
Walking distance (in meters) will be measured with the 6 minute walk test.
Full Information
NCT ID
NCT02550015
First Posted
September 8, 2015
Last Updated
March 9, 2020
Sponsor
Norwegian University of Science and Technology
1. Study Identification
Unique Protocol Identification Number
NCT02550015
Brief Title
High Intensity Interval Training After Stroke
Official Title
The Effect of High Intensity Interval Training on Maximal Oxygen Uptake and Risk Factors for Recurrent Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
September 2015 (Actual)
Primary Completion Date
December 2, 2018 (Actual)
Study Completion Date
December 2, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Exercise training, Oxygen consumption
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Training
Arm Type
Experimental
Arm Description
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
Arm Title
standard care
Arm Type
Other
Arm Description
Standard clinical follow-up care, including general information about importance of physical activity as part of a healthy lifestyle
Intervention Type
Behavioral
Intervention Name(s)
High intensity interval training
Intervention Description
Uphill treadmill walking
Intervention Type
Behavioral
Intervention Name(s)
General information
Intervention Description
Standard care
Primary Outcome Measure Information:
Title
Maximal Oxygen Uptake
Description
A graded treadmill test of maximal oxygen uptake using a breath by breath ergospirometer
Time Frame
1 year after inclusion
Secondary Outcome Measure Information:
Title
Change in blood pressure (systolic and diastolic)
Description
Blood pressure will be measured at rest
Time Frame
8 weeks and 12 months after inclusion
Title
Walking speed
Description
Walking speed (in minutes:seconds) will be measured with the 10 meter walk test and the Timed Up and Go test.
Time Frame
8 weeks and 12 months after inclusion
Title
Leisure time activity and inactive time
Description
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.
Time Frame
8 weeks and 12 months after inclusion
Title
Balance tested with the Bergs Balance Test
Time Frame
8 weeks and 12 months after inclusion
Title
Change in Blood tests
Description
The following blood tests will be taken: Hemoglobin, HDL, LDL, Cholesterol, Total Cholesterol, C peptides, Triglycerides and HbA1c
Time Frame
8 weeks and 12 months after inclusion
Title
Independence assessed by Functional Independence Measure (FIM)
Time Frame
8 weeks and 12 months after inclusion
Title
Self reported physical activity level assessed by International Physical Activity Questionnaire
Time Frame
8 weeks and 12 months after inclusion
Title
Cognitive function assessed by Montreal Cognitive Assessment and Trail Making A and B
Time Frame
8 weeks and 12 months after inclusion
Title
Walking distance
Description
Walking distance (in meters) will be measured with the 6 minute walk test.
Time Frame
8 weeks and 12 months after inclusion
Other Pre-specified Outcome Measures:
Title
New cardiovascular or cerebrovascular incidents
Description
Gathered from the participants and their electronic journal system
Time Frame
8 weeks and 12 months after inclusion
Title
Severity of stroke
Description
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
Time Frame
8 weeks and 12 months after inclusion
Title
Anxiety and depression after stroke
Description
Hospital and Anxiety and Depression Scale will be used to get information about the participants level of anxiety and depression
Time Frame
8 weeks and 12 months after inclusion
Title
Degree of disability and dependence
Description
Modified Rankin Scale (mRS)
Time Frame
8 weeks and 12 months after inclusion
Title
Health status assessed by The Norwegian version of EQ-5D-5L questionnaire
Time Frame
8 weeks and 12 months after inclusion
Title
Submaximal oxygen consumption during treadmill walking
Description
Oxygen consumption will be measured at a standardized speed and inclination.
Time Frame
8 weeks and 12 months after inclusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Torunn Askim, phd
Organizational Affiliation
Norwegian University of Science and Technology
Official's Role
Study Director
Facility Information:
Facility Name
Department of Neuroscience
City
Trondheim
Country
Norway
12. IPD Sharing Statement
Citations:
PubMed Identifier
32145280
Citation
Gjellesvik TI, Becker F, Tjonna AE, Indredavik B, Nilsen H, Brurok B, Torhaug T, Busuladzic M, Lydersen S, Askim T. Effects of High-Intensity Interval Training After Stroke (the HIIT-Stroke Study): A Multicenter Randomized Controlled Trial. Arch Phys Med Rehabil. 2020 Jun;101(6):939-947. doi: 10.1016/j.apmr.2020.02.006. Epub 2020 Mar 4.
Results Reference
result
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High Intensity Interval Training After Stroke
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