High Intensity Interval Training After Stroke

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Behavioral: High intensity interval training; Behavioral: General information

• Registration Number: NCT02550015
• Lead Sponsor: Norwegian University of Science and Technology

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 Timeline

• Study Start: 2015-09
• Study First Submitted: 2015-09-08
• Study First Submitted QC: 2015-09-14
• Study First Posted: 2015-09-15
• Primary Completion: 2018-12-02
• Study Completion: 2018-12-02
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-09
• Last Update Posted: 2020-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Training	High intensity interval 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
standard care	General information	Standard clinical follow-up care, including general information about importance of physical activity as part of a healthy lifestyle

Primary Outcome Measures

Name	Time	Method
Maximal Oxygen Uptake	1 year after inclusion	A graded treadmill test of maximal oxygen uptake using a breath by breath ergospirometer

Secondary Outcome Measures

Name	Time	Method
Change in blood pressure (systolic and diastolic)	8 weeks and 12 months after inclusion	Blood pressure will be measured at rest
Walking speed	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.
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	Walking distance (in meters) will be measured with the 6 minute walk test.
Leisure time activity and inactive time	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.
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	The following blood tests will be taken: Hemoglobin, HDL, LDL, Cholesterol, Total Cholesterol, C peptides, Triglycerides and HbA1c
Self reported physical activity level assessed by International Physical Activity Questionnaire	8 weeks and 12 months after inclusion

Trial Locations

Locations (1)

Department of Neuroscience; 🇳🇴 Trondheim, Norway