High Intensity Interval Training After Stroke

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02550015
• Other study ID #: 2015/563
• Status: Completed
• Phase: N/A
• Start date: September 2015
• Est. completion date: December 2, 2018

Study information

• Verified date: March 2020
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 2, 2018
• Est. primary completion date: December 2, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Behavioral:
• High intensity interval training
Uphill treadmill walking
• General information
Standard care

Locations

Country	Name	City	State
Norway	Department of Neuroscience	Trondheim

Sponsors (1)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology

Country where clinical trial is conducted

Norway, 

References & Publications (1)

Gjellesvik TI, Becker F, Tjønna AE, Indredavik B, Nilsen H, Brurok B, Tørhaug 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	New cardiovascular or cerebrovascular incidents	Gathered from the participants and their electronic journal system	8 weeks and 12 months after inclusion
Other	Severity of stroke	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
Other	Anxiety and depression after stroke	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
Other	Degree of disability and dependence	Modified Rankin Scale (mRS)	8 weeks and 12 months after inclusion
Other	Health status assessed by The Norwegian version of EQ-5D-5L questionnaire		8 weeks and 12 months after inclusion
Other	Submaximal oxygen consumption during treadmill walking	Oxygen consumption will be measured at a standardized speed and inclination.	8 weeks and 12 months after inclusion
Primary	Maximal Oxygen Uptake	A graded treadmill test of maximal oxygen uptake using a breath by breath ergospirometer	1 year after inclusion
Secondary	Change in blood pressure (systolic and diastolic)	Blood pressure will be measured at rest	8 weeks and 12 months after inclusion
Secondary	Walking speed	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
Secondary	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.	8 weeks and 12 months after inclusion
Secondary	Balance tested with the Bergs Balance Test		8 weeks and 12 months after inclusion
Secondary	Change in Blood tests	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
Secondary	Independence assessed by Functional Independence Measure (FIM)		8 weeks and 12 months after inclusion
Secondary	Self reported physical activity level assessed by International Physical Activity Questionnaire		8 weeks and 12 months after inclusion
Secondary	Cognitive function assessed by Montreal Cognitive Assessment and Trail Making A and B		8 weeks and 12 months after inclusion
Secondary	Walking distance	Walking distance (in meters) will be measured with the 6 minute walk test.	8 weeks and 12 months after inclusion