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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT02550015
Date of registration: 08/09/2015
Prospective Registration: No
Primary sponsor: Norwegian University of Science and Technology
Public title: High Intensity Interval Training After Stroke
Scientific title: The Effect of High Intensity Interval Training on Maximal Oxygen Uptake and Risk Factors for Recurrent Stroke
Date of first enrolment: September 2015
Target sample size: 70
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02550015
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).  
Phase:  N/A
Countries of recruitment
Norway
Contacts
Name:     Torunn Askim, phd
Address: 
Telephone:
Email:
Affiliation:  Norwegian University of Science and Technology
Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All
Health Condition(s) or Problem(s) studied
Stroke
Intervention(s)
Behavioral: General information
Behavioral: High intensity interval training
Primary Outcome(s)
Maximal Oxygen Uptake [Time Frame: 1 year after inclusion]
Secondary Outcome(s)
Self reported physical activity level assessed by International Physical Activity Questionnaire [Time Frame: 8 weeks and 12 months after inclusion]
Balance tested with the Bergs Balance Test [Time Frame: 8 weeks and 12 months after inclusion]
Independence assessed by Functional Independence Measure (FIM) [Time Frame: 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]
Change in Blood tests [Time Frame: 8 weeks and 12 months after inclusion]
Leisure time activity and inactive time [Time Frame: 8 weeks and 12 months after inclusion]
Walking speed [Time Frame: 8 weeks and 12 months after inclusion]
Walking distance [Time Frame: 8 weeks and 12 months after inclusion]
Change in blood pressure (systolic and diastolic) [Time Frame: 8 weeks and 12 months after inclusion]
Secondary ID(s)
2015/563
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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