Understanding Changes in Heart Function After Exercise in People With Stroke
Recruitment status was Recruiting
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| First Received Date ICMJE | August 24, 2010 | ||||||||||||||||||||||||
| Last Updated Date | May 11, 2011 | ||||||||||||||||||||||||
| Start Date ICMJE | September 2010 | ||||||||||||||||||||||||
| Estimated Primary Completion Date | October 2011 (final data collection date for primary outcome measure) | ||||||||||||||||||||||||
| Current Primary Outcome Measures ICMJE |
Stroke risk factors (blood pressure, heart rate, lipid profiles, glucose metabolism), cardiorespiratory fitness [ Time Frame: assessed at baseline (0 months), post-program (6 months) and follow up (8 months) ] [ Designated as safety issue: No ] | ||||||||||||||||||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||||||||||||
| Change History | Complete list of historical versions of study NCT01189045 on ClinicalTrials.gov Archive Site | ||||||||||||||||||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||||||||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||||||||||
| Descriptive Information | |||||||||||||||||||||||||
| Brief Title ICMJE | Understanding Changes in Heart Function After Exercise in People With Stroke | ||||||||||||||||||||||||
| Official Title ICMJE | Beyond VO2peak: Understanding Exercise-induced Changes in Cardiovascular Function After Stroke | ||||||||||||||||||||||||
| Brief Summary | Little is known about how exercise can affect heart function in stroke survivors. This study will look at changes in cardiovascular fitness and function after 6 months of exercise. Volunteers will be tested before and after the program and again 2 months later to measure the effects on stroke risk factors, fitness level and flexibility of the arteries. Blood tests will measure cholesterol levels and other signs of inflammation. This study will help us better understand how exercise after stroke can improve heart function and heart health, and ultimately help in lowering future stroke risk. |
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| Detailed Description | Purpose To determine the effects of aerobic exercise after stroke on cardiorespiratory fitness, cardiovascular function, stroke risk factors, walking and health-related quality of life. This study will also examine the retention of these effects after the exercise program ends. Methods A randomized controlled study design will be used. Sixty participants will be randomized to participate in one of 2 treatment arms (6 months duration, 3 days / week, 1 hour / session):
Participants will be evaluated at 3 time points - baseline (0 months), post-intervention (6 months) and follow up (8 months) - for stroke risk factors, cardiorespiratory fitness, arterial stiffness, echocardiography measures, inflammatory biomarkers, ambulatory capacity and health-related quality of life. |
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| Study Type ICMJE | Interventional | ||||||||||||||||||||||||
| Study Phase | Not Provided | ||||||||||||||||||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
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| Condition ICMJE | Stroke | ||||||||||||||||||||||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||||||||||||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||||||||||||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||||||||||||||||||
| Estimated Enrollment ICMJE | 60 | ||||||||||||||||||||||||
| Estimated Completion Date | April 2012 | ||||||||||||||||||||||||
| Estimated Primary Completion Date | October 2011 (final data collection date for primary outcome measure) | ||||||||||||||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||||||||||||||||||
| Ages | 50 Years to 80 Years | ||||||||||||||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||||||||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Canada | ||||||||||||||||||||||||
| Administrative Information | |||||||||||||||||||||||||
| NCT Number ICMJE | NCT01189045 | ||||||||||||||||||||||||
| Other Study ID Numbers ICMJE | H10-00735 | ||||||||||||||||||||||||
| Has Data Monitoring Committee | No | ||||||||||||||||||||||||
| Responsible Party | Janice Eng, University of British Columbia - Vancouver Coastal Health Research Institute | ||||||||||||||||||||||||
| Study Sponsor ICMJE | University of British Columbia | ||||||||||||||||||||||||
| Collaborators ICMJE | Not Provided | ||||||||||||||||||||||||
| Investigators ICMJE |
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| Information Provided By | University of British Columbia | ||||||||||||||||||||||||
| Verification Date | May 2011 | ||||||||||||||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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