Understanding Changes in Heart Function After Exercise in People With Stroke
The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by University of British Columbia.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
University of British Columbia
Information provided by:
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01189045
First received: August 24, 2010
Last updated: May 11, 2011
Last verified: May 2011
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Stroke |
Behavioral: Aerobic Exercise Program Behavioral: Non-aerobic Exercise Program |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | Beyond VO2peak: Understanding Exercise-induced Changes in Cardiovascular Function After Stroke |
Resource links provided by NLM:
Further study details as provided by University of British Columbia:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- Arterial stiffness and inflammatory biomarkers [ Time Frame: assessed at 0, 6 and 8 months ] [ Designated as safety issue: No ]
- Echocardiography measures [ Time Frame: assessed at 0 and 6 months ] [ Designated as safety issue: No ]
- Ambulatory capacity and health related quality of life [ Time Frame: assessed at 0, 6 and 8 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 60 |
| Study Start Date: | September 2010 |
| Estimated Study Completion Date: | April 2012 |
| Estimated Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Aerobic Program
The Aerobic Program will be the Experimental arm of this trial, where a structured, progressive aerobic exercise will be conducted in a class format
|
Behavioral: Aerobic Exercise Program
The AEROBIC PROGRAM will be the Experimental arm of this trial. It will be a structured, progressive aerobic training program that will be 6 months in duration. Classes will be held 3 times / week, for 1 hour / session.
|
|
Active Comparator: Balance and Flexibility Program
The Balance and Flexibility Program will be a non-aerobic intervention that will act as an Active Comparator. Stretching, balance exercises, yoga- or Tai Chi-style classes will be conducted.
|
Behavioral: Non-aerobic Exercise Program
The BALANCE AND FLEXIBILITY (non-aerobic) PROGRAM will be the Active Comparator arm of this trial. It will be comprised of upper and lower body stretching, or balance activities, yoga- or Tai Chi-style classes. This program will be 6 months in duration. Classes will be held 3 times / week, for 1 hour / session.
|
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):
- BALANCE AND FLEXIBILITY (non-aerobic) PROGRAM will be comprised of individualized upper and lower body stretching, or balance activities, yoga- or Tai Chi-style classes.
- AEROBIC PROGRAM will be comprised of a structured, progressive aerobic training program.
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.
Eligibility| Ages Eligible for Study: | 50 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Age 50-80 years old
- Has experienced a stroke
- At least 12 months post-stroke
- Able to stand independently
- Able to walk at least 5 metres (assisted devices and guarded supervision is permitted)
Exclusion Criteria:
- Stroke of non-cardiogenic origin (aneurysm, tumour)
- Actively engaged in other stroke rehabilitation services
- Class C or D American Heart Association Risk Criteria (uncontrolled arrhythmias)
- Resting blood pressure > 160/100 mmHg
- Significant musculoskeletal problems (rheumatoid arthritis) or other neurological conditions (e.g. Parkinson's)
- Has a pacemaker
- Pain or other co-morbidities (e.g. unclipped aneurysms, uncontrolled seizures etc.) which would preclude participation
- Behavioural issues that would limit participation in exercise
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01189045
Contacts
| Contact: Chihya Hung | 604-714-4108 | chihya.hung@vch.ca |
Locations
| Canada, British Columbia | |
| Vancouver General Hospital | Recruiting |
| Vancouver, British Columbia, Canada | |
| GF Strong Rehabilitation Centre | Recruiting |
| Vancouver, British Columbia, Canada | |
Sponsors and Collaborators
University of British Columbia
Investigators
| Principal Investigator: | Janice Eng, PhD | The University of British Columbia - Vancouver Coastal Health Research Institute |
| Study Director: | Penelope Brasher, PhD | Vancover General Hospital |
| Study Director: | Andrei Krassioukov, MD, PhD | University of British Columbia |
| Study Director: | Kenneth Madden, MD | University of British Columbia |
| Study Director: | Ada Tang | University of British Columbia |
| Study Director: | Teresa Tsang, MD | University of British Columbia |
More Information
No publications provided
| Responsible Party: | Janice Eng, University of British Columbia - Vancouver Coastal Health Research Institute |
| ClinicalTrials.gov Identifier: | NCT01189045 History of Changes |
| Other Study ID Numbers: | H10-00735 |
| Study First Received: | August 24, 2010 |
| Last Updated: | May 11, 2011 |
| Health Authority: | Canada: Health Canada |
Keywords provided by University of British Columbia:
|
Stroke Exercise Rehabilitation Risk factors |
Additional relevant MeSH terms:
|
Stroke Cerebral Infarction Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Vascular Diseases Cardiovascular Diseases Brain Infarction Brain Ischemia |
ClinicalTrials.gov processed this record on June 18, 2013