Understanding Changes in Heart Function After Exercise in People With Stroke

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Beyond VO2peak: Understanding Exercise-induced Changes in Cardiovascular Function After Stroke

Conditions
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Stroke

Intervention / Treatment
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* Behavioral: Aerobic Exercise Program
* Behavioral: Non-aerobic Exercise Program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aerobic Program<br>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<br>* 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.<br>|
| Active Comparator: Balance and Flexibility Program<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stroke risk factors (blood pressure, heart rate, lipid profiles, glucose metabolism), cardiorespiratory fitness |  | assessed at baseline (0 months), post-program (6 months) and follow up (8 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arterial stiffness and inflammatory biomarkers |  | assessed at 0, 6 and 8 months | 
| Echocardiography measures |  | assessed at 0 and 6 months | 
| Ambulatory capacity and health related quality of life |  | assessed at 0, 6 and 8 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, Exercise, Rehabilitation, Risk factors