Understanding Changes in Heart Function After Exercise in People With Stroke

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Behavioral: Non-aerobic Exercise Program; Behavioral: Aerobic Exercise Program

• Registration Number: NCT01189045
• Lead Sponsor: University of British Columbia

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.

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):

1. 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.

2. 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.

Study Timeline

• Study First Submitted: 2010-08-24
• Study First Submitted QC: 2010-08-24
• Study First Posted: 2010-08-26
• Study Start: 2010-09
• Primary Completion: 2011-10
• Study Completion: 2012-04
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-08
• Last Update Posted: 2017-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Balance and Flexibility Program	Non-aerobic Exercise 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.
Aerobic Program	Aerobic Exercise 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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Ambulatory capacity and health related quality of life	assessed at 0, 6 and 8 months
Echocardiography measures	assessed at 0 and 6 months
Arterial stiffness and inflammatory biomarkers	assessed at 0, 6 and 8 months

Trial Locations

Locations (2)

Vancouver General Hospital; 🇨🇦 Vancouver, British Columbia, Canada

GF Strong Rehabilitation Centre; 🇨🇦 Vancouver, British Columbia, Canada