Understanding Changes in Heart Function After Exercise in People With Stroke

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

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.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Behavioral: Aerobic Exercise Program; Behavioral: Non-aerobic Exercise Program

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada
      • Vancouver General Hospital
    • Vancouver, British Columbia, Canada
      • GF Strong Rehabilitation Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): April 1, 2012

Study Registration Dates

• First Submitted: August 24, 2010
• First Submitted That Met QC Criteria: August 24, 2010
• First Posted (Estimate): August 26, 2010

Study Record Updates

• Last Update Posted (Actual): May 10, 2017
• Last Update Submitted That Met QC Criteria: May 8, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Rehabilitation; Exercise; Stroke; Risk factors
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: H10-00735