Understanding Changes in Heart Function After Exercise in People With Stroke

Sponsor

University of British Columbia (Other)

Overall Status

Completed

CT.gov ID

NCT01189045

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

1.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke	Behavioral: Aerobic Exercise Program Behavioral: Non-aerobic Exercise Program	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2010

Actual Primary Completion Date :

Oct 1, 2011

Actual Study Completion Date :

Apr 1, 2012

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	GF Strong Rehabilitation Centre	Vancouver	British Columbia	Canada
2	Vancouver General Hospital	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