Understanding Changes in Heart Function After Exercise in People With Stroke

NCT ID: NCT01189045

Last Updated: 2017-05-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2012-04-30

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Aerobic Exercise Program

Intervention Type: BEHAVIORAL

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.

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.

Group Type: ACTIVE_COMPARATOR

Non-aerobic Exercise Program

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Janice Eng

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Janice Eng, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of British Columbia - Vancouver Coastal Health Research Institute

Penelope Brasher, PhD

Role: STUDY_DIRECTOR

Vancover General Hospital

Andrei Krassioukov, MD, PhD

Role: STUDY_DIRECTOR

University of British Columbia

Kenneth Madden, MD

Role: STUDY_DIRECTOR

University of British Columbia

Ada Tang

Role: STUDY_DIRECTOR

University of British Columbia

Teresa Tsang, MD

Role: STUDY_DIRECTOR

University of British Columbia

Locations

GF Strong Rehabilitation Centre

Vancouver, British Columbia, Canada

Vancouver General Hospital

Vancouver, British Columbia, Canada

Countries

Canada

Other Identifiers

H10-00735

Identifier Type: -

Identifier Source: org_study_id