Understanding Changes in Heart Function After Exercise in People With Stroke

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by University of British Columbia.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01189045
First received: August 24, 2010
Last updated: May 11, 2011
Last verified: May 2011

August 24, 2010
May 11, 2011
September 2010
October 2011   (final data collection date for primary outcome measure)
Stroke risk factors (blood pressure, heart rate, lipid profiles, glucose metabolism), cardiorespiratory fitness [ Time Frame: assessed at baseline (0 months), post-program (6 months) and follow up (8 months) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01189045 on ClinicalTrials.gov Archive Site
  • Arterial stiffness and inflammatory biomarkers [ Time Frame: assessed at 0, 6 and 8 months ] [ Designated as safety issue: No ]
  • Echocardiography measures [ Time Frame: assessed at 0 and 6 months ] [ Designated as safety issue: No ]
  • Ambulatory capacity and health related quality of life [ Time Frame: assessed at 0, 6 and 8 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Stroke
  • 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.
  • 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.
  • 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
    Intervention: Behavioral: Aerobic Exercise Program
  • 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.
    Intervention: Behavioral: Non-aerobic Exercise Program
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
April 2012
October 2011   (final data collection date for primary outcome measure)

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
Both
50 Years to 80 Years
No
Contact: Chihya Hung 604-714-4108 chihya.hung@vch.ca
Canada
 
NCT01189045
H10-00735
No
Janice Eng, University of British Columbia - Vancouver Coastal Health Research Institute
University of British Columbia
Not Provided
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
University of British Columbia
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP