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NCT Number: NCT01189045

Understanding Changes in Heart Function After Exercise in People With 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.

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Key information

Conditions

Stroke Behavior Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Motor Activity Nervous System Diseases Vascular Diseases

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

GF Strong Rehabilitation Centre, Vancouver, British Columbia, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aerobic Exercise Program

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.

Non-aerobic Exercise Program

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.

Primary outcomes

  1. 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)

Secondary outcomes

  1. Arterial stiffness and inflammatory biomarkers

    Time frame: assessed at 0, 6 and 8 months

  2. Echocardiography measures

    Time frame: assessed at 0 and 6 months

  3. Ambulatory capacity and health related quality of life

    Time frame: assessed at 0, 6 and 8 months

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Aug 26, 2010
Registry last updated
May 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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