Clinical trial NCT01189045: Understanding Changes in Heart Function After Exercise in People With Stroke
Official title: Beyond VO2peak: Understanding Exercise-induced Changes in Cardiovascular Function After Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Stroke
Exercise
Rehabilitation
Risk factors
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2010-08-26
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Stroke risk factors (blood pressure, heart rate, lipid profiles, glucose metabolism), cardiorespiratory fitness
timeFrame: assessed at baseline (0 months), post-program (6 months) and follow up (8 months)
Secondary outcomes:
measure: Arterial stiffness and inflammatory biomarkers
timeFrame: assessed at 0, 6 and 8 months
measure: Echocardiography measures
timeFrame: assessed at 0 and 6 months
measure: Ambulatory capacity and health related quality of life
timeFrame: assessed at 0, 6 and 8 months
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: GF Strong Rehabilitation Centre
state: British Columbia
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
Study officials:
affiliation: The University of British Columbia - Vancouver Coastal Health Research Institute
name: Janice Eng, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Vancover General Hospital
name: Penelope Brasher, PhD
role: STUDY_DIRECTOR
affiliation: University of British Columbia
name: Andrei Krassioukov, MD, PhD
role: STUDY_DIRECTOR
affiliation: University of British Columbia
name: Kenneth Madden, MD
role: STUDY_DIRECTOR
affiliation: University of British Columbia
name: Ada Tang
role: STUDY_DIRECTOR
affiliation: University of British Columbia
name: Teresa Tsang, MD
role: STUDY_DIRECTOR
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