Understanding Changes in Heart Function After Exercise in People With Stroke

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01189045
• Other study ID #: H10-00735
• Status: Completed
• Phase: N/A
• First received: August 24, 2010
• Last updated: May 8, 2017
• Start date: September 2010
• Est. completion date: April 2012

Study information

• Verified date: May 2017
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 2012
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	GF Strong Rehabilitation Centre	Vancouver	British Columbia
Canada	Vancouver General Hospital	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Arterial stiffness and inflammatory biomarkers		assessed at 0, 6 and 8 months
Secondary	Echocardiography measures		assessed at 0 and 6 months
Secondary	Ambulatory capacity and health related quality of life		assessed at 0, 6 and 8 months