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Understanding Changes in Heart Function After Exercise in People With Stroke

Primary Purpose

Stroke

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Aerobic Exercise Program

Non-aerobic Exercise Program

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, Exercise, Rehabilitation, Risk factors

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

GF Strong Rehabilitation Centre
Vancouver General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Aerobic Program

Balance and Flexibility Program

Arm Description

The Aerobic Program will be the Experimental arm of this trial, where a structured, progressive aerobic exercise will be conducted in a class format

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.

Outcomes

Primary Outcome Measures

Stroke risk factors (blood pressure, heart rate, lipid profiles, glucose metabolism), cardiorespiratory fitness

Secondary Outcome Measures

Arterial stiffness and inflammatory biomarkers

Echocardiography measures

Ambulatory capacity and health related quality of life

Full Information

NCT ID

NCT01189045

First Posted

August 24, 2010

Last Updated

May 8, 2017

Sponsor

University of British Columbia

1. Study Identification

Unique Protocol Identification Number

NCT01189045

Brief Title

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

2. Study Status

Record Verification Date

May 2017

Overall Recruitment Status

Completed

Study Start Date

September 2010 (undefined)

Primary Completion Date

October 2011 (Actual)

Study Completion Date

April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of British Columbia

4. Oversight

Data Monitoring Committee

5. Study Description

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): 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke

Keywords

Stroke, Exercise, Rehabilitation, Risk factors

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Aerobic Program

Arm Type

Experimental

Arm Description

The Aerobic Program will be the Experimental arm of this trial, where a structured, progressive aerobic exercise will be conducted in a class format

Arm Title

Balance and Flexibility Program

Arm Type

Active Comparator

Arm Description

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 Type

Behavioral

Intervention Name(s)

Aerobic Exercise Program

Intervention Description

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

Intervention Name(s)

Non-aerobic Exercise Program

Intervention Description

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 Outcome Measure Information:

Title

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 Outcome Measure Information:

Title

Arterial stiffness and inflammatory biomarkers

Time Frame

assessed at 0, 6 and 8 months

Title

Echocardiography measures

Time Frame

assessed at 0 and 6 months

Title

Ambulatory capacity and health related quality of life

Time Frame

assessed at 0, 6 and 8 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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

Overall Study Officials: