NCT01189045

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Sep 2010

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 24, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 26, 2010

Completed
6 days until next milestone

Study Start

First participant enrolled

September 1, 2010

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

May 10, 2017

Status Verified

May 1, 2017

Enrollment Period

1.1 years

First QC Date

August 24, 2010

Last Update Submit

May 8, 2017

Conditions

Stroke

Keywords

StrokeExerciseRehabilitationRisk factors

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Arterial stiffness and inflammatory biomarkers

    assessed at 0, 6 and 8 months

  • Echocardiography measures

    assessed at 0 and 6 months

  • Ambulatory capacity and health related quality of life

    assessed at 0, 6 and 8 months

Study Arms (2)

Aerobic Program

EXPERIMENTAL

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

Behavioral: Aerobic Exercise Program

Balance and Flexibility Program

ACTIVE COMPARATOR

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.

Behavioral: Non-aerobic Exercise Program

Interventions

Aerobic Exercise ProgramBEHAVIORAL

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.

Aerobic Program
Non-aerobic Exercise ProgramBEHAVIORAL

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.

Balance and Flexibility Program

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

GF Strong Rehabilitation Centre

Vancouver, British Columbia, Canada

Location

Vancouver General Hospital

Vancouver, British Columbia, Canada

Location

MeSH Terms

Conditions

StrokeMotor Activity

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesBehavior

Study Officials

  • Janice Eng, PhD

    The University of British Columbia - Vancouver Coastal Health Research Institute

    PRINCIPAL INVESTIGATOR

  • 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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 24, 2010

First Posted

August 26, 2010

Study Start

September 1, 2010

Primary Completion

October 1, 2011

Study Completion

April 1, 2012

Last Updated

May 10, 2017

Record last verified: 2017-05

Locations

CA(2)