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Understanding Changes in Heart Function After Exercise in People With Stroke

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01189045
Enrollment
60
Registered
2010-08-26
Start date
2010-09-30
Completion date
2012-04-30
Last updated
2017-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

Stroke, Exercise, Rehabilitation, Risk factors

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.

Interventions

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.

BEHAVIORALNon-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.

Sponsors

University of British Columbia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Stroke risk factors (blood pressure, heart rate, lipid profiles, glucose metabolism), cardiorespiratory fitnessassessed at baseline (0 months), post-program (6 months) and follow up (8 months)

Secondary

MeasureTime frame
Arterial stiffness and inflammatory biomarkersassessed at 0, 6 and 8 months
Echocardiography measuresassessed at 0 and 6 months
Ambulatory capacity and health related quality of lifeassessed at 0, 6 and 8 months

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026