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Completed

NCT Number: NCT05429255

Aerobic Exercise in Patients With Stroke

The purpose of this study is to compare aerobic training to exergame training in people with chronic mild/moderate stroke. The objectives of this study are two-fold: 1) To evaluate the effects of a home-based aerobic exercise cycle ergometer program on cardiorespiratory fitness, mobility, cognitive, and exercise self-efficacy outcomes in subacute and chronic stroke patients; and 2) to evaluate the effects of an exergaming program on the same outcomes.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Columbia University Irving Medical Center / NewYork-Presbyterian Hospital

New York, 10032, United States

About this study

Annually, 13.7 million strokes occur worldwide, placing it as a leading cause of death and disability, especially among older adults. Stroke survivors often face significant cognitive and motor impairments for months to years after a stroke event, creating significant deficits in functional capacity during activities of daily living (ADLs), as well as in overall quality of life. Stroke patients have identified interventions to improve cognitive outcomes, mobility training, and exercise programs as top priorities for guiding research pursuits.

Aerobic exercise has been shown to produce significant improvements in key stroke rehabilitation outcomes, including functional movement, balance and cardiorespiratory fitness. Exercise programs have been shown to improve a variety of functional outcomes important for carrying out ADLs, including gait speed, gait endurance, Berg Balance Score, and 3-meter Timed Up and Go. Additionally, there is mounting evidence that aerobic exercise may improve cognitive recovery post-stroke. However, the research showing these effects has largely focused on exercise programs incorporated in a hospital or rehabilitation facility where patients are actively supervised by rehabilitation specialists. The American Heart Association recognizes that long-term and widely-applicable solutions for increasing exercise in post-stroke populations must hold the goal of exercise independence in the home and community settings.

Cycle ergometry, commonly known as an exercise bike, is a staple for stroke rehabilitation programs given its minimal fall risk and ability to produce moderate to vigorous intensity physical activity in participants. Exercise programs using cycle ergometry have been shown to produce all previously mentioned functional and cardiorespiratory improvements in stroke survivors, however, the translation of this effectiveness to the home-environment is unknown. Additionally, cycle ergometry may have smaller effects on functional mobility outcomes than walking interventions, forcing prescribing physicians and patients to choose between long-term improvement and reduced fall risk. One potential alternative or supplement to traditional aerobic exercise programs is exergaming, interventions which use physically active video games to engage participants in exercise. Exergames have been shown to be safe and produce moderate intensity physical activity levels in subacute and chronic stroke patients. Additionally, they have been shown to increase a variety of functional outcomes when added to standard post-stroke rehabilitation care, however, like aerobic exercise programs, previous research has focused on the supervised clinical setting, and it is unknown if they produce similar effects to aerobic exercise.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Stroke greater than 3 months ago
  • NIH stroke scale score less than 15

Exclusion criteria

  • Other neurological impairments
  • Medically unstable
  • Inability to exercise
  • Joint pain
  • Heart failure or other heart arrythmias

Treatment and study plan

Aerobic Exercise

Behavioral

Bicycle training

Exergame training

Behavioral

Nintendo Wii

Primary outcomes

  1. Average Gait Speed

    Time frame: baseline and 1 month

    Participants will walk as fast as possible on a 9-m runway 3 times, and the results will be averaged.

Secondary outcomes

  1. VO2max

    Time frame: baseline and 1 month

    Maximal oxygen consumption (VO2max) will be determined by a breath by-breath measurement of VO2 with a Vmax Encore Metabolic System (CareFusion Corp, San Diego, CA), while participants perform a progressive ramped exercise test using an electronic-braked lower body cycle ergometer.

  2. Timed up and GO

    Time frame: baseline and 1 month

    Participants will be asked to stand up from a seated position, walk 10 feet at a normal pace, then return to the chair and sit down. The examiner will time the procedure.

  3. Berg Balance Scale

    Time frame: baseline and 1 month

    Participants will complete the 14 part Berg Balance test which requires them to complete basic functional movements that are each evaluated on a 4-point scale.

  4. Cognition

    Time frame: baseline and 1 month

    Cognition will be assessed using a standardized, computerized test that is a part of the NIH Toolbox for Assessment of Neurological and Behavioral Function. It assesses various cognitive domains through simple, validated cognitive tasks.

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Registry information

Official study title

Aerobic Training vs Exergame Training in Patients With Chronic Mild-Moderate Stroke

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jun 23, 2022
Registry last updated
May 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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