Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05429255 |
| Other study ID # |
AAAU0558 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 23, 2022 |
| Est. completion date |
August 2024 |
Study information
| Verified date |
December 2023 |
| Source |
Columbia University |
| Contact |
Brian Schibler |
| Phone |
212-305-3535 |
| Email |
bms2222[@]cumc.columbia.edu |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
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.
