University of Delaware
Newark, Delaware, 19712, United States
NCT Number: NCT02835313
Stroke survivors, as a group, are extremely inactive and this has serious consequences for them, including an increased risk of a second stroke and developing other diseases. This study investigates a novel intervention designed to improve everyday activity after stroke by combining walking training to improve walking capacity with a program to encourage more daily walking.
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Notify Me21 year–85 year
All sexes
Interventional
Not applicable
Newark, Delaware, 19712, United States
As a group, stroke survivors are more physically inactive than even the most sedentary older adults. Lack of physical activity has serious consequences in persons with stroke, including an increased risk of recurrent stroke, developing other diseases and mortality. Current rehabilitation interventions do little to improve real-world walking activity after stroke, suggesting that simply improving walking capacity is not sufficient for improving daily physical activity after stroke. Rather, the investigator's hypothesize that the combination of a fast walking intervention that improves walking capacity, with a step activity monitoring program that facilitates translation of gains from the clinic to the "real-world", would generate greater improvements in real world walking activity than with either intervention alone. Data from the investigator's lab provides support for this hypothesis; however, it suggests that the greater efficacy of combining the 2 interventions depends on a participant's initial walking activity. Thus, the investigator's do not expect that one intervention will be superior to the others for all participants, but rather that the combined intervention will be superior for those with low levels of baseline walking activity, speed and endurance. The specific objective of this study is to test whether and for whom combining fast walking training with a step activity monitoring program (FAST+SAM) is superior in improving real-world walking activity compared to fast walking training alone (FAST) or a step activity monitoring and feedback program alone (SAM) in those with chronic stroke. Using a randomized controlled experimental design, 225 chronic (> 6 months) stroke survivors, will complete 12 weeks of fast walking training (FAST), a step activity monitoring program (SAM) or a fast walking training + step activity monitoring program (FAST+SAM). Moderation of specific intervention outcomes by baseline characteristics will be evaluated to determine for whom the interventions are effective.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Subjects participate in fast walking training 3x/week for 12 weeks.
Subjects participate in fast walking training plus a step activity monitoring program 3x/week for 12 weeks
Subjects participate in a step activity monitoring program 3x/week for 12 weeks
Time frame: Change from Baseline to 3 months (Post)
average change in steps per day between two time points, measured over at least a 3-day period for each time point
Time frame: Change from 3 months (Post) to 6 months
average change in steps per day between two time points, measured over at least a 3-day period for each time point
Time frame: Change from 3 months (Post) to 12 months
average change in steps per day between two time points, measured over at least a 3-day period for each time point
Time frame: Change from Baseline to 3 months (Post)
change between two time points in endurance (measured by distance attained on the 6 minute walk test)
Time frame: Change from 3 months (Post) to 6 months
change between two time points in endurance (measured by distance attained on the 6 minute walk test)
Time frame: Change from 3 months (Post) to 12 months
change between two time points in endurance (measured by distance attained on the 6 minute walk test)
Time frame: Change from Baseline to 3 months (Post)
change between two time points in average self-selected speed on the 10m walk test
Time frame: Change from 3 months (Post) to 6 months
change between two time points in average self-selected speed on the 10m walk test
Time frame: Change from 3 months (Post) to 12 months
change between two time points in average self-selected speed on the 10m walk test
Time frame: Change from Baseline to 3 months (Post)
change between two time points in average oxygen consumption at ventilatory threshold
Time frame: Change from 3 months (Post) to 6 months
change between two time points in average oxygen consumption at ventilatory threshold
Time frame: Change from 3 months (Post) to 12 months
change between two time points in average oxygen consumption at ventilatory threshold
University of Delaware
Other
Acronym: PROWALKS
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