Stroke
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALFAST alone
Subjects participate in fast walking training 3x/week for 12 weeks.
BEHAVIORALFAST+SAM
Subjects participate in fast walking training plus a step activity monitoring program 3x/week for 12 weeks
BEHAVIORALSAM alone
Subjects participate in a step activity monitoring program 3x/week for 12 weeks
Sponsors
University of Pennsylvania
Christiana Care Health Services
Indiana University
University of Delaware
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Age 21-85 2. Chronic stroke (\>6 months post stroke) 3. Able to walk at self-selected speed without assistance from another person (assistive devices are allowed) 4. Self-selected walking speed \>0.3 m/s and \<1.0 m/s 5. Average steps/day \<8,000 6. Resting heart rate between 40-100 beats per minute 7. Resting blood pressure between 90/60 to 170/90.
Exclusion criteria
1. Evidence of cerebellar stroke 2. Other potentially disabling neurologic conditions in addition to stroke 3. Lower limb Botulinum toxin injection \<4 months earlier 4. Current participation in physical therapy 5. Inability to walk outside the home prior to the stroke 6. Coronary artery bypass graft, stent placement or myocardial infarction within past 3 months 7. Musculoskeletal pain that limits activity 8. Inability to communicate with investigators 9. score \>1 on question 1b and \>0 on question 1c on the NIH Stroke Scale.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Steps Per Day | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Six-minute Walk Test Distance | Change from Baseline to 3 months (Post) | change between two time points in endurance (measured by distance attained on the 6 minute walk test) |
| Self-selected Gait Speed | Change from Baseline to 3 months (Post) | change between two time points in average self-selected speed on the 10m walk test |
| Oxygen Consumption | Change from Baseline to 3 months (Post) | change between two time points in average oxygen consumption at ventilatory threshold |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| FAST+SAM Subjects participate in fast walking training in combination with a step activity monitoring program
FAST+SAM: Subjects participate in fast walking training plus a step activity monitoring program 3x/week for 12 weeks | 80 |
| FAST Alone Subjects participate in fast walking training
FAST: Subjects participate in fast walking training 3x/week for 12 weeks. | 89 |
| SAM Alone Subjects participate in a step activity monitoring program
SAM: Subjects participate in a step activity monitoring program 3x/week for 12 weeks | 81 |
| Total | 250 |
Baseline characteristics
| Characteristic | FAST Alone | SAM Alone | FAST+SAM | Total |
|---|---|---|---|---|
| Age, Continuous | 63 years STANDARD_DEVIATION 11.96 | 62 years STANDARD_DEVIATION 12.91 | 62 years STANDARD_DEVIATION 13.07 | 63 years STANDARD_DEVIATION 12.61 |
| Ambulatory assistive device use | 46 Participants | 47 Participants | 36 Participants | 129 Participants |
| Body mass index | 29.79 kg/m^2 STANDARD_DEVIATION 6.39 | 31.58 kg/m^2 STANDARD_DEVIATION 7.05 | 30.13 kg/m^2 STANDARD_DEVIATION 5.45 | 30.48 kg/m^2 STANDARD_DEVIATION 6.35 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 2 Participants | 3 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 84 Participants | 79 Participants | 77 Participants | 240 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Lower extremity orthotic use | 21 Participants | 25 Participants | 22 Participants | 68 Participants |
| Race/Ethnicity, Customized American Indian or Alaskan Native | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian | 7 Participants | 2 Participants | 4 Participants | 13 Participants |
| Race/Ethnicity, Customized Black or African American | 20 Participants | 26 Participants | 20 Participants | 66 Participants |
| Race/Ethnicity, Customized More than one race | 5 Participants | 5 Participants | 6 Participants | 16 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Unknown or not reported | 1 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized White | 55 Participants | 48 Participants | 49 Participants | 152 Participants |
| Region of Enrollment United States | 89 participants | 81 participants | 80 participants | 250 participants |
| Self-selected gait speed | 0.71 meters/sec STANDARD_DEVIATION 0.2 | 0.68 meters/sec STANDARD_DEVIATION 0.22 | 0.68 meters/sec STANDARD_DEVIATION 0.22 | 0.69 meters/sec STANDARD_DEVIATION 0.21 |
| Sex: Female, Male Female | 41 Participants | 39 Participants | 36 Participants | 116 Participants |
| Sex: Female, Male Male | 48 Participants | 42 Participants | 44 Participants | 134 Participants |
| Side of hemiparesis Both affected | 3 Participants | 5 Participants | 4 Participants | 12 Participants |
| Side of hemiparesis Left | 43 Participants | 42 Participants | 39 Participants | 124 Participants |
| Side of hemiparesis Right | 43 Participants | 34 Participants | 37 Participants | 114 Participants |
| Six-minute walk test distance | 296 meters STANDARD_DEVIATION 113 | 279 meters STANDARD_DEVIATION 110 | 283 meters STANDARD_DEVIATION 122 | 287 meters STANDARD_DEVIATION 115 |
| Steps per day | 3959 steps/day STANDARD_DEVIATION 2021 | 3845 steps/day STANDARD_DEVIATION 2193 | 3768 steps/day STANDARD_DEVIATION 2074 | 3861 steps/day STANDARD_DEVIATION 2088 |
| Time since stroke | 46 months STANDARD_DEVIATION 62.25 | 46 months STANDARD_DEVIATION 73.22 | 42 months STANDARD_DEVIATION 48.75 | 45 months STANDARD_DEVIATION 62.04 |
| VO2 at ventilatory threshold | 8.77 mL/kg per min STANDARD_DEVIATION 2.98 | 9.37 mL/kg per min STANDARD_DEVIATION 2.66 | 9.63 mL/kg per min STANDARD_DEVIATION 3.35 | 9.24 mL/kg per min STANDARD_DEVIATION 3.02 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 80 | 1 / 89 | 0 / 81 |
| other Total, other adverse events | 25 / 80 | 38 / 89 | 19 / 81 |
| serious Total, serious adverse events | 14 / 80 | 9 / 89 | 3 / 81 |
Outcome results
Primary
Steps Per Day
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)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| FAST+SAM | Steps Per Day | 1307 steps per day |
| FAST Alone | Steps Per Day | 406 steps per day |
| SAM Alone | Steps Per Day | 1542 steps per day |
Primary
Steps Per Day
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| FAST+SAM | Steps Per Day | -400 steps per day |
| FAST Alone | Steps Per Day | -160 steps per day |
| SAM Alone | Steps Per Day | -1016 steps per day |
Primary
Steps Per Day
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| FAST+SAM | Steps Per Day | -568 steps per day |
| FAST Alone | Steps Per Day | -610 steps per day |
| SAM Alone | Steps Per Day | -1072 steps per day |
Secondary
Oxygen Consumption
change between two time points in average oxygen consumption at ventilatory threshold
Time frame: Change from 3 months (Post) to 12 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| FAST+SAM | Oxygen Consumption | -0.08 mL/kg/min |
| FAST Alone | Oxygen Consumption | -1.32 mL/kg/min |
| SAM Alone | Oxygen Consumption | -0.15 mL/kg/min |
Secondary
Oxygen Consumption
change between two time points in average oxygen consumption at ventilatory threshold
Time frame: Change from Baseline to 3 months (Post)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| FAST+SAM | Oxygen Consumption | 0.31 mL/kg/min |
| FAST Alone | Oxygen Consumption | 0.27 mL/kg/min |
| SAM Alone | Oxygen Consumption | 0.01 mL/kg/min |
Secondary
Oxygen Consumption
change between two time points in average oxygen consumption at ventilatory threshold
Time frame: Change from 3 months (Post) to 6 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| FAST+SAM | Oxygen Consumption | -0.32 mL/kg/min |
| FAST Alone | Oxygen Consumption | -0.53 mL/kg/min |
| SAM Alone | Oxygen Consumption | 0.13 mL/kg/min |
Secondary
Self-selected Gait Speed
change between two time points in average self-selected speed on the 10m walk test
Time frame: Change from Baseline to 3 months (Post)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| FAST+SAM | Self-selected Gait Speed | 0.14 meters/sec |
| FAST Alone | Self-selected Gait Speed | 0.13 meters/sec |
| SAM Alone | Self-selected Gait Speed | 0.11 meters/sec |
Secondary
Self-selected Gait Speed
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| FAST+SAM | Self-selected Gait Speed | -0.02 meters/sec |
| FAST Alone | Self-selected Gait Speed | -0.03 meters/sec |
| SAM Alone | Self-selected Gait Speed | -0.02 meters/sec |
Secondary
Self-selected Gait Speed
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| FAST+SAM | Self-selected Gait Speed | -0.02 meters/sec |
| FAST Alone | Self-selected Gait Speed | -0.05 meters/sec |
| SAM Alone | Self-selected Gait Speed | -0.04 meters/sec |
Secondary
Six-minute Walk Test Distance
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)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| FAST+SAM | Six-minute Walk Test Distance | 39 meters |
| FAST Alone | Six-minute Walk Test Distance | 43 meters |
| SAM Alone | Six-minute Walk Test Distance | 25 meters |
Secondary
Six-minute Walk Test Distance
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| FAST+SAM | Six-minute Walk Test Distance | -13 meters |
| FAST Alone | Six-minute Walk Test Distance | -10 meters |
| SAM Alone | Six-minute Walk Test Distance | -15 meters |
Secondary
Six-minute Walk Test Distance
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| FAST+SAM | Six-minute Walk Test Distance | -18 meters |
| FAST Alone | Six-minute Walk Test Distance | -21 meters |
| SAM Alone | Six-minute Walk Test Distance | -16 meters |