Stroke
Conditions
Keywords
stroke, exercise
Brief summary
This study will compare the Adaptive Physical Activity program (APA) to a less vigorous group exercise program, (Sittercise) to see if APA leads to greater improvements in walking endurance, quality of life, and participation in social activities.
Detailed description
The purpose of this study is to translate the Italian APA exercise model into a sustainable, evidence-based VA community program of exercise for older adults with chronic stroke. The investigators' short-term objectives are to test study hypotheses using a Randomized Clinical Trial (RCT) with an Attention Control (also referred to as the Sittercise exercise program). The investigators will also explore factors related to exercise adherence in a community program for chronic stroke survivors. The investigators' longer term objective is to disseminate this model to facilitate the development of a network of community-based exercise programs for older adults with chronic stroke. In the RCT the investigators propose to offer courses in Office of Aging (OoA) Senior Centers and National Rehabilitation Hospital. At the conclusion of the research study, the OoA plans to continue offering APA-stroke courses. Through partnership, the Veterans Health Administration (VHA) and the Administration of Aging (AoA) can potentially replicate this model at the community throughout the U.S. using local OoA Senior Centers and other facilities that would increase community access for Veterans.
Interventions
BEHAVIORALAPA-Stroke
Exercise program design specifically for individuals with residual hemiparetic gait deficits due to stroke. Exercises are progressive, beginning with a 5 minute walk at the beginning and end of each class and gradually progressing to a 15 minute walk at the beginning and end of each class. Exercises focus on walking and are designed to improve walking ability and balance. Program includes a homework component.
BEHAVIORALSittercise
Not stroke specific. This less vigorous exercise program consists of seated exercise focusing on stretching to improve general range of movement and weight exercises to strengthen the trunk, arms, and legs. There is no assigned exercise homework.
Sponsors
University of Maryland, Baltimore County
Howard County Office on Aging
MedStar National Rehabilitation Network
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* evidence of stroke (ischemic or hemorrhagic) minimum 6 months prior in men or women ages 40 or older; * residual hemiparetic gait deficits; * already completed all conventional inpatient and outpatient physical therapy; * ability to rise from a chair unaided and without an assistive device
Exclusion criteria
* cardiac history of active unstable angina, recent (less than 3 months) myocardial infarction, or congestive heart failure (NYHA category II or higher); * orthopedic, circulatory, or chronic pain conditions restricting exercise; * active cancer; poorly controlled hypertension ( greater than 180/100 on 2 readings separated by 5 minutes rest); * dementia; * severe receptive or global aphasia with inability to follow 2-step commands; * co-morbid non-stroke neurological disorder that impairs mobility (e.g. multiple sclerosis or Parkinson's); * untreated clinical depression; * inability to complete the 6-Minute Walk test during baseline testing
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 6 Minute Walk Test (6MWT) | measured at baseline, 3 months, 6 months | Total distance walked for 6 minutes (in meters) is the primary outcome measure. Participants use the same assistive devices and/or orthoses they use when walking across a parking lot. They are instructed to cover as much distance as they can over a flat 100 foot walking surface demarcated by traffic cones during the six minute time period. Change in distance covered is the outcome variable of interest for this study. Walking a greater distance (e.g. more meters during the 6 minute test) reflects improvement in walking speed and endurance. We computed the slopes (i.e. rates of change from baseline to 3-months and 6-months) using a random effects ANOVA (random intercept and random slope), and determined if the slopes were different using unpaired Student's t-tests. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Balance as Measured by the Berg Balance Scale (BBS) | measured at baseline, 3 months, 6 months | The Berg is a widely used test for assessing balance and to predict fall risk in the elderly. It has been validated with patients post stroke. The Berg consists of 14 items, each graded on a scale of 0-4. Thus a score for the Berg could in theory range from a minimum of 0 to a maximum of 56. A score below 45 is indicative of balance impairment; thus the lower the score the greater the fall risk. We computed the slopes (i.e. rates of change from baseline to 3-months and 6-months) using a random effects ANOVA (random intercept and random slope), and determined if the slopes were different using unpaired Student's t-tests. |
| Short Physical Performance Battery (SPPB) | measured at baseline, 3 months, 6 months | The SPPB, which is extensively used in stroke studies, includes three components and a composite score. Components include gait speed, a repeated chair stand, and a standing balance test. Scores for gait speed, chair stand, and total balance are calculated and then summed for the total score. Each component can range from 0-4 points, thus the maximum composite score can range from 0-12 points, with 0 reflecting the lowest functioning while a score of 12 indicates the subject reached the maximum measured competency in all three domains. We computed the slopes (i.e. rates of change from baseline to 3-months and 6-months) using a random effects ANOVA (random intercept and random slope), and determined if the slopes were different using unpaired Student's t-tests. |
| Stroke Impact Scale (SIS) | measured at baseline, 3 months, 6 months | The SIS Version 3.0 is a self report scale widely used to assess health status after stroke. It includes 59 items and assesses 8 domains (strength, hand function, ADL/IADL, mobility, communication, emotion, memory and thinking, and participation/role function). The SIS uses a 5-point Likert Scale. Summative scores for each domain range from 0-100. Total scores range from 0 to 800. A higher score reflects better function. We computed the slopes (i.e. rates of change from baseline to 3-months and 6-months) using a random effects ANOVA (random intercept and random slope), and determined if the slopes were different using unpaired Student's t-tests. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| APA-Stroke The APA-stroke exercise program designed specifically for individuals with hemiparetic gait deficits due to stroke. These progressive exercises focus on walking, balance and weight shifting and include an exercise homework component.
APA-Stroke: Exercise program design specifically for individuals with residual hemiparetic gait deficits due to stroke. Exercises are progressive, beginning with a 5 minute walk at the beginning and end of each class and gradually progressing to a 15 minute walk at the beginning and end of each class. Exercises focus on walking and are designed to improve walking ability and balance. Program includes a homework component. | 43 |
| Sittercise Sittercise is not stroke specific. This less vigorous exercise program consists of seated exercise, focusing on stretching to improve general range of motion and weight exercises to strengthen the trunk, arms, and legs. There is no assigned exercise homework associated with this group.
Sittercise: Not stroke specific. This less vigorous exercise program consists of seated exercise focusing on stretching to improve general range of movement and weight exercises to strengthen the trunk, arms, and legs. There is no assigned exercise homework. | 33 |
| Total | 76 |
Baseline characteristics
| Characteristic | Total | Sittercise | APA-Stroke |
|---|---|---|---|
| 6 Minute Walk Test (MWT) | 181.52 meters STANDARD_DEVIATION 97.4 | 171.69 meters STANDARD_DEVIATION 97.42 | 189.07 meters STANDARD_DEVIATION 97.38 |
| Age, Continuous | 64 years STANDARD_DEVIATION 10.3 | 65 years STANDARD_DEVIATION 11.7 | 63 years STANDARD_DEVIATION 9.2 |
| Berg Balance | 44.58 units on a scale STANDARD_DEVIATION 9.03 | 43.00 units on a scale STANDARD_DEVIATION 9.02 | 44.76 units on a scale STANDARD_DEVIATION 9.03 |
| Hemiparesis Left | 45 participants | 18 participants | 27 participants |
| Hemiparesis Missing | 5 participants | 2 participants | 3 participants |
| Hemiparesis Right | 26 participants | 13 participants | 13 participants |
| Race/Ethnicity, Customized Black | 38 participants | 14 participants | 24 participants |
| Race/Ethnicity, Customized Missing | 1 participants | 0 participants | 1 participants |
| Race/Ethnicity, Customized Other | 7 participants | 6 participants | 1 participants |
| Race/Ethnicity, Customized White | 30 participants | 13 participants | 17 participants |
| Region of Enrollment United States | 76 participants | 33 participants | 43 participants |
| Sex: Female, Male Female | 37 Participants | 16 Participants | 21 Participants |
| Sex: Female, Male Male | 39 Participants | 17 Participants | 22 Participants |
| Short Physical Performance Battery (SPPB) | 6.36 units on a scale STANDARD_DEVIATION 2.65 | 6.06 units on a scale STANDARD_DEVIATION 2.64 | 6.60 units on a scale STANDARD_DEVIATION 2.66 |
| Stroke Impact Scale (SIS) | 476.29 units on a scale STANDARD_DEVIATION 201.75 | 490.79 units on a scale STANDARD_DEVIATION 201.76 | 466.62 units on a scale STANDARD_DEVIATION 201.75 |
| Year since stroke | 5.2 years STANDARD_DEVIATION 6.6 | 4.7 years STANDARD_DEVIATION 8.5 | 5.5 years STANDARD_DEVIATION 5.2 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 6 / 43 | 4 / 33 |
| serious Total, serious adverse events | 0 / 43 | 0 / 33 |
Outcome results
Primary
6 Minute Walk Test (6MWT)
Total distance walked for 6 minutes (in meters) is the primary outcome measure. Participants use the same assistive devices and/or orthoses they use when walking across a parking lot. They are instructed to cover as much distance as they can over a flat 100 foot walking surface demarcated by traffic cones during the six minute time period. Change in distance covered is the outcome variable of interest for this study. Walking a greater distance (e.g. more meters during the 6 minute test) reflects improvement in walking speed and endurance. We computed the slopes (i.e. rates of change from baseline to 3-months and 6-months) using a random effects ANOVA (random intercept and random slope), and determined if the slopes were different using unpaired Student's t-tests.
Time frame: measured at baseline, 3 months, 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| APA-Stroke | 6 Minute Walk Test (6MWT) | Six-Months | 228 meters | Standard Error 22 |
| APA-Stroke | 6 Minute Walk Test (6MWT) | Baseline | 189 meters | Standard Error 15 |
| APA-Stroke | 6 Minute Walk Test (6MWT) | Three-months | 211 meters | Standard Error 21 |
| Sittercise | 6 Minute Walk Test (6MWT) | Six-Months | 167 meters | Standard Error 23 |
| Sittercise | 6 Minute Walk Test (6MWT) | Baseline | 172 meters | Standard Error 17 |
| Sittercise | 6 Minute Walk Test (6MWT) | Three-months | 170 meters | Standard Error 23 |
p-value: <0.25ANOVA
Comparison: Within group change over timep-value: <0.004ANOVA
Comparison: Within group change over timep-value: 0.218ANOVA
Secondary
Balance as Measured by the Berg Balance Scale (BBS)
The Berg is a widely used test for assessing balance and to predict fall risk in the elderly. It has been validated with patients post stroke. The Berg consists of 14 items, each graded on a scale of 0-4. Thus a score for the Berg could in theory range from a minimum of 0 to a maximum of 56. A score below 45 is indicative of balance impairment; thus the lower the score the greater the fall risk. We computed the slopes (i.e. rates of change from baseline to 3-months and 6-months) using a random effects ANOVA (random intercept and random slope), and determined if the slopes were different using unpaired Student's t-tests.
Time frame: measured at baseline, 3 months, 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| APA-Stroke | Balance as Measured by the Berg Balance Scale (BBS) | Baseline | 44.8 units on a scale | Standard Error 1.1 |
| APA-Stroke | Balance as Measured by the Berg Balance Scale (BBS) | Three-Months | 46.5 units on a scale | Standard Error 1.5 |
| APA-Stroke | Balance as Measured by the Berg Balance Scale (BBS) | Six-Months | 47.6 units on a scale | Standard Error 1.1 |
| Sittercise | Balance as Measured by the Berg Balance Scale (BBS) | Baseline | 43.0 units on a scale | Standard Error 1.9 |
| Sittercise | Balance as Measured by the Berg Balance Scale (BBS) | Three-Months | 43.0 units on a scale | Standard Error 2 |
| Sittercise | Balance as Measured by the Berg Balance Scale (BBS) | Six-Months | 41.6 units on a scale | Standard Error 2.3 |
p-value: 0.47ANOVA
Comparison: Within group change over timep-value: 0.225ANOVA
Comparison: Within group change over timep-value: 0.88ANOVA
Secondary
Short Physical Performance Battery (SPPB)
The SPPB, which is extensively used in stroke studies, includes three components and a composite score. Components include gait speed, a repeated chair stand, and a standing balance test. Scores for gait speed, chair stand, and total balance are calculated and then summed for the total score. Each component can range from 0-4 points, thus the maximum composite score can range from 0-12 points, with 0 reflecting the lowest functioning while a score of 12 indicates the subject reached the maximum measured competency in all three domains. We computed the slopes (i.e. rates of change from baseline to 3-months and 6-months) using a random effects ANOVA (random intercept and random slope), and determined if the slopes were different using unpaired Student's t-tests.
Time frame: measured at baseline, 3 months, 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| APA-Stroke | Short Physical Performance Battery (SPPB) | Baseline | 6.60 units on a scale | Standard Error 0.4 |
| APA-Stroke | Short Physical Performance Battery (SPPB) | Three-Months | 6.76 units on a scale | Standard Error 0.48 |
| APA-Stroke | Short Physical Performance Battery (SPPB) | Six-Months | 7.12 units on a scale | Standard Error 0.51 |
| Sittercise | Short Physical Performance Battery (SPPB) | Baseline | 6.10 units on a scale | Standard Error 0.48 |
| Sittercise | Short Physical Performance Battery (SPPB) | Three-Months | 5.92 units on a scale | Standard Error 0.5 |
| Sittercise | Short Physical Performance Battery (SPPB) | Six-Months | 5.96 units on a scale | Standard Error 0.61 |
p-value: 0.98ANOVA
Comparison: Within group change over timep-value: 0.54ANOVA
Comparison: Within group change over timep-value: 0.59ANOVA
Secondary
Stroke Impact Scale (SIS)
The SIS Version 3.0 is a self report scale widely used to assess health status after stroke. It includes 59 items and assesses 8 domains (strength, hand function, ADL/IADL, mobility, communication, emotion, memory and thinking, and participation/role function). The SIS uses a 5-point Likert Scale. Summative scores for each domain range from 0-100. Total scores range from 0 to 800. A higher score reflects better function. We computed the slopes (i.e. rates of change from baseline to 3-months and 6-months) using a random effects ANOVA (random intercept and random slope), and determined if the slopes were different using unpaired Student's t-tests.
Time frame: measured at baseline, 3 months, 6 months
Population: SIS data were incomplete for six sittercise participants, hence the discrepancy between number of participants analyzed and the flow data reported above.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| APA-Stroke | Stroke Impact Scale (SIS) | Baseline | 467 units on a scale | Standard Error 32 |
| APA-Stroke | Stroke Impact Scale (SIS) | Three-Months | 463 units on a scale | Standard Error 35 |
| APA-Stroke | Stroke Impact Scale (SIS) | Six-Months | 562 units on a scale | Standard Error 23 |
| Sittercise | Stroke Impact Scale (SIS) | Baseline | 491 units on a scale | Standard Error 36 |
| Sittercise | Stroke Impact Scale (SIS) | Three-Months | 576 units on a scale | Standard Error 17 |
| Sittercise | Stroke Impact Scale (SIS) | Six-Months | 579 units on a scale | Standard Error 18 |
Comparison: Random effects ANOVA with random intercept and random slope was used to compare the time course of change in our outcome measures across three time points: baseline, three, and six-months in our two experimental groups--APA-stroke and Sittercise.p-value: 0.98ANOVA
p-value: 0.02ANOVA
p-value: 0.051ANOVA