Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| H 30467 | Other Identifier | UMB BRAAN Number | |
| HP-00044066 | Other Identifier | UMB CICERO Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Maryland, Baltimore County | OTHER |
| Howard County Office on Aging | UNKNOWN |
| MedStar National Rehabilitation Network | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| APA-Stroke | Experimental | 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. |
|
| Sittercise | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| APA-Stroke | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | measured at baseline, 3 months, 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Mary Stuart, ScD | VA Maryland Health Care System, Baltimore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MedStar National Rehabilitation Hospital | Washington D.C. | District of Columbia | 20010 | United States | ||
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Error | meters | measured at baseline, 3 months, 6 months |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| muscle pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mary Stuart, ScD, VA Research Investigator | VA Medical Center, Baltimore Maryland | 410-455-2084 | stuart@umbc.edu |
Not provided
| ID | Term |
|---|---|
| D020521 | Stroke |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Sittercise | Behavioral | 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. |
|
| measured at baseline, 3 months, 6 months |
| 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. | measured at baseline, 3 months, 6 months |
| 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. | measured at baseline, 3 months, 6 months |
| VA Maryland Health Care System, Baltimore |
| Baltimore |
| Maryland |
| 21201 |
| United States |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Hemiparesis | Number | participants |
|
| Year since stroke | Mean | Standard Deviation | years |
|
| Berg Balance | The Berg consists of 14 items, each graded on a scale of 0-4. 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. | Mean | Standard Deviation | units on a scale |
|
| Short Physical Performance Battery (SPPB) | 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. | Mean | Standard Deviation | units on a scale |
|
| 6 Minute Walk Test (MWT) | Mean | Standard Deviation | meters |
|
| Stroke Impact Scale (SIS) | SIS Version 3.0 is a self report scale that includes 59 items and assesses 8 domains (strength, hand function, ADL/IADL, mobility, communication, emotion, memory and thinking, and participation/role function). Summative scores for each domain range from 0-100. Total scores range from 0-800. A higher score reflects better function. | Mean | Standard Deviation | units on a scale |
|
| OG001 | 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. |
|
|
|
| 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. | Posted | Mean | Standard Error | units on a scale | measured at baseline, 3 months, 6 months |
|
|
|
|
| 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. | Posted | Mean | Standard Error | units on a scale | measured at baseline, 3 months, 6 months |
|
|
|
|
| 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. | SIS data were incomplete for six sittercise participants, hence the discrepancy between number of participants analyzed and the flow data reported above. | Posted | Mean | Standard Error | units on a scale | measured at baseline, 3 months, 6 months |
|
|
|
|
| 0 |
| 43 |
| 6 |
| 43 |
| EG001 | 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. | 0 | 33 | 4 | 33 |
| faintness | Cardiac disorders | Non-systematic Assessment |
|
| fall | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Controlled fall without injury |
|
| shortness of breath | Cardiac disorders | Non-systematic Assessment |
|
| chest pain | Cardiac disorders | Non-systematic Assessment |
|
Not provided
Not provided
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001519 | Behavior |
| Six-Months |
|
Within group change over time |
| ANOVA |
| .225 |
Random effects ANOVA, random intercept, random slope estimating within group change (slope) over time |
| Slope |
| .215 |
| Standard Deviation |
| 0.175 |
| 2-Sided |
| No |
| Superiority or Other |
| Within group change over time | ANOVA | .88 | Random effects ANOVA, random intercept, random slope estimating within group change (slope) over time | Slope | .029 | Standard Deviation | 0.187 | 2-Sided | No | Superiority or Other |
| Six-Months |
|
Within group change over time |
| ANOVA |
| .54 |
Random effects ANOVA, random intercept, random slope estimating within group change (slope) over time |
| Slope |
| .033 |
| Standard Deviation |
| .054 |
| 2-Sided |
| No |
| Superiority or Other |
| Within group change over time | ANOVA | .59 | Random effects ANOVA, random intercept, random slope estimating within group change (slope) over time | Slope | .031 | Standard Deviation | 0.057 | 2-Sided | No | Superiority or Other |
| Six-Months |
|
| ANOVA |
| .02 |
Random effects ANOVA, random intercept, random slope estimating within group change (slope) over time |
| Slope |
| 15.49 |
| Standard Deviation |
| 6.19 |
| 2-Sided |
| No |
| Superiority or Other |
| ANOVA | .051 | Random effects ANOVA, random intercept, random slope estimating within group change (slope) over time | Slope | 15.193 | Standard Deviation | 7.553 | 2-Sided | No | Superiority or Other |