APA-Stroke: Adaptive Physical Activity for Chronic Stroke

• Sponsor: VA Office of Research and Development (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT00773370
• Collaborator: University of Maryland, Baltimore County (Other), Howard County Office on Aging (Other), MedStar National Rehabilitation Network (Other)
• Enrollment: 76
• Locations: 2
• Arms: 2
• Duration (Months): 62.9
• Patients Per Site: 38
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke	Behavioral: APA-Stroke; Behavioral: Sittercise	Phase 1

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 76 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Adaptive Physical Activity for Chronic Stroke
• Study Start Date: Jan 1, 2009
• Actual Primary Completion Date: Feb 1, 2014
• Actual Study Completion Date: Apr 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Behavioral: 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.
Active Comparator: 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.	Behavioral: 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.

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

2. 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.

3. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	MedStar National Rehabilitation Hospital	Washington	District of Columbia	United States	20010
2	VA Maryland Health Care System, Baltimore	Baltimore	Maryland	United States	21201

Sponsors and Collaborators

• VA Office of Research and Development
• University of Maryland, Baltimore County
• Howard County Office on Aging
• MedStar National Rehabilitation Network

Investigators

• Principal Investigator: Mary Stuart, ScD, VA Maryland Health Care System, Baltimore

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT00773370
• Other Study ID Numbers: B6329-R; H 30467; HP-00044066
• First Posted: Oct 16, 2008
• Last Update Posted: Aug 15, 2016
• Last Verified: Aug 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by VA Office of Research and Development: stroke; exercise
• Additional relevant MeSH terms: Stroke

Study Results

Participant Flow

Arm/Group Title	APA-Stroke	Sittercise
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	43	33
COMPLETED	25	23
NOT COMPLETED	18	10

Baseline Characteristics

Arm/Group Title	APA-Stroke	Sittercise	Total
Arm/Group Description	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.	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.	Total of all reporting groups
Overall Participants	43	33	76
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	63 (9.2)	65 (11.7)	64 (10.3)
Sex: Female, Male (Count of Participants)
Female	21 48.8%	16 48.5%	37 48.7%
Male	22 51.2%	17 51.5%	39 51.3%
Race/Ethnicity, Customized (participants) [Number]
White	17 39.5%	13 39.4%	30 39.5%
Black	24 55.8%	14 42.4%	38 50%
Other	1 2.3%	6 18.2%	7 9.2%
Missing	1 2.3%	0 0%	1 1.3%
Region of Enrollment (participants) [Number]
United States	43 100%	33 100%	76 100%
Hemiparesis (participants) [Number]
Left	27 62.8%	18 54.5%	45 59.2%
Right	13 30.2%	13 39.4%	26 34.2%
Missing	3 7%	2 6.1%	5 6.6%
Year since stroke (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	5.5 (5.2)	4.7 (8.5)	5.2 (6.6)
Berg Balance (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	44.76 (9.03)	43.00 (9.02)	44.58 (9.03)
Short Physical Performance Battery (SPPB) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	6.60 (2.66)	6.06 (2.64)	6.36 (2.65)
6 Minute Walk Test (MWT) (meters) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [meters]	189.07 (97.38)	171.69 (97.42)	181.52 (97.40)
Stroke Impact Scale (SIS) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	466.62 (201.75)	490.79 (201.76)	476.29 (201.75)

Outcome Measures

1. Primary Outcome

Title	6 Minute Walk Test (6MWT)
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	APA-Stroke	Sittercise
Arm/Group Description	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.	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.
Measure Participants	25	23
Baseline	189 (15)	172 (17)
Three-months	211 (21)	170 (23)
Six-Months	228 (22)	167 (23)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	APA-Stroke, Sittercise
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.25
	Comments	Random effects ANOVA with random intercept and random slope compared the time course (slopes) of change in our outcome measures across three time points: baseline, three, and six-months in our two experimental groups--APA-stroke and Sittercise.
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	difference between slopes
	Estimated Value	8.43
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Deviation; Value: 7.17
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	APA-Stroke
	Comments	Within group change over time
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.004
	Comments	Random effects ANOVA, random intercept, random slope estimating within group change (slope) over time
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	Slope
	Estimated Value	14.95
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Deviation; Value: 4.92
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Sittercise
	Comments	Within group change over time
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.218
	Comments	Random effects ANOVA, random intercept, random slope estimating within group change (slope) over time
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	Slope
	Estimated Value	6.52
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Deviation; Value: 5.13
	Estimation Comments

2. Secondary Outcome

Title	Balance as Measured by the Berg Balance Scale (BBS)
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	APA-Stroke	Sittercise
Arm/Group Description	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.	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.
Measure Participants	25	23
Baseline	44.8 (1.1)	43.0 (1.9)
Three-Months	46.5 (1.5)	43.0 (2.0)
Six-Months	47.6 (1.1)	41.6 (2.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	APA-Stroke, Sittercise
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.47
	Comments	Random effects ANOVA with random intercept and random slope compared the time course (slopes) of change in our outcome measures across three time points: baseline, three, and six-months in our two experimental groups--APA-stroke and Sittercise.
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	Difference between slopes
	Estimated Value	0.186
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Deviation; Value: 0.256
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	APA-Stroke
	Comments	Within group change over time
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.225
	Comments	Random effects ANOVA, random intercept, random slope estimating within group change (slope) over time
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	Slope
	Estimated Value	.215
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Deviation; Value: 0.175
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Sittercise
	Comments	Within group change over time
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.88
	Comments	Random effects ANOVA, random intercept, random slope estimating within group change (slope) over time
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	Slope
	Estimated Value	.029
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Deviation; Value: 0.187
	Estimation Comments

3. Secondary Outcome

Title	Short Physical Performance Battery (SPPB)
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	APA-Stroke	Sittercise
Arm/Group Description	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.	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.
Measure Participants	25	23
Baseline	6.60 (.40)	6.10 (.48)
Three-Months	6.76 (.48)	5.92 (.50)
Six-Months	7.12 (.51)	5.96 (.61)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	APA-Stroke, Sittercise
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.98
	Comments	Random effects ANOVA with random intercept and random slope compared the time course (slopes) of change in our outcome measures across three time points: baseline, three, and six-months in our two experimental groups--APA-stroke and Sittercise.
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	Difference between slopes
	Estimated Value	.002
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Deviation; Value: .078
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	APA-Stroke
	Comments	Within group change over time
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.54
	Comments	Random effects ANOVA, random intercept, random slope estimating within group change (slope) over time
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	Slope
	Estimated Value	.033
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Deviation; Value: .054
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Sittercise
	Comments	Within group change over time
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.59
	Comments	Random effects ANOVA, random intercept, random slope estimating within group change (slope) over time
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	Slope
	Estimated Value	.031
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Deviation; Value: 0.057
	Estimation Comments

4. Secondary Outcome

Title	Stroke Impact Scale (SIS)
Description	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

Outcome Measure Data

Analysis Population Description

SIS data were incomplete for six sittercise participants, hence the discrepancy between number of participants analyzed and the flow data reported above.

Arm/Group Title	APA-Stroke	Sittercise
Arm/Group Description	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.	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.
Measure Participants	25	17
Baseline	467 (32)	491 (36)
Three-Months	463 (35)	576 (17)
Six-Months	562 (23)	579 (18)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	APA-Stroke, Sittercise
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.98
	Comments
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	Slope
	Estimated Value	0.296
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Deviation; Value: 9.77
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	APA-Stroke
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.02
	Comments	Random effects ANOVA, random intercept, random slope estimating within group change (slope) over time
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	Slope
	Estimated Value	15.49
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Deviation; Value: 6.19
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Sittercise
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.051
	Comments	Random effects ANOVA, random intercept, random slope estimating within group change (slope) over time
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	Slope
	Estimated Value	15.193
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Deviation; Value: 7.553
	Estimation Comments

Adverse Events

Arm/Group Title	APA-Stroke		Sittercise
Arm/Group Description	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.		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.
All Cause Mortality
	APA-Stroke		Sittercise
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	APA-Stroke		Sittercise
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/43 (0%)		0/33 (0%)
Other (Not Including Serious) Adverse Events
	APA-Stroke		Sittercise
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/43 (14%)		4/33 (12.1%)
Cardiac disorders
faintness	2/43 (4.7%)		0/33 (0%)
shortness of breath	1/43 (2.3%)		0/33 (0%)
chest pain	1/43 (2.3%)		0/33 (0%)
Musculoskeletal and connective tissue disorders
muscle pain	1/43 (2.3%)		2/33 (6.1%)
fall	1/43 (2.3%)		2/33 (6.1%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.