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Adaptive Physical Activity for Chronic Stroke (APA-Stroke)

This study has been completed.
Sponsor:
Collaborators:
University of Maryland, Baltimore County
Howard County Office on Aging
MedStar National Rehabilitation Network
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT00773370
First received: October 15, 2008
Last updated: August 11, 2016
Last verified: August 2016
Results First Received: February 26, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Stroke
Interventions: Behavioral: APA-Stroke
Behavioral: Sittercise

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
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.

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.


Participant Flow:   Overall Study
    APA-Stroke   Sittercise
STARTED   43   33 
COMPLETED   25   23 
NOT COMPLETED   18   10 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
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.

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.

Total Total of all reporting groups

Baseline Measures
   APA-Stroke   Sittercise   Total 
Overall Participants Analyzed 
[Units: Participants]
 43   33   76 
Age 
[Units: Years]
Mean (Standard Deviation)
 63  (9.2)   65  (11.7)   64  (10.3) 
Gender 
[Units: Participants]
     
Female   21   16   37 
Male   22   17   39 
Race/Ethnicity, Customized 
[Units: Participants]
     
White   17   13   30 
Black   24   14   38 
Other   1   6   7 
Missing   1   0   1 
Region of Enrollment 
[Units: Participants]
     
United States   43   33   76 
Hemiparesis 
[Units: Participants]
     
Left   27   18   45 
Right   13   13   26 
Missing   3   2   5 
Year since stroke 
[Units: Years]
Mean (Standard Deviation)
 5.5  (5.2)   4.7  (8.5)   5.2  (6.6) 
Berg Balance [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 44.76  (9.03)   43.00  (9.02)   44.58  (9.03) 
[1] 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.
Short Physical Performance Battery (SPPB) [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 6.60  (2.66)   6.06  (2.64)   6.36  (2.65) 
[1] 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.
6 Minute Walk Test (MWT) 
[Units: Meters]
Mean (Standard Deviation)
 189.07  (97.38)   171.69  (97.42)   181.52  (97.40) 
Stroke Impact Scale (SIS) [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 466.62  (201.75)   490.79  (201.76)   476.29  (201.75) 
[1] 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.


  Outcome Measures
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1.  Primary:   6 Minute Walk Test (6MWT)   [ Time Frame: measured at baseline, 3 months, 6 months ]

2.  Secondary:   Balance as Measured by the Berg Balance Scale (BBS)   [ Time Frame: measured at baseline, 3 months, 6 months ]

3.  Secondary:   Short Physical Performance Battery (SPPB)   [ Time Frame: measured at baseline, 3 months, 6 months ]

4.  Secondary:   Stroke Impact Scale (SIS)   [ Time Frame: measured at baseline, 3 months, 6 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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.


Results Point of Contact:  
Name/Title: Mary Stuart, ScD, VA Research Investigator
Organization: VA Medical Center, Baltimore Maryland
phone: 410-455-2084
e-mail: stuart@umbc.edu



Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00773370     History of Changes
Other Study ID Numbers: B6329-R
H 30467 ( Other Identifier: UMB BRAAN Number )
HP-00044066 ( Other Identifier: UMB CICERO Number )
Study First Received: October 15, 2008
Results First Received: February 26, 2016
Last Updated: August 11, 2016
Health Authority: United States: Federal Government