Adaptive Physical Activity for Chronic Stroke (APA-Stroke)
This study will compare the Adaptive Physical Activity program (APA) to a less vigorous group exercise program, (Sittercize) to see if APA leads to greater improvements in walking endurance, quality of life, and participation in social activities.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Adaptive Physical Activity for Chronic Stroke|
- walking speed as measured by the 6 minute walk [ Time Frame: measured at baseline, 3 months, 6 months, 9 months and 12 months ] [ Designated as safety issue: No ]
- free-living ambulatory activity as measured by the step activity monitor [ Time Frame: measured at baseline, 3 months, 6 months, 9 months and 12 months ] [ Designated as safety issue: No ]
- balance as measured by the Berg Balance Scale [ Time Frame: measured at baseline, 3 months, 6 months, 9 months and 12 months ] [ Designated as safety issue: No ]
- walking speed as measured by the 30 foot walk [ Time Frame: measured at baseline, 3 months, 6 months, 9 months and 12 months ] [ Designated as safety issue: No ]
|Study Start Date:||January 2009|
|Study Completion Date:||April 2014|
|Primary Completion Date:||February 2014 (Final data collection date for primary outcome measure)|
Experimental: Arm 1
APA 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.
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: Arm 2
Sittercize 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.
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.
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. Our short-term objectives are to test study hypotheses using a Randomized Clinical Trial (RCT) with an Attention Control (also referred to as the "Sittercize" exercise program). We will also explore factors related to exercise adherence in a community program for chronic stroke survivors. Our 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 we propose to offer courses in Office of Aging (OoA) Senior Centers and a Veterans of Foreign Wars (VFW) hall. 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, VFWs, and other facilities that would increase community access for veterans.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00773370
|United States, Maryland|
|VA Maryland Health Care System, Baltimore|
|Baltimore, Maryland, United States, 21201|
|Principal Investigator:||Mary Stuart, ScD||VA Maryland Health Care System, Baltimore|