Adaptive Physical Activity for Chronic Stroke "APA-Stroke"

Completed

Phase 1 Results

Trial Description

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.

Conditions

Interventions

  • APA-Stroke Behavioral
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: 1
    Description: 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.
    ARM 2: Kind: Experimental
    Label: Arm 1
    Description: 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.
    ARM 3: Kind: Experimental
    Label: APA-Stroke
    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.
  • Sittercize Behavioral
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: 2
    Description: 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.
    ARM 2: Kind: Experimental
    Label: Arm 2
    Description: 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.
  • Sittercise Behavioral
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Sittercise
    Description: 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.

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Prevention
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary walking speed as measured by the 6 minute walk measured at baseline, 3 months, 6 months, 9 months and 12 months No
Secondary free-living ambulatory activity as measured by the step activity monitor measured at baseline, 3 months, 6 months, 9 months and 12 months No
Secondary balance as measured by the Berg Balance Scale measured at baseline, 3 months, 6 months, 9 months and 12 months No
Secondary walking speed as measured by the 30 foot walk measured at baseline, 3 months, 6 months, 9 months and 12 months No
Primary 6 Minute Walk Test (6MWT) measured at baseline, 3 months, 6 months No
Secondary Balance as Measured by the Berg Balance Scale (BBS) measured at baseline, 3 months, 6 months No
Secondary Short Physical Performance Battery (SPPB) measured at baseline, 3 months, 6 months No
Secondary Stroke Impact Scale (SIS) measured at baseline, 3 months, 6 months No

Sponsors