Adaptive Physical Activity for Chronic Stroke (APA-Stroke)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
University of Maryland, Baltimore County
Howard County Office on Aging
MedStar National Rehabilitation Network
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00773370
First received: October 15, 2008
Last updated: October 16, 2013
Last verified: October 2013

October 15, 2008
October 16, 2013
January 2009
February 2014   (final data collection date for primary outcome measure)
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 ]
walking speed as measured by the 6 minute walk [ Time Frame: measured at baseline, 3 months, and 6 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00773370 on ClinicalTrials.gov Archive Site
  • 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 ]
free-living ambulatory activity [ Time Frame: baseline, 3 months, 6 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Adaptive Physical Activity for Chronic Stroke
Adaptive Physical Activity for Chronic 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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Stroke
  • 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.
  • Behavioral: Sittercize
    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.
  • 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.
    Intervention: Behavioral: APA-Stroke
  • 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.
    Intervention: Behavioral: Sittercize
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
160
April 2014
February 2014   (final data collection date for primary outcome measure)

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. MS or Parkinson's);
  • untreated clinical depression;
  • inability to complete the "6-Minute Walk" test during baseline testing
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00773370
B6329-R, H 30467, HP-00044066
No
Department of Veterans Affairs
Department of Veterans Affairs
  • University of Maryland, Baltimore County
  • Howard County Office on Aging
  • MedStar National Rehabilitation Network
Principal Investigator: Mary Stuart, ScD VA Maryland Health Care System, Baltimore
Department of Veterans Affairs
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP