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
  Purpose
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 Intervention Phase
Stroke
Behavioral: APA-Stroke
Behavioral: Sittercise
Phase 1

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • 6 Minute Walk Test (6MWT) [ Time Frame: measured at baseline, 3 months, 6 months ] [ Designated as safety issue: No ]
    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:
  • Balance as Measured by the Berg Balance Scale (BBS) [ Time Frame: measured at baseline, 3 months, 6 months ] [ Designated as safety issue: No ]
    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.

  • Short Physical Performance Battery (SPPB) [ Time Frame: measured at baseline, 3 months, 6 months ] [ Designated as safety issue: No ]
    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.

  • Stroke Impact Scale (SIS) [ Time Frame: measured at baseline, 3 months, 6 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 76
Study Start Date: January 2009
Study Completion Date: April 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00773370

Locations
United States, District of Columbia
MedStar National Rehabilitation Hospital
Washington, District of Columbia, United States, 20010
United States, Maryland
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
  More Information

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00773370     History of Changes
Other Study ID Numbers: B6329-R  H 30467  HP-00044066 
Study First Received: October 15, 2008
Results First Received: February 26, 2016
Last Updated: August 11, 2016
Health Authority: United States: Federal Government
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by VA Office of Research and Development:
stroke
exercise

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 30, 2016