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Adaptive Physical Activity for Chronic Stroke (APA-Stroke)

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ClinicalTrials.gov Identifier: NCT00773370
Recruitment Status : Completed
First Posted : October 16, 2008
Results First Posted : August 15, 2016
Last Update Posted : August 15, 2016
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Stroke Behavioral: APA-Stroke Behavioral: Sittercise Phase 1

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Adaptive Physical Activity for Chronic Stroke
Study Start Date : January 2009
Primary Completion Date : February 2014
Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. 6 Minute Walk Test (6MWT) [ Time Frame: measured at baseline, 3 months, 6 months ]
    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 :
  1. Balance as Measured by the Berg Balance Scale (BBS) [ Time Frame: measured at baseline, 3 months, 6 months ]
    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.

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

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


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 ( Other Identifier: UMB BRAAN Number )
HP-00044066 ( Other Identifier: UMB CICERO Number )
First Posted: October 16, 2008    Key Record Dates
Results First Posted: August 15, 2016
Last Update Posted: August 15, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
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