Clinical trial NCT00773370: Adaptive Physical Activity for Chronic Stroke
Official title: Adaptive Physical Activity for Chronic Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Stroke
Keywords: stroke
exercise
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: University of Maryland, Baltimore County
name: Howard County Office on Aging
name: MedStar National Rehabilitation Network
First posted: 2008-10-16
Enrollment: 76
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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 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

Primary outcomes:
measure: 6 Minute Walk Test (6MWT)
timeFrame: measured at baseline, 3 months, 6 months
Secondary outcomes:
measure: Balance as Measured by the Berg Balance Scale (BBS)
timeFrame: measured at baseline, 3 months, 6 months
measure: Short Physical Performance Battery (SPPB)
timeFrame: measured at baseline, 3 months, 6 months
measure: Stroke Impact Scale (SIS)
timeFrame: measured at baseline, 3 months, 6 months
Other outcomes:
Locations:
city: Washington
country: United States
facility: MedStar National Rehabilitation Hospital
state: District of Columbia
city: Baltimore
country: United States
facility: VA Maryland Health Care System, Baltimore
state: Maryland
Study officials:
affiliation: VA Maryland Health Care System, Baltimore
name: Mary Stuart, ScD
role: PRINCIPAL_INVESTIGATOR
References: