Adaptive Physical Activity for Chronic Stroke (APA-Stroke)

VA Office of Research and Development

Status and phase: Completed; Phase 1

Conditions: Stroke

Treatments: Behavioral: Sittercise; Behavioral: APA-Stroke

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT00773370

B6329-R

H 30467 (Other Identifier)

HP-00044066 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 76 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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76 participants in 2 patient groups

APA-Stroke

Experimental group

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.

Treatment:

Behavioral: APA-Stroke

Sittercise

Active Comparator group

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.

Treatment:

Behavioral: Sittercise