Adaptive Physical Activity for Chronic Stroke

NCT ID: NCT00773370

Last Updated: 2016-08-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2014-04-30

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

APA-Stroke

Intervention Type: BEHAVIORAL

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.

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.

Group Type: ACTIVE_COMPARATOR

Sittercise

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Maryland, Baltimore County

OTHER

Sponsor Role: collaborator

Howard County Office on Aging

UNKNOWN

Sponsor Role: collaborator

MedStar National Rehabilitation Network

OTHER

Sponsor Role: collaborator

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mary Stuart, ScD

Role: PRINCIPAL_INVESTIGATOR

VA Maryland Health Care System, Baltimore

Locations

MedStar National Rehabilitation Hospital

Washington D.C., District of Columbia, United States

VA Maryland Health Care System, Baltimore

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

H 30467

Identifier Type: OTHER

Identifier Source: secondary_id

HP-00044066

Identifier Type: OTHER

Identifier Source: secondary_id

B6329-R

Identifier Type: -

Identifier Source: org_study_id