Adaptive Physical Activity for Chronic Stroke

Stroke Clinical Trial

— APA-Stroke  

Official title:

Adaptive Physical Activity for Chronic Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00773370
• Other study ID #: B6329-R
• Secondary ID: H 30467HP-000440
• Status: Completed
• Phase: Phase 1
• First received: October 15, 2008
• Last updated: August 11, 2016
• Start date: January 2009
• Est. completion date: April 2014

Study information

• Verified date: August 2016
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: April 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Stroke

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	VA Maryland Health Care System, Baltimore	Baltimore	Maryland
United States	MedStar National Rehabilitation Hospital	Washington	District of Columbia

Sponsors (4)

Lead Sponsor	Collaborator
VA Office of Research and Development	Howard County Office on Aging, MedStar National Rehabilitation Network, University of Maryland, Baltimore County

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	6 Minute Walk Test (6MWT)	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.	measured at baseline, 3 months, 6 months	No
Secondary	Balance as Measured by the Berg Balance Scale (BBS)	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.	measured at baseline, 3 months, 6 months	No
Secondary	Short Physical Performance Battery (SPPB)	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.	measured at baseline, 3 months, 6 months	No
Secondary	Stroke Impact Scale (SIS)	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.	measured at baseline, 3 months, 6 months	No