Adaptive Physical Activity for Chronic Stroke

NCT00773370 | Completed Phase 1 Results

• 3 other identifiers: B6329-RH 30467HP-00044066
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 2

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.

Conditions

Stroke

Keywords

stroke; exercise

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Balance as Measured by the Berg Balance Scale (BBS)

  measured at baseline, 3 months, 6 months

• Short Physical Performance Battery (SPPB)

  measured at baseline, 3 months, 6 months

• Stroke Impact Scale (SIS)

  measured at baseline, 3 months, 6 months

Study Arms (2)

APA-Stroke

EXPERIMENTAL

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

Sittercise

ACTIVE COMPARATOR

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

Interventions

APA-Stroke 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.

APA-Stroke

Sittercise 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.

Sittercise

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead
• University of Maryland, Baltimore County: collaborator
• Howard County Office on Aging: collaborator
• MedStar National Rehabilitation Network: collaborator

Study Sites (2)

MedStar National Rehabilitation Hospital

Washington D.C., District of Columbia, 20010, United States

Location

VA Maryland Health Care System, Baltimore

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Stroke; Motor Activity

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Behavior

Results Point of Contact

• Title: Mary Stuart, ScD, VA Research Investigator
• Organization: VA Medical Center, Baltimore Maryland

stuart@umbc.edu

410-455-2084

Study Officials

• Mary Stuart, ScD

  VA Maryland Health Care System, Baltimore

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2008
• First Posted: October 16, 2008
• Study Start: January 1, 2009
• Primary Completion: February 1, 2014
• Study Completion: April 1, 2014
• Last Updated: August 15, 2016
• Results First Posted: August 15, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)