Trial record 13 of 1145 for:
physical activity | Open Studies | NIH, U.S. Fed
Adaptive Physical Activity for Chronic Stroke (APA-Stroke)
This study is currently recruiting participants.
Verified April 2013 by Department of Veterans Affairs
Sponsor:
Collaborators:
University of Maryland, Baltimore County
Howard County Office on Aging
National Rehabilitation Hospital
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00773370
First received: October 15, 2008
Last updated: April 30, 2013
Last verified: April 2013
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Purpose
This study will compare the Adaptive Physical Activity program (APA) to a less vigorous group exercise program, (Sittercize) to see if APA leads to greater improvements in walking endurance, quality of life, and participation in social activities.
| Condition | Intervention | Phase |
|---|---|---|
|
Stroke |
Behavioral: APA-Stroke Behavioral: Sittercize |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Adaptive Physical Activity for Chronic Stroke |
Resource links provided by NLM:
Further study details as provided by Department of Veterans Affairs:
Primary Outcome Measures:
- walking speed as measured by the 6 minute walk [ Time Frame: measured at baseline, 3 months, 6 months, 9 months and 12 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- free-living ambulatory activity as measured by the step activity monitor [ Time Frame: measured at baseline, 3 months, 6 months, 9 months and 12 months ] [ Designated as safety issue: No ]
- balance as measured by the Berg Balance Scale [ Time Frame: measured at baseline, 3 months, 6 months, 9 months and 12 months ] [ Designated as safety issue: No ]
- walking speed as measured by the 30 foot walk [ Time Frame: measured at baseline, 3 months, 6 months, 9 months and 12 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 160 |
| Study Start Date: | January 2009 |
| Estimated Study Completion Date: | April 2014 |
| Estimated Primary Completion Date: | February 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm 1
APA 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
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.
|
|
Active Comparator: Arm 2
Sittercize 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: Sittercize
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.
|
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. Our short-term objectives are to test study hypotheses using a Randomized Clinical Trial (RCT) with an Attention Control (also referred to as the "Sittercize" exercise program). We will also explore factors related to exercise adherence in a community program for chronic stroke survivors. Our 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 we propose to offer courses in Office of Aging (OoA) Senior Centers and a Veterans of Foreign Wars (VFW) hall. 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, VFWs, and other facilities that would increase community access for veterans.
Eligibility| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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. MS or Parkinson's);
- untreated clinical depression;
- inability to complete the "6-Minute Walk" test during baseline testing
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00773370
Contacts
| Contact: Jessica Hammers, BS | (410) 605-7000 ext 4842 | jessica.hammers@va.gov |
| Contact: Tara L McDonnell | (410) 455-1390 | taram2@umbc.edu |
Locations
| United States, Maryland | |
| VA Maryland Health Care System, Baltimore | Recruiting |
| Baltimore, Maryland, United States, 21201 | |
| Contact: Tara L McDonnell 410-455-1390 taram2@umbc.edu | |
| Contact: Mary Stuart, ScD (410) 455-2084 stuart@umbc.edu | |
| Principal Investigator: Mary Stuart, ScD | |
Sponsors and Collaborators
University of Maryland, Baltimore County
Howard County Office on Aging
National Rehabilitation Hospital
Investigators
| Principal Investigator: | Mary Stuart, ScD | VA Maryland Health Care System, Baltimore |
More Information
No publications provided
| Responsible Party: | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT00773370 History of Changes |
| Other Study ID Numbers: | B6329-R, H 30467, HP-00044066 |
| Study First Received: | October 15, 2008 |
| Last Updated: | April 30, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Department of Veterans Affairs:
|
stroke exercise |
Additional relevant MeSH terms:
|
Stroke Cerebral Infarction Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Vascular Diseases Cardiovascular Diseases Brain Infarction Brain Ischemia |
ClinicalTrials.gov processed this record on May 23, 2013