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Testing Adaptive Physical Activity in Stroke (TAPAS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by Baltimore VA Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
University of Maryland
Information provided by:
Baltimore VA Medical Center
ClinicalTrials.gov Identifier:
NCT01042990
First received: January 5, 2010
Last updated: NA
Last verified: December 2009
History: No changes posted
  Purpose

"Testing Adaptive Physical Activity in Stroke" tests the idea that adaptive physical activity (APA) will improve fitness, balance and walking function, daily step activity, and outcomes related to quality of life in individuals with chronic stroke. Adaptive physical activity is an exercise model that combines aerobic exercise with balance and gait training in a socially reinforcing group setting. Individualized homework assignments encourage integration of exercise into daily life routines. Our specific aims are:

  1. to determine whether APA improves cardiovascular fitness and metabolic health
  2. to measure the effects of APA on gait and balance, ambulatory activity, and ADL function
  3. to determine whether APA affects self-reported outcomes related to self-efficacy, fatigue, and stroke-specific quality of life

Condition Intervention
Stroke
 Other: Adaptive Physical Activity

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Testing Adaptive Physical Activity in Stroke

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Baltimore VA Medical Center:

Primary Outcome Measures:
  • VO2 Peak [ Time Frame: baseline, 3 months, 6 months, and 3 months post-intervention ] [ Designated as safety issue: Yes ]
  • Berg Balance Scale [ Time Frame: baseline, 3 months, 6 months, and 3 months post-intervention ] [ Designated as safety issue: Yes ]
  • Dynamic Gait Index [ Time Frame: Baseline, 3 months, 6 months, and 3 months post intervention ] [ Designated as safety issue: Yes ]
  • Step Activity Monitoring [ Time Frame: Baseline, 3 months, 6 months, and 3 months post-intervention ] [ Designated as safety issue: No ]
  • 6 Minute Walks [ Time Frame: Baseline, 3 months, 6 months, and 3 months post-intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Psychosocial questionnaires [ Time Frame: baseline, 3 months, 6 months, and 3 months post-intervention ] [ Designated as safety issue: No ]

Estimated Enrollment: 54
Study Start Date: September 2008
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Home Exercise Only
Participants receive education and instruction on a home exercise program which they do on their own, with intermittent encouragement from study personnel.
 Other: Adaptive Physical Activity
Structured gait, balance, and progressive walking program performed in a group gym setting 3x/week for 6 months
Experimental: APA
Participants exercise in a gym setting 3x/week for six months, performing gait and balance exercises along with a progressive walking program.
 Other: Adaptive Physical Activity
Structured gait, balance, and progressive walking program performed in a group gym setting 3x/week for 6 months
Experimental: APA+TM
Participants exercise in a gym setting 3x/week for six months, performing a combined program of adaptive physical activity (gait and balance training) and progressive treadmill walking.
 Other: Adaptive Physical Activity
Structured gait, balance, and progressive walking program performed in a group gym setting 3x/week for 6 months

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Ischemic stroke greater than or equal to 6 months prior in men or women ages 40- or older. Hemorrhagic stroke greater than or equal to one year prior in men or women ages 40-or older.
  2. Residual hemiparetic gait deficits.
  3. Already completed all conventional inpatient and outpatient physical therapy.
  4. Adequate language and neurocognitive function to participate in exercise testing and training (specific screening instruments used.)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01042990

Contacts
Contact: Kathleen M Michael, PhD 410-605-7000 ext 4844 kmichael@grecc.umaryland.edu
Contact: Jeffrey Beans, BS 410-605-7000 ext 4168 jbeans@grecc.umaryland.edu

Locations
United States, Maryland
Baltimore VAMC Recruiting
Baltimore, Maryland, United States, 21201
Contact: Kathleen M Michael, PhD     410-605-7000 ext 4844     kmichael@grecc.umaryland.edu    
Principal Investigator: Kathleen M Michael, PhD            
Sub-Investigator: Marianne Shauhgnessy, PhD            
Sub-Investigator: Peter Normandt, MS            
Principal Investigator: Richard F Macko, MD            
Sub-Investigator: Andrew P Goldberg, MD            
Sponsors and Collaborators
Baltimore VA Medical Center
University of Maryland
Investigators
Principal Investigator: Richard F Macko, MD University of Maryland
Principal Investigator: Kathleen M Michael, PhD University of Maryland
Principal Investigator: Andrew P Goldberg, MD University of Maryland
  More Information

Publications:

Responsible Party: Richard F. Macko, University of Maryland
ClinicalTrials.gov Identifier: NCT01042990     History of Changes
Other Study ID Numbers: HP-00040264
Study First Received: January 5, 2010
Last Updated: January 5, 2010
Health Authority: United States: Federal Government

Keywords provided by Baltimore VA Medical Center:
Stroke
Exercise
Balance
Dynamic Gait
Cardiovascular Fitness

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 22, 2013