Testing Adaptive Physical Activity in Stroke (TAPAS)

January 5, 2010 updated by: Baltimore VA Medical Center

"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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Recruiting
        • Baltimore VAMC
        • Contact:
        • 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
VO2 Peak
Time Frame: baseline, 3 months, 6 months, and 3 months post-intervention
baseline, 3 months, 6 months, and 3 months post-intervention
Berg Balance Scale
Time Frame: baseline, 3 months, 6 months, and 3 months post-intervention
baseline, 3 months, 6 months, and 3 months post-intervention
Dynamic Gait Index
Time Frame: Baseline, 3 months, 6 months, and 3 months post intervention
Baseline, 3 months, 6 months, and 3 months post intervention
Step Activity Monitoring
Time Frame: Baseline, 3 months, 6 months, and 3 months post-intervention
Baseline, 3 months, 6 months, and 3 months post-intervention
6 Minute Walks
Time Frame: Baseline, 3 months, 6 months, and 3 months post-intervention
Baseline, 3 months, 6 months, and 3 months post-intervention

Secondary Outcome Measures

Outcome Measure
Time Frame
Psychosocial questionnaires
Time Frame: baseline, 3 months, 6 months, and 3 months post-intervention
baseline, 3 months, 6 months, and 3 months post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baltimore VA Medical Center

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Anticipated)

September 1, 2011

Study Completion (Anticipated)

September 1, 2011

Study Registration Dates

First Submitted

January 5, 2010

First Submitted That Met QC Criteria

January 5, 2010

First Posted (Estimate)

January 6, 2010

Study Record Updates

Last Update Posted (Estimate)

January 6, 2010

Last Update Submitted That Met QC Criteria

January 5, 2010

Last Verified

December 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HP-00040264

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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