Recruiting

Adaptive Physical Activity

Sponsor:

Baltimore VA Medical Center

Code:

NCT01042990

Conditions

Stroke

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Interventions

Adaptive Physical Activity

Study Details

Brief summary:

"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

Conditions

Stroke

Study ID

NCT01042990

Start date

Sep, 2008

Status verified date

Dec, 2009

Completion date

Sep, 2011

Anticipated

Primary completion date

Sep, 2011

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

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 Design

Enrollment

54 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

experimental: APA

Participants exercise in a gym setting 3x/week for six months, performing gait and balance exercises along with a progressive walking program.

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.

Interventions

Adaptive Physical Activity

Structured gait, balance, and progressive walking program performed in a group gym setting 3x/week for 6 months

Primary outcome measure

  • VO2 Peak [ Time Frame: 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 ]
  • Dynamic Gait Index [ Time Frame: 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 ]
  • 6 Minute Walks [ Time Frame: Baseline, 3 months, 6 months, and 3 months post-intervention ]

Central Contacts and Locations

Central contacts

Kathleen M Michael, PhD

410-605-7000kmichael@grecc.umaryland.edu

Jeffrey Beans, BS

410-605-7000jbeans@grecc.umaryland.edu

Locations

Baltimore VAMC

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

Kathleen M Michael, PhD

410-605-7000kmichael@grecc.umaryland.edu

Principal Investigator:

Kathleen M Michael, PhD

More Information

Sponsor

Baltimore VA Medical Center

Last update posted

Jan 6, 2010

Last verified

Dec, 2009

Keywords

  • Stroke
  • Exercise
  • Balance
  • Dynamic Gait
  • Cardiovascular Fitness

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Baltimore VA Medical Center on 2010-01-06.