Testing Adaptive Physical Activity in Stroke

Stroke Clinical Trial

— TAPAS  

Official title:

Testing Adaptive Physical Activity in Stroke

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01042990
• Other study ID #: HP-00040264
• Status: Recruiting
• Phase: N/A
• First received: January 5, 2010
• Last updated: January 5, 2010
• Start date: September 2008
• Est. completion date: September 2011

Study information

• Verified date: December 2009
• Source: Baltimore VA Medical Center
• Contact: Kathleen M Michael, PhD
• Phone: 410-605-7000
• Email: kmichael[@]grecc.umaryland.edu
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 54
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• Adaptive Physical Activity
Structured gait, balance, and progressive walking program performed in a group gym setting 3x/week for 6 months

Locations

Country	Name	City	State
United States	Baltimore VAMC	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Baltimore VA Medical Center	University of Maryland

Country where clinical trial is conducted

United States, 

References & Publications (1)

Michael K, Goldberg AP, Treuth MS, Beans J, Normandt P, Macko RF. Progressive adaptive physical activity in stroke improves balance, gait, and fitness: preliminary results. Top Stroke Rehabil. 2009 Mar-Apr;16(2):133-9. doi: 10.1310/tsr1602-133. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VO2 Peak		baseline, 3 months, 6 months, and 3 months post-intervention	Yes
Primary	Berg Balance Scale		baseline, 3 months, 6 months, and 3 months post-intervention	Yes
Primary	Dynamic Gait Index		Baseline, 3 months, 6 months, and 3 months post intervention	Yes
Primary	Step Activity Monitoring		Baseline, 3 months, 6 months, and 3 months post-intervention	No
Primary	6 Minute Walks		Baseline, 3 months, 6 months, and 3 months post-intervention	No
Secondary	Psychosocial questionnaires		baseline, 3 months, 6 months, and 3 months post-intervention	No