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Testing Adaptive Physical Activity in Stroke (TAPAS)

Primary Purpose

Stroke

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Adaptive Physical Activity

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, Exercise, Balance, Dynamic Gait, Cardiovascular Fitness

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.
Residual hemiparetic gait deficits.
Already completed all conventional inpatient and outpatient physical therapy.
Adequate language and neurocognitive function to participate in exercise testing and training (specific screening instruments used.)

Sites / Locations

Baltimore VAMCRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Arm Label

Home Exercise Only

APA

APA+TM

Arm Description

Participants receive education and instruction on a home exercise program which they do on their own, with intermittent encouragement from study personnel.

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

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.

Outcomes

Primary Outcome Measures

VO2 Peak

Berg Balance Scale

Dynamic Gait Index

Step Activity Monitoring

6 Minute Walks

Secondary Outcome Measures

Psychosocial questionnaires

Full Information

NCT ID

NCT01042990

First Posted

January 5, 2010

Last Updated

January 5, 2010

Sponsor

Baltimore VA Medical Center

Collaborators

University of Maryland

1. Study Identification

Unique Protocol Identification Number

NCT01042990

Brief Title

Testing Adaptive Physical Activity in Stroke

Acronym

TAPAS

Official Title

Testing Adaptive Physical Activity in Stroke

Study Type

Interventional

2. Study Status

Record Verification Date

December 2009

Overall Recruitment Status

Unknown status

Study Start Date

September 2008 (undefined)

Primary Completion Date

September 2011 (Anticipated)

Study Completion Date

September 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Baltimore VA Medical Center

Collaborators

University of Maryland

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke

Keywords

Stroke, Exercise, Balance, Dynamic Gait, Cardiovascular Fitness

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

54 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Home Exercise Only

Arm Type

Active Comparator

Arm Description

Participants receive education and instruction on a home exercise program which they do on their own, with intermittent encouragement from study personnel.

Arm Title

APA

Arm Type

Experimental

Arm Description

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

Arm Title

APA+TM

Arm Type

Experimental

Arm Description

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.

Intervention Type

Other

Intervention Name(s)

Adaptive Physical Activity

Intervention Description

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

Primary Outcome Measure Information:

Title

VO2 Peak

Time Frame

baseline, 3 months, 6 months, and 3 months post-intervention

Title

Berg Balance Scale

Time Frame

baseline, 3 months, 6 months, and 3 months post-intervention

Title

Dynamic Gait Index

Time Frame

Baseline, 3 months, 6 months, and 3 months post intervention

Title

Step Activity Monitoring

Time Frame

Baseline, 3 months, 6 months, and 3 months post-intervention

Title

6 Minute Walks

Time Frame

Baseline, 3 months, 6 months, and 3 months post-intervention

Secondary Outcome Measure Information:

Title

Psychosocial questionnaires

Time Frame

baseline, 3 months, 6 months, and 3 months post-intervention

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Residual hemiparetic gait deficits. Already completed all conventional inpatient and outpatient physical therapy. Adequate language and neurocognitive function to participate in exercise testing and training (specific screening instruments used.)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Kathleen M Michael, PhD

Phone

410-605-7000

Ext

4844

kmichael@grecc.umaryland.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Jeffrey Beans, BS

Phone

410-605-7000

Ext

4168

jbeans@grecc.umaryland.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Richard F Macko, MD

Organizational Affiliation

University of Maryland

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Kathleen M Michael, PhD

Organizational Affiliation

University of Maryland

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Andrew P Goldberg, MD

Organizational Affiliation

University of Maryland

Official's Role

Principal Investigator

Facility Information:

Facility Name

Baltimore VAMC

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21201

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kathleen M Michael, PhD

Phone

410-605-7000

Ext

4844

kmichael@grecc.umaryland.edu

First Name & Middle Initial & Last Name & Degree

Kathleen M Michael, PhD

First Name & Middle Initial & Last Name & Degree

Marianne Shauhgnessy, PhD

First Name & Middle Initial & Last Name & Degree

Peter Normandt, MS

First Name & Middle Initial & Last Name & Degree

Richard F Macko, MD

First Name & Middle Initial & Last Name & Degree

Andrew P Goldberg, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

19581199

Citation

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.

Results Reference

result

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Testing Adaptive Physical Activity in Stroke

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