NCT01042990

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
54

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Sep 2008

Typical duration for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

January 5, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 6, 2010

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

January 6, 2010

Status Verified

December 1, 2009

Enrollment Period

3 years

First QC Date

January 5, 2010

Last Update Submit

January 5, 2010

Conditions

Stroke

Keywords

StrokeExerciseBalanceDynamic GaitCardiovascular Fitness

Outcome Measures

Primary Outcomes (5)

  • VO2 Peak

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

  • Berg Balance Scale

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

  • Dynamic Gait Index

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

  • Step Activity Monitoring

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

  • 6 Minute Walks

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

Secondary Outcomes (1)

  • Psychosocial questionnaires

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

Study Arms (3)

Home Exercise Only

ACTIVE COMPARATOR

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

APA

EXPERIMENTAL

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

APA+TM

EXPERIMENTAL

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

Interventions

Adaptive Physical ActivityOTHER

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

APAAPA+TMHome Exercise Only

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baltimore VAMC

Baltimore, Maryland, 21201, United States

RECRUITING

Related 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.

    PMID: 19581199RESULT

MeSH Terms

Conditions

StrokeMotor Activity

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesBehavior

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kathleen M Michael, PhD

CONTACT

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

Jeffrey Beans, BS

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED

Study Record Dates

First Submitted

January 5, 2010

First Posted

January 6, 2010

Study Start

September 1, 2008

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

January 6, 2010

Record last verified: 2009-12

Locations

US(1)