NCT00431821

Brief Summary

Regular exercise has been demonstrated to improve muscle strength, balance, coordination as well as improve cardiovascular fitness levels and overall quality of life in stroke survivors. This study is designed to test the feasibility and effectiveness of a 12-week intervention to education and encourage stroke survivors to exercise following discharge from rehabilitation settings using a walking program and targeted functional activity homework.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

October 1, 2006

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 2, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 6, 2007

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

July 22, 2013

Status Verified

July 1, 2013

Enrollment Period

4.3 years

First QC Date

February 2, 2007

Last Update Submit

July 18, 2013

Conditions

Cerebrovascular AccidentStroke

Keywords

ExerciseRehabilitationStroke

Outcome Measures

Primary Outcomes (1)

  • Ambulatory Activity Profile

    6 months

Study Arms (2)

Arm 1

OTHER

Home-based exercise prescriptions with weekly motivational telephone calls.

Behavioral: Exercise

Arm 2

OTHER

Stroke education program with matched attention phone calls

Other: Stroke education

Interventions

ExerciseBEHAVIORAL

Home-based exercise prescriptions with weekly motivational telephone calls.

Arm 1
Stroke educationOTHER

Stroke education program with matched attention phone calls

Arm 2

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old ischemic Stroke patients,
  • Stroke onset \<90 days at enrollment,
  • Hemiparetic gait disorder,
  • Patients able to walk 30ft with or w/out assistive device,
  • Sufficient English comprehension to understand instructions, provide consent, and answer questions,
  • Lives within 30 miles of the Greater Baltimore area.

You may not qualify if:

  • Dementia (extended MMSE \<85 or \<80 if education level below 9th grade),
  • Untreated major clinical depression (CES-D\>16) and confirmed with clinical interview,
  • Heavy alcohol use (\<3 oz liquor, 3, 4-oz glasses of wine, or 3, 12- oz beers daily),
  • Active cancer, or any illness with a life expectancy of less than 6 months,
  • Any condition in which exercise activity would be contraindicated including, but not limited to: unstable angina, cardiac ischemic event within the past 6 months, congestive heart failure (Stage III or IV), major orthopedic chronic pain or non-stroke neuromuscular disorders restricting exercise, oxygen-dependent COPD or peripheral neuropathy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Baltimore, Maryland, 21201, United States

Location

Related Publications (2)

  • Crocker TF, Brown L, Lam N, Wray F, Knapp P, Forster A. Information provision for stroke survivors and their carers. Cochrane Database Syst Rev. 2021 Nov 23;11(11):CD001919. doi: 10.1002/14651858.CD001919.pub4.

    PMID: 34813082DERIVED

  • Saunders DH, Mead GE, Fitzsimons C, Kelly P, van Wijck F, Verschuren O, Backx K, English C. Interventions for reducing sedentary behaviour in people with stroke. Cochrane Database Syst Rev. 2021 Jun 29;6(6):CD012996. doi: 10.1002/14651858.CD012996.pub2.

    PMID: 34184251DERIVED

MeSH Terms

Conditions

StrokeMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Marianne Shaughnessy, RN PhD

    Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2007

First Posted

February 6, 2007

Study Start

October 1, 2006

Primary Completion

February 1, 2011

Study Completion

October 1, 2012

Last Updated

July 22, 2013

Record last verified: 2013-07

Locations

US(1)