NCT00430456

Brief Summary

Individuals disabled by stroke are at risk of losing cardiovascular fitness and muscle due to disease. This worsens disability and can increase the risk of having another stroke or a heart attack. We would like to find out if and how different types of regular exercise (intense walking, long walking) can increase fitness, balance and improve walking function and activities of daily living in individuals who have suffered a stroke.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P75+ for phase_1 stroke

Timeline
Completed

Started Aug 2006

Longer than P75 for phase_1 stroke

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

August 1, 2006

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 31, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 2, 2007

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

June 12, 2012

Status Verified

June 1, 2012

Enrollment Period

4.6 years

First QC Date

January 31, 2007

Last Update Submit

June 11, 2012

Conditions

Stroke

Keywords

Aerobic exerciseBalance, posturalCardiovascular deconditioningGaitMRI, functionalPhysical therapy techniquesSelf EfficacyTreadmill test

Outcome Measures

Primary Outcomes (1)

  • Peak Aerobic Fitness

    3 and 6 months

Secondary Outcomes (7)

  • Economy of Gait

    3 and 6 months

  • 6 minute walk

    3 and 6 months

  • Fastest Comfortable 10-meter walk

    3 and 6 months

  • Self-Selected 10-meter walk

    3 and 6 months

  • 48-hour Step Activity Monitoring

    3 and 6 months

  • +2 more secondary outcomes

Study Arms (2)

Arm 1

OTHER

Higher Intensity, Shorter Duration Treadmill Training

Procedure: Exercise

Arm 2

ACTIVE COMPARATOR

Lower Intensity, Longer Duration Treadmill Training

Procedure: Exercise

Interventions

ExercisePROCEDURE

Treadmill Training

Arm 1Arm 2

Eligibility Criteria

Age40 Years - 85 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- 85 yrs. Hemorrhagic stroke greater than or equal to one year prior in men or women ages 40-85 years.
  • 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.)

You may not qualify if:

  • Already performing aerobic exercise 3 X / week.
  • Increased alcohol consumption.
  • Cardiac history of:
  • unstable angina,
  • recent (less than 3 months) myocardial infarction, congestive heart failure (NYHA category II-IV);
  • hemodynamically significant valvular dysfunction.
  • Medical History:
  • recent hospitalization (less than 3 months) for severe medical disease,
  • PAOD with claudication,
  • orthopedic or chronic pain condition restricting exercise, pulmonary or renal failure,
  • active cancer,
  • untreated poorly controlled hypertension measured on at least 2 occasions ( greater than160/100) or diabetes mellitus (fasting glucose greater than 180 mg/dl, HgA1C greater than 10%) unable to be controlled medically within 3 months; g) Anemia defined by hematocrit less than 30 . (5) Neurological history of
  • dementia with Mini-Mental Status Score less than 23 (less than 17 if education level at or below 8th grade), and diagnostic confirmation by neurologist or psychiatrist,
  • severe receptive or global aphasia which confounds testing and training, operationally defined as unable to follow 2 point commands,
  • hemiparetic gait from a prior stroke preceding the index stroke defining eligibility,
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Maryland Health Care System, Baltimore

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Stroke

Interventions

Exercise

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Fred Ivey, PhD

    VA Maryland Health Care System, Baltimore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2007

First Posted

February 2, 2007

Study Start

August 1, 2006

Primary Completion

March 1, 2011

Study Completion

June 1, 2012

Last Updated

June 12, 2012

Record last verified: 2012-06

Locations

US(1)