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Treadmill Exercise Prescriptions to Improve Fitness Versus Ambulatory Function After Stroke. (STEPs)

Primary Purpose

Stroke

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Exercise
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Aerobic exercise, Balance, postural, Cardiovascular deconditioning, Gait, MRI, functional, Physical therapy techniques, Self Efficacy, Treadmill test

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 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.
  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.)

Exclusion Criteria:

  1. Already performing aerobic exercise 3 X / week.
  2. Increased alcohol consumption.
  3. Cardiac history of:

    • unstable angina,
    • recent (less than 3 months) myocardial infarction, congestive heart failure (NYHA category II-IV);
    • hemodynamically significant valvular dysfunction.
  4. 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,
    • non-stroke neuromuscular disorder restricting exercise (e.g. Parkinson's Syndrome),
    • untreated major depression. (6) BMI > 40.

Special fMRI Exclusion Criteria:

  1. Metallic implants above the waist, except sternal wire implants.
  2. Any type of implanted stimulator(cardiac, spinal, bladder, auditory
  3. Claustrophobia
  4. Pregnancy- A negative urine pregnancy test will be required prior to undergoing fMRI for women of child- bearing potential.

Sites / Locations

  • VA Maryland Health Care System, Baltimore

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Active Comparator

Arm Label

Arm 1

Arm 2

Arm Description

Higher Intensity, Shorter Duration Treadmill Training

Lower Intensity, Longer Duration Treadmill Training

Outcomes

Primary Outcome Measures

Peak Aerobic Fitness

Secondary Outcome Measures

Economy of Gait
6 minute walk
Fastest Comfortable 10-meter walk
Self-Selected 10-meter walk
48-hour Step Activity Monitoring
Scales of Mobility, Function, Fatigue and Self-Efficacy
Neuroplasticity (BOLD fMRI)

Full Information

First Posted
January 31, 2007
Last Updated
June 11, 2012
Sponsor
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT00430456
Brief Title
Treadmill Exercise Prescriptions to Improve Fitness Versus Ambulatory Function After Stroke.
Acronym
STEPs
Official Title
Treadmill Exercise Prescriptions to Improve Fitness Versus Ambulatory Function After Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
This randomized study compares effects of duration vs. velocity-based TM training regimens on fitness and ambulatory function in chronic stroke patients. Phase 1 - patients are screened (Mini Mental Status, CESD for depression, alcohol intake survey) and undergo routine medical and CV evaluations and blood labs in VA RRDC Assessment Clinic to establish medical eligibility. Standard neurological evaluations (NIH Stroke Scale, Modified Asworth Spasticity Scale, range of motion and manual motor testing) and review of imaging records assess neurological eligibility, deficit profiles and stroke subtypes. Physician supervised treadmill tolerance test and peak effort constant velocity exercise stress test with vital signs monitoring determine treadmill safety, functional eligibility to participate (must walk 3 minutes at 0.2 MPH with handrail support), and cardiopulmonary safety in response to strenuous exertion. Eligible candidates undergo baseline testing (phase 2) including measures of fitness (VO2 peak, gait economy), ambulatory function and BOLD fMRI of knee movement. Phase 3 - 6 months TM training with either velocity or duration based progression, followed by Phase 4 -repeat of fitness and ambulatory function tests after 3 months, and Phase 5 - repeat of all baseline tests after 6 months training

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Aerobic exercise, Balance, postural, Cardiovascular deconditioning, Gait, MRI, functional, Physical therapy techniques, Self Efficacy, Treadmill test

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Other
Arm Description
Higher Intensity, Shorter Duration Treadmill Training
Arm Title
Arm 2
Arm Type
Active Comparator
Arm Description
Lower Intensity, Longer Duration Treadmill Training
Intervention Type
Procedure
Intervention Name(s)
Exercise
Intervention Description
Treadmill Training
Primary Outcome Measure Information:
Title
Peak Aerobic Fitness
Time Frame
3 and 6 months
Secondary Outcome Measure Information:
Title
Economy of Gait
Time Frame
3 and 6 months
Title
6 minute walk
Time Frame
3 and 6 months
Title
Fastest Comfortable 10-meter walk
Time Frame
3 and 6 months
Title
Self-Selected 10-meter walk
Time Frame
3 and 6 months
Title
48-hour Step Activity Monitoring
Time Frame
3 and 6 months
Title
Scales of Mobility, Function, Fatigue and Self-Efficacy
Time Frame
6 months
Title
Neuroplasticity (BOLD fMRI)
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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.) Exclusion Criteria: 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, non-stroke neuromuscular disorder restricting exercise (e.g. Parkinson's Syndrome), untreated major depression. (6) BMI > 40. Special fMRI Exclusion Criteria: Metallic implants above the waist, except sternal wire implants. Any type of implanted stimulator(cardiac, spinal, bladder, auditory Claustrophobia Pregnancy- A negative urine pregnancy test will be required prior to undergoing fMRI for women of child- bearing potential.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fred Ivey, PhD
Organizational Affiliation
VA Maryland Health Care System, Baltimore
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Maryland Health Care System, Baltimore
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States

12. IPD Sharing Statement

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