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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00430456
First received: January 31, 2007
Last updated: June 11, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention Phase
Stroke
Procedure: Exercise
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treadmill Exercise Prescriptions to Improve Fitness Versus Ambulatory Function After Stroke

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Peak Aerobic Fitness [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Economy of Gait [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
  • 6 minute walk [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
  • Fastest Comfortable 10-meter walk [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
  • Self-Selected 10-meter walk [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
  • 48-hour Step Activity Monitoring [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
  • Scales of Mobility, Function, Fatigue and Self-Efficacy [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Neuroplasticity (BOLD fMRI) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 120
Study Start Date: August 2006
Study Completion Date: June 2012
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm 1
Higher Intensity, Shorter Duration Treadmill Training
Procedure: Exercise
Treadmill Training
Active Comparator: Arm 2
Lower Intensity, Longer Duration Treadmill Training
Procedure: Exercise
Treadmill Training

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

  Eligibility

Ages Eligible for Study:   40 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00430456

Locations
United States, Maryland
VA Maryland Health Care System, Baltimore
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
Investigators
Principal Investigator: Fred Ivey, PhD VA Maryland Health Care System, Baltimore
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00430456     History of Changes
Other Study ID Numbers: H26843
Study First Received: January 31, 2007
Last Updated: June 11, 2012
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Aerobic exercise
Balance, postural
Cardiovascular deconditioning
Gait
MRI, functional
Physical therapy techniques
Self Efficacy
Treadmill test

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on October 19, 2014