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

Treadmill Exercise Prescriptions to Improve Fitness Versus Ambulatory Function After Stroke

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.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Procedure: Exercise

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

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • VA Maryland Health Care System, Baltimore

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Peak Aerobic Fitness	3 and 6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Scales of Mobility, Function, Fatigue and Self-Efficacy	6 months
Neuroplasticity (BOLD fMRI)	6 months

Collaborators and Investigators

• Sponsor: US Department of Veterans Affairs
• Investigators: Principal Investigator: Fred Ivey, PhD, VA Maryland Health Care System, Baltimore

Study record dates

Study Major Dates

• Study Start: August 1, 2006
• Primary Completion (Actual): March 1, 2011
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: January 31, 2007
• First Submitted That Met QC Criteria: February 1, 2007
• First Posted (Estimate): February 2, 2007

Study Record Updates

• Last Update Posted (Estimate): June 12, 2012
• Last Update Submitted That Met QC Criteria: June 11, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Keywords: Aerobic exercise; Gait; Self Efficacy; Balance, postural; MRI, functional; Physical therapy techniques; Cardiovascular deconditioning; Treadmill test
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: H26843