Treadmill Exercise Prescriptions to Improve Fitness Versus Ambulatory Function After Stroke. - Full Text View

Sponsor:	Department of Veterans Affairs
Information provided by:	Department of Veterans Affairs
ClinicalTrials.gov Identifier:	NCT00430456

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 I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Treadmill Exercise Prescriptions to Improve Fitness Versus Ambulatory Function After Stroke

Resource links provided by NLM:

MedlinePlus related topics: Exercise and Physical Fitness

U.S. FDA Resources

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 ]

Estimated Enrollment:	120
Study Start Date:	August 2006
Estimated Study Completion Date:	September 2010
Estimated Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1	Procedure: Exercise Treadmill Training
2: Active Comparator 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:

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.

Contacts and Locations

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

Department of Veterans Affairs

Investigators

Principal Investigator:

Fred Ivey, PhD

VA Maryland Health Care System, Baltimore

More Information

Publications:

Luft AR, Forrester L, Macko RF, McCombe-Waller S, Whitall J, Villagra F, Hanley DF. Brain activation of lower extremity movement in chronically impaired stroke survivors. Neuroimage. 2005 May 15;26(1):184-94.

Michael KM, Allen JK, Macko RF. Reduced ambulatory activity after stroke: the role of balance, gait, and cardiovascular fitness. Arch Phys Med Rehabil. 2005 Aug;86(8):1552-6.

Macko RF, Ivey FM, Forrester LW, Hanley D, Sorkin JD, Katzel LI, Silver KH, Goldberg AP. Treadmill exercise rehabilitation improves ambulatory function and cardiovascular fitness in patients with chronic stroke: a randomized, controlled trial. Stroke. 2005 Oct;36(10):2206-11. Epub 2005 Sep 8.

Ivey FM, Ryan AS, Hafer-Macko CE, Garrity BM, Sorkin JD, Goldberg AP, Macko RF. High prevalence of abnormal glucose metabolism and poor sensitivity of fasting plasma glucose in the chronic phase of stroke. Cerebrovasc Dis. 2006;22(5-6):368-71. Epub 2006 Aug 3.

Michael KM, Allen JK, Macko RF. Fatigue after stroke: relationship to mobility, fitness, ambulatory activity, social support, and falls efficacy. Rehabil Nurs. 2006 Sep-Oct;31(5):210-7.

Ivey FM, Hafer-Macko CE, Macko RF. Exercise rehabilitation after stroke. NeuroRx. 2006 Oct;3(4):439-50. Review.

Patterson SL, Forrester LW, Rodgers MM, Ryan AS, Ivey FM, Sorkin JD, Macko RF. Determinants of walking function after stroke: differences by deficit severity. Arch Phys Med Rehabil. 2007 Jan;88(1):115-9.

Ivey FM, Ryan AS, Hafer-Macko CE, Goldberg AP, Macko RF. Treadmill aerobic training improves glucose tolerance and indices of insulin sensitivity in disabled stroke survivors: a preliminary report. Stroke. 2007 Oct;38(10):2752-8. Epub 2007 Aug 16.

Ivey FM, Hafer-Macko CE, Macko RF. Exercise training for cardiometabolic adaptation after stroke. J Cardiopulm Rehabil Prev. 2008 Jan-Feb;28(1):2-11. Review.

Ivey FM, Hafer-Macko CE, Macko RF. Task-oriented treadmill exercise training in chronic hemiparetic stroke. J Rehabil Res Dev. 2008;45(2):249-59. Review.

Ryan AS, Macko RF, Peters MN, Ivey FM, Prior SJ, Joseph LJ, Hafer-Macko CE. Plasma adiponectin levels are associated with insulin sensitivity in stroke survivors. J Stroke Cerebrovasc Dis. 2009 May-Jun;18(3):214-20.

Responsible Party:	Department of Veterans Affairs ( Ivey, Fred - Principal Investigator )
Study ID Numbers:	H26843
Study First Received:	January 31, 2007
Last Updated:	January 6, 2010
ClinicalTrials.gov Identifier:	NCT00430456 History of Changes
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:

Cerebral Infarction
Nervous System Diseases
Stroke
Vascular Diseases
Brain Ischemia

Central Nervous System Diseases
Cardiovascular Diseases
Brain Infarction
Brain Diseases
Cerebrovascular Disorders

ClinicalTrials.gov processed this record on February 08, 2010