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StrokePhase 1STEPsNCT00430456

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

A Phase 1 study testing Exercise in people with Stroke, run by US Department of Veterans Affairs at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 to 85 years
Conditions the study is for
Stroke
What is being tested?
Exercise
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteUnited States
Study dates
Aug 2006to Jun 2012
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.)

Who cannot join

  • 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.
Show all 22Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • VA Maryland Health Care System, Baltimore

    Baltimore, Maryland, 21201

Other trials in United States

About this study

Official title: 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.

Read the 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

Conditions
Stroke
Being tested
Exercise
Keywords
Aerobic exercise, Balance, postural, Cardiovascular deconditioning, Gait, MRI, functional, Physical therapy techniques, Self Efficacy, Treadmill test
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ExerciseProcedure or surgery

    Treadmill Training

Study groups in NCT00430456
Study groupRoleWhat they receive
Arm 1OtherHigher Intensity, Shorter Duration Treadmill Training
Receives: Procedure: Exercise
Arm 2Active comparatorLower Intensity, Longer Duration Treadmill Training
Receives: Procedure: Exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Peak Aerobic Fitness

    Measured: 3 and 6 months

Secondary outcomes (7)

  1. Economy of Gait

    Measured: 3 and 6 months

  2. 6 minute walk

    Measured: 3 and 6 months

  3. Fastest Comfortable 10-meter walk

    Measured: 3 and 6 months

  4. Self-Selected 10-meter walk

    Measured: 3 and 6 months

  5. 48-hour Step Activity Monitoring

    Measured: 3 and 6 months

  6. Scales of Mobility, Function, Fatigue and Self-Efficacy

    Measured: 6 months

  7. Neuroplasticity (BOLD fMRI)

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Feb 2007 (estimated)
  2. Study startAug 2006
  3. Primary completionMar 2011
  4. Study completionJun 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00430456
Sponsor's protocol ID
H26843
Acronym
STEPs
Status last verified
Jun 2012
First submitted
31 Jan 2007
Last updated
12 Jun 2012
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Exercise in people with Stroke, run by US Department of Veterans Affairs at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Peak Aerobic Fitness (time frame: 3 and 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00430456.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2012.

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