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Inflammatory Abnormalities in Muscle After Stroke: Effects of Exercise

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00387712
First Posted: October 13, 2006
Last Update Posted: September 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
VA Office of Research and Development
  Purpose
The purpose of this study is to first define whether abnormalities of skeletal muscle are related to the presence of inflammation and to poor motor performance and whether this can be modified by exercise interventions.

Condition Intervention
Stroke Inflammation Other: Velocity based treadmill training Other: Duration based treadmill training

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Inflammatory Abnormalities in Muscle After Stroke: Effects of Exercise

Resource links provided by NLM:


Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • Cardiovascular Fitness (VO2 Peak) [ Time Frame: Baseline to 6 month ]
    Cardiovascular fitness is measured by collecting the expired gases during a progressive graded treadmill test.

  • Paretic Thigh Skeletal Muscle Myosin Heavy Chain Myosin Heavy Chain Isoform 2a [ Time Frame: Baseline to 6 month ]
    Skeletal muscle punch biopsies are obtained from the bilateral (paretic and non-paretic) vastus lateralis thigh muscle, at baseline and after 6 month interventions. Homogenized muscle messenger ribonucleic acid (mRNA) for myosin heavy chain isoforms are analyzed by real time polymerase chain reaction as fluorescent units with normalization to an acidic ribosomal protein, a housekeeping gene.


Secondary Outcome Measures:
  • 30 Foot Walk Time (Sec) [ Time Frame: baseline to 6 month ]
    Participants are instructed to walk fast as comfortable on a straight pathway on the floor demarcated by cones. They may use their usual canes, walkers, and orthotics while they walk. The walks are timed, the value is the mean of three trials with an interval rest between each trial.


Enrollment: 99
Study Start Date: October 2006
Study Completion Date: August 2014
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Velocity based treadmill training
6 month of progressive treadmill walking with treadmill speed gradually progressed to meet the training heart rate goals for moderate intensity aerobic exercise, when hemiparetic gait velocity can no longer be safely progressed, incline is added to achieve the heart rate training goals.
Other: Velocity based treadmill training
6 month of progressive treadmill walking with a safety harness and hand rail support to prevent falls. Treadmill speed is gradually progressed to meet the training heart rate goals for moderate aerobic exercise, when hemiparetic gait velocity can no longer be progressed, incline is added to achieve heart rate training goals. Progression is also based on participant's tolerance, abilities and safety.
Experimental: Duration based treadmill training
6 month of progressive treadmill walking with duration is gradually progressed to meet the endurance goals for low aerobic intensity exercise, gait velocity and incline do not progress.
Other: Duration based treadmill training
6 month of progressive treadmill walking with a safety harness and hand rail support to prevent falls. Treadmill duration is gradually progressed to meet the endurance goals for low aerobic intensity exercise, gait velocity and incline do not progress. Progression is based on participant's tolerance, abilities and safety.

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  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Chronic stroke (>6 months after initial stroke)
  • Age 40-80
  • Stable neurologic deficits
  • Able to walk with an assistive device
  • Language skills to understand the training program safely

Exclusion Criteria:

  • No anticoagulation or medical conditions that preclude exercise.
  • No dementias or depression
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00387712


Locations
United States, Maryland
VA Maryland Health Care System, Baltimore
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Charlene Hafer-Macko, MD VA Maryland Health Care System, Baltimore
  More Information

Additional Information:
Publications:

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00387712     History of Changes
Other Study ID Numbers: B3834-R
First Submitted: October 12, 2006
First Posted: October 13, 2006
Results First Submitted: February 21, 2017
Results First Posted: September 14, 2017
Last Update Posted: September 14, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by VA Office of Research and Development:
exercise
inflammation
motor performance
skeletal muscle
chronic stroke survivors
treadmill exercise

Additional relevant MeSH terms:
Stroke
Inflammation
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes