Inflammatory Abnormalities in Muscle After Stroke: Effects of Exercise

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00387712
First received: October 12, 2006
Last updated: March 24, 2014
Last verified: March 2014
  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 Phase
Stroke
Inflammation
Other: Chronic stroke treadmill exercise to improve function
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: Inflammatory Abnormalities in Muscle After Stroke: Effects of Exercise

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Cardiovascular fitness (VO2 peak) [ Time Frame: 6 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Muscle strength [ Time Frame: 6 month ] [ Designated as safety issue: No ]
  • Walking (step activity monitor, 10 meter walking speed, 6 minute walking distance [ Time Frame: 6 month ] [ Designated as safety issue: No ]
  • Bilateral thigh muscle protein and inflammation [ Time Frame: 6 month ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: October 2006
Estimated Study Completion Date: August 2015
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Chronic hemiparetice stroke survivors randomized to velocity based treadmill training
Other: Chronic stroke treadmill exercise to improve function
6 month of treadmill exercise with a safety harness to prevent falls. Exercise is gradually progressed in walking speed and time on treadmill based on individual participant's tolerance, abilities and safety. Stroke participants are randomized to a) walking longer duration or b) walking at faster speeds on a treadmill for 6 months.
Experimental: Arm 2
Chronic hemiparetice stroke survivors randomized to duration based treadmill training
Other: Chronic stroke treadmill exercise to improve function
6 month of treadmill exercise with a safety harness to prevent falls. Exercise is gradually progressed in walking speed and time on treadmill based on individual participant's tolerance, abilities and safety. Stroke participants are randomized to a) walking longer duration or b) walking at faster speeds on a treadmill for 6 months.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00387712

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

Additional Information:
Publications:

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00387712     History of Changes
Other Study ID Numbers: B3834-R
Study First Received: October 12, 2006
Last Updated: March 24, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
exercise
inflammation
motor performance
skeletal muscle
chronic stroke survivors
treadmill exercise

Additional relevant MeSH terms:
Congenital Abnormalities
Inflammation
Stroke
Cerebral Infarction
Pathologic Processes
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 April 16, 2014