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 22, 2013
Last verified: March 2013
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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 22, 2013 |
| 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 May 16, 2013