Inflammatory Abnormalities in Muscle After Stroke: Effects of Exercise

NCT00387712 | Completed Results DMC

• 1 other identifier: B3834-R
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke; Inflammation

Keywords

exercise; inflammation; motor performance; skeletal muscle; chronic stroke survivors; treadmill exercise

Outcome Measures

Primary Outcomes (2)

• Cardiovascular Fitness (VO2 Peak)

  Cardiovascular fitness is measured by collecting the expired gases during a progressive graded treadmill test.

  Baseline to 6 month

• Paretic Thigh Skeletal Muscle Myosin Heavy Chain Myosin Heavy Chain Isoform 2a

  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.

  Baseline to 6 month

Secondary Outcomes (1)

• 30 Foot Walk Time (Sec)

  baseline to 6 month

Study Arms (2)

Velocity based treadmill training

EXPERIMENTAL

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

Duration based treadmill training

EXPERIMENTAL

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

Interventions

Velocity based treadmill training OTHER

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.

Velocity based treadmill training

Duration based treadmill training OTHER

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.

Duration based treadmill training

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• No anticoagulation or medical conditions that preclude exercise.
• No dementias or depression

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Maryland Health Care System, Baltimore

Baltimore, Maryland, 21201, United States

Location

Related Publications (9)

• 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. doi: 10.1097/01.HCR.0000311501.57022.a8.

  PMID: 18277823 BACKGROUND

• 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. doi: 10.1682/jrrd.2007.02.0035.

  PMID: 18566943 BACKGROUND

• Prior SJ, McKenzie MJ, Joseph LJ, Ivey FM, Macko RF, Hafer-Macko CE, Ryan AS. Reduced skeletal muscle capillarization and glucose intolerance. Microcirculation. 2009 Apr;16(3):203-12. doi: 10.1080/10739680802502423. Epub 2009 Feb 16.

  PMID: 19225985 BACKGROUND

• McKenzie MJ, Yu S, Macko RF, McLenithan JC, Hafer-Macko CE. Human genome comparison of paretic and nonparetic vastus lateralis muscle in patients with hemiparetic stroke. J Rehabil Res Dev. 2008;45(2):273-81. doi: 10.1682/jrrd.2007.02.0036.

  PMID: 18566945 BACKGROUND

• Ivey FM, Ryan AS, Hafer-Macko CE, Macko RF. Improved cerebral vasomotor reactivity after exercise training in hemiparetic stroke survivors. Stroke. 2011 Jul;42(7):1994-2000. doi: 10.1161/STROKEAHA.110.607879. Epub 2011 Jun 2.

  PMID: 21636819 BACKGROUND

• Ryan AS, Ivey FM, Prior S, Li G, Hafer-Macko C. Skeletal muscle hypertrophy and muscle myostatin reduction after resistive training in stroke survivors. Stroke. 2011 Feb;42(2):416-20. doi: 10.1161/STROKEAHA.110.602441. Epub 2010 Dec 16.

  PMID: 21164115 BACKGROUND

• Hafer-Macko CE, Ryan AS, Ivey FM, Macko RF. Skeletal muscle changes after hemiparetic stroke and potential beneficial effects of exercise intervention strategies. J Rehabil Res Dev. 2008;45(2):261-72. doi: 10.1682/jrrd.2007.02.0040.

  PMID: 18566944 RESULT

• Ryan AS, Buscemi A, Forrester L, Hafer-Macko CE, Ivey FM. Atrophy and intramuscular fat in specific muscles of the thigh: associated weakness and hyperinsulinemia in stroke survivors. Neurorehabil Neural Repair. 2011 Nov-Dec;25(9):865-72. doi: 10.1177/1545968311408920. Epub 2011 Jul 6.

  PMID: 21734070 RESULT

• Ivey FM, Stookey AD, Hafer-Macko CE, Ryan AS, Macko RF. Higher Treadmill Training Intensity to Address Functional Aerobic Impairment after Stroke. J Stroke Cerebrovasc Dis. 2015 Nov;24(11):2539-46. doi: 10.1016/j.jstrokecerebrovasdis.2015.07.002. Epub 2015 Aug 21.

  PMID: 26303787 RESULT

Related Links

• Click here for more information about this study: Inflammatory Abnormalities in Muscle After Stroke: Effects of Exercise
• Click here for more information about this study: Inflammatory Abnormalities in Muscle After Stroke: Effects of Exercise
• Click here for more information about this study: Inflammatory Abnormalities in Muscle After Stroke: Effects of Exercise

MeSH Terms

Conditions

Stroke; Inflammation; Motor Activity

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Limitations and Caveats

Limitations of the study, such as early termination, led to smaller numbers of participants analyzed and technical problems with measurement and participant inability to attend testing or complete testing led to unreliable and missing data.

Results Point of Contact

• Title: Charlene Hafer-Macko
• Organization: Baltimore VAMC

charlene.hafer-macko@va.gov

410-605-7000

Study Officials

• Charlene Hafer-Macko, MD

  VA Maryland Health Care System, Baltimore

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2006
• First Posted: October 13, 2006
• Study Start: October 1, 2006
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2014
• Last Updated: September 14, 2017
• Results First Posted: September 14, 2017

Record last verified: 2017-06

Locations

US (1)