Skeletal Muscle Properties and the Metabolic Cost of Walking Post-stroke

This study has been completed.
Sponsor:
Collaborator:
Medical University of South Carolina
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00721357
First received: July 21, 2008
Last updated: July 29, 2015
Last verified: July 2015
Results First Received: January 8, 2015  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Cross-Sectional
Condition: Stroke
Interventions: Behavioral: Treadmill walking
Other: Magnetic resonance spectroscopy

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Stroke

those with condition

Treadmill walking: Subjects will perform treadmill walking at a self-selected velocity

Magnetic resonance spectroscopy: Muscle oxidative capacity will be assessed via Magnetic resonance spectroscopy (31P-MRS)

Control

those without condition

Treadmill walking: Subjects will perform treadmill walking at a self-selected velocity

Magnetic resonance spectroscopy: Muscle oxidative capacity will be assessed via Magnetic resonance spectroscopy (31P-MRS)


Participant Flow:   Overall Study
    Stroke     Control  
STARTED     15     15  
COMPLETED     15     15  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Stroke

those with condition

Treadmill walking: Subjects will perform treadmill walking at a self-selected velocity

Magnetic resonance spectroscopy: Muscle oxidative capacity will be assessed via Magnetic resonance spectroscopy (31P-MRS)

Control

those without condition

Treadmill walking: Subjects will perform treadmill walking at a self-selected velocity

Magnetic resonance spectroscopy: Muscle oxidative capacity will be assessed via Magnetic resonance spectroscopy (31P-MRS)

Total Total of all reporting groups

Baseline Measures
    Stroke     Control     Total  
Number of Participants  
[units: participants]
  15     15     30  
Age  
[units: years]
Mean (Standard Deviation)
  57.3  (9.2)     54.2  (5.1)     57.3  (9.2)  
Gender  
[units: participants]
     
Female     7     5     12  
Male     8     10     18  
walking speed [1]
[units: meters per second]
Mean (Standard Deviation)
  0.57  (0.23)     1.17  (0.15)     0.87  (0.20)  
muscle oxidative capacity [2]
[units: millimolar inorganic phosphate]
Mean (Standard Deviation)
  5.1  (0.87)     3.2  (0.56)     4.2  (0.72)  
muscle mechanical energy expenditure [3]
[units: Joules per kg]
Mean (Standard Deviation)
  374  (161)     242  (66)     309  (112)  
[1] The overground speed the individuals walk when instructed to "walk at you normal comfortable speed".
[2] This measures specific compounds in leg muscles to estimate how well they would perform repeated physical tasks (e.g. walking).
[3] This is a calculation of how much work is done by each joint (i.e. ankle, knee and hip) of each leag during walking.



  Outcome Measures

1.  Primary:   Oxygen Consumption During Walking   [ Time Frame: within one week of enrollment ]

2.  Secondary:   Muscle Mechanical Energy Expenditure   [ Time Frame: one time measure ]
Results not yet reported.   Anticipated Reporting Date:   12/2015   Safety Issue:   No

3.  Secondary:   Magnetic Resonance Spectroscopy of Muscle Metabolic Properties   [ Time Frame: within one week of enrollment ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Chris Gregory
Organization: Ralph H Johnson VAMC
phone: (843)792-1078
e-mail: Christopher.Gregory@va.gov


No publications provided


Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00721357     History of Changes
Other Study ID Numbers: B6341-W
Study First Received: July 21, 2008
Results First Received: January 8, 2015
Last Updated: July 29, 2015
Health Authority: United States: Federal Government