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Quantitative Fatigue and Muscle Performance in Multiple Sclerosis

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.
 
ClinicalTrials.gov Identifier: NCT02913209
Recruitment Status : Active, not recruiting
First Posted : September 23, 2016
Last Update Posted : February 17, 2020
Sponsor:
Information provided by (Responsible Party):
Michael Harris-Love, Washington D.C. Veterans Affairs Medical Center

Brief Summary:
Fatigue is consistently rated as the top symptomatic complaint for individuals with multiple sclerosis (MS). Currently, the MS Fatigue Impact Scale (MFIS), a subsection of the Multiple Sclerosis Quality of Life (MSQoL), is the clinical standard used by neurologists for monitoring and tracking fatigue in individuals with MS. However, fatigue is multidimensional phenomenon and subjective measures have had poor or limited relationships with functional status. While previous study has focused on contributing factors to fatigue such as sleep disorders and diminished cortical excitability, this line of inquiry has neglected the role of muscle structure and function on fatigue in every day functional tasks. An alternative approach is to assess quantitative fatigue using anaerobic testing methods. However, more knowledge is needed to understand the role that quantitative fatigue plays in self-reported fatigue measures and function of daily activities. Our purpose is to determine the association between quantitative fatigue tests with performance-based measures of mobility and self-reported health-related quality of life. Our secondary goal is to understand how the intrinsic properties of muscle tissue influence muscle performance in Veterans with MS.

Condition or disease
Multiple Sclerosis Fatigue

Detailed Description:
Participants will complete study assessments at the DC VAMC. Disease severity will be assessed by medical staff completing the EDSS. Peak torque assessment for the knee flexors and extensors will be performed on an isokinetic dynamometer (Biodex System 4). Muscle morphology measures of the rectus femoris will be obtained using diagnostic musculoskeletal B-mode ultrasound (Phillips EPIQ 7 180 Plus) with a 10 Mhz linear transducer. The sonographic measures will include muscle thickness and echogenicity. The mode of exercise testing and the type of muscle action will influence the assessment of fatigue. Therefore, isokinetic fatigue measures for the knee extensors will be assessed on separate visits (at least 48 hours apart). Performance-based measures of function will include an assessment of patient mobility and the 25-foot walk test. Muscle power will be estimated by the timed sit to stand test. Subjective measures of fatigue and quality of life include the MSQoL, MFIS, and Neurology Quality of Life Adult Fatigue Bank (AFB).

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Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Quantitative Fatigue and Muscle Performance in Multiple Sclerosis
Study Start Date : April 2016
Actual Primary Completion Date : October 2018
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Group/Cohort
Multiple Sclerosis Fatigue (MSF) Cohort
Participants will complete study assessments over 4 visits to the DC VAMC. Disease severity will be assessed by the EDSS, and a cognitive battery will be completed. Peak torque assessment for the knee flexors and extensors will be performed on an isokinetic dynamometer (Biodex System 4). Muscle morphology measures of the rectus femoris will be obtained using diagnostic musculoskeletal ultrasound. The sonographic measures will include muscle thickness and echogenicity. Isokinetic and isoinertial mode fatigue measures for the knee extensors will be assessed on separate visits (at least 48 hours apart). Performance-based measures of function will include an assessment of patient mobility and the 25-foot walk test. Muscle power will be estimated by the timed sit to stand test. Subjective measures of fatigue and quality of life include the MSQoL, MFIS, and Neurology Quality of Life Adult Fatigue Bank (AFB).



Primary Outcome Measures :
  1. Fatigue Index [ Time Frame: Day 1 ]
    Initial visit

  2. Maximal Volitional Contraction [ Time Frame: Day 1 ]
    Initial visit


Secondary Outcome Measures :
  1. The Adult Myopathy Assessment Tool [ Time Frame: Day 1 ]
    Initial visit

  2. 25 foot walk Test [ Time Frame: Day 1 ]
    Initial visit

  3. Chair Stand Test [ Time Frame: Day 1 ]
    Initial visit

  4. Modified Fatigue Impact Scale [ Time Frame: Day 1 ]
    Initial visit

  5. Multiple Sclerosis Quality of Life [ Time Frame: Day 1 ]
    Initial visit

  6. Adult Fatigue Bank [ Time Frame: Day 1 ]
    Initial visit

  7. Ultrasound caliper measure of rectus femoris thickness [ Time Frame: Day 1 ]
    Initial visit

  8. Ultrasound image post-processing of rectus femoris grayscale [ Time Frame: Day 1 ]
    Initial visit


Other Outcome Measures:
  1. Kurtzke Expanded Disability Status Scale [ Time Frame: Day 1 ]
    Initial visit



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Men and women between the ages of 20 and 85 years (n=30) with a history of multiple sclerosis (Expanded Disability Status Scale, EDSS < 7.0) will be consecutively recruited from the DC VAMC Neurology Service and Multiple Sclerosis Center of Excellence.
Criteria

Inclusion Criteria:

  • A male or female Veteran participant must have a medical diagnosis of multiple sclerosis
  • Veteran will be between the ages of 20 and 85 years old

Exclusion Criteria:

  • Veterans with an EDSS score > 7.0
  • Veterans with any cardiac condition that may cause sudden decompensation during exertional fatigue testing (e.g., severe congestive heart failure and uncontrolled hypertension)
  • Veterans found to have severe depression (BDI score >28)
  • Veterans with lower extremity amputation
  • Steroid Infusion less than 2 weeks prior to enrollment
  • Veterans with a lower extremity joint replacement
  • Veterans that exhibit severe cognitive impairment
  • Defined as loss of orientation to person, place and/or time and an inability to follow three step commands.
  • Veterans that are unable to perform a stand pivot transfer with minimal assist

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): NCT02913209


Sponsors and Collaborators
Washington D.C. Veterans Affairs Medical Center
Investigators
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Principal Investigator: Michael Harris-Love, DSc Washington DC VA Medical Center
Publications:
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Responsible Party: Michael Harris-Love, Assoc. Director of the CRC Human Performance Research Unit, Washington D.C. Veterans Affairs Medical Center
ClinicalTrials.gov Identifier: NCT02913209    
Other Study ID Numbers: MRIB 01772
First Posted: September 23, 2016    Key Record Dates
Last Update Posted: February 17, 2020
Last Verified: February 2020
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Fatigue
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases