Quantitative Fatigue and Muscle Performance in Multiple Sclerosis

Sponsor
Washington D.C. Veterans Affairs Medical Center (U.S. Fed)
Overall Status
Unknown status
CT.gov ID
NCT02913209
Collaborator
(none)
30
56

Study Details

Study Description

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 Intervention/Treatment Phase

    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).

    Study Design

    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 :
    Apr 1, 2016
    Actual Primary Completion Date :
    Oct 1, 2018
    Anticipated Study Completion Date :
    Dec 1, 2020

    Arms and Interventions

    Arm Intervention/Treatment
    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).

    Outcome Measures

    Primary Outcome Measures

    1. Fatigue Index [Day 1]

      Initial visit

    2. Maximal Volitional Contraction [Day 1]

      Initial visit

    Secondary Outcome Measures

    1. The Adult Myopathy Assessment Tool [Day 1]

      Initial visit

    2. 25 foot walk Test [Day 1]

      Initial visit

    3. Chair Stand Test [Day 1]

      Initial visit

    4. Modified Fatigue Impact Scale [Day 1]

      Initial visit

    5. Multiple Sclerosis Quality of Life [Day 1]

      Initial visit

    6. Adult Fatigue Bank [Day 1]

      Initial visit

    7. Ultrasound caliper measure of rectus femoris thickness [Day 1]

      Initial visit

    8. Ultrasound image post-processing of rectus femoris grayscale [Day 1]

      Initial visit

    Other Outcome Measures

    1. Kurtzke Expanded Disability Status Scale [Day 1]

      Initial visit

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Washington D.C. Veterans Affairs Medical Center

    Investigators

    • Principal Investigator: Michael Harris-Love, DSc, Washington DC VA Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    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:
    Sep 23, 2016
    Last Update Posted:
    Feb 17, 2020
    Last Verified:
    Feb 1, 2020
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 17, 2020