Quantitative Fatigue and Muscle Performance in Multiple Sclerosis

NCT02913209 | Unknown

• 1 other identifier: MRIB 01772
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Multiple Sclerosis; Fatigue

Outcome Measures

Primary Outcomes (2)

• Fatigue Index

  Initial visit

  Day 1

• Maximal Volitional Contraction

  Initial visit

  Day 1

Secondary Outcomes (8)

• The Adult Myopathy Assessment Tool

  Day 1

• 25 foot walk Test

  Day 1

• Chair Stand Test

  Day 1

• Modified Fatigue Impact Scale

  Day 1

• Multiple Sclerosis Quality of Life

  Day 1

Other Outcomes (1)

• Kurtzke Expanded Disability Status Scale

  Day 1

Study Arms (1)

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).

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington D.C. Veterans Affairs Medical Center: lead

Related Publications (1)

• Seamon BA, Harris-Love MO. Clinical Assessment of Fatigability in Multiple Sclerosis: A Shift from Perception to Performance. Front Neurol. 2016 Nov 7;7:194. doi: 10.3389/fneur.2016.00194. eCollection 2016. No abstract available.

  PMID: 27872608 BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis; Fatigue

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael Harris-Love, DSc

  Washington DC VA Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Director of the CRC Human Performance Research Unit

Study Record Dates

• First Submitted: August 2, 2016
• First Posted: September 23, 2016
• Study Start: April 1, 2016
• Primary Completion: October 1, 2018
• Study Completion: December 1, 2020
• Last Updated: February 17, 2020

Record last verified: 2020-02