Quantitative Fatigue and Muscle Performance in Multiple Sclerosis

NCT ID: NCT02913209

Last Updated: 2020-02-17

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2020-12-31

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.

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).

Conditions

Multiple Sclerosis; Fatigue

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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).

No interventions assigned to this group

Eligibility 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Washington D.C. Veterans Affairs Medical Center

FED

Sponsor Role: lead

Responsible Party

Michael Harris-Love

Assoc. Director of the CRC Human Performance Research Unit

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael Harris-Love, DSc

Role: PRINCIPAL_INVESTIGATOR

Washington DC VA Medical Center

References

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.

Reference Type: BACKGROUND

PMID: 27872608 (View on PubMed)

Other Identifiers

MRIB 01772

Identifier Type: -

Identifier Source: org_study_id