Quantitative Fatigue and Muscle Performance in Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:

Quantitative Fatigue and Muscle Performance in Multiple Sclerosis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02913209
• Other study ID #: MRIB 01772
• Status: Active, not recruiting
• Start date: April 2016
• Est. completion date: December 2020

Study information

• Verified date: February 2020
• Source: Washington D.C. Veterans Affairs Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: December 2020
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatigue
• Multiple Sclerosis
• Sclerosis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Washington D.C. Veterans Affairs Medical Center

References & 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. eCollection 2016. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Kurtzke Expanded Disability Status Scale	Initial visit	Day 1
Primary	Fatigue Index	Initial visit	Day 1
Primary	Maximal Volitional Contraction	Initial visit	Day 1
Secondary	The Adult Myopathy Assessment Tool	Initial visit	Day 1
Secondary	25 foot walk Test	Initial visit	Day 1
Secondary	Chair Stand Test	Initial visit	Day 1
Secondary	Modified Fatigue Impact Scale	Initial visit	Day 1
Secondary	Multiple Sclerosis Quality of Life	Initial visit	Day 1
Secondary	Adult Fatigue Bank	Initial visit	Day 1
Secondary	Ultrasound caliper measure of rectus femoris thickness	Initial visit	Day 1
Secondary	Ultrasound image post-processing of rectus femoris grayscale	Initial visit	Day 1