Multiple SclerosisNCT02913209
Quantitative Fatigue and Muscle Performance in Multiple Sclerosis
An observational study of Multiple Sclerosis and Fatigue, run by Washington D.C. Veterans Affairs Medical Center.
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… Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Multiple Sclerosis, Fatigue
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Apr 2016to Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
About this study
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.
Read the 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
- Medical subject headings
- Multiple Sclerosis, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue Index
Initial visit
Measured: Day 1
Maximal Volitional Contraction
Initial visit
Measured: Day 1
Secondary outcomes (8)
The Adult Myopathy Assessment Tool
Initial visit
Measured: Day 1
25 foot walk Test
Initial visit
Measured: Day 1
Chair Stand Test
Initial visit
Measured: Day 1
Modified Fatigue Impact Scale
Initial visit
Measured: Day 1
Multiple Sclerosis Quality of Life
Initial visit
Measured: Day 1
Adult Fatigue Bank
Initial visit
Measured: Day 1
Ultrasound caliper measure of rectus femoris thickness
Initial visit
Measured: Day 1
Ultrasound image post-processing of rectus femoris grayscale
Initial visit
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2016 (estimated)
- Study startApr 2016
- Primary completionOct 2018
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington D.C. Veterans Affairs Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Michael Harris-Love, Washington D.C. Veterans Affairs Medical Center
- Investigators
- Michael Harris-Love, DSc, Principal investigator, Washington DC VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02913209
- Sponsor's protocol ID
- MRIB 01772
- Status last verified
- Feb 2020
- First submitted
- 2 Aug 2016
- Last updated
- 17 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 27872608
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Fatigue and Muscle Performance in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT02913209
- Acronym / sponsor ID
- MRIB 01772
- Conditions
- Multiple Sclerosis, Fatigue
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Washington D.C. Veterans Affairs Medical CenterUS federal agency
- Study start
- Apr 2016
- Primary completion
- Oct 2018 (actual)
- Study completion
- Dec 2020 (estimated)
- First posted
- 23 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Fatigue Index
Time frame: Day 1
Initial visit
Maximal Volitional Contraction
Time frame: Day 1
Initial visit
8 secondary outcomes
The Adult Myopathy Assessment Tool
Time frame: Day 1
25 foot walk Test
Time frame: Day 1
Chair Stand Test
Time frame: Day 1
Modified Fatigue Impact Scale
Time frame: Day 1
Multiple Sclerosis Quality of Life
Time frame: Day 1
Adult Fatigue Bank
Time frame: Day 1
Ultrasound caliper measure of rectus femoris thickness
Time frame: Day 1
Ultrasound image post-processing of rectus femoris grayscale
Time frame: Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2020.
- Background: PubMed 27872608Seamon 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Harris-Love, DSc principal investigator
Washington DC VA Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis and Fatigue, run by Washington D.C. Veterans Affairs Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue Index (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02913209, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2020.