MusculRA: The Effects of Rheumatoid Arthritis on Skeletal Muscle Biomechanics — MusculRA  

Rheumatoid Arthritis Clinical Trial

Official title: MusculRA: The Effects of Rheumatoid Arthritis on Skeletal Muscle Biomechanics

Status Completed

Clinical Trial Summary

Persons with rheumatoid arthritis (RA) suffer from increased disability and mortality, in part resulting from skeletal muscle impairments. In this study, our objective is to determine if skeletal muscle biomechanical properties are altered in RA. Up to 15 participants with early RA defined as duration of disease/symptoms of less than 6 months (where "duration" denotes the length of time the patient has had symptoms/disease, not the length of time since RA diagnosis) AND prior to starting biologic Disease-modifying anti-rheumatic drugs (bDMARD) therapy and 15 age-, sex-, and BMI-matched controls will undergo clinical assessments of skeletal muscle stiffness and elasticity as measured by the hand-held MyotonPro device. Additional study participant assessments include cardiopulmonary exercise testing, muscle strength testing, body composition measurement using BodPod, muscle oxidative capacity testing using near-infrared spectroscopy, and thigh muscle needle biopsies to compare clinical findings to an ex vivo cultured myobundle system. Primary statistical analyses will be comparisons of skeletal muscle parameters in RA compared to controls and correlations to determine relationships between variables. Thigh muscle biopsies are a low-risk procedure that may cause minor local soreness and bleeding; all other clinical assessments are non-invasive and will induce minimal discomfort to participants.

Clinical Trial Description

Study design: Up to 30 adults, 25-75 yrs. of age may be recruited and enrolled to participate in a cross-sectional study. Subjects will be divided between two cohorts: 1) persons with early RA (n=15) and 2) age-, sex-, Body Mass Index (BMI)-matched healthy controls (n=15). The goal is to have equal numbers between groups complete the study. Early RA defined as duration of disease/symptoms of less than 6 months (where "duration" denotes the length of time the patient has had symptoms/disease, not the length of time since RA diagnosis) AND prior to starting biologic DMARD therapy were chosen to minimize the effect of medications on skeletal muscle.

Demographics and comorbidities will be assessed via self-report during an initial phone screening interview, with confirmation from the computerized medical record. Once it has been determined that the subject meets pre-screening criteria, they will be scheduled for Visit-1.

Phone Pre-Screening: Demographics and comorbidities will be assessed via self-report during an initial phone screening interview, with confirmation from the electronic medical record. Once it has been determined that the subject meets pre-screening criteria, they will be scheduled for a virtual study information/consent session.

Online surveys: After completion of the e-consent process, participants will be provided a REDCap survey link via email to complete some online questionnaires about their overall health, pain, fatigue, physical function, sleep and ability to manage their disease.

The study involves two on-site study visits at the Duke Center for Living; each visit lasts approximately 2.5 hours.

Study participants will undergo the following at Visit 1:

• Brief medical history including list of medications

• PROMIS Measures (If unable to complete online prior to Visit-1)

• Anthropometric Measurements: Height/Weight/Body Mass Index

• Vitals: Resting Blood Pressure and Heart Rate

• Fasting Blood Draw

• Physician RA Joint Assessment: Disease Activity (DAS-28) Assessment

• MyotonPro Skeletal Muscle Biomechanical Assessments

• NIRS Muscle Oxidative Capacity Test

• Muscle Biopsy

Brief Medical History and Medication Review: A brief medical history including list of medications will be performed by study staff.

Questionnaires: Using Duke's REDCap (Research Electronic Data Capture) interface, a battery of Patient-Reported Outcomes Measurement Information System (PROMIS) self-reported health outcome measures has been added to a computerized interface and will be associated with this investigation. Measures include global health, pain, fatigue, physical function, self-efficacy for disease management and sleep. Of note, staff testing of this battery indicated this could be completed between 10 and 12 minutes; the investigators project participants may take longer, expecting approximately 30 minutes. Except for global health, scoring is performed by the computerized REDCap interface. Specific measure names and versions as listed in REDCap are listed below:

• PROMIS SF v1.1 Global Health

• PROMIS SF v2.0 Physical Function 20a

• PROMIS Scale v1.0 Pain Intensity 3a

• PROMIS SF v1.0 General Life Satisfaction 5a

• PROMIS Bank v1.0 Short Form Fatigue 8a

• Stanford Brief Activity Survey

Study participants will undergo the following at Visit 2:

• BodPod and Minimal Waist Circumference

• Strength Tests

• Isometric Leg Extension Machine - Quadriceps / Hamstrings Strength

• Hand Dynamometer - Grip Strength

• Cardiopulmonary Exercise Test ;

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Healthy Controls
• Rheumatoid Arthritis

• NCT number: NCT04226131
• Study type: Interventional
• Source: Duke University
• Status: Completed
• Phase: N/A
• Start date: September 9, 2020
• Completion date: July 7, 2023