MusculRA: The Effects of Rheumatoid Arthritis on Skeletal Muscle Biomechanics

Summary

Participation Requirements

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 ...

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: Once the phone screening is complete and the subject appears to meet all of the study criteria, a REDCap web address will be sent to the participant via email in order to complete study questionnaires online about their overall health, pain, fatigue, physical function, sleep and ability to manage their disease. Study participants will undergo the following at Visit 1: Consent: The consent visit will take place at the Duke Center for Living and will last approximately three hours. The study staff will explain the study and the consent form in detail. Once the required consent documentation has been signed and dated appropriately, the subject will undergo the following: 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 BodPod and Minimal Waist Circumference 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 Visit 2 Assessments: Cardiopulmonary Exercise Test Strength Tests Isometric Leg Extension Machine - Quadriceps / Hamstrings Strength Hand Dynamometer - Grip Strength

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