MusculRA: The Effects of Rheumatoid Arthritis on Skeletal Muscle Biomechanics
Sleutelwoorden
Abstract
Omschrijving
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
- Leg Extension Machine - Quadriceps / Hamstrings Strength
- Hand Dynamometer - Grip Strength
Datums
| Laatst geverifieerd: | 12/31/2019 |
| Eerste ingediend: | 01/08/2020 |
| Geschatte inschrijving ingediend: | 01/08/2020 |
| Eerst geplaatst: | 01/12/2020 |
| Laatste update ingediend: | 06/28/2020 |
| Laatste update geplaatst: | 06/29/2020 |
| Werkelijke startdatum van het onderzoek: | 08/31/2020 |
| Geschatte primaire voltooiingsdatum: | 01/30/2021 |
| Geschatte voltooiingsdatum van het onderzoek: | 01/30/2021 |
Conditie of ziekte
Interventie / behandeling
Other: Blood Draw
Other: Disease Activity (DAS-28) Assessment
Other: Skeletal Muscle Mitochondrial Respiratory Capacity
Other: Muscle Biopsy
Other: Body Composition
Other: Cardiopulmonary Exercise Test (CPET)
Other: Strength Testing
Other: Questionnaires
Other: Skeletal Muscle Biomechanical Property Assessment
Fase
Armgroepen
| Arm | Interventie / behandeling |
|---|---|
| Other: Early Rheumatoid Arthritis (RA) 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 | |
| Other: Age-, Sex-, BMI-matched Healthy Controls Healthy Controls. |
Geschiktheidscriteria
| Leeftijden die in aanmerking komen voor studie | 25 Years Naar 25 Years |
| Geslachten die in aanmerking komen voor studie | All |
| Accepteert gezonde vrijwilligers | Ja |
| Criteria | Inclusion Criteria: Study participants will include 25-75 year-old adults with early rheumatoid arthritis and healthy age-, gender-, and BMI-matched controls. - Rheumatoid arthritis participants will all be seropositive (positive rheumatoid factor or anti-citrullinated protein antibody) or with erosions typical of RA on radiographs. - Meet 2010 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Classification Criteria for RA. - 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. - Participants will not be engaging in regular exercise (According to 2018 US guidelines): not more than 150 minutes per week of moderate intensity exercise or 75 minutes per week of vigorous intensity exercise) for at least three months prior to consent. Exclusion Criteria: - Early RA participants will be excluded if they have already started bDMARD therapy. - The investigators will exclude persons using non-aspirin anticoagulants that would complicate the biopsy. There will be a wash-out period of seven days for anti-platelet agents, and three days for NSAIDs prior to biopsies. - Uncontrolled thyroid diseases - Chronic obstructive lung disease - Parkinson's disease - Ankylosing spondylitis - Congestive Heart Failure Class III and above will be excluded based on recognized effects on skeletal muscle. - Patients with absolute or relative contraindications to exercise will be excluded: recent (<6 months) acute cardiac event, unstable angina, uncontrolled dysrhythmias causing symptoms or hemodynamic compromise, symptomatic aortic stenosis, uncontrolled symptomatic heart failure, acute pulmonary embolus, acute myocarditis or pericarditis, suspected or known dissecting aneurism or acute systemic infection, left main coronary stenosis, moderate stenotic valvular heart disease, outflow tract obstruction, high degree atrioventricular (AV) block, ventricular aneurysm. - Uncontrolled metabolic disease (e.g. diabetes, thyrotoxicosis, myxoedema) - Uncontrolled pulmonary disease (e.g. severe COPD or pulmonary fibrosis) - Mental or physical impairment leading to inability to exercise adequately - Pregnant women will be excluded as determined via menstrual history/self-reporting. |
Resultaat
Primaire uitkomstmaten
1. Muscle stiffness and elasticity [Baseline]
Secundaire uitkomstmaten
1. Myobundle function [Baseline]
2. Janus kinase/signal transducers and activators of transcription 3 pathway (JAK/STAT3) signaling in skeletal muscle [Baseline]
