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NCT04226131 · ClinicalTrials.gov registry record · NA
MusculRA: The Effects of Rheumatoid Arthritis on Skeletal Muscle Biomechanics
A NA study, sponsored by Duke University.
- Completed
- Registry status
- NA
- Development phase
- 21
- Enrollment target
NCT04226131 is a NA study that has completed, run by Duke University. The registered enrollment target is 21 participants.
The verdict
NCT04226131, a NA study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- NA
- Development phase
- 21 participants
- Enrollment target
Study 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.
Interventions
- OTHER Blood Draw
- OTHER Body Composition
- OTHER Disease Activity (DAS-28) Assessment
- OTHER Skeletal Muscle Mitochondrial Respiratory Capacity
- OTHER Muscle Biopsy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2020-09-09 |
| Est. Completion | 2023-07-07 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04226131
The ClinicalTrials.gov registry entry for NCT04226131 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Blood Draw is the first listed.
NCT04226131 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04226131 about?
NCT04226131 is a clinical study titled "MusculRA: The Effects of Rheumatoid Arthritis on Skeletal Muscle Biomechanics". 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 durati...
What is the current status of trial NCT04226131?
This trial is currently completed. It is a NA study. The enrollment target is 21 participants. The study started on 2020-09-09. Estimated completion is 2023-07-07.
What interventions are being tested in trial NCT04226131?
The interventions under investigation include: Blood Draw (OTHER), Body Composition (OTHER), Disease Activity (DAS-28) Assessment (OTHER), Skeletal Muscle Mitochondrial Respiratory Capacity (OTHER), Muscle Biopsy (OTHER).
Who is sponsoring clinical trial NCT04226131?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
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