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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: Completed NA study, sponsored by Duke University.
NCT04226131 is a NA study that has completed, run by Duke University. The registered enrollment target is 21 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Determine whether passive skeletal muscle stiffness (Newtons/meters) and elasticity (logarithmic decrement) are different in RA compared to matched healthy controls.
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 |
What the finished NCT04226131 record still lists
NCT04226131 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 5 interventions - of which Blood Draw is the first listed.
NCT04226131 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04226131's enrollment target sits among peer trials
21 1762nd of 2000 higher than 233 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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