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CompletedNCT03543488Updated Jun 1, 2018

Neuromusuclar Adaptations in the Rheumatoid Arthritis Disease

An observational study in Arthritis, Rheumatoid and Muscular Weakness, sponsored by Federal University of Rio Grande do Sul. Completed. Open to female participants aged 25 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-06-01.

Sponsored by Federal University of Rio Grande do Sul · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
70
Ages
25 Years to 75 Years
Sex
Female
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Study summary

Rheumatoid arthritis (RA) is a chronic autoimmune disease that causes joint inflammation and progressive joint destruction. Rheumatoid cachexia is one of the structural manifestations of RA, and consists of a reduction in muscle mass, due to an increased muscle protein catabolism induced by inflammatory cytokines. This muscle mass loss generates an impairment in physical function and functional capacity in RA patients. The aim of study was to verify neuromuscular and functional responses in middle-aged women with RA compared to paired healthy women.

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Conditions studied

  • Arthritis, Rheumatoid
  • Muscular Weakness
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In context

Arthritis

3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.

This study's enrollment of 70 is below the median of 155 across 1,057 observational studies indexed under Arthritis.

Browse Arthritis studies →

Lead sponsor

Federal University of Rio Grande do Sul is the lead sponsor of 118 studies on the registry; 20 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
25 Years to 75 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

35 RA patients (class I and II according American Rheumatism Association) and 35 healthy women, age- and body size-matched to the RA patients, were recruited as controls (CG).

Inclusion criteria

  • RA patients with a class I and II RA diagnosis according to the American Rheumatism Association's 1987 revised criteria, were recruited from a university hospital's rheumatology clinic.

Exclusion criteria

Exclusion Criteria:

  • presence of any cardiovascular, neuromuscular and metabolic diseases or severe limitations in mobility
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
70 participants (actual)
Patient registry
No

Groups and cohorts

  • Rheumatoid Arthritis Patients

    Forty women (range 25-75 years), with a class I and II RA diagnosis according to the American Rheumatism Association's 1987 revised criteria, were recruited from a university hospital's rheumatology clinic. Exclusion criteria included the presence of any cardiovascular, neuromuscular and metabolic diseases or severe limitations in mobility. Five patients were excluded for not attending the inclusion criteria, leading to a final number of 35 RA patients.

    Diagnostic Test: Neuromuscular and functional capacity tests

  • Healthy Women

    Thirty-five healthy women, age- and body size-matched to the RA patients, were recruited as controls (CG).

    Diagnostic Test: Neuromuscular and functional capacity tests

Interventions

  • Diagnostic testNeuromuscular and functional capacity tests

    The Timed Up and Go test; Maximal knee-extensor muscle strength (isometric and concentric tests) was measured with a Biodex System 3 dynamometer; A B-mode ultrasonography system with a linear-array probe (60 mm, 7.5 MHz) was used to determine VL and RF muscle thickness, pennation angle, fascicle length and tendon CSA. Measurements were obtained with the volunteer seated in the dynamometer, during isometric contraction at 90° of knee flexion. An 8-channel EMG system was synchronized with the dynamometer through a Windaq data acquisition system and used to evaluate the vastus lateralis and rectus femoris electrical activity during isometric knee-extensor tests.

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What researchers measure

Primary outcomes

  1. Knee-Extensor Muscular Strength

    Maximal knee-extensor muscle strength (isometric and concentric tests), in different angles and velocities were measured with a Biodex System 3 dynamometer (Biodex Medical Systems, Shirley, NY, USA). A 2-min interval was observed between contractions. We used the peak torque of each maximal test to analysis.

    Time frame: Only one day.

  2. Muscle architecture and tendon parameters

    An ultrasonography system was used to determine VL and RF muscle thickness, pennation angle and fascicle length. Muscle architecture measurements were obtained with the volunteer seated in the dynamometer, during isometric contraction at 90° of knee flexion. Muscle thickness was considered the distance between deep and superficial aponeuroses. The best fascicle in each image was used for pennation angle and fascicle length analysis. Pennation angle was calculated as the angle between the muscle fascicle and the deep aponeurosis, whereas fascicle length was measured as the length of the fascicular path between the two aponeuroses. Furthermore, patellar tendon cross-section area was measured with probe perpendicular to tendon during isometric contractions.

    Time frame: Only one day.

  3. Functional Capacity

    Timed Up and Go test

    Time frame: Only one day.

  4. Quadriceps muscle activation

    Vastus Lateralis and Rectus Femoris muscle activation during strength tests

    Time frame: Only one day.

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 1, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03543488
Lead sponsor
Federal University of Rio Grande do Sul
Collaborators
Hospital de Clinicas de Porto Alegre
Responsible party
Marco Aurélio Vaz, PhD (Principal investigator, Federal University of Rio Grande do Sul) — Principal investigator
First posted
Jun 1, 2018
Start date
Jun 1, 2013
Primary completion
Nov 20, 2013
Completion
Mar 3, 2014
Last update
Jun 1, 2018

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.

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