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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03543488
Other study ID # 09634
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 1, 2013
Est. completion date March 3, 2014

Study information

Verified date May 2018
Source Federal University of Rio Grande do Sul
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 70
Est. completion date March 3, 2014
Est. primary completion date November 20, 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 25 Years to 75 Years
Eligibility 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:

- presence of any cardiovascular, neuromuscular and metabolic diseases or severe limitations in mobility

Study Design


Intervention

Diagnostic Test:
Neuromuscular 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.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Federal University of Rio Grande do Sul Hospital de Clinicas de Porto Alegre

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Only one day.
Primary 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. Only one day.
Primary Functional Capacity Timed Up and Go test Only one day.
Primary Quadriceps muscle activation Vastus Lateralis and Rectus Femoris muscle activation during strength tests Only one day.
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