Neuromusuclar Adaptations in the Rheumatoid Arthritis Disease
Neuromusuclar Responses and Functional Outcomes in Middle-aged Women With Rheumatoid Arthritis.
1 other identifier
observational
70
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jun 2013
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 20, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 3, 2014
CompletedFirst Submitted
Initial submission to the registry
May 8, 2018
CompletedFirst Posted
Study publicly available on registry
June 1, 2018
CompletedJune 1, 2018
May 1, 2018
6 months
May 8, 2018
May 18, 2018
Conditions
Outcome Measures
Primary Outcomes (4)
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.
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.
Functional Capacity
Timed Up and Go test
Only one day.
Quadriceps muscle activation
Vastus Lateralis and Rectus Femoris muscle activation during strength tests
Only one day.
Study Arms (2)
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.
Healthy Women
Thirty-five healthy women, age- and body size-matched to the RA patients, were recruited as controls (CG).
Interventions
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.
Eligibility Criteria
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).
You may qualify if:
- 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.
You may not qualify if:
- presence of any cardiovascular, neuromuscular and metabolic diseases or severe limitations in mobility
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
May 8, 2018
First Posted
June 1, 2018
Study Start
June 1, 2013
Primary Completion
November 20, 2013
Study Completion
March 3, 2014
Last Updated
June 1, 2018
Record last verified: 2018-05
Data Sharing
- IPD Sharing
- Will not share