Arthritis, RheumatoidNCT03543488
Neuromusuclar Adaptations in the Rheumatoid Arthritis Disease
An observational study of Arthritis, Rheumatoid and Muscular Weakness, run by Federal University of Rio Grande do Sul.
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. Read more about this study
- Who is it for?
- Ages 25 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Arthritis, Rheumatoid, Muscular Weakness
- What is being tested?
- Neuromuscular and functional capacity tests
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2013to 3 Mar 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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).
Who may be able to join
- 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.
Who cannot join
- presence of any cardiovascular, neuromuscular and metabolic diseases or severe limitations in mobility
About this study
Official title: Neuromusuclar Responses and Functional Outcomes in Middle-aged Women With Rheumatoid Arthritis.
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.
- Conditions
- Arthritis, Rheumatoid, Muscular Weakness
- Being tested
- Neuromuscular and functional capacity tests
- Medical subject headings
- Arthritis, Rheumatoid, Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuromuscular and functional capacity testsDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Diagnostic Test: Neuromuscular and functional capacity tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Only one day.
Functional Capacity
Timed Up and Go test
Measured: Only one day.
Quadriceps muscle activation
Vastus Lateralis and Rectus Femoris muscle activation during strength tests
Measured: Only one day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2018
- Study start1 Jun 2013
- Primary completion20 Nov 2013
- Study completion3 Mar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthritis, RheumatoidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital de Clinicas de Porto Alegre
- Responsible party
- Principal investigator, Marco Aurélio Vaz, PhD, Federal University of Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03543488
- Sponsor's protocol ID
- 09634
- Status last verified
- May 2018
- First submitted
- 8 May 2018
- Last updated
- 1 Jun 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromusuclar Responses and Functional Outcomes in Middle-aged Women With Rheumatoid Arthritis.
- ClinicalTrials.gov ID
- NCT03543488
- Acronym / sponsor ID
- 09634
- Conditions
- Arthritis, Rheumatoid, Muscular Weakness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Federal University of Rio Grande do SulUniversity, hospital or other
- Collaborators
- Hospital de Clinicas de Porto Alegre
- Study start
- 1 Jun 2013 (actual)
- Primary completion
- 20 Nov 2013 (actual)
- Study completion
- 3 Mar 2014 (actual)
- First posted
- 1 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rheumatoid Arthritis Patients | – | Diagnostic Test: Neuromuscular and functional capacity testsForty 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 | – | Diagnostic Test: Neuromuscular and functional capacity testsThirty-five healthy women, age- and body size-matched to the RA patients, were recruited as controls (CG). |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- presence of any cardiovascular, neuromuscular and metabolic diseases or severe limitations in mobility
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuromuscular and functional capacity testsThe 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. | Diagnostic test | Healthy Women, Rheumatoid Arthritis Patients |
Primary outcome
Knee-Extensor Muscular Strength
Time frame: Only one day.
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.
Muscle architecture and tendon parameters
Time frame: Only one day.
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.
Functional Capacity
Time frame: Only one day.
Timed Up and Go test
Quadriceps muscle activation
Time frame: Only one day.
Vastus Lateralis and Rectus Femoris muscle activation during strength tests
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthritis, Rheumatoid and Muscular Weakness, run by Federal University of Rio Grande do Sul.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee-Extensor Muscular Strength (time frame: Only one day.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2018.