- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT03543488
Neuromusuclar Adaptations in the Rheumatoid Arthritis Disease
Neuromusuclar Responses and Functional Outcomes in Middle-aged Women With Rheumatoid Arthritis.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Typ studie
Zápis (Aktuální)
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
---|---|
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.
|
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. |
Healthy Women
Thirty-five healthy women, age- and body size-matched to the RA patients, were recruited as controls (CG).
|
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. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Knee-Extensor Muscular Strength
Časové okno: 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.
|
Only one day.
|
Muscle architecture and tendon parameters
Časové okno: 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.
|
Only one day.
|
Functional Capacity
Časové okno: Only one day.
|
Timed Up and Go test
|
Only one day.
|
Quadriceps muscle activation
Časové okno: Only one day.
|
Vastus Lateralis and Rectus Femoris muscle activation during strength tests
|
Only one day.
|
Spolupracovníci a vyšetřovatelé
Spolupracovníci
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 09634
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