Clinical trial NCT04834050: Can 4 Weeks of Exercise Program Change Quadriceps Architecture in Patients With Rheumatoid Arthritis
Official title: Can 4 Weeks of Exercise Program Change Quadriceps Architecture in Patients With Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthritis, Rheumatoid
Knee Osteoarthritis
Quadriceps Muscle Atrophy
Ultrasonography
Exercise
Lead sponsor: Hatay Dortyol State Hospital
Sponsor class: OTHER_GOV
First posted: 2021-04-06
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Quadriceps femoris (QF) atrophy is seen in rheumatoid arthritis and knee osteoarthritis (OA) patients. Exercise therapy is mile stone in knee OA patients also it can help thicken QF muscle of RA patients. We primarily aimed to demonstrate the influence of 4 weeks of knee isometric home-based training on QF muscle parts thickness and pennation angle measurements of RA patients with ultrasonography (USG). This study included 12 patients with RA, 12 patients with knee OA as positive control group and 13 volunteers as healthy control group. All participants were given 4 weeks of quadriceps-hamstring isometric home-based training. At baseline and at the end of the program, WOMAC and Lequesne algofunctional index scores of knee OA patients and DAS28-CRP scores of RA patients were recorded. Dominant knee thickness and pennation angle measurements of QF muscle parts were evaluated by ultrasonography.


Eligibility criteria: The inclusion criteria for all participants were being between 18-65 yy.

The inclusion criteria for RA patients were: confirmed diagnosis of RA according to 2010 ACR/EULAR classification criteria and lack of any other inflammatory articular diseases.

The inclusion criteria for knee OA patients were: diagnosis according to ACR classification criteria of knee OA with grade 2-3 according to the Kellgren-Lawrence grading system and lack of any other inflammatory articular diseases.

Volunteers who did not have any knee pain, no clinical degenerative or inflammatory signs were included in the healthy control group.

-

Exclusion criteria for all participants were: being out of age range, history of knee joint trauma, surgery or knee joint injection in the previous 6 months, presence of any other disease that can affect thigh muscles (radiculopathy, myopathy, hip problems). Patients with secondary knee OA were not included.

-

Primary outcomes:
measure: Change of quadriceps femoris parts thickness measures
timeFrame: At baseline and after 4 weeks of intervention
measure: Change of quadriceps femoris parts pennation angles
timeFrame: At baseline and after 4 weeks of intervention
Secondary outcomes:
measure: Change of The Western Ontario and McMaster Universities Arthritis Index (WOMAC) score of knee OA
timeFrame: At baseline and after 4 weeks of intervention
measure: Change of Disease activity score 28-C reactive protein (DAS28-CRP)
timeFrame: At baseline and after 4 weeks of intervention
measure: Change of Lequesne scores of knee OA patients
timeFrame: At baseline and after 4 weeks of intervention
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University Faculty of Medicine
Study officials:
References: