Back to resultsCan 4 Weeks of Exercise Program Change Quadriceps Architecture in Patients With Rheumatoid Arthritis
Primary Purpose
Arthritis, Rheumatoid, Knee Osteoarthritis, Quadriceps Muscle Atrophy
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Quadriceps femoris isometric home-based exercise
Sponsored by
About this trial
This is an interventional treatment trial for Arthritis, Rheumatoid
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.
-
Sites / Locations
- Gazi University Faculty of Medicine
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Rheumatoid arthritis patients
Knee Osteoarthritis patients
Healthy patients
Arm Description
Outcomes
Primary Outcome Measures
Change of quadriceps femoris parts thickness measures
Dominant knee vastus lateralis, medialis, intermedius and rectus femoris thicknesses of 3 groups were calculated at baseline and at the end of intervention.
Change of quadriceps femoris parts pennation angles
Pennation angles of vastus lateralis, medialis and intermedius were calculated at baseline and at the end of exercise program.
Secondary Outcome Measures
Change of The Western Ontario and McMaster Universities Arthritis Index (WOMAC) score of knee OA
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) scores of knee OA patients were calculated at baseline and at the end of exercise program. The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is divided into 3 subscales: Pain, stiffness, physical function. The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. A sum of scores of 3 subscales were multipled with 100 and divided by 96 and resulted in WOMAC score of the patients.
Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Change of Disease activity score 28-C reactive protein (DAS28-CRP)
Disease activity score 28-C reactive protein (DAS28-CRP) scores of RA patients were calculated at baseline and at the end of program. A score lower than 2.6 means remission, score between 2.6 and 3.2 means low disease activity, score between 3.2 and 5.1 means moderate disease activity and score higher than 5.1 means high disease activity.
Change of Lequesne scores of knee OA patients
Lequesne algofunctional index scores of knee OA patients were calculated at baseline and at the end of the intervention. The Lequesne OA index is scored as the sum of questions ranging from 0 to 24, higher scores meaning worse outcome.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04834050
Brief Title
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
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
June 12, 2019 (Actual)
Study Completion Date
February 20, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ovgu Bickici
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis, Rheumatoid, Knee Osteoarthritis, Quadriceps Muscle Atrophy, Ultrasonography, Exercise
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rheumatoid arthritis patients
Arm Type
Experimental
Arm Title
Knee Osteoarthritis patients
Arm Type
Experimental
Arm Title
Healthy patients
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Quadriceps femoris isometric home-based exercise
Intervention Description
All 3 groups of participants were given 4-week (5 days/week) quadriceps-hamstring isometric home-based exercise training for their both knees. Exercises were performed (with maximal effort for 10 seconds) at a rate of 20 repetitions per day. Training was performed at outpatient clinic for 30 minutes.
Primary Outcome Measure Information:
Title
Change of quadriceps femoris parts thickness measures
Description
Dominant knee vastus lateralis, medialis, intermedius and rectus femoris thicknesses of 3 groups were calculated at baseline and at the end of intervention.
Time Frame
At baseline and after 4 weeks of intervention
Title
Change of quadriceps femoris parts pennation angles
Description
Pennation angles of vastus lateralis, medialis and intermedius were calculated at baseline and at the end of exercise program.
Time Frame
At baseline and after 4 weeks of intervention
Secondary Outcome Measure Information:
Title
Change of The Western Ontario and McMaster Universities Arthritis Index (WOMAC) score of knee OA
Description
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) scores of knee OA patients were calculated at baseline and at the end of exercise program. The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is divided into 3 subscales: Pain, stiffness, physical function. The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. A sum of scores of 3 subscales were multipled with 100 and divided by 96 and resulted in WOMAC score of the patients.
Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Time Frame
At baseline and after 4 weeks of intervention
Title
Change of Disease activity score 28-C reactive protein (DAS28-CRP)
Description
Disease activity score 28-C reactive protein (DAS28-CRP) scores of RA patients were calculated at baseline and at the end of program. A score lower than 2.6 means remission, score between 2.6 and 3.2 means low disease activity, score between 3.2 and 5.1 means moderate disease activity and score higher than 5.1 means high disease activity.
Time Frame
At baseline and after 4 weeks of intervention
Title
Change of Lequesne scores of knee OA patients
Description
Lequesne algofunctional index scores of knee OA patients were calculated at baseline and at the end of the intervention. The Lequesne OA index is scored as the sum of questions ranging from 0 to 24, higher scores meaning worse outcome.
Time Frame
At baseline and after 4 weeks of intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
-
Facility Information:
Facility Name
Gazi University Faculty of Medicine
City
Ankara
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Can 4 Weeks of Exercise Program Change Quadriceps Architecture in Patients With Rheumatoid Arthritis
We'll reach out to this number within 24 hrs