Arthritis, RheumatoidNCT04834050
Can 4 Weeks of Exercise Program Change Quadriceps Architecture in Patients With Rheumatoid Arthritis
A study testing Quadriceps femoris isometric home-based exercise in people with Arthritis, Rheumatoid and Knee Osteoarthritis, run by Ovgu Bickici at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Arthritis, Rheumatoid, Knee Osteoarthritis, Quadriceps Muscle Atrophy
- What is being tested?
- Quadriceps femoris isometric home-based exercise
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2018to 20 Feb 2020
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
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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.
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Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Arthritis, Rheumatoid, Knee Osteoarthritis, Quadriceps Muscle Atrophy, Ultrasonography, Exercise
- Being tested
- Quadriceps femoris isometric home-based exercise
- Medical subject headings
- Arthritis, Rheumatoid, Osteoarthritis, Knee, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quadriceps femoris isometric home-based exerciseProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Rheumatoid arthritis patients | Experimental | Not described Receives: Procedure: Quadriceps femoris isometric home-based exercise |
| Knee Osteoarthritis patients | Experimental | Not described Receives: Procedure: Quadriceps femoris isometric home-based exercise |
| Healthy patients | Experimental | Not described Receives: Procedure: Quadriceps femoris isometric home-based exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline and after 4 weeks 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.
Measured: At baseline and after 4 weeks of intervention
Secondary outcomes (3)
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.
Measured: At baseline and after 4 weeks of intervention
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.
Measured: At baseline and after 4 weeks of intervention
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.
Measured: At baseline and after 4 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2021
- Study start1 Oct 2018
- Primary completion12 Jun 2019
- Study completion20 Feb 2020
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ovgu Bickici
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Ovgu Bickici, Hatay Dortyol State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04834050
- Sponsor's protocol ID
- 26022019
- Status last verified
- Apr 2021
- First submitted
- 31 Mar 2021
- Last updated
- 6 Apr 2021
- Results posted
- No
- Data monitoring committee
- 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 6 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can 4 Weeks of Exercise Program Change Quadriceps Architecture in Patients With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT04834050
- Acronym / sponsor ID
- 26022019
- Conditions
- Arthritis, Rheumatoid, Knee Osteoarthritis, Quadriceps Muscle Atrophy, Ultrasonography, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Ovgu BickiciOther government
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 12 Jun 2019 (actual)
- Study completion
- 20 Feb 2020 (actual)
- First posted
- 6 Apr 2021 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Rheumatoid arthritis patients | Experimental | Procedure: Quadriceps femoris isometric home-based exercise |
| Knee Osteoarthritis patients | Experimental | Procedure: Quadriceps femoris isometric home-based exercise |
| Healthy patients | Experimental | Procedure: Quadriceps femoris isometric home-based exercise |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Quadriceps femoris isometric home-based exerciseAll 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. | Procedure or surgery | Healthy patients, Knee Osteoarthritis patients, Rheumatoid arthritis patients |
Primary outcome
Change of quadriceps femoris parts thickness measures
Time frame: At baseline and after 4 weeks of intervention
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
Time frame: At baseline and after 4 weeks of intervention
Pennation angles of vastus lateralis, medialis and intermedius were calculated at baseline and at the end of exercise program.
3 secondary outcomes
Change of The Western Ontario and McMaster Universities Arthritis Index (WOMAC) score of knee OA
Time frame: At baseline and after 4 weeks of intervention
Change of Disease activity score 28-C reactive protein (DAS28-CRP)
Time frame: At baseline and after 4 weeks of intervention
Change of Lequesne scores of knee OA patients
Time frame: At baseline and after 4 weeks of intervention
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 6 Apr 2021.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quadriceps femoris isometric home-based exercise in people with Arthritis, Rheumatoid and Knee Osteoarthritis, run by Ovgu Bickici at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 6 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Change of quadriceps femoris parts thickness measures (time frame: At baseline and after 4 weeks of intervention). The study lists 2 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 6 Apr 2021.