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CompletedNCT04834050Updated Apr 6, 2021

Can 4 Weeks of Exercise Program Change Quadriceps Architecture in Patients With Rheumatoid Arthritis

An interventional study of Quadriceps femoris isometric home-based exercise in Arthritis, Rheumatoid, Knee Osteoarthritis and Quadriceps Muscle Atrophy, sponsored by Ovgu Bickici. Completed at 1 site in Turkey. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-04-06.

Sponsored by Ovgu Bickici · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 5 months after the study started (first participant enrolled Oct 2018, registered Mar 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
37
Allocation
Non-randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

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Conditions studied

  • Arthritis, Rheumatoid
  • Knee Osteoarthritis
  • Quadriceps Muscle Atrophy
  • Ultrasonography
  • Exercise
03

In context

Arthritis

3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.

This study's enrollment of 37 is below the median of 90 across 2,377 interventional studies indexed under Arthritis.

Browse Arthritis studies →

Lead sponsor

This is the only study on the registry with Ovgu Bickici as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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.

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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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05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
37 participants (actual)

Study arms

  • Experimental
    Rheumatoid arthritis patients

    Procedure: Quadriceps femoris isometric home-based exercise

  • Experimental
    Knee Osteoarthritis patients

    Procedure: Quadriceps femoris isometric home-based exercise

  • Experimental
    Healthy patients

    Procedure: Quadriceps femoris isometric home-based exercise

Interventions

  • ProcedureQuadriceps femoris isometric home-based exercise

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: At baseline and after 4 weeks of intervention

  2. 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.

    Time frame: At baseline and after 4 weeks of intervention

Secondary outcomes

  1. 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.

    Time frame: At baseline and after 4 weeks of intervention

  2. 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.

    Time frame: At baseline and after 4 weeks of intervention

  3. 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.

    Time frame: At baseline and after 4 weeks of intervention

07

Study locations

1 site
  • Gazi University Faculty of Medicine
    Ankara, Turkey
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 6, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04834050
Lead sponsor
Ovgu Bickici
Responsible party
Ovgu Bickici (OB, Hatay Dortyol State Hospital) — Sponsor-investigator
First posted
Apr 6, 2021
Start date
Oct 1, 2018
Primary completion
Jun 12, 2019
Completion
Feb 20, 2020
Last update
Apr 6, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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