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NCT Number: NCT04834050

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

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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Key information

Conditions

Arthritis, Rheumatoid Arthritis Autoimmune Diseases Behavior Connective Tissue Diseases Exercise Immune System Diseases Joint Diseases Knee Osteoarthritis Motor Activity Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Quadriceps Muscle Atrophy Rheumatic Diseases Skin and Connective Tissue Diseases Ultrasonography

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gazi University Faculty of Medicine

Ankara, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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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Treatment and study plan

Quadriceps femoris isometric home-based exercise

Procedure

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 outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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

    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.

  2. Change of Disease activity score 28-C reactive protein (DAS28-CRP)

    Time frame: At baseline and after 4 weeks of intervention

    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.

  3. Change of Lequesne scores of knee OA patients

    Time frame: At baseline and after 4 weeks of intervention

    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.

Sponsors and collaborators

Lead sponsor

Ovgu Bickici

Other Gov

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Apr 6, 2021
Registry last updated
Apr 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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