Rheumatic ArthritisNCT06887725
Exercise Training and Knee Joint Proprioception in Rheumatoid Arthritis
A study testing Exercise in people with Rheumatic Arthritis, run by Aysima Barlak at 1 site in Turkey (Türkiye).
Trial summary
Rheumatoid arthritis (RA) is a chronic disorder that affects 0.5% to 1% of adults and is the result of an autoimmune attack against joint tissues. In recent years, advances in anti-rheumatoid drugs and treatment strategies have improved the health status of patients with RA. Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- Rheumatic Arthritis
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jan 2022to 24 Dec 2024
- 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 45 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being diagnosed with RA
- Being able to walk
- Being between the ages of 40-65.
- Accepting to participate in the study and approving the informed consent form.
- Being literate and able to use technological devices.
Who cannot join
- Having acute inflammatory pathology in the knee joint.
- Knee arthroplasty surgery.
- Intra-articular or systemic corticosteroid use in the last 3 months.
- Having participated in an FTR program in the last 3 months.
- Advanced musculoskeletal, cardiac or peripheral vascular disease.
- Significant system or organ failure.
- Having a disease that will affect cognitive functions such as Alzheimer's disease or dementia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Exercise Training on Knee Joint Proprioception in Patients With Rheumatoid A Exercise Training on Knee Joint Proprioception in Patients With Rheumatoid Arthritisrthritis
Rheumatoid arthritis (RA) is a chronic disorder that affects 0.5% to 1% of adults and is the result of an autoimmune attack against joint tissues. In recent years, advances in anti-rheumatoid drugs and treatment strategies have improved the health status of patients with RA. However, many patients do not achieve disease remission and experience progressive functional impairment. According to 2003 data from the National Health Interview Survey in the United States, by 2030, approximately 25% of adults aged 18 years and older are expected to have doctor-diagnosed arthritis, and 9.3% of adults are expected to have arthritis-related activity limitations.
In order for patients with RA to perform activities of daily living, it is very important for them to maintain their balance, i.e., their sense of proprioception. It is known that knee proprioception is decreased in RA. In addition, the presence of pain, decreased muscle strength, and functionality in patients with RA lead many of them to adopt a sedentary lifestyle.
The main aim of this study was to evaluate the effects of exercise training on knee joint proprioception in individuals with RA. In addition, it also aims to examine how exercise training improves pain, functionality, performance, fear of falling, biopsychosocial status, and quality of life. The importance of this research is that it provides more scientific data for improving knee joint proprioception in individuals with RA and guides clinical practice. It is also expected to contribute to the development of a comprehensive approach to improving the quality of life of patients by demonstrating not only the physical but also the psychological and functional effects of exercise training.
- Conditions
- Rheumatic Arthritis
- Being tested
- Exercise
- Keywords
- exercise, proprioception, biopsychosocial model, knee, muscle strength
- Medical subject headings
- Rheumatic Fever, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
The Cognitive Exercise Therapy Approach (Bilişsel Egzersiz Terapi Yaklaşımı-BETY) is an innovative exercise approach developed based on the biopsychosocial model. The parameters that form the basis of BETY are function-oriented core stabilization exercises, information management in pain, information management in mood, and information management in sexuality. BETY was shaped by the feedback of individuals with rheumatism who participated in regular exercise sessions for years and was introduced to the literature as a treatment method aiming to create changes in the cognitive structures of patients through exercise.
| Study group | Role | What they receive |
|---|---|---|
| Training Group | Experimental | Not described Receives: Other: Exercise |
| Kontrol Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive Exercise Therapy Approach (BETY)- Biopsychosocial Questionnaire
it is a 30-item Likert-type scale developed through repeated statistics of feedback from rheumatic individuals who have participated in exercise sessions for many years, expressing the healing characteristics. It evaluates the individual from a biopsychosocial perspective with the subheadings of pain, functionality-fatigue, mood, sociability, sexuality and sleep. It is scored between 0 and 120. BETY-BQ evaluates the individual from a holistic perspective with six subheadings: pain (5 items), functionality (9 items), mood (10 items), sociability (3 items), sexuality (2 items) and sleep (1 item). A high score indicates a low biopsychosocial status.
Measured: 3 mounths
Secondary outcomes (10)
Proprioception of the knee joint
Joint position sense was evaluated for proprioception measurement. All measurements were performed by a sports physician using a Biodex System III Isokinetic Dynamometer (Biodex Corp, Shirley, NY). For the reproduction test, which evaluates joint position sense, the passive method in the sitting position was used. The evaluation was performed for 30° and 60° knee flexion angles.
Measured: 3 mounths
Health Assessment Questionnaire (HAQ)
It is a scale developed to question functional inadequacy in daily living activities. The scale questions a total of 8 activities, including dressing, sitting up, eating, walking, hygiene, reaching out, grasping and daily tasks, and consists of 20 questions. Each question is scored between 0 and 3. High scores indicate a decrease in the individual's functionality.
Measured: 3 mounths
Hospital Anxiety Depression Scale (HADS)
It is a scale consisting of 14 questions (7 questions about depression, 7 questions about anxiety) that the individual is asked to answer by thinking about the last few days, and is scored between 0 and 3. The cut-off values of the scale are 10 for the anxiety subscale and 7 for the depression subscale. High total scores indicate high levels of anxiety or depression
Measured: 3 mounths
WOMAC Osteoarthritis Index
WOMAC assesses pain, endurance and physical functioning, functional status and stiffness. This scale has gained increasing acceptance in the assessment of OA since its introduction in 1986. The pain subscale includes five items asking about pain with activity, at rest and at night. The stiffness heading includes two questions. The functional status heading includes an assessment of difficulty in 17 different activities. The items are scored from 0 to 4 according to difficulty and the degree of pain and stiffness felt, with a higher total score indicating greater severity of the disease.
Measured: 3 mounths
McGill pain scale short form (SF McGill)
The form consists of three parts. In the first part, 11 of the 15 descriptive word groups evaluate the sensory and 4 evaluate the perceptual dimension of pain. These descriptive words are rated on an intensity scale from 0 to 3 (0=None, 1=Mild, 2=Moderate, 3=Very). In the first part of the scale, a total of 3 pain scores are obtained: sensory pain score, perceptual pain score and total pain score. The second part of the form includes five word groups ranging from "mild pain" to "unbearable pain" to determine the severity of the patient's pain. In the third part, the patient's current pain intensity is assessed using a visual analogy scale (VAS).
Measured: 3 mounths
Time Up and Go Test
It is a test that evaluates fall risk and mobility in the elderly. With this test, the time (sec.) for individuals to get up from a chair, walk a distance of 3 meters and sit back on the chair was measured. A trial test was performed once. Then the test was performed twice and the average of the two measurements was taken.
Measured: 3 mounths
10-step stair climbing test
10-step stair climbing test:It is a test that evaluates the individual's stair climbing activity, lower extremity strength and dynamic balance.
On a staircase with a railing, the 9th step is marked and the individual is asked to climb up and down as fast as he/she can and this time (sec) is measured with a stopwatch.
Measured: 3 mounths
6 min walk test
This is a submaximal exercise test used to determine exercise capacity.
Measured: 3 mounths
Fall efficacy scale
Developed in 1990 by Tinetti et al., it assesses a person's perception of stability and fear of falling during daily activities indoors. It consists of 10 items, answers are scored between 1 and 10. A score above 70 indicates fear of falling
Measured: 3 mounths
World health organization quality of life scale-short form (WHOQOL-BREF)
Developed by the World Health Organization (WHO), the scale has two versions: long (WHOQOL-100) and short (WHOQOL-BREF). The WHOQOL-BREF scale consists of a total of 26 questions, 24 of which question perceived quality of life and 2 of which question perceived health status. It consists of 4 domains: physical, psychological, social relations and environmental domains. Since each domain independently expresses the quality of life in its own domain, domain scores are calculated between 4 and 20. The higher the score, the better the quality of life.
Measured: 3 mounths
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2025
- Study start2 Jan 2022
- Primary completion20 Dec 2024
- Study completion24 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatic ArthritisStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aysima Barlak
- Sponsor type
- University, hospital or other
- Collaborators
- Hacettepe University, Hasan Kalyoncu University
- Responsible party
- Sponsor-investigator, Aysima Barlak, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06887725
- Sponsor's protocol ID
- 2022/140
- Status last verified
- Dec 2022
- First submitted
- 16 Mar 2025
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Akgoz A, Yakut Y, Tufekci O, Aktas BE, Sari EO, Barlak A, Bayramlar K, Apras Bilgen S, Korkusuz F, Unal E. Biopsychosocial model-based exercise improves muscle strength, proprioception, pain, function, and quality of life in rheumatoid arthritis patients with knee involvement: a randomized controlled clinical tiral. Rheumatol Int. 2025 Sep 6;45(9):221. doi: 10.1007/s00296-025-05976-3.
PubMed 40913677
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Exercise Training on Knee Joint Proprioception in Patients With Rheumatoid A Exercise Training on Knee Joint Proprioception in Patients With Rheumatoid Arthritisrthritis
- ClinicalTrials.gov ID
- NCT06887725
- Acronym / sponsor ID
- 2022/140
- Conditions
- Rheumatic Arthritis
- Keywords
- exercise, proprioception, biopsychosocial model, knee, muscle strength
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Aysima BarlakUniversity, hospital or other
- Collaborators
- Hacettepe University, Hasan Kalyoncu University
- Study start
- 2 Jan 2022 (actual)
- Primary completion
- 20 Dec 2024 (actual)
- Study completion
- 24 Dec 2024 (actual)
- First posted
- 20 Mar 2025 (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.
Rheumatoid arthritis (RA) is a chronic disorder that affects 0.5% to 1% of adults and is the result of an autoimmune attack against joint tissues. In recent years, advances in anti-rheumatoid drugs and treatment strategies have improved the health status of patients with RA. However, many patients do not achieve disease remission and experience progressive functional impairment. According to 2003 data from the National Health Interview Survey in the United States, by 2030, approximately 25% of adults aged 18 years and older are expected to have doctor-diagnosed arthritis, and 9.3% of adults are expected to have arthritis-related activity limitations.
In order for patients with RA to perform activities of daily living, it is very important for them to maintain their balance, i.e., their sense of proprioception. It is known that knee proprioception is decreased in RA. In addition, the presence of pain, decreased muscle strength, and functionality in patients with RA lead many of them to adopt a sedentary lifestyle.
The main aim of this study was to evaluate the effects of exercise training on knee joint proprioception in individuals with RA. In addition, it also aims to examine how exercise training improves pain, functionality, performance, fear of falling, biopsychosocial status, and quality of life. The importance of this research is that it provides more scientific data for improving knee joint proprioception in individuals with RA and guides clinical practice. It is also expected to contribute to the development of a comprehensive approach to improving the quality of life of patients by demonstrating not only the physical but also the psychological and functional effects of exercise training.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Training Group | Experimental | Other: Exercise |
| Kontrol Group | No intervention | – |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Being diagnosed with RA
- Being able to walk
- Being between the ages of 40-65.
- Accepting to participate in the study and approving the informed consent form.
- Being literate and able to use technological devices.
Key exclusion criteria (7 listed)
- Having acute inflammatory pathology in the knee joint.
- Knee arthroplasty surgery.
- Intra-articular or systemic corticosteroid use in the last 3 months.
- Having participated in an FTR program in the last 3 months.
- Advanced musculoskeletal, cardiac or peripheral vascular disease.
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 |
|---|---|---|
| ExerciseThe Cognitive Exercise Therapy Approach (Bilişsel Egzersiz Terapi Yaklaşımı-BETY) is an innovative exercise approach developed based on the biopsychosocial model. The parameters that form the basis of BETY are function-oriented core stabilization exercises, information management in pain, information management in mood, and information management in sexuality. BETY was shaped by the feedback of individuals with rheumatism who participated in regular exercise sessions for years and was introduced to the literature as a treatment method aiming to create changes in the cognitive structures of patients through exercise. | Other | Training Group |
Primary outcome
Cognitive Exercise Therapy Approach (BETY)- Biopsychosocial Questionnaire
Time frame: 3 mounths
it is a 30-item Likert-type scale developed through repeated statistics of feedback from rheumatic individuals who have participated in exercise sessions for many years, expressing the healing characteristics. It evaluates the individual from a biopsychosocial perspective with the subheadings of pain, functionality-fatigue, mood, sociability, sexuality and sleep. It is scored between 0 and 120. BETY-BQ evaluates the individual from a holistic perspective with six subheadings: pain (5 items), functionality (9 items), mood (10 items), sociability (3 items), sexuality (2 items) and sleep (1 item). A high score indicates a low biopsychosocial status.
10 secondary outcomes
Proprioception of the knee joint
Time frame: 3 mounths
Health Assessment Questionnaire (HAQ)
Time frame: 3 mounths
Hospital Anxiety Depression Scale (HADS)
Time frame: 3 mounths
WOMAC Osteoarthritis Index
Time frame: 3 mounths
McGill pain scale short form (SF McGill)
Time frame: 3 mounths
Time Up and Go Test
Time frame: 3 mounths
10-step stair climbing test
Time frame: 3 mounths
6 min walk test
Time frame: 3 mounths
Fall efficacy scale
Time frame: 3 mounths
World health organization quality of life scale-short form (WHOQOL-BREF)
Time frame: 3 mounths
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 20 Mar 2025.
- Derived from this study: PubMed 40913677Akgoz A, Yakut Y, Tufekci O, Aktas BE, Sari EO, Barlak A, Bayramlar K, Apras Bilgen S, Korkusuz F, Unal E. Biopsychosocial model-based exercise improves muscle strength, proprioception, pain, function, and quality of life in rheumatoid arthritis patients with knee involvement: a randomized controlled clinical tiral. Rheumatol Int. 2025 Sep 6;45(9):221. doi: 10.1007/s00296-025-05976-3.
- 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 Exercise in people with Rheumatic Arthritis, run by Aysima Barlak 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?
The sponsor lists 5 inclusion and 7 exclusion criteria. 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 20 Mar 2025. 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?
Cognitive Exercise Therapy Approach (BETY)- Biopsychosocial Questionnaire (time frame: 3 mounths). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06887725, which also lists 1 linked publication.
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 20 Mar 2025.