Kinesiophobia (Fear of Movement)NCT07435272
Kinesiophobia in Rheumatoid Arthritis: Associations With Functional Disability, Disease Activity, and Related Clinical Factors
An observational study of Kinesiophobia (Fear of Movement) and Rhematoid Arthritis, run by Minia University.
Trial summary
Objectives: Impairment of physical function is a core feature of RA, particularly in patients with high disease activity where pain and inflammation directly limit movement. but, Reduced mobility in RA is not exclusively driven by inflammatory pathology. Read more about this study
- Who is it for?
- Ages 18 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Kinesiophobia (Fear of Movement), Rhematoid Arthritis, Rheumatoid Arthritis (RA)
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2026to 1 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Two hundred adult patients previously diagnosed with RA according to ACR/EULAR 2010 criteria for RA and 200 apparently healthy volunteers with age and sex matching will be involved in the study. All patients included in this study will be verbally briefed about the details and the nature of the study \& will sign a written informed consent according to the local Ethics Committee of Minia University Faculty of Medicine. The study will be conducted in Rheumatology department, Minia university Hospital, Egypt.
Who may be able to join
- Age: adult population with RA (18-69)
- Disease duration ≥ 6 months
Who cannot join
- Juvenile cases
- Other rheumatic diseases (SLE, AS, 1ry OA, etc.)
- Trauma
- Comorbidities that affect mobility, e.g., UMNL (including stroke), parkinsonism, multiple sclerosis, cerebral palsy, dementia, peripheral neuropathy, chronic pain conditions, etc.
- Previous history of psychiatric illness before onset of RA (anxiety, depression, etc.)
- Pregnancy and lactation
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Marwa Abdelhakim Shaban Maghlouf, Resident Doctor contact
Ahmed Elsayed Hafez, Assistant Professor contact
About this study
Objectives: Impairment of physical function is a core feature of RA, particularly in patients with high disease activity where pain and inflammation directly limit movement. but, Reduced mobility in RA is not exclusively driven by inflammatory pathology. There are non-inflammatory factors, including kinesiophobia, fatigue, depression, and anxiety, may significantly contribute to functional limitation and may initiate a self-perpetuating cycle in which movement avoidance leads to physical deconditioning, muscle weakness, and progressive functional decline. The aim of this study is to examine the relationship between kinesiophobia and functional outcomes in patients with rheumatoid arthritis, and to investigate its associations with disease activity, pain, fatigue, depressive symptoms, anxiety, and sarcopenia, with a focus on factors relevant to functional assessment and rehabilitation.
Patients and Methods
Read more
A case - control study will be conducted on Two hundred adult patients previously diagnosed with RA according to ACR/EULAR 2010 criteria for RA and 200 apparently healthy volunteers with age and sex matching will be involved in the study. The study will be conducted in Rheumatology department, Minia university Hospital, Egypt. All patients will be subjected to history taking, clinical examination, and assessment of the following parameters:
- Kinesiophobia: using the Arabic version of TSK-17
- Disease activity: using DAS 28
- pain severity using the Visual Analogue Scale (VAS)
- Fatigue: using the Arabic version of the Fatigue Severity Scale (FSS)
- Depression: using the Arabic version of the BDI-2
- Anxiety: using the Arabic version of the BAI
- sarcopenia using the Arabic version of the SARC-F questionnaire
- Functional disability: using the Arabic version of the HAQ-DI
- Physical activity:using IPAQ-SF
Read the detailed description
Rheumatoid arthritis (RA) is a chronic systemic inflammatory autoimmune disease affecting approximately 0.5-1% of the global population. It is characterized by persistent synovial inflammation leading to progressive cartilage and bone destruction, resulting in functional impairment and substantial physical, social, and psychological burden.
Impairment of physical function and mobility is a core feature of RA, particularly in patients with high disease activity or advanced joint damage, where pain and inflammation directly limit movement and daily activities.
However, reduced mobility in RA is not exclusively driven by inflammatory pathology. Increasing evidence suggests that non-inflammatory factors, including kinesiophobia, fatigue, depression, and anxiety, may significantly contribute to functional limitation.
Kinesiophobia, defined as an excessive and irrational fear of movement related to pain or perceived risk of injury, constitutes a major challenge for patients with RA. This condition may initiate a self-perpetuating cycle in which movement avoidance leads to physical deconditioning, muscle weakness, and progressive functional decline. Such fear often arises from maladaptive interpretations of pain as a harmful sensory experience, resulting in avoidance behaviors and dysfunctional pain-related cognitions.
In RA, altered pain-related cognitive processing and heightened fear responses appear particularly relevant, contributing to increased kinesiophobia as disease severity progresses. Importantly, elevated disease activity does not necessarily indicate the presence of kinesiophobia, as some patients may experience pain-related functional impairment in the absence of fear of movement. Conversely, kinesiophobia may develop in patients with low disease activity or minimal joint destruction, in whom fear itself-rather than active inflammation-becomes the principal driver of movement avoidance and disability.
Several studies have demonstrated associations between kinesiophobia and disease activity, pain, fatigue, depressive symptoms, and anxiety in RA. These interrelated factors may reinforce fear-based avoidance behaviors that are not fully explained by objective inflammatory burden. Depression and fatigue are common non-inflammatory manifestations of RA and are closely linked to disease burden and functional impairment, further contributing to reduced physical activity. Anxiety is also highly prevalent in RA and has been identified as an important contributor to fear of movement, even among patients with relatively low disease activity.
In addition, sarcopenia has emerged as a clinically relevant comorbidity in RA. Recognized as a distinct clinical entity in the ICD-10 since 2016 in accordance with the European Working Group on Sarcopenia in Older People )EWGSOP2( recommendations, sarcopenia is characterized by reduced muscle mass and strength with impaired physical performance. It may be primary (age-related), typically manifesting in individuals aged 70 years and older, or secondary to chronic inflammatory conditions such as RA. Its reported prevalence ranges from 3% to 24% depending on diagnostic criteria and increases with age, although it is increasingly recognized in younger patients with autoimmune diseases. In RA, sarcopenia affects approximately 20-30% of patients and is associated with greater disease severity and poorer functional outcomes.
Collectively, these findings underscore kinesiophobia as a multidimensional, non-inflammatory factor interacting with inflammatory, psychological, and musculoskeletal components of RA. This highlights the importance of systematically assessing kinesiophobia to better understand functional outcomes and to inform comprehensive, rehabilitation-oriented management strategies.
Methods:
All patients will be subjected to:
- Full history taking and clinical examination.
- Disease activity: the disease activity will be evaluated by disease activity score 28 (DAS 28).
- Kinesiophobia: The TSK-17 will be used as it represents the original validated version and has been culturally adapted and validated in Arabic populations. This questionnaire consists of 17 items. Each item is rated on a four-point Likert scale ranging from 1 (strongly disagree) to 4 (strongly agree). The total score is calculated after inversion of the scores of items 4, 8, 12 and 16 yielding a total score between 17 and 68, where higher scores reflect greater fear of movement-related pain. A score of 37 differentiates between high and low scores. The scale is simple to administer, does not require specialized training, and involves no additional cost.
- Pain: pain severity will be measured using Visual Analogue Scale (VAS).
- Fatigue: The Arabic version of Fatigue Severity Scale (FSS) will be used. FSS includes 9 items that evaluate fatigue severity in the past week. Each item is scored between 1 (strongly disagree) and 7 (strongly agree). The average score of the 9-items represents the FSS total score. Higher scores indicate more severity.
- Depression: The Arabic version of 21-item Beck Depression Inventory (BDI) will be used to assess depressive symptoms. Each item is scored ranging from 0 to 3, then the total BDI score is calculated by summing the scores of all items. The total score will range from 0 to 63, with higher scores reflecting greater severity of depression.
- Anxiety: The Arabic version of the Beck Anxiety Inventory (BAI) will be utilized to assess anxiety symptoms. It is self-report questionnaire consisting of 21 items with good validity and reliability. Each item is scored from 0 to 3 with calculating the total score by finding the sum of the 21 items. Score of (0-21) = low anxiety, Score of (22-35) = moderate anxiety and Score of (36 and above) = potentially concerning levels of anxiety.
- Sarcopenia: Assessment of sarcopenia will be done using the Arabic version of the SARC-F questionnaire. The SARC-F includes questions on five items: strength, assistance in walking, rising from a chair, climbing stairs, and falls. Each item is scored from 0 to 2 points, with a total score of 10 points. Total scores ≥4 indicates sarcopenia.
- Functional disability: The Arabic version of Health Assessment Questionnaire Disability Index (HAQ-DI) will be used. The HAQ-DI includes 8 domains (dressing and grooming, arising, eating, walking, hygiene, reach, grip, and activities) and 20-items were used measuring functional disability over the past week. Each item is scored between 0 (without difficulty) and 3 (unable to do). The highest sub-category score represents each domain score. The total HAQ-DI score is the average score of eight domains that ranges between 0 and 3. higher scores means more disability.
- Physical activity:
The Arabic version of The International Physical Activity Questionnaire - Short Form (IPAQ-SF) will be used to assess physical activity. IPAQ-SF is a widely used, 9-item self-report tool that measures activity levels in adults (15-69 years) across walking, moderate-intensity and vigorous-intensity activities, estimating MET-minutes per week for overall activity and sitting time.
- Conditions
- Kinesiophobia (Fear of Movement), Rhematoid Arthritis, Rheumatoid Arthritis (RA), Rheumatoid
- Keywords
- Kinesiophobia, Fear of Movement, Rheumatoid Arthritis, Functional Disability, Disease Activity, Pain, Fatigue, Anxiety, Depression, sarcopenia
- Medical subject headings
- Kinesiophobia, Arthritis, Rheumatoid, Pain, Fatigue, Anxiety Disorders, Depression, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Grpoup 1 | Two hundred adult patients previously diagnosed with RA according to ACR/EULAR 2010 criteria for RA | |
| Group 2 | 200 apparently healthy volunteers with age and sex matching |
What is being measured
The primary outcome is the main question the study is designed to answer.
examine the relationship between kinesiophobia and rheumatoid arthritis
examine the correlation between kinesiophobia and functional outcomes in patients with rheumatoid arthritis, and to investigate correlations of Tampa Scale of Kinesiophobia with
1- disease activity using DAS28 2, pain using VAS 3, fatigue using FSS 4, depressive symptoms using BDI II 5, anxiety using BAI 6, sarcopenia using SARC-F 7, functional disability using HAQ-DI 8. and physical activity using IPAQ-SF AA, with a focus on factors
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start1 Mar 2026 (estimated)
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (34)Papers the sponsor has linked to this study.
- Other trials for Kinesiophobia (Fear of Movement)Studies of the same condition, open and under way.
- More trials run by Minia UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Abdelhakim Shaban Maghlouf, Minia University
- Investigators
- Ahmed Elsayed Hafez, Assistant Professor, Principal investigator, Rheumatology, Rehabilitation and Physical Medicine Department, Faculty of Medicine, Minia UniversityRasha Samir Refaat, Assistant Professor, Study chair, Psychiatry Department, Faculty of Medicine, Minia UniversityWalaa Fawzy Mohamed, Lecturer, Study chair, Rheumatology, Rehabilitation and Physical Medicine department, Faculty of Medicine, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07435272
- Sponsor's protocol ID
- Kinesiophobia in RA
- Status last verified
- Feb 2026
- First submitted
- 20 Feb 2026
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.
PubMed 1290069433. Al-Hazzaa HM. Reliability and validity of the Arabic version of the International Physical Activity Questionnaire (IPAQ). Annals of Saudi Medicine. 2007;27(6):429-435
Malmstrom TK, Morley JE. SARC-F: a simple questionnaire to rapidly diagnose sarcopenia. J Am Med Dir Assoc. 2013 Aug;14(8):531-2. doi: 10.1016/j.jamda.2013.05.018. Epub 2013 Jun 25. No abstract available.
PubMed 23810110Alqahtani BA, Alenazi AM, Alshehri MM, Alhowimel AS, Alharbi BA, Alhwoaimel NA. Cross-cultural adaptation and validation of the Arabic version of the SARC-F for evaluating sarcopenia in Saudi older adults. BMC Geriatr. 2025 Oct 14;25(1):773. doi: 10.1186/s12877-025-06349-y.
PubMed 41087906Beck AT, Epstein N, Brown G, Steer RA. An inventory for measuring clinical anxiety: psychometric properties. J Consult Clin Psychol. 1988 Dec;56(6):893-7. doi: 10.1037//0022-006x.56.6.893. No abstract available.
PubMed 320419929. Al-Rumaih M, Abdel-Khalek A. Differentiation between anxiety and depression using cognitive and affective models. J Psychol Stud. 2002;12:541-578.
28. Al-Shatti TS. Psychometric properties of the Arabic version of the Beck Anxiety Inventory in Kuwait. J Educ Psychol Sci. 2015;16:431-463.
27. Beck AT, Steer RA, Brown GK. Manual for the Beck Depression Inventory-II. San Antonio: Psychological Corporation; 1996.
Farhood LF, Dimassi H. Validation of an Arabic version of the GHQ-28 against the Beck depression inventory for screening for depression in war-exposed civilians. Psychol Rep. 2015 Apr;116(2):470-84. doi: 10.2466/08.PR0.116k23w9. Epub 2015 Mar 31.
PubMed 25826434Krupp LB, LaRocca NG, Muir-Nash J, Steinberg AD. The fatigue severity scale. Application to patients with multiple sclerosis and systemic lupus erythematosus. Arch Neurol. 1989 Oct;46(10):1121-3. doi: 10.1001/archneur.1989.00520460115022.
PubMed 2803071Al-Sobayel HI, Al-Hugail HA, AlSaif RM, Albawardi NM, Alnahdi AH, Daif AM, Al-Arfaj HF. Validation of an Arabic version of Fatigue Severity Scale. Saudi Med J. 2016 Jan;37(1):73-8. doi: 10.15537/smj.2016.1.13055.
PubMed 26739978Bruce B, Fries JF. The Stanford Health Assessment Questionnaire: a review of its history, issues, progress, and documentation. J Rheumatol. 2003 Jan;30(1):167-78.
PubMed 1250840822. El Meidany YM, El Gaafary MM, Ahmed I. Adaptation and validation of an Arabic version of the Health Assessment Questionnaire for patients with rheumatoid arthritis. Rev Rhum Engl Ed. 2003;70(5):401-407.
Price DD, McGrath PA, Rafii A, Buckingham B. The validation of visual analogue scales as ratio scale measures for chronic and experimental pain. Pain. 1983 Sep;17(1):45-56. doi: 10.1016/0304-3959(83)90126-4.
PubMed 622691720. Miller R, Kori S, Todd D. The Tampa Scale: a measure of kinesiophobia. Clin J Pain. 1991;7(1):51-52.
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kinesiophobia in Rheumatoid Arthritis: Associations With Functional Disability, Disease Activity, and Related Clinical Factors
- ClinicalTrials.gov ID
- NCT07435272
- Acronym / sponsor ID
- Kinesiophobia in RA
- Conditions
- Kinesiophobia (Fear of Movement), Rhematoid Arthritis, Rheumatoid Arthritis (RA), Rheumatoid
- Keywords
- Kinesiophobia, Fear of Movement, Rheumatoid Arthritis, Functional Disability, Disease Activity, Pain, Fatigue, Anxiety
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 27 Feb 2026 (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.
Objectives: Impairment of physical function is a core feature of RA, particularly in patients with high disease activity where pain and inflammation directly limit movement. but, Reduced mobility in RA is not exclusively driven by inflammatory pathology. There are non-inflammatory factors, including kinesiophobia, fatigue, depression, and anxiety, may significantly contribute to functional limitation and may initiate a self-perpetuating cycle in which movement avoidance leads to physical deconditioning, muscle weakness, and progressive functional decline. The aim of this study is to examine the relationship between kinesiophobia and functional outcomes in patients with rheumatoid arthritis, and to investigate its associations with disease activity, pain, fatigue, depressive symptoms, anxiety, and sarcopenia, with a focus on factors relevant to functional assessment and rehabilitation.
Patients and Methods
A case - control study will be conducted on Two hundred adult patients previously diagnosed with RA according to ACR/EULAR 2010 criteria for RA and 200 apparently healthy volunteers with age and sex matching will be involved in the study. The study will be conducted in Rheumatology department, Minia university Hospital, Egypt. All patients will be subjected to history taking, clinical examination, and assessment of the following parameters:
- Kinesiophobia: using the Arabic version of TSK-17
- Disease activity: using DAS 28
- pain severity using the Visual Analogue Scale (VAS)
- Fatigue: using the Arabic version of the Fatigue Severity Scale (FSS)
- Depression: using the Arabic version of the BDI-2
- Anxiety: using the Arabic version of the BAI
- sarcopenia using the Arabic version of the SARC-F questionnaire
- Functional disability: using the Arabic version of the HAQ-DI
- Physical activity:using IPAQ-SF
Detailed description
Rheumatoid arthritis (RA) is a chronic systemic inflammatory autoimmune disease affecting approximately 0.5-1% of the global population. It is characterized by persistent synovial inflammation leading to progressive cartilage and bone destruction, resulting in functional impairment and substantial physical, social, and psychological burden.
Impairment of physical function and mobility is a core feature of RA, particularly in patients with high disease activity or advanced joint damage, where pain and inflammation directly limit movement and daily activities.
However, reduced mobility in RA is not exclusively driven by inflammatory pathology. Increasing evidence suggests that non-inflammatory factors, including kinesiophobia, fatigue, depression, and anxiety, may significantly contribute to functional limitation.
Kinesiophobia, defined as an excessive and irrational fear of movement related to pain or perceived risk of injury, constitutes a major challenge for patients with RA. This condition may initiate a self-perpetuating cycle in which movement avoidance leads to physical deconditioning, muscle weakness, and progressive functional decline. Such fear often arises from maladaptive interpretations of pain as a harmful sensory experience, resulting in avoidance behaviors and dysfunctional pain-related cognitions.
In RA, altered pain-related cognitive processing and heightened fear responses appear particularly relevant, contributing to increased kinesiophobia as disease severity progresses. Importantly, elevated disease activity does not necessarily indicate the presence of kinesiophobia, as some patients may experience pain-related functional impairment in the absence of fear of movement. Conversely, kinesiophobia may develop in patients with low disease activity or minimal joint destruction, in whom fear itself-rather than active inflammation-becomes the principal driver of movement avoidance and disability.
Several studies have demonstrated associations between kinesiophobia and disease activity, pain, fatigue, depressive symptoms, and anxiety in RA. These interrelated factors may reinforce fear-based avoidance behaviors that are not fully explained by objective inflammatory burden. Depression and fatigue are common non-inflammatory manifestations of RA and are closely linked to disease burden and functional impairment, further contributing to reduced physical activity. Anxiety is also highly prevalent in RA and has been identified as an important contributor to fear of movement, even among patients with relatively low disease activity.
In addition, sarcopenia has emerged as a clinically relevant comorbidity in RA. Recognized as a distinct clinical entity in the ICD-10 since 2016 in accordance with the European Working Group on Sarcopenia in Older People )EWGSOP2( recommendations, sarcopenia is characterized by reduced muscle mass and strength with impaired physical performance. It may be primary (age-related), typically manifesting in individuals aged 70 years and older, or secondary to chronic inflammatory conditions such as RA. Its reported prevalence ranges from 3% to 24% depending on diagnostic criteria and increases with age, although it is increasingly recognized in younger patients with autoimmune diseases. In RA, sarcopenia affects approximately 20-30% of patients and is associated with greater disease severity and poorer functional outcomes.
Collectively, these findings underscore kinesiophobia as a multidimensional, non-inflammatory factor interacting with inflammatory, psychological, and musculoskeletal components of RA. This highlights the importance of systematically assessing kinesiophobia to better understand functional outcomes and to inform comprehensive, rehabilitation-oriented management strategies.
Methods:
All patients will be subjected to:
- Full history taking and clinical examination.
- Disease activity: the disease activity will be evaluated by disease activity score 28 (DAS 28).
- Kinesiophobia: The TSK-17 will be used as it represents the original validated version and has been culturally adapted and validated in Arabic populations. This questionnaire consists of 17 items. Each item is rated on a four-point Likert scale ranging from 1 (strongly disagree) to 4 (strongly agree). The total score is calculated after inversion of the scores of items 4, 8, 12 and 16 yielding a total score between 17 and 68, where higher scores reflect greater fear of movement-related pain. A score of 37 differentiates between high and low scores. The scale is simple to administer, does not require specialized training, and involves no additional cost.
- Pain: pain severity will be measured using Visual Analogue Scale (VAS).
- Fatigue: The Arabic version of Fatigue Severity Scale (FSS) will be used. FSS includes 9 items that evaluate fatigue severity in the past week. Each item is scored between 1 (strongly disagree) and 7 (strongly agree). The average score of the 9-items represents the FSS total score. Higher scores indicate more severity.
- Depression: The Arabic version of 21-item Beck Depression Inventory (BDI) will be used to assess depressive symptoms. Each item is scored ranging from 0 to 3, then the total BDI score is calculated by summing the scores of all items. The total score will range from 0 to 63, with higher scores reflecting greater severity of depression.
- Anxiety: The Arabic version of the Beck Anxiety Inventory (BAI) will be utilized to assess anxiety symptoms. It is self-report questionnaire consisting of 21 items with good validity and reliability. Each item is scored from 0 to 3 with calculating the total score by finding the sum of the 21 items. Score of (0-21) = low anxiety, Score of (22-35) = moderate anxiety and Score of (36 and above) = potentially concerning levels of anxiety.
- Sarcopenia: Assessment of sarcopenia will be done using the Arabic version of the SARC-F questionnaire. The SARC-F includes questions on five items: strength, assistance in walking, rising from a chair, climbing stairs, and falls. Each item is scored from 0 to 2 points, with a total score of 10 points. Total scores ≥4 indicates sarcopenia.
- Functional disability: The Arabic version of Health Assessment Questionnaire Disability Index (HAQ-DI) will be used. The HAQ-DI includes 8 domains (dressing and grooming, arising, eating, walking, hygiene, reach, grip, and activities) and 20-items were used measuring functional disability over the past week. Each item is scored between 0 (without difficulty) and 3 (unable to do). The highest sub-category score represents each domain score. The total HAQ-DI score is the average score of eight domains that ranges between 0 and 3. higher scores means more disability.
- Physical activity:
The Arabic version of The International Physical Activity Questionnaire - Short Form (IPAQ-SF) will be used to assess physical activity. IPAQ-SF is a widely used, 9-item self-report tool that measures activity levels in adults (15-69 years) across walking, moderate-intensity and vigorous-intensity activities, estimating MET-minutes per week for overall activity and sitting time.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Grpoup 1 | – | –Two hundred adult patients previously diagnosed with RA according to ACR/EULAR 2010 criteria for RA |
| Group 2 | – | –200 apparently healthy volunteers with age and sex matching |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Two hundred adult patients previously diagnosed with RA according to ACR/EULAR 2010 criteria for RA and 200 apparently healthy volunteers with age and sex matching will be involved in the study. All patients included in this study will be verbally briefed about the details and the nature of the study \& will sign a written informed consent according to the local Ethics Committee of Minia University Faculty of Medicine. The study will be conducted in Rheumatology department, Minia university Hospital, Egypt.
Key inclusion criteria (2 listed)
- Age: adult population with RA (18-69)
- Disease duration ≥ 6 months
Key exclusion criteria (6 listed)
- Juvenile cases
- Other rheumatic diseases (SLE, AS, 1ry OA, etc.)
- Trauma
- Comorbidities that affect mobility, e.g., UMNL (including stroke), parkinsonism, multiple sclerosis, cerebral palsy, dementia, peripheral neuropathy, chronic pain conditions, etc.
- Previous history of psychiatric illness before onset of RA (anxiety, depression, etc.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
examine the relationship between kinesiophobia and rheumatoid arthritis
Time frame: Baseline
examine the correlation between kinesiophobia and functional outcomes in patients with rheumatoid arthritis, and to investigate correlations of Tampa Scale of Kinesiophobia with 1- disease activity using DAS28 2, pain using VAS 3, fatigue using FSS 4, depressive symptoms using BDI II 5, anxiety using BAI 6, sarcopenia using SARC-F 7, functional disability using HAQ-DI 8. and physical activity using IPAQ-SF AA, with a focus on factors
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
- Background: PubMed 12900694Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.
- Background33. Al-Hazzaa HM. Reliability and validity of the Arabic version of the International Physical Activity Questionnaire (IPAQ). Annals of Saudi Medicine. 2007;27(6):429-435
- Background: PubMed 23810110Malmstrom TK, Morley JE. SARC-F: a simple questionnaire to rapidly diagnose sarcopenia. J Am Med Dir Assoc. 2013 Aug;14(8):531-2. doi: 10.1016/j.jamda.2013.05.018. Epub 2013 Jun 25. No abstract available.
- Background: PubMed 41087906Alqahtani BA, Alenazi AM, Alshehri MM, Alhowimel AS, Alharbi BA, Alhwoaimel NA. Cross-cultural adaptation and validation of the Arabic version of the SARC-F for evaluating sarcopenia in Saudi older adults. BMC Geriatr. 2025 Oct 14;25(1):773. doi: 10.1186/s12877-025-06349-y.
- Background: PubMed 3204199Beck AT, Epstein N, Brown G, Steer RA. An inventory for measuring clinical anxiety: psychometric properties. J Consult Clin Psychol. 1988 Dec;56(6):893-7. doi: 10.1037//0022-006x.56.6.893. No abstract available.
- Background29. Al-Rumaih M, Abdel-Khalek A. Differentiation between anxiety and depression using cognitive and affective models. J Psychol Stud. 2002;12:541-578.
- Background28. Al-Shatti TS. Psychometric properties of the Arabic version of the Beck Anxiety Inventory in Kuwait. J Educ Psychol Sci. 2015;16:431-463.
- Background27. Beck AT, Steer RA, Brown GK. Manual for the Beck Depression Inventory-II. San Antonio: Psychological Corporation; 1996.
- Background: PubMed 25826434Farhood LF, Dimassi H. Validation of an Arabic version of the GHQ-28 against the Beck depression inventory for screening for depression in war-exposed civilians. Psychol Rep. 2015 Apr;116(2):470-84. doi: 10.2466/08.PR0.116k23w9. Epub 2015 Mar 31.
- Background: PubMed 2803071Krupp LB, LaRocca NG, Muir-Nash J, Steinberg AD. The fatigue severity scale. Application to patients with multiple sclerosis and systemic lupus erythematosus. Arch Neurol. 1989 Oct;46(10):1121-3. doi: 10.1001/archneur.1989.00520460115022.
- Background: PubMed 26739978Al-Sobayel HI, Al-Hugail HA, AlSaif RM, Albawardi NM, Alnahdi AH, Daif AM, Al-Arfaj HF. Validation of an Arabic version of Fatigue Severity Scale. Saudi Med J. 2016 Jan;37(1):73-8. doi: 10.15537/smj.2016.1.13055.
- Background: PubMed 12508408Bruce B, Fries JF. The Stanford Health Assessment Questionnaire: a review of its history, issues, progress, and documentation. J Rheumatol. 2003 Jan;30(1):167-78.
- Individual participant dataSharing planned: Undecided
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Temporomandibular Disorders (TMDs), Kinesiophobia
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.
Marwa Abdelhakim Shaban Maghlouf, Resident Doctor contact
Ahmed Elsayed Hafez, Assistant Professor contact
Ahmed Elsayed Hafez, Assistant Professor principal investigator
Rheumatology, Rehabilitation and Physical Medicine Department, Faculty of Medicine, Minia University
Rasha Samir Refaat, Assistant Professor study chair
Psychiatry Department, Faculty of Medicine, Minia University
Walaa Fawzy Mohamed, Lecturer study chair
Rheumatology, Rehabilitation and Physical Medicine department, Faculty of Medicine, Minia University
Questions about this trial
What is this clinical trial studying?
An observational study of Kinesiophobia (Fear of Movement) and Rhematoid Arthritis, run by Minia University.
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 2 inclusion and 6 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: opening soon, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marwa Abdelhakim Shaban Maghlouf, Resident Doctor (+201154704022, marwat.shaeban422@med.s-mu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
examine the relationship between kinesiophobia and rheumatoid arthritis (time frame: Baseline). 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 NCT07435272, which also lists 34 linked publications.
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 3 Mar 2026.