Clinical trial NCT05996705: Fatigue in Patients With Rheumatoid Arthritis
Official title: Fatigue and Related Factors in Patients With Rheumatoid Arthritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Keywords: fatigue
disease activity
rheumatoid arthritis
Lead sponsor: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Sponsor class: OTHER
First posted: 2023-08-18
Enrollment: 141
Sex: ALL
Minimum age (years): 16
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients (38 males, 103 females) over 16 years of age who were diagnosed with RA according to the 2002 ACR-EULAR RA criteria.

Brief summary: Rheumatoid arthritis (RA) is a disease characterized by autoimmune systemic inflammatory polyarthritis, particularly affecting the joints of the hands. In addition to joint findings, extra-articular symptoms such as muscle pain, fatigue, fever and malaise are also common.

Fatigue is characterized by a feeling of extreme tiredness and persistent exhaustion. The prevalence of fatigue is between 14% and 15% in healthy adults. Although fatigue is common in patients with RA, it may remain in the background in clinical evaluation. The etiology of fatigue in RA is related to inflammation, pain, psychosocial factors and sleep disturbance, it has not been fully explained.

Detailed description: Rheumatoid arthritis (RA) is a disease characterized by autoimmune systemic inflammatory polyarthritis, particularly affecting the joints of the hands. In addition to joint findings, extra-articular symptoms such as muscle pain, fatigue, fever and malaise are also common.

Fatigue is characterized by a feeling of extreme tiredness and persistent exhaustion. The prevalence of fatigue is between 14% and 15% in healthy adults. Although fatigue is common in patients with RA, it may remain in the background in clinical evaluation. The etiology of fatigue in RA is related to inflammation, pain, psychosocial factors and sleep disturbance, it has not been fully explained.

There are various studies in the literature examining fatigue and factors associated with fatigue in patients with RA. This study aimed to contribute to the literature by determining the relationship of fatigue with physical function, pain values at rest and in motion, gender, age, pain, disease activity, gender and disease duration in RA patients.

Eligibility criteria: Inclusion Criteria:

* Age between 16-85 years
* Patients diagnosed with RA according to 2002 ACR-EULAR RA criteria.

Exclusion Criteria:

* Malignancy
* Neurological disease
* Major psychiatric disorder
* Thyroid disease
* Anemia and hypovitaminosis

Primary outcomes:
measure: Visual Analogue Scale (VAS)
timeFrame: through study completion, an average of one month
measure: Disease Activity Score-28 (DAS28)
timeFrame: through study completion, an average of one month
measure: Health Assessment Questionnaire (HAQ)
timeFrame: through study completion, an average of one month
measure: Fatigue Symptom Inventory (FSI).
timeFrame: through study completion, an average of one month
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Physical Medicine and Rehabilitation Training and Research Hospital
Study officials:
affiliation: Specialist
name: Gizem Kılınç Kamacı, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sandikci SC, Ozbalkan Z. Fatigue in rheumatic diseases. Eur J Rheumatol. 2015 Sep;2(3):109-113. doi: 10.5152/eurjrheum.2015.0029. Epub 2015 Sep 1.
citation: Pollard LC, Choy EH, Gonzalez J, Khoshaba B, Scott DL. Fatigue in rheumatoid arthritis reflects pain, not disease activity. Rheumatology (Oxford). 2006 Jul;45(7):885-9. doi: 10.1093/rheumatology/kel021. Epub 2006 Jan 31.