Fatigue in Patients With Rheumatoid Arthritis

NCT05996705 | Completed

• 1 other identifier: 40
• Study Type: observational
• Target: 141
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis

Keywords

fatigue; disease activity; rheumatoid arthritis

Outcome Measures

Primary Outcomes (4)

• Visual Analogue Scale (VAS)

  Pain levels were evaluated with Visual Analogue Scale (VAS) (0 = no pain and 10 = the worst pain you can imagine) in motion and at rest.

  through study completion, an average of one month

• Disease Activity Score-28 (DAS28)

  Disease activity was assessed with the Disease Activity Score-28 (DAS28). Since the signs and symptoms of rheumatoid arthritis are very diverse, the DAS 28 scale, which evaluates disease activity in a combination of many parameters and has validity, was developed. DAS28 score below 3.2 is considered as low disease activity, between 3.2 and 5.1 as moderate disease activity, and above 5.1 as high disease activity. According to ACR criteria, a score below 2.6 is considered remission.

  through study completion, an average of one month

• Health Assessment Questionnaire (HAQ)

  Physical functioning and health-related quality of life were assessed with the Health Assessment Questionnaire (HAQ). The HAQ is approved by the American College of Rheumatology (ACR) for the assessment of physical function in rheumatoid arthritis. HAQ questions are given a score of 0 if the respondent can do them without any difficulty, 1 if they have some difficulty, 2 if they have a lot of difficulty and 3 if they cannot do them at all. The highest (worst) score in each domain is considered as the score of that domain. The HAQ score is obtained by summing the scores of the domains and dividing the total score by eight. If the HAQ score is 0-1, it is considered as mild-moderate disability, 1-2: moderate-severe disability, 2-3: severe-very severe disability.

  through study completion, an average of one month

• Fatigue Symptom Inventory (FSI).

  Fatigue was assessed with the Fatigue Symptom Inventory (FSI). It is a scale consisting of 14 questions in total. The FSI assesses maximum, minimum, average and current levels of fatigue over the past week on an 11-point scale (0: not tired at all, 10: extremely tired).

  through study completion, an average of one month

Interventions

Determining the relationship of fatigue with some parameters OTHER

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

• Age: 16 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Gaziler Physical Medicine and Rehabilitation Education and Research Hospital: lead

Study Sites (1)

Ankara Physical Medicine and Rehabilitation Training and Research Hospital

Ankara, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 27708942 BACKGROUND

• 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.

  PMID: 16449363 BACKGROUND

MeSH Terms

Conditions

Arthritis, Rheumatoid; Fatigue

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Gizem Kılınç Kamacı, MD

  Specialist

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: August 10, 2023
• First Posted: August 18, 2023
• Study Start: June 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: August 22, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)