Fatigue in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

Fatigue and Related Factors in Patients With Rheumatoid Arthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05996705
• Other study ID #: 40
• Status: Completed
• Start date: June 1, 2014
• Est. completion date: March 1, 2016

Study information

• Verified date: August 2023
• Source: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 141
• Est. completion date: March 1, 2016
• Est. primary completion date: March 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Fatigue
• Rheumatoid Arthritis

Intervention

Other:
• Determining the relationship of fatigue with some parameters
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.

Locations

Country	Name	City	State
Turkey	Ankara Physical Medicine and Rehabilitation Training and Research Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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