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CompletedNCT05996705Updated Aug 22, 2023

Fatigue in Patients With Rheumatoid Arthritis

An observational study in Rheumatoid Arthritis, sponsored by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital. Completed at 1 site in Turkey. Open to participants aged 16 Years to 85 Years. Per ClinicalTrials.gov, last updated 2023-08-22.

Sponsored by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital · Observational

Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
141
Ages
16 Years to 85 Years
Sex
All
01

Study 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.

Read the 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.

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Conditions studied

  • Rheumatoid Arthritis

Keywords

  • fatigue
  • disease activity
  • rheumatoid arthritis
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In context

Arthritis

3,554 studies on the registry are indexed under Arthritis; 318 are open to participants now.

This study's enrollment of 141 is close to the median of 155 across 1,057 observational studies indexed under Arthritis.

Browse Arthritis studies →

Lead sponsor

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital is the lead sponsor of 80 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
16 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Malignancy
  • Neurological disease
  • Major psychiatric disorder
  • Thyroid disease
  • Anemia and hypovitaminosis
05

Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
141 participants (actual)
Patient registry
No

Interventions

  • OtherDetermining 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.

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: through study completion, an average of one month

  2. 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.

    Time frame: through study completion, an average of one month

  3. 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.

    Time frame: through study completion, an average of one month

  4. 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).

    Time frame: through study completion, an average of one month

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Study locations

1 site
  • Ankara Physical Medicine and Rehabilitation Training and Research Hospital
    Ankara, Turkey
08

References and documents

Publications

  • 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. PubMed 27708942 ↗
  • 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. PubMed 16449363 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 22, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05996705
Lead sponsor
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Responsible party
Yasin Demir (Associate professor, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital) — Principal investigator
First posted
Aug 18, 2023
Start date
Jun 1, 2014
Primary completion
Mar 1, 2016
Completion
Mar 1, 2016
Last update
Aug 22, 2023

Study contacts

Gizem Kılınç Kamacı, MD
principal investigator · Specialist

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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