Fatigue in Patients With Rheumatoid Arthritis

Sponsor
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05996705
Collaborator
(none)
141
1
21
6.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Determining the relationship of fatigue with some parameters

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.

Study Design

Study Type:
Observational
Actual Enrollment :
141 participants
Observational Model:
Case-Only
Time Perspective:
Cross-Sectional
Official Title:
Fatigue and Related Factors in Patients With Rheumatoid Arthritis
Actual Study Start Date :
Jun 1, 2014
Actual Primary Completion Date :
Mar 1, 2016
Actual Study Completion Date :
Mar 1, 2016

Outcome Measures

Primary Outcome Measures

  1. Visual Analogue Scale (VAS) [through study completion, an average of one month]

    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.

  2. Disease Activity Score-28 (DAS28) [through study completion, an average of one month]

    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.

  3. Health Assessment Questionnaire (HAQ) [through study completion, an average of one month]

    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.

  4. Fatigue Symptom Inventory (FSI). [through study completion, an average of one month]

    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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ankara Physical Medicine and Rehabilitation Training and Research Hospital Ankara Turkey

Sponsors and Collaborators

  • Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Investigators

  • Principal Investigator: Gizem Kılınç Kamacı, MD, Specialist

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Yasin Demir, Associate professor, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
ClinicalTrials.gov Identifier:
NCT05996705
Other Study ID Numbers:
  • 40
First Posted:
Aug 18, 2023
Last Update Posted:
Aug 22, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Yasin Demir, Associate professor, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 22, 2023