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Fatigue in Patients With Rheumatoid Arthritis

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ClinicalTrials.gov Identifier: NCT05996705
Recruitment Status : Completed
First Posted : August 18, 2023
Last Update Posted : August 22, 2023
Sponsor:
Information provided by (Responsible Party):
Yasin Demir, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Study Description
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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
Rheumatoid Arthritis 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
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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 : June 1, 2014
Actual Primary Completion Date : March 1, 2016
Actual Study Completion Date : March 1, 2016

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • 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.

Outcome Measures
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Primary Outcome Measures :
  1. Visual Analogue Scale (VAS) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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). [ Time Frame: 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
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Ages Eligible for Study:   16 Years to 85 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   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.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05996705


Locations
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Turkey
Ankara Physical Medicine and Rehabilitation Training and Research Hospital
Ankara, Turkey
Sponsors and Collaborators
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Investigators
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Principal Investigator: Gizem Kılınç Kamacı, MD Specialist
More Information
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Publications:

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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: August 18, 2023    Key Record Dates
Last Update Posted: August 22, 2023
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yasin Demir, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital:
fatigue
disease activity
rheumatoid arthritis
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Fatigue
Joint Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases