Rheumatoid ArthritisNCT05996705
Fatigue in Patients With Rheumatoid Arthritis
An observational study of Rheumatoid Arthritis, run by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 16 to 85 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Determining the relationship of fatigue with some parameters
- How many people
- 141 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2014to 1 Mar 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Age between 16-85 years
- Patients diagnosed with RA according to 2002 ACR-EULAR RA criteria.
Who cannot join
- Malignancy
- Neurological disease
- Major psychiatric disorder
- Thyroid disease
- Anemia and hypovitaminosis
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Physical Medicine and Rehabilitation Training and Research Hospital
Ankara
About this study
Official title: Fatigue and Related Factors in Patients With Rheumatoid Arthritis
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.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Determining the relationship of fatigue with some parameters
- Keywords
- fatigue, disease activity, rheumatoid arthritis
- Medical subject headings
- Arthritis, Rheumatoid, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Determining the relationship of fatigue with some parametersOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: through study completion, an average of one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2023
- Study start1 Jun 2014
- Primary completion1 Mar 2016
- Study completion1 Mar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasin Demir, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
- Investigators
- Gizem Kılınç Kamacı, MD, Principal investigator, Specialist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05996705
- Sponsor's protocol ID
- 40
- Status last verified
- Aug 2023
- First submitted
- 10 Aug 2023
- Last updated
- 22 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 27708942Pollard 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
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fatigue and Related Factors in Patients With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT05996705
- Acronym / sponsor ID
- 40
- Conditions
- Rheumatoid Arthritis
- Keywords
- fatigue, disease activity, rheumatoid arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- Gaziler Physical Medicine and Rehabilitation Education and Research HospitalUniversity, hospital or other
- Study start
- 1 Jun 2014 (actual)
- Primary completion
- 1 Mar 2016 (actual)
- Study completion
- 1 Mar 2016 (actual)
- First posted
- 18 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 16 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Age between 16-85 years
- Patients diagnosed with RA according to 2002 ACR-EULAR RA criteria.
Key exclusion criteria (5 listed)
- Malignancy
- Neurological disease
- Major psychiatric disorder
- Thyroid disease
- Anemia and hypovitaminosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Determining the relationship of fatigue with some parametersDetermining 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. | Other | – |
Primary outcome
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.
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.
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.
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2023.
- Background: PubMed 27708942Sandikci 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.
- Background: PubMed 16449363Pollard 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gizem Kılınç Kamacı, MD principal investigator
Specialist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis, run by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (VAS) (time frame: through study completion, an average of one month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05996705, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2023.