NCT Number: NCT07504887
This study aims to evaluate the effects of aerobic exercise therapy on quality of life, functional capacity, mood, and fatigue in patients with rheumatoid arthritis. Additionally, the study investigates the impact of aerobic exercise on inflammatory markers, pain, and disease activity.
Interested in participating?
Request Info30 year–70 year
All sexes
Interventional
Not applicable
Kütahya, 43000, Turkey (Türkiye)
Location status: Recruiting
Busra ARI, MD.
SUB_INVESTIGATOR
Fatima YAMAN, Assoc. Prof.
SUB_INVESTIGATOR
Mehmet Ali ASTARCIOGLU, Prof. Dr.
SUB_INVESTIGATOR
Vural KAVUNCU, Prof. Dr.
CONTACT
Vural KAVUNCU, Prof. Dr.
PRINCIPAL_INVESTIGATOR
Rheumatoid arthritis (RA) is a chronic systemic autoimmune disease characterized by joint inflammation, pain, and functional limitations. Exercise therapy is widely used in rehabilitation to improve functional capacity and quality of life in RA patients.
In this study, patients with low disease activity RA will be divided into two groups:
Standard medical treatment + education Standard medical treatment + education + aerobic exercise
The aerobic exercise program will be conducted 5 days per week for 6 weeks. Outcomes including functional capacity (VO2 max), quality of life, fatigue, mood, and inflammatory markers will be assessed before and after the intervention.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Standard medical treatment
Patient education
Frequency: 5 days/week Duration: 6 weeks (30 sessions) Exercise intensity: 50-70% of Wmax Includes warm-up, aerobic phase, and cool-down
Time frame: Baseline and at the end of 6 weeks (42th day)
RAQoL is a disease-specific instrument consisting of 30 items scored as yes/no. Total scores range from 0 to 30, with higher scores indicating poorer quality of life. The Turkish version has established validity and reliability.
Time frame: Baseline and at the end of 6 weeks (42th day)
HAQ evaluates functional ability in daily living activities using 20 items. Each item is scored from 0 (no difficulty) to 3 (unable to perform). The final score is calculated as the average of item scores, ranging from 0 to 3, with higher scores indicating worse functional status.
Time frame: Baseline and at the end of 6 weeks (42th day)
VO₂ max (mL/kg/min) is measured using cardiopulmonary exercise testing (CPET) on a cycle ergometer. It is considered the gold standard for assessing aerobic capacity.
Time frame: Baseline and at the end of 6th week (42th day)
The 6MWT evaluates submaximal exercise capacity. Participants are instructed to walk as far as possible within 6 minutes on a 30-meter corridor. Total walking distance (meters) is recorded. Higher distances indicate better functional capacity.
Time frame: Baseline and at the end of 6 weeks (42th day)
BDI is a 21-item self-reported questionnaire assessing depressive symptoms. Scores range from 0 to 63, with higher scores indicating more severe depression.
Time frame: Baseline and after 6 weeks
FSS is a 9-item scale assessing fatigue severity using Likert-type responses. Higher scores indicate greater fatigue severity.
Time frame: Baseline and at the end of 6th week (42th day)
Pain intensity is measured on a 10 cm visual analog scale, where 0 indicates no pain and 10 indicates worst possible pain.
Time frame: Baseline and at the end of 6 weeks (42th day)
DAS-28 is a composite index including tender/swollen joint count, ESR or CRP levels, and patient global assessment. Lower scores indicate lower disease activity.
Time frame: Baseline and at the end of 6 weeks (42th day)
C-reactive protein (CRP) Erythrocyte sedimentation rate (ESR) Neutrophil-to-lymphocyte ratio (NLR)
Time frame: Baseline and at the end of 6th weeks (42th day)
RAQoL is a disease-specific questionnaire consisting of 30 yes/no items. Scores range from 0 to 30, with higher scores indicating poorer quality of life.
Contact information is provided by the study sponsor or research team.
Kutahya Health Sciences University
Other
Evaluation of the Effects of Aerobic Exercise Therapy on Quality of Life, Functional Capacity, Mood, Fatigue, and Inflammatory Markers in Patients With Rheumatoid Arthritis
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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