Rheumatic Diseases, Rheumatic Disorder
Conditions
Keywords
RHEUMATIC DISEASE, RHEUMATIC ARTRIT, PAIN, PHYSICAL MEDICINE AND REHABILITATION
Brief summary
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.
Detailed description
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.
Interventions
Standard medical treatment
OTHERPatient Education
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
Sponsors
Kutahya Health Sciences University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosed with RA according to ACR/EULAR 2010 criteria * Female patients aged 30-70 years * Low disease activity (DAS-28 \< 3.2) * Voluntary participation
Exclusion criteria
* Cardiovascular diseases (CAD, heart failure, etc.) * Respiratory diseases * Neurological disorders * BMI \> 35 * Malignancy * Pregnancy or breastfeeding * Recent medication change (last 3 months) * Musculoskeletal conditions preventing exercise
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rheumatoid Arthritis Quality of Life Questionnaire | 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. |
| Health Assessment Questionnaire (HAQ) | 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. |
| Functional Capacity (Cardiopulmonary Fitness) | 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. |
| 6-Minute Walk Test (6MWT) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Beck Depression Inventory (BDI) | 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. |
| Fatigue Severity Scale (FSS) | Baseline and after 6 weeks | FSS is a 9-item scale assessing fatigue severity using Likert-type responses. Higher scores indicate greater fatigue severity. |
| Visual analogue Scale for pain | 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. |
| Disease Activity Score-28 (DAS-28) | 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. |
| Inflammatory Markers | Baseline and at the end of 6 weeks (42th day) | C-reactive protein (CRP) Erythrocyte sedimentation rate (ESR) Neutrophil-to-lymphocyte ratio (NLR) |
| The Rheumatoid Arthritis Quality of Life Questionnaire | 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. |
Countries
Turkey (Türkiye)
Contacts
CONTACTVural KAVUNCU, Prof. Dr.
Outcome results
None listed