Systemic Lupus Erythematosus (SLE) is a chronic autoimmune disease characterized by systemic inflammation, fatigue, central sensitization, and chronic pain. While physical exercise is strongly recommended to enhance functional capacity and manage fatigue, heightened central sensitivity and pain often limit adherence and clinical gains.
Resonance frequency breathing (paced diaphragmatic breathing at 6 breaths per minute, 0.1 Hz) stimulates the baroreflex and facilitates autonomic regulation, which may alleviate central pain processing. This randomized controlled trial aims to evaluate the effects of resonance frequency breathing added to a standard exercise program compared with exercise alone on central sensitization, pain thresholds, fatigue, pain catastrophizing, functional capacity, respiratory muscle strength, disease activity, and quality of life in patients with SLE.
Participants will be randomly allocated to either a Standard Exercise Group or a Standard Exercise + Resonance Breathing Group for an 8-week intervention.
Clinically diagnosed with Systemic Lupus Erythematosus (SLE) according to the 2019 ACR/EULAR classification criteria
Aged between 18 and 65 years
Central Sensitization Inventory (CSI) score of 40 or higher (CSI >= 40)
Stable medical therapy with no pharmacological regimen changes within the last 3 months
Presence of severe cardiovascular or pulmonary contraindications that preclude safe participation in exercise or paced breathing training
Major surgical operation within the preceding 6 months
Current pregnancy
Active severe disease flare-up
Parallel
Resonance Frequency Breathing
BehavioralDiaphragmatic paced breathing at 6 breaths per minute (0.1 Hz) with a 4:6 second inhalation-to-exhalation ratio via pursed-lip technique, performed 10-20 minutes daily using the offline mobile application "Prana Breath" under a progressive motor learning framework
Standard Exercise Program
BehavioralAn 8-week structured exercise program comprising aerobic, progressive resistance, joint range of motion, and stretching exercises administered twice weekly under supervision and supported by home activity logs to achieve 150 minutes of weekly aerobic exercise.
Change in Central Sensitization Inventory (CSI) Score
The Central Sensitization Inventory (CSI) assesses somatic and emotional symptoms associated with central sensitization. Part A comprises 25 items scored on a 5-point Likert scale ranging from 0 (never) to 4 (always), yielding a total score from 0 to 100. Higher scores indicate greater central sensitization severity, with a score of 40 or higher indicating the presence of central sensitivity syndromes.
Change in Pressure Pain Threshold (PPT)
Pressure pain threshold is evaluated using a digital pressure algometer over symptomatic local regions and remote reference sites (e.g., upper trapezius and tibialis anterior). The pressure is applied at a continuous rate until the participant first perceives the sensation of pressure becoming painful. Measurements are recorded in kg/cm² and repeated to obtain an average value for analysis. Higher threshold values indicate lower pain sensitivity.
Change in Multidimensional Assessment of Fatigue (MAF) Global Fatigue Index
The Multidimensional Assessment of Fatigue (MAF) questionnaire evaluates four dimensions of fatigue: severity, distress, degree of interference with activities of daily living, and timing/frequency across 16 items. It generates a Global Fatigue Index (GFI) ranging from 1 to 50. Higher GFI scores represent greater degrees of fatigue.
Change in Pain Catastrophizing Scale (PCS) Score
The Pain Catastrophizing Scale (PCS) is a 13-item self-report questionnaire assessing catastrophic thoughts and feelings about pain across three subscales: rumination, magnification, and helplessness. Items are rated on a 5-point Likert scale from 0 (not at all) to 4 (all the time), producing a total score between 0 and 52. Higher scores reflect greater levels of pain catastrophizing.
Change in Six-Minute Walk Test (6MWT) Distance
Submaximal functional exercise capacity is evaluated using the 6-Minute Walk Test (6MWT) along a flat, unobstructed 30-meter indoor corridor according to standard clinical guidelines. The total distance traversed within 6 minutes is recorded in meters. A greater walking distance indicates better functional exercise capacity
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
