An interventional study of Resonance Frequency Breathing and Standard Exercise Program in Systemic Lupus Erythematosus (SLE), Central Sensitization and Chronic Pain, sponsored by Istanbul University - Cerrahpasa. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by Istanbul University - Cerrahpasa · Not applicable, Interventional, and Treatment
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.
This is a prospective, two-arm, parallel-group, single-blind randomized controlled clinical trial. Eligible patients diagnosed with Systemic Lupus Erythematosus will be randomized into two arms:
Control Group: Receives an 8-week multi-component standard exercise program (aerobic, resistance, range of motion, and stretching exercises).
Intervention Group: Receives the identical 8-week standard exercise program combined with slow resonance frequency breathing training at 6 breaths per minute (0.1 Hz) guided by the offline mobile application "Prana Breath".
Clinical and functional assessments will be conducted at baseline (Week 0) and at the end of the intervention (Week 8).
1,222 studies on the registry are indexed under Lupus Erythematosus, Systemic; 399 are open to participants now.
This study's planned enrollment of 38 is below the median of 50 across 881 interventional studies indexed under Lupus Erythematosus, Systemic.
Browse Lupus Erythematosus, Systemic studies →Istanbul University - Cerrahpasa is the lead sponsor of 693 studies on the registry; 213 are open to participants now.
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Exclusion Criteria:
Participants receive an 8-week multi-component standard exercise program including aerobic exercise, progressive resistance training, range of motion, and stretching exercises. Supervised clinical sessions are conducted twice weekly, complemented by home exercises to achieve 150 minutes of weekly aerobic activity.
Behavioral: Standard Exercise Program
Participants receive the identical 8-week standard exercise program combined with diaphragmatic resonance frequency breathing at 6 breaths per minute (0.1 Hz) with a 4:6 inhalation-to-exhalation ratio using a pursed-lip technique. Breathing practice is performed daily (10-20 min/day), guided by the offline mobile application "Prana Breath" and a printed instructional brochure.
Behavioral: Resonance Frequency Breathing · Behavioral: Standard Exercise Program
Diaphragmatic 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
An 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.
Time frame: Baseline (Week 0) and post-intervention (Week 8)
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.
Time frame: Baseline (Week 0) and post-intervention (Week 8)
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.
Time frame: Baseline (Week 0) and post-intervention (Week 8)
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.
Time frame: Baseline (Week 0) and post-intervention (Week 8)
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
Time frame: Baseline (Week 0) and post-intervention (Week 8)
Change in Respiratory Muscle Strength (MIP and MEP)
Maximal Inspiratory Pressure (MIP) and Maximal Expiratory Pressure (MEP) are assessed using a digital respiratory pressure meter to determine inspiratory and expiratory muscle strength, respectively. The maximum pressure achieved during forceful respiratory maneuvers is recorded in centimeters of water (cmH2O). Higher values indicate greater respiratory muscle strength.
Time frame: Baseline (Week 0) and post-intervention (Week 8)
Change in Lupus Quality of Life (LupusQoL) Questionnaire Score
The LupusQoL is a disease-specific 34-item health-related quality of life instrument covering 8 domains: physical health, emotional health, body image, pain, planning, fatigue, intimate relationships, and burden to others. Items are rated from 0 to 4 and transformed linearly to domain scores ranging from 0 to 100. Higher scores represent better health-related quality of life.
Time frame: Baseline (Week 0) and post-intervention (Week 8)
Change in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) Score
The SLEDAI is a physician-completed clinical and laboratory index consisting of 24 weighted descriptors representing active organ manifestations in systemic lupus erythematosus. The total score ranges from 0 to 105, with higher scores reflecting higher levels of systemic disease activity
Time frame: Baseline (Week 0) and post-intervention (Week 8)
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Jun 2027, 7 months later.
Of 120 non-industry interventional studies with no phase under Lupus Erythematosus, Systemic, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 37. This study's planned 7 months is below that.
Counting every sponsor, half of 127 studies reached it within 22 months; a quarter within 10 and three quarters within 37.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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