Systemic Lupus Erythematosus (SLE), Central Sensitization, Chronic Pain
Conditions
Keywords
Resonance Frequency Breathing, Fatigue, Quality of Life, Pain Threshold, Exercise Therapy, Pain Catastrophizing, Respiratory Muscle Strength
Brief summary
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.
Detailed description
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).
Interventions
BEHAVIORALResonance Frequency Breathing
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
BEHAVIORALStandard Exercise Program
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.
Sponsors
Istanbul University - Cerrahpasa
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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 * Willing and cognitively able to provide written informed consent and adhere to the intervention protocol
Exclusion criteria
* 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 * Regular and ongoing practice of structured breathing exercises, pranayama, or yoga
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Central Sensitization Inventory (CSI) Score | Baseline (Week 0) and post-intervention (Week 8) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pressure Pain Threshold (PPT) | Baseline (Week 0) and post-intervention (Week 8) | 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 | Baseline (Week 0) and post-intervention (Week 8) | 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 | Baseline (Week 0) and post-intervention (Week 8) | 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 | Baseline (Week 0) and post-intervention (Week 8) | 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 |
| Change in Respiratory Muscle Strength (MIP and MEP) | Baseline (Week 0) and post-intervention (Week 8) | 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. |
| Change in Lupus Quality of Life (LupusQoL) Questionnaire Score | Baseline (Week 0) and post-intervention (Week 8) | 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. |
| Change in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) Score | Baseline (Week 0) and post-intervention (Week 8) | 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 |
Countries
Turkey (Türkiye)
Contacts
CONTACTMerve Coşan, PT, MSc Candidate
STUDY_DIRECTORTuğba Çivi Karaaslan, PT, PhD
Istanbul University - Cerrahpasa
Outcome results
None listed