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Starting soon Not applicable

Effectiveness of Resonance Frequency Breathing Exercises in Patients With Systemic Lupus Erythematosus and Central Sensitization

NCT07868289 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2026-11-01
Last updated
2026-10-09

Condition(s) studied

Systemic Lupus Erythematosus (SLE)Central SensitizationChronic Pain

Investigational drug(s) / intervention(s)

Resonance Frequency BreathingStandard Exercise Program

Resonance 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

Standard 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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
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

Primary outcome measure(s)

  • 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.

Trial sites (1)

FacilityCityRegionStatus
Istanbul University-Cerrahpasa, Cerrahpasa Faculty of Medicine, Department of Internal Medicine, Division of Rheumatology Istanbul Istanbul
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07868289 on ClinicalTrials.gov ↗ ← All trials in Turkey