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

NCT07868289 | Not Yet Recruiting

• 1 other identifier: ZBxg1s45
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Systemic Lupus Erythematosus (SLE); Central Sensitization; Chronic Pain

Keywords

Resonance Frequency Breathing; Fatigue; Quality of Life; Pain Threshold; Exercise Therapy; Pain Catastrophizing; Respiratory Muscle Strength

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline (Week 0) and post-intervention (Week 8)

Secondary Outcomes (7)

• Change in Pressure Pain Threshold (PPT)

  Baseline (Week 0) and post-intervention (Week 8)

• Change in Multidimensional Assessment of Fatigue (MAF) Global Fatigue Index

  Baseline (Week 0) and post-intervention (Week 8)

• Change in Pain Catastrophizing Scale (PCS) Score

  Baseline (Week 0) and post-intervention (Week 8)

• Change in Six-Minute Walk Test (6MWT) Distance

  Baseline (Week 0) and post-intervention (Week 8)

• Change in Respiratory Muscle Strength (MIP and MEP)

  Baseline (Week 0) and post-intervention (Week 8)

Study Arms (2)

Standard Exercise Group

ACTIVE COMPARATOR

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

Standard Exercise + Resonance Breathing Group

EXPERIMENTAL

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

Interventions

Resonance Frequency Breathing BEHAVIORAL

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 + Resonance Breathing Group

Standard Exercise Program BEHAVIORAL

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.

Standard Exercise + Resonance Breathing Group; Standard Exercise Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Istanbul University-Cerrahpasa, Cerrahpasa Faculty of Medicine, Department of Internal Medicine, Division of Rheumatology

Istanbul, Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Chronic Pain; Fatigue

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Tuğba Çivi Karaaslan, PT, PhD

  Istanbul University - Cerrahpasa

  STUDY DIRECTOR

Central Study Contacts

Merve Coşan, PT, MSc Candidate

CONTACT

+90 535 8746765; merve.cosan@ogr.iuc.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist, MSc Student

Study Record Dates

• First Submitted: October 5, 2026
• First Posted: October 9, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: October 9, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)