Systemic Lupus Erythematosus (SLE)NCT07868289
Effectiveness of Resonance Frequency Breathing Exercises in Patients With Systemic Lupus Erythematosus and Central Sensitization
A study testing Resonance Frequency Breathing and Standard Exercise Program in people with Systemic Lupus Erythematosus (SLE) and Central Sensitization, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Systemic Lupus Erythematosus (SLE), Central Sensitization, Chronic Pain
- What is being tested?
- Resonance Frequency Breathing and Standard Exercise Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2026to 1 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Istanbul University-Cerrahpasa, Cerrahpasa Faculty of Medicine, Department of Internal Medicine, Division of Rheumatology
Istanbul, Istanbul
Merve Coşan, PT, MSc Candidate, +90 535 8746765, merve.cosan@ogr.iuc.edu.tr
About this study
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.
Read the 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).
- Being tested
- Resonance Frequency Breathing, Standard Exercise Program
- Keywords
- Resonance Frequency Breathing, Fatigue, Quality of Life, Pain Threshold, Exercise Therapy, Pain Catastrophizing, Respiratory Muscle Strength
- Medical subject headings
- Lupus Erythematosus, Systemic, Chronic Pain, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resonance Frequency BreathingBehavioural
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 ProgramBehavioural
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Resonance Frequency Breathing; Behavioral: Standard Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (Week 0) and post-intervention (Week 8)
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: Baseline (Week 0) and post-intervention (Week 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus Erythematosus (SLE)Studies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve Coşan, Istanbul University - Cerrahpasa
- Investigators
- Tuğba Çivi Karaaslan, PT, PhD, Study director, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07868289
- Sponsor's protocol ID
- ZBxg1s45
- Status last verified
- Oct 2026
- First submitted
- 5 Oct 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Resonance Frequency Breathing Exercises in Patients With Systemic Lupus Erythematosus and Central Sensitization
- ClinicalTrials.gov ID
- NCT07868289
- Acronym / sponsor ID
- ZBxg1s45
- Keywords
- Resonance Frequency Breathing, Fatigue, Quality of Life, Pain Threshold, Exercise Therapy, Pain Catastrophizing, Respiratory Muscle Strength
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 9 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Exercise Group | Active comparator | Behavioral: Standard Exercise ProgramParticipants 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. |
| Standard Exercise + Resonance Breathing Group | Experimental | Behavioral: Resonance Frequency Breathing, Behavioral: Standard Exercise ProgramParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resonance Frequency BreathingDiaphragmatic 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 | Behavioural | Standard Exercise + Resonance Breathing Group |
| Standard Exercise ProgramAn 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. | Behavioural | Standard Exercise + Resonance Breathing Group, Standard Exercise Group |
Primary outcome
Change in Central Sensitization Inventory (CSI) Score
Time frame: 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.
7 secondary outcomes
Change in Pressure Pain Threshold (PPT)
Time frame: Baseline (Week 0) and post-intervention (Week 8)
Change in Multidimensional Assessment of Fatigue (MAF) Global Fatigue Index
Time frame: Baseline (Week 0) and post-intervention (Week 8)
Change in Pain Catastrophizing Scale (PCS) Score
Time frame: Baseline (Week 0) and post-intervention (Week 8)
Change in Six-Minute Walk Test (6MWT) Distance
Time frame: Baseline (Week 0) and post-intervention (Week 8)
Change in Respiratory Muscle Strength (MIP and MEP)
Time frame: Baseline (Week 0) and post-intervention (Week 8)
Change in Lupus Quality of Life (LupusQoL) Questionnaire Score
Time frame: Baseline (Week 0) and post-intervention (Week 8)
Change in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) Score
Time frame: Baseline (Week 0) and post-intervention (Week 8)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tuğba Çivi Karaaslan, PT, PhD study director
Istanbul University - Cerrahpasa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resonance Frequency Breathing and Standard Exercise Program in people with Systemic Lupus Erythematosus (SLE) and Central Sensitization, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Merve Coşan, PT, MSc Candidate (+90 535 8746765, merve.cosan@ogr.iuc.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Central Sensitization Inventory (CSI) Score (time frame: Baseline (Week 0) and post-intervention (Week 8)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.