Impact of Slow Breathing and Its Interaction With Psychological Variables From the Fear-Avoidance Model of Pain on Heart Rate Variability and Resistance Exercise Performance in Women With Fibromyalgia.
| Registry | NCT07404384, acronym Breath-fibro |
|---|---|
| Status | Enrolling by invitation |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, basic science |
| Enrollment | 159 (Estimated) |
| Sponsor | University of Malaga (Other); collaborators: Asociación de Pacientes de Fibromialgia y Síndrome de Fatiga Crónica de Málaga (APAFIMA), Asociación de Fibromialgia y Síndrome de Fatiga Crónica de Málaga (AFIBROMA) |
| Conditions | Fibromyalgia, Fibromyalgia Syndrome |
| Interventions | Slow Breathing with Visual Pacer, Slow Breathing without Visual Pacer, Spontaneous Breathing (Active Control) (Behavioral) |
| Dates | start 2026-02-01 (estimated), primary completion 2026-04-01 (estimated), completion 2027-05-01 (estimated), first posted 2026-02-11, last updated 2026-02-11 |
| Locations | 2 sites in Spain |
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All trials for Fibromyalgia All trials for Fibromyalgia Syndrome All trials of Slow Breathing with Visual Pacer All trials of Slow Breathing without Visual Pacer
This randomized controlled trial investigates whether slow breathing techniques influence heart rate variability, exercise self-efficacy, and resistance exercise performance in women with fibromyalgia. Participants will be randomly assigned to one of three breathing conditions (slow breathing with visual pacer, slow breathing without pacer, or spontaneous breathing) before performing a biceps curl resistance exercise. The study will examine how breathing patterns interact with psychological variables (anxiety sensitivity, pain catastrophizing, pain hypervigilance, and kinesiophobia) to affect physiological and performance outcomes.
Background: Fibromyalgia is considered one of the most representative central sensitivity syndromes, where central sensitization is the predominant characteristic. Resistance and strength training have demonstrated efficacy as therapeutic strategies for fibromyalgia patients. Slow breathing has been shown to reduce anxiety, perceived stress, and pain intensity while increasing heart rate variability (HRV), a biomarker of stress reactivity. The Fear-Avoidance Model of Pain demonstrates that anxiety sensitivity, pain catastrophizing, hypervigilance, and fear of pain/movement largely determine activity levels in chronic pain patients. However, no studies have examined how slow breathing interacts with these psychological variables to enhance resistance exercise performance in fibromyalgia patients.
Study Design: Single-session, three-arm randomized controlled trial with parallel group assignment.
Experimental Procedure:
Phase 1 - Baseline Assessment:
* Semi-structured interview for demographic and clinical information
* Administration of self-report questionnaires (detailed below)
* 5-minute baseline HRV measurement (seated, eyes open, spontaneous breathing)
* Respiration rate inferred from HRV
Phase 2 - Resistance Exercise Preparation:
* Determination of optimal weight for biceps curl exercise using submaximal protocol
* Warm-up: 3 minutes walking + 10 unloaded practice repetitions
* Progressive weight testing to determine 50% 1-RM equivalent
Phase 3 - Breathing Intervention (8 minutes): Participants randomly assigned to:
* Condition A: Slow breathing with visual pacer (6 breaths/min: 4-sec inhale, 6-sec exhale) displayed continuously
* Condition B: Slow breathing without pacer (same pattern, brief training then self-paced)
* Condition C: Spontaneous breathing at participant's natural rate
* HRV continuously recorded during all breathing conditions. Respiration rate inferred from HRV.
Phase 4 - Resistance Exercise Test:
* Biceps curl exercise at 50% estimated 1-RM
* Maximum repetitions to voluntary exhaustion
* Proper form maintained (back against wall, arms close to body, full range of motion)
Phase 5 - Post-Exercise Assessment:
* Immediate measurement of dependent variables (detailed below)
* 8 min. of rest
* HRV recording 5 min.
Safety Monitoring: Continuous observation by trained evaluators; clear stopping criteria.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Slow Breathing with Visual Pacer | Experimental | Behavioral: Slow Breathing with Visual Pacer | Participants perform 8 minutes of paced slow breathing (6 breaths/min) with continuous visual guidance before resistance exercise test. |
| Slow Breathing without Visual Pacer | Experimental | Behavioral: Slow Breathing without Visual Pacer | Participants perform 8 minutes of self-paced slow breathing (6 breaths/min target) after brief training, without continuous visual guidance, before resistance exercise test. |
| Spontaneous Breathing | Experimental | Behavioral: Spontaneous Breathing (Active Control) | Participants breathe naturally at their spontaneous rate for equivalent duration before resistance exercise test. |
Sex: Female, ages: 18 Years to any
Inclusion Criteria: 1. Female sex 2. Age ≥ 18 years 3. Medical diagnosis of fibromyalgia confirmed by physician 4. Capacity to understand and sign informed consent form 5. Fluency in spoken and written Spanish Exclusion Criteria: 1. Current or past severe mental illness or neurodegenerative disease 2. Current treatment for oncological pathology, degenerative disease, or terminal illness 3. Musculoskeletal injury contraindicating biceps curl exercise 4. Connective tissue disease or arthritis 5. Inability to perform biceps curl exercise due to physical limitations
| Facility | City | Country | Status |
|---|---|---|---|
| Asociación de Fibromialgia y Síndrome de Fatiga Crónica de Málaga (AFIBROMA) | Málaga, Málaga | Spain | |
| Asociación de Pacientes de Fibromialgia y Síndrome de Fatiga Crónica de Málaga (APAFIMA) | Málaga, Málaga | Spain |