Fibromyalgia, Fibromyalgia Syndrome
Conditions
Keywords
Slow Breathing, Diaphragmatic Breathing, Heart Rate Variability, Resistance Exercise, Fear-Avoidance Model, Central Sensitivity Syndrome, Exercise Performance, Pain Catastrophizing, Kinesiophobia
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALSlow Breathing with Visual Pacer
Participants receive brief training using a visual pacer displayed on computer screen showing a line that rises during inhalation and falls during exhalation. The pacing is set to 6 respiratory cycles per minute (4 seconds inhalation, 6 seconds exhalation). Participants place one hand below chest and abdomen to monitor diaphragmatic movement. After training, participants continue slow breathing with the visual pacer continuously displayed, maintaining the prescribed respiratory rate.
BEHAVIORALSlow Breathing without Visual Pacer
Participants receive identical brief training using the visual pacer to learn the slow breathing pattern (6 cycles per minute: 4 seconds inhalation, 6 seconds exhalation). Hand placement below chest and abdomen to monitor diaphragmatic movement. After training, the visual pacer is removed and participants attempt to maintain the slow breathing pattern independently without external guidance.
BEHAVIORALSpontaneous Breathing (Active Control)
Participants spend equivalent time breathing at their natural, spontaneous rate. They receive similar attention from evaluators but no specific breathing instructions. Participants are instructed to breathe normally at their usual pace and rhythm.
Sponsors
University of Malaga
Asociación de Pacientes de Fibromialgia y Síndrome de Fatiga Crónica de Málaga (APAFIMA)
Asociación de Fibromialgia y Síndrome de Fatiga Crónica de Málaga (AFIBROMA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Intervention model description
Three-arm parallel group design with 1:1:1 randomization to slow breathing with pacer, slow breathing without pacer, or spontaneous breathing control
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Heart Rate Variability (HRV) - Change from Baseline | Measured: 5 min baseline, 8 min during breathing intervention, and 5 min post-exercise recovery. | Root mean square of successive differences (RMSSD) in milliseconds |
| Number of Biceps Curl Repetitions | Immediately during the resistance exercise test (single session). | Number of properly executed biceps curl repetitions at 50% estimated 1-RM performed to voluntary exhaustion with proper form maintained. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Exercise-Related Self-Efficacy | Immediately post-exercise. | Single-item 0-10 numeric rating scale. |
| Fatigue | Immediately post-exercise | Borg Rating Of Perceived Exertion. Rating of perceived exertion is an outcome measure scale used to gauge one's exercise intensity without the need to rely on physiological parameters. The scale rates exertion from a scale of 6 (no exertion) to 20 (maximum effort). |
| Change in Current Pain Intensity | Immediately post-exercise | Numeric Rating Scale (NRS) 0-10 |
| Change in Anxiety | Immediately post-exercise. | Numeric Rating Scale (NRS) 0-10 |
| Perceived effort required to do the biceps exercise | Immediately post-exercise | Numeric Rating Scale (NRS) 0-10. |
| Breathing Difficulty | Immediately after breathing intervention. | Numeric Rating Scale (NRS) 0-10 |
Countries
Spain
Contacts
PRINCIPAL_INVESTIGATORMarcin Czub, PhD
University of Wrocław
PRINCIPAL_INVESTIGATORRosa Esteve, PhD
University of Malaga
PRINCIPAL_INVESTIGATORElena R. Serrano-Ibáñez, PhD
University of Malaga
PRINCIPAL_INVESTIGATORJoanna Piskorz, PhD
University of Wrocław
Outcome results
None listed