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.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- University of Malaga
- Enrollment
- 159
- Locations
- 2
- Primary Endpoint
- Heart Rate Variability (HRV) - Change from Baseline
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age ≥ 18 years
- •Medical diagnosis of fibromyalgia confirmed by physician
- •Capacity to understand and sign informed consent form
- •Fluency in spoken and written Spanish
Exclusion Criteria
- •Current or past severe mental illness or neurodegenerative disease
- •Current treatment for oncological pathology, degenerative disease, or terminal illness
- •Musculoskeletal injury contraindicating biceps curl exercise
- •Connective tissue disease or arthritis
- •Inability to perform biceps curl exercise due to physical limitations
Arms & Interventions
Spontaneous Breathing
Participants breathe naturally at their spontaneous rate for equivalent duration before resistance exercise test.
Intervention: Spontaneous Breathing (Active Control) (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.
Intervention: Slow Breathing with Visual Pacer (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.
Intervention: Slow Breathing without Visual Pacer (Behavioral)
Outcomes
Primary Outcomes
Heart Rate Variability (HRV) - Change from Baseline
Time Frame: 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
Time Frame: 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 Outcomes
- Exercise-Related Self-Efficacy(Immediately post-exercise.)
- Fatigue(Immediately post-exercise)
- Change in Current Pain Intensity(Immediately post-exercise)
- Change in Anxiety(Immediately post-exercise.)
- Perceived effort required to do the biceps exercise(Immediately post-exercise)
- Breathing Difficulty(Immediately after breathing intervention.)
Investigators
Elena R. Serrano-Ibáñez
Principal Investigator
University of Malaga