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NCT Number: NCT07404384

Slow Breathing and Resistance Exercise in Fibromyalgia

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Asociación de Fibromialgia y Síndrome de Fatiga Crónica de Málaga (AFIBROMA), Málaga, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female sex
  • 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

Treatment and study plan

Slow Breathing with Visual Pacer

Behavioral

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.

Slow Breathing without Visual Pacer

Behavioral

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.

Spontaneous Breathing (Active Control)

Behavioral

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.

Primary outcomes

  1. 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

  2. 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

  1. Exercise-Related Self-Efficacy

    Time frame: Immediately post-exercise.

    Single-item 0-10 numeric rating scale.

  2. Fatigue

    Time frame: 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).

  3. Change in Current Pain Intensity

    Time frame: Immediately post-exercise

    Numeric Rating Scale (NRS) 0-10

  4. Change in Anxiety

    Time frame: Immediately post-exercise.

    Numeric Rating Scale (NRS) 0-10

  5. Perceived effort required to do the biceps exercise

    Time frame: Immediately post-exercise

    Numeric Rating Scale (NRS) 0-10.

  6. Breathing Difficulty

    Time frame: Immediately after breathing intervention.

    Numeric Rating Scale (NRS) 0-10

Sponsors and collaborators

Lead sponsor

University of Malaga

Other

Collaborators

  • Asociación de Fibromialgia y Síndrome de Fatiga Crónica de Málaga (AFIBROMA)
  • Asociación de Pacientes de Fibromialgia y Síndrome de Fatiga Crónica de Málaga (APAFIMA)

Registry information

Official study title

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.

Acronym: Breath-fibro

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Feb 11, 2026
Registry last updated
Feb 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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