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| Name | Class |
|---|---|
| Asociación de Pacientes de Fibromialgia y Síndrome de Fatiga Crónica de Málaga (APAFIMA) | UNKNOWN |
| Asociación de Fibromialgia y Síndrome de Fatiga Crónica de Málaga (AFIBROMA) | UNKNOWN |
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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:
Phase 2 - Resistance Exercise Preparation:
Phase 3 - Breathing Intervention (8 minutes): Participants randomly assigned to:
Phase 4 - Resistance Exercise Test:
Phase 5 - Post-Exercise Assessment:
Safety Monitoring: Continuous observation by trained evaluators; clear stopping criteria.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Slow Breathing with Visual Pacer | Experimental | Participants perform 8 minutes of paced slow breathing (6 breaths/min) with continuous visual guidance before resistance exercise test. |
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| Slow Breathing without Visual Pacer | Experimental | 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 | Participants breathe naturally at their spontaneous rate for equivalent duration before resistance exercise test. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Heart Rate Variability (HRV) - Change from Baseline | Root mean square of successive differences (RMSSD) in milliseconds | Measured: 5 min baseline, 8 min during breathing intervention, and 5 min post-exercise recovery. |
| Number of Biceps Curl Repetitions | Number of properly executed biceps curl repetitions at 50% estimated 1-RM performed to voluntary exhaustion with proper form maintained. | Immediately during the resistance exercise test (single session). |
| Measure | Description | Time Frame |
|---|---|---|
| Exercise-Related Self-Efficacy | Single-item 0-10 numeric rating scale. | Immediately post-exercise. |
| Fatigue | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marcin Czub, PhD | University of Wrocław | Principal Investigator |
| Rosa Esteve, PhD | University of Malaga | Principal Investigator |
| Elena R. Serrano-Ibáñez, PhD | University of Malaga | Principal Investigator |
| Joanna Piskorz, PhD | University of Wrocław | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asociación de Fibromialgia y Síndrome de Fatiga Crónica de Málaga (AFIBROMA) | Málaga | Málaga | 29010 | Spain | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18191990 | Background | Yunus MB. Central sensitivity syndromes: a new paradigm and group nosology for fibromyalgia and overlapping conditions, and the related issue of disease versus illness. Semin Arthritis Rheum. 2008 Jun;37(6):339-52. doi: 10.1016/j.semarthrit.2007.09.003. Epub 2008 Jan 14. | |
| 35727200 | Background | Rogers AH, Farris SG. A meta-analysis of the associations of elements of the fear-avoidance model of chronic pain with negative affect, depression, anxiety, pain-related disability and pain intensity. Eur J Pain. 2022 Sep;26(8):1611-1635. doi: 10.1002/ejp.1994. Epub 2022 Jul 7. |
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We will share the joint database through a web link for public access.
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| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| D007040 | Hypoventilation |
| D000092442 | Kinesiophobia |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
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Three-arm parallel group design with 1:1:1 randomization to slow breathing with pacer, slow breathing without pacer, or spontaneous breathing control
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|
| 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. |
|
| Immediately post-exercise |
| Change in Current Pain Intensity | Numeric Rating Scale (NRS) 0-10 | Immediately post-exercise |
| Change in Anxiety | Numeric Rating Scale (NRS) 0-10 | Immediately post-exercise. |
| Perceived effort required to do the biceps exercise | Numeric Rating Scale (NRS) 0-10. | Immediately post-exercise |
| Breathing Difficulty | Numeric Rating Scale (NRS) 0-10 | Immediately after breathing intervention. |
| Asociación de Pacientes de Fibromialgia y Síndrome de Fatiga Crónica de Málaga (APAFIMA) |
| Málaga |
| Málaga |
| 29010 |
| Spain |
| 36046406 | Background | Bamert M, Inauen J. Physiological stress reactivity and recovery: Some laboratory results transfer to daily life. Front Psychol. 2022 Aug 15;13:943065. doi: 10.3389/fpsyg.2022.943065. eCollection 2022. |
| 34652480 | Background | da Silva JM, de Barros BS, Almeida GJ, O'Neil J, Imoto AM. Dosage of resistance exercises in fibromyalgia: evidence synthesis for a systematic literature review up-date and meta-analysis. Rheumatol Int. 2022 Mar;42(3):413-429. doi: 10.1007/s00296-021-05025-9. Epub 2021 Oct 15. |
| 37285017 | Background | Goheen J, Anderson JAE, Zhang J, Northoff G. From Lung to Brain: Respiration Modulates Neural and Mental Activity. Neurosci Bull. 2023 Oct;39(10):1577-1590. doi: 10.1007/s12264-023-01070-5. Epub 2023 Jun 7. |
| 30657077 | Background | Andrade A, de Azevedo Klumb Steffens R, Sieczkowska SM, Peyre Tartaruga LA, Torres Vilarino G. A systematic review of the effects of strength training in patients with fibromyalgia: clinical outcomes and design considerations. Adv Rheumatol. 2018 Oct 22;58(1):36. doi: 10.1186/s42358-018-0033-9. |
| D009422 |
| Nervous System Diseases |
| D012131 | Respiratory Insufficiency |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010698 | Phobic Disorders |
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |