Slow Breathing and Resistance Exercise in Fibromyalgia

NCT07404384 | Enrolling By Invitation DMC

• 1 other identifier: UW-UMA_177-2025-H
• Study Type: interventional
• Target: 159
• Locations: 1 country
• Sites: 2

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.

Conditions

Fibromyalgia; Fibromyalgia Syndrome

Keywords

Slow Breathing; Diaphragmatic Breathing; Heart Rate Variability; Resistance Exercise; Fear-Avoidance Model; Central Sensitivity Syndrome; Exercise Performance; Pain Catastrophizing; Kinesiophobia

Outcome Measures

Primary Outcomes (2)

• 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).

Secondary Outcomes (6)

• 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

Study Arms (3)

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.

Behavioral: Slow Breathing with Visual Pacer

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.

Behavioral: Slow Breathing without Visual Pacer

Spontaneous Breathing

EXPERIMENTAL

Participants breathe naturally at their spontaneous rate for equivalent duration before resistance exercise test.

Behavioral: Spontaneous Breathing (Active Control)

Interventions

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 with Visual Pacer

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.

Slow Breathing without Visual Pacer

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.

Spontaneous Breathing

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Malaga: lead
• Asociación de Pacientes de Fibromialgia y Síndrome de Fatiga Crónica de Málaga (APAFIMA): collaborator
• Asociación de Fibromialgia y Síndrome de Fatiga Crónica de Málaga (AFIBROMA): collaborator

Study Sites (2)

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

Málaga, Málaga, 29010, Spain

Location

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

Málaga, Málaga, 29010, Spain

Location

Related Publications (6)

• 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.

  PMID: 18191990 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.

  PMID: 35727200 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.

  PMID: 36046406 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.

  PMID: 34652480 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.

  PMID: 37285017 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.

  PMID: 30657077 BACKGROUND

MeSH Terms

Conditions

Fibromyalgia; Hypoventilation; Kinesiophobia

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Respiratory Insufficiency; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Phobic Disorders; Anxiety Disorders; Mental Disorders

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Three-arm parallel group design with 1:1:1 randomization to slow breathing with pacer, slow breathing without pacer, or spontaneous breathing control

Study Record Dates

• First Submitted: February 4, 2026
• First Posted: February 11, 2026
• Study Start: February 1, 2026
• Primary Completion: April 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: February 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

ES (2)