Breathing Therapy for Patients in General Practice

NCT06575920 | Completed

• 1 other identifier: UAgder
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Medically unexplained physical symptoms (MUPS) capture conditions characterized by symptoms without corresponding objective findings, such as asthenia, low back pain, fibromyalgia, irritable bowel syndrome, or chronic fatigue syndrome. In order to establish the grounds for a RCT. this pilot study aims to investigate the effectiveness and feasibility of a 5-week breathing retraining programme on patients who meet the criteria for MUPS.

Conditions

Mind-Body Therapies

Outcome Measures

Primary Outcomes (5)

• Nijmegen Questionnaire

  To detect dysfunctional breathing (DB). The NQ consists of 16 questions ranked on a five-point Likert scale where "never" counts as 0 and "very often" counts as 4, giving a total DB score between 0-64. Healthy, asymptomatic individuals generally have a DB score between 7-12. A score above 19 is suggestive of DB.

  Base line, end of intervention, and 3 months post-interventions

• Subjective Health Complaints Inventory

  Measures 29 subjective health problems. The form lists 29 common somatic and psychological ailments, where the degree of complaints and duration must be stated for the last 30 days, graded on a four-point scale. The 29 individual health issues were grouped into five sub-issues \[musculoskeletal pain (8 items), pseudoneurology (7 items), gastrointestinal disorders (7 items), allergic disorders (5 items), colds (2 items)\], and a total score comprising all items. All scales were scored 0-100 (where 0 indicates no symptom pressure and 100 the highest possible symptom pressure).

  Base line, end of intervention, and 3 months post-interventions

• Measure Yourself Medical Outcome Profile

  Participants are asked to rate four items (symptom 1, symptom 2, well-being, and impact of symptoms on their daily activity status) on a scale of 0-6 where 0 is "As good as it could be" and 6 is "As bad as it could be". Participants report one or two symptoms (physical or mental) which bother them the most, consider how bad each symptom was during the last week, and score them accordingly. They also report how much these symptoms affected a particular activity, their well-being during the last week, use of medication, and any possible adverse effects or worsening of symptoms. The symptom pressure and general well-being (scales 0-6) are presented.

  Base line, end of intervention, and 3 months post-interventions

• Carbon dioxide levels

  End-tidal CO2 (EtCO2) (Microstream™) is an objective measure of hyperventilation and is easily detected through a nasal cannula with a capnograph together with respiratory rate (RR). The normal values of EtCO2 are 4.7 kPa - 6 kPa (45). Values below 4.6 are regarded as hypocapnia.

  Base line, end of intervention, and 3 months post-interventions

• Heart rate variability

  The registrations of HRV were performed using HeartMath with the participants in a sitting position, relaxed, and breathing regularly. In the 1990s, HeartMath Institute researchers identified a physiological state called heart coherence. Physiologically, the coherence state is marked by the development of a smooth, sine-wave-like pattern in the heart rate variability trace. This characteristic pattern, called heart rhythm coherence, is the primary indicator of the psychophysiological coherence state. The emWave Coherence score is a measure of the degree of coherence in the heart rhythm pattern. A coherent heart rhythm is a stable, regular, repeating rhythm resembling a sine wave at a single frequency between 0.04 - 0.24 Hz (3 - 15 cycles per minute). The more stable and regular the heart rhythm frequency, the higher the coherence score. Scores range from 0 - 16.

  Base line, end of intervention, and 3 months post-interventions

Secondary Outcomes (1)

• Patient adherence and attrition rates

  Base line, end of intervention, and 3 months post-interventions

Study Arms (1)

Intervention

EXPERIMENTAL

Patients who met the inclusion criteria were asked by the GP if they wanted to participate in the study and, if accepted, their contact information was sent to the researchers (N=18). At the first session, the researcher informed participants of the content and duration of the intervention programme and collected signed informed consent from a total of 15 participants.

Behavioral: Breathing excercizes

Interventions

Breathing excercizes BEHAVIORAL

The intervention comprised six sessions. The first week involved obtaining informed consent, taking measurements and providing a brief introduction to breath and coherent breathing exercises. This was followed by four weekly sessions, each consisting of 90 minutes combining lectures and breathing exercises. At the final session, measurements and feasibility data were collected.

Intervention

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years
• dysfunctional breathing,
• sufficient laguage skills to fill out forms

You may not qualify if:

• Participants with asthma
• Participants with,chronic obstructive pulmonary disease
• Participants with respiratory allergy that is not optimally treated medically.

Sponsors & Collaborators

• University of Agder: lead
• UiT The Arctic University of Norway: collaborator
• The University of New South Wales: collaborator

Study Sites (1)

University of Agder

Arendal, Agder, Norway

Location

Related Publications (1)

• Svenningsen H, Stub T, Courtney R, Karlsen TI. Breathing therapy for patients with medically unexplained physical symptoms and dysfunctional breathing: A pilot and feasibility trial. PLoS One. 2025 Jul 11;20(7):e0325951. doi: 10.1371/journal.pone.0325951. eCollection 2025.

  PMID: 40644391 DERIVED

Study Officials

• Silje Haugland, PhD

  University of Agder

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The principal investigator kept all records and collected data, which was blinded from the care provider, whose role was solely to perform lectures and exercises.,
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Pilot and fesability study.

Study Record Dates

• First Submitted: August 26, 2024
• First Posted: August 28, 2024
• Study Start: October 11, 2023
• Primary Completion: November 15, 2023
• Study Completion: February 14, 2024
• Last Updated: April 6, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: The data will be available after acceptance from a scientific journal for a period of five years.
• Access Criteria: Data will be deposited at Sikt - Norwegian Agency for Shared Services in Education and Research

Locations

NO (1)