Breathing Therapy for Patients in General Practice

NCT ID: NCT06575920

Last Updated: 2025-04-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-11
• Study Completion Date: 2024-02-14

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.

Detailed Description

Medically unexplained physical symptoms (MUPS) are symptoms without an identifiable organic cause that lead to functional impairment. MUPS is highly prevalent in general practice consultations. This pilot study aimed to investigate the effectiveness and feasibility of a 5-week breathing retraining program for patients meeting the criteria for MUPS. The study used a quantitative observational design with pre- and post-intervention measurements. Fifteen participants with MUPS and dysfunctional breathing (assessed by the Nijmegen Questionnaire) were recruited from two general practitioner offices. The intervention consisted of 5 weekly sessions including education on breathing physiology and weekly breathing exercises focused on nasal breathing and resonance breathing techniques. One week post intervention, improvements were observed in dysfunctional breathing scores, lower symptom severity, higher general well-being, and reduced musculoskeletal pain complaints. At 3 months post-intervention, sustained improvements were seen in dysfunctional breathing, general well-being, musculoskeletal pain, and additionally lower pseudoneurological, gastrointestinal, and allergy complaints, as well as lower overall symptom burden and improved end-tidal CO2 levels.

The study concluded that the 5-week breathing program showed promising results for improving multiple patient-reported outcomes in MUPS. Recruitment, adherence, and acceptability of the program were satisfactory. A randomized controlled trial is recommended to further evaluate the efficacy of this breathing intervention for MUPS patients.

Conditions

Mind-Body Therapies

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Intervention

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.

Group Type: EXPERIMENTAL

Breathing excercizes

Intervention Type: 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.

Interventions

Breathing excercizes

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 Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UiT The Arctic University of Norway

OTHER

Sponsor Role: collaborator

The University of New South Wales

OTHER

Sponsor Role: collaborator

University of Agder

OTHER

Sponsor Role: lead

Responsible Party

Tor Ivar Karlsen

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Silje Haugland, PhD

Role: STUDY_DIRECTOR

University of Agder

Locations

University of Agder

Arendal, Agder, Norway

Countries

Norway

References

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.

Reference Type: DERIVED

PMID: 40644391 (View on PubMed)

Other Identifiers

UAgder

Identifier Type: -

Identifier Source: org_study_id