Clinical trial NCT06575920: Breathing Therapy for Patients in General Practice
Official title: Breathing Therapy for Patients With Medically Unexplained Physical Symptoms and Dysfunctional Breathing: A Pilot and Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mind-Body Therapies
Lead sponsor: University of Agder
Sponsor class: OTHER
Collaborators: name: UiT The Arctic University of Norway
name: The University of New South Wales
First posted: 2024-08-28
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pilot and fesability study.
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Nijmegen Questionnaire
timeFrame: Base line, end of intervention, and 3 months post-interventions
measure: Subjective Health Complaints Inventory
timeFrame: Base line, end of intervention, and 3 months post-interventions
measure: Measure Yourself Medical Outcome Profile
timeFrame: Base line, end of intervention, and 3 months post-interventions
measure: Carbon dioxide levels
timeFrame: Base line, end of intervention, and 3 months post-interventions
measure: Heart rate variability
timeFrame: Base line, end of intervention, and 3 months post-interventions
Secondary outcomes:
measure: Patient adherence and attrition rates
timeFrame: Base line, end of intervention, and 3 months post-interventions
Other outcomes:
Locations:
city: Arendal
country: Norway
facility: University of Agder
state: Agder
Study officials:
affiliation: University of Agder
name: Silje Haugland, PhD
role: STUDY_DIRECTOR
References: