N/A
N=28
Adapting Body Reprogramming for Severe Asthma: a Feasibility Study
Severe Asthma
Bottom Line
View on ClinicalTrials.gov: NCT04980755 ↗Enrolled (actual)
28
Serious AEs
—
Results posted
Jul 2025
Primary outcome: Primary: Number of Participants Taking Part Who Completed All 4 Weeks of the Course — 13 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Body Reprogramming (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Royal Devon and Exeter NHS Foundation Trust
- Primary completion
- Jun 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Taking Part Who Completed All 4 Weeks of the Course |
13 | — |
| PRIMARY Number and Percentage of Participants Who Complete the Study Questionnaires |
8 | — |
| PRIMARY Number and Percentage of Participants Who Complete the Study Questionnaires |
8 | — |
| SECONDARY Number of Participants Who Attended Two or More Sessions and Were Invited to a Follow-up Interview |
19 | — |
| SECONDARY Of Those Invited, the Number Who Accepted an Invitation to Take Part in a Follow-up Interview |
12 | — |
Summary
There are many symptoms associated with severe asthma, not all of them related to the lung. These are referred to as extra-pulmonary symptoms and their relationship with quality of life is complex.
Body reprogramming (BR) is a non-drug intervention originally developed for fibromyalgia patients with the aim of improving health and wellbeing in a personalised way, with evidence-based lifestyle changes. The frequency and severity of multiple symptoms in severe asthma is similar to fibromyalgia and the investigators propose that BR may be a suitable non-drug intervention for severe asthma patients who are about to step up drug treatment.
Our study aims are therefore to assess how BR may be suitable for people with severe asthma, and to adapt and optimise the programme for these people. In two phases, severe asthma patients will be recruited via a regional severe asthma clinic at the Royal Devon & Exeter National Health Service (NHS) Trust and invited to take part in a short course of BR. In phase one, patients will be asked to attend four weekly researcher-led sessions of BR via video call and be given practice tasks to report on at the subsequent session. Questionnaires will be completed for the first and last session. At the end of BR, patients will also be invited to take part in a focus group. The data collected will inform development of the programme for phase two, which will involve recruitment of severe asthma patient who are about to start biologic drug treatment for their severe asthma
Eligibility Criteria
Inclusion Criteria
- Phase one:
- Aged ≥18 years attending the regional specialist severe asthma service in Royal Devon and Exeter hospitals.
- Diagnosed with severe asthma as per European Respiratory Society/American Thoracic Society (ERS/ATS) definition.
- Requiring high dose inhaled corticosteroids (NICE definition of high dose ICS).
- Eight or more non-respiratory symptoms per week (approximately 60% of patients with severe asthma have a moderate or high extra-pulmonary symptom burden) as measured by the General Symptom Questionnaire
- Phase two:
- Diagnosed with severe asthma as per ERS/ATS definition.
- Requiring high dose inhaled corticosteroids (NICE definition of high dose ICS).
- Patients with severe asthma who have been approved for biologic treatment according to national guidance and have been assessed by a multi-disciplinary team will be offered the intervention pending starting their biologic treatment.
- Patients with eight or more non-respiratory symptoms per week as measured by the GSQ.
Exclusion Criteria
- Phase one and Phase two
- Unable or unwilling to partake.
- In the opinion of the patient's treating physician, the patient has another condition which is significantly impairs their ability to take part in the BR.
- No access to the internet or appropriate IT equipment.
Data sourced from ClinicalTrials.gov (NCT04980755). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.