Adapting Body Reprogramming for Severe Asthma: a Feasibility Study

NCT04980755 | Completed Results

• 1 other identifier: 2109166
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Severe Asthma

Outcome Measures

Primary Outcomes (3)

• Number of Participants Taking Part Who Completed All 4 Weeks of the Course

  Consistent course attendance with the course will be used to infer participants level of engagement with the course content. Reasons for consistent attendance, or poor attendance, will be explored further with participants during the semi-structured interviews.

  Week 4

• Number and Percentage of Participants Who Complete the Study Questionnaires

  By capturing this information, we will determine if one of our study questionnaires is routinely unfinished by the study participants. Reasons for this can be explored during the focus groups or one to one interviews.

  Baseline

• Number and Percentage of Participants Who Complete the Study Questionnaires

  See outcome 2

  4 weeks

Secondary Outcomes (2)

• Number of Participants Who Attended Two or More Sessions and Were Invited to a Follow-up Interview

  5 weeks

• Of Those Invited, the Number Who Accepted an Invitation to Take Part in a Follow-up Interview

  5 weeks

Study Arms (2)

Phase one

EXPERIMENTAL

Participants will be asked to attend four weekly sessions of Body Reprogramming via group video call. Each session will include up to 8 patients and will consist of a 25-30 minute live presentation

Other: Body Reprogramming

Phase two

EXPERIMENTAL

We anticipate that participant sin phase two will complete the same intervention, but it may be somewhat modified following participant feedback in phase one.

Other: Body Reprogramming

Interventions

Body Reprogramming OTHER

An educational intervention originally designed for patients with fibromyalgia.

Phase one; Phase two

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Royal Devon and Exeter NHS Foundation Trust: lead
• University of Plymouth: collaborator
• Plymouth Marjon University: collaborator

Study Sites (1)

Royal Devon and Exeter Hospital

Exeter, Devon, EX2 5DW, United Kingdom

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Dr Joseph Lanario
• Organization: University of Plymouth

joseph.lanario@plymouth.ac.uk

01752 764403

Study Officials

• Matthew Masoli, MD

  Royal Devon and Exeter Hopsitals NHS Trust

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2021
• First Posted: July 28, 2021
• Study Start: July 28, 2021
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: July 11, 2025
• Results First Posted: July 11, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)