Not Yet RecruitingNot Applicable

LIving BEtteR With asThma studY:: A Multimodal Intervention to Address Multimorbidity in Difficult Asthma

30 participantsStarted 2024-10

Plain-language summary

Multimorbidity is a significant issue for many patients with difficult asthma. With patients, we have co-designed a multimodal intervention comprising prescribed exercise, dietary support, breathing pattern retraining and behaviour change to target multimorbidity in difficult asthma

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. clinical diagnosis of difficult asthma as defined by BTS steps 4-5 and
✓. enrolled in WATCH or meet WATCH inclusion criteria.
✓. Demonstration of suboptimal symptom control through an ACQ ≥ 1.5 at enrolment
✓. Normal lung function or mild/moderate airflow obstruction at baseline (FEV1\>50% predicted)
✓. Not achieving WHO recommendations for physical activity for people living with chronic health conditions(62) (150-300 minutes of moderate-intensity aerobic physical activity; or at least 75-150 minutes of vigorous-intensity aerobic physical activity; or an equivalent combination of moderate- and vigorous-intensity activity throughout the week) 6)12 lead ECG without clinically significant abnormality -

Exclusion criteria

✕. Intercurrent exacerbation or exacerbation within 4 weeks prior to enrolment in study requiring treatment with oral corticosteroids and/or antibiotics. Note participants can be rescreened 4 weeks post exacerbation if they had not commenced the study
✕. Initiation of biologic treatment within 6 months prior to recruitment or during study participation
✕. Investigator determined significant change in regular asthma medication in the 12 weeks preceding or during trial period
✕. Other medical or psychiatric conditions (including cognitive decline) limiting ability to exercise or that may in the opinion of the study clinician carry inherent risk for exercise
✕. Contraindication to ISWT
✕. Positive pregnancy test
✕. Beta blocker treatment (due to impact on exercise prescription using HR) -

What they're measuring

Improvement in Asthma Control Questionnaire score

Timeframe: pre and post intervention, at 12 month follow up

Trial details

NCT IDNCT06513117

SponsorUniversity of Southampton

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-04

Contact for this trial

Anna Freeman, PhD MBBS

0238120 5232 a.freeman@soton.ac.uk

View on ClinicalTrials.gov More Asthma trials