Status:
NOT_YET_RECRUITING
LIving BEtteR With asThma studY:: A Multimodal Intervention to Address Multimorbidity in Difficult Asthma
Lead Sponsor:
University of Southampton
Collaborating Sponsors:
University Hospital Southampton NHS Foundation Trust
Conditions:
Asthma
Multi Morbidity
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief 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 p...
Detailed Description
Multimorbidity (living with more than 2 additional health conditions) is very common for patients with Difficult Asthma, and has an impact on symptom burden and exacerbation frequency. The investigato...
Eligibility Criteria
Inclusion
- Aged 18 to 80 years Able and willing to give informed consent Diagnosis of asthma determined by
- 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
- 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) -
Key Trial Info
Start Date :
October 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2028
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06513117
Start Date
October 1 2024
End Date
April 1 2028
Last Update
July 26 2024
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