NCT06513117Not yet recruiting
LIving BEtteR With asThma studY:: A Multimodal Intervention to Address Multimorbidity in Difficult Asthma
LIving BEtteR With asThma studY: A Multimodal Intervention to Address Multimorbidity in Difficult Asthma
Source: ClinicalTrials.gov · Last updated 26 Jul 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 9 Jul 2024
- Start date
- Oct 2024
- Primary completion date
- Apr 2027
- Lead sponsor
- University of Southampton
- Diseases
- Asthma
- NCT number
- NCT06513117
What you commit to
- Study type: Interventional
- Planned participants: 30
- From Oct 2024 to the primary completion date, Apr 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 illness
- 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
Other
- Contraindication to ISWT
- Positive pregnancy test
- Beta blocker treatment (due to impact on exercise prescription using HR) -
Who the study is looking for
- 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 -
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.