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

ConditionsAsthmaMulti Morbidity
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity of Southampton

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Behaviour change

    Behavioral

    healthy conversations to support behaviour change

  • Dietary support

    Behavioral

    Guidance on healthy eating

  • Breathing pattern retraining

    Behavioral

    guidance on breathing pattern in exercise

  • Exercise training

    Behavioral

    Exercise intervention prescribed to participant fitness level

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Multimodal Intervention (Exercise, breathing retraining nutritional and behaviour change support)Experimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Improvement in Asthma Control Questionnaire score

Primary feasibility outcome is feasibility and acceptability to patients. Primary clinical endpoint outcome measure will be a minimal clinically significant improvement in ACQ 6 score (\>0.5). Score scale is from 0-6, with \< 1.5 demonstrating good asthma symptom control.

Time frame
pre and post intervention, at 12 month follow up

Secondary outcomes

1

Improvement in exercise capacity, QoL scores, exacerbation frequency

Increase in exercise capacity as assessed through oxygen uptake of \> 2ml/kg/min at anaerobic threshold (AT) on maximal, symptom limited, incremental shuttle walk test.

Time frame
pre and post intervention, at 12 month follow up
2

Asthma Quality of Life Questionnaire (AQLQ)

32 questions scored on Likert scale 1-7. Score is mean of 32 answers, range 1-7 (higher =better quality of life

Time frame
pre and post intervention, at 12 month follow up
3

Exacerbation frequency

number of asthma exacerbations requiring oral corticosteroid treatment

Time frame
pre and post intervention, at 12 month follow up

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Southampton

Lead sponsor

University Hospital Southampton NHS Foundation Trust

Collaborator

Source ClinicalTrials.gov

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