AsthmaLIBERTYNCT06513117
LIving BEtteR With asThma studY:: A Multimodal Intervention to Address Multimorbidity in Difficult Asthma
A study testing Behaviour change, Dietary support and Breathing pattern retraining in people with Asthma and Multi Morbidity, run by University of Southampton.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Asthma, Multi Morbidity
- What is being tested?
- Behaviour change, Dietary support and Breathing pattern retraining
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Oct 2024to Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 -
Who cannot join
- 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) -
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: LIving BEtteR With asThma studY: A Multimodal Intervention to Address Multimorbidity in Difficult Asthma
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
Read the 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 investigators want to find out if a personalised intervention (i.e. exercise training, behavioural change support, breathing retraining and dietary and emotional self-management support) to address mutimorbidity is feasible and tolerable and can improve asthma symptoms in difficult asthma. The investigators also want to find out if this intervention continues to benefit patients and help them to continue lifestyle changes after the intervention has finished.
The aim of this exercise training will be to improve fitness. The investigators believe that increases in physical fitness will improve symptom burden through reductions in inflammation and improved resilience. The aim of the dietary and emotional self-management support is to help participants develop their own solutions for healthy eating and keeping emotionally well. The aim of the behavioural change programme is to help participants continue these lifestyle changes post intervention and manage the challenges of living with difficult asthma alongside other multiple health conditions.
This is a pilot study, so all participants will receive the intervention.
Participants with difficult asthma and multimorbidity (more than 2 additional long term health conditions alongside asthma) will be invited to take part in the study. Participants will undertake in a 6-month/ 24 week supervised multimodal health improvement programme (combining exercise training, behavioural change support, breathing retraining and dietary and emotional self-management support. This programme will run alongside their treatment. The programme will be delivered by highly trained Health Guides, who are trained exercise professionals and have received additional training including how to support people to change their behaviour to be able to look after their own physical and emotional wellbeing by themselves in the long run. During the first 12 weeks, participants will take part in 2 community gym based sessions and 1 home based exercise session every week, all supervised by the Health Guide (in person in the gym and through a video or telephone call at home). For weeks 12-24, they will complete 1 community gym based session and 1 virtual/home based session, supervised by the Health Guide, and 1 session on their own. The sessions with the Health Guide will consist of:
- exercise programme, tailored to individual needs and abilities.
- breathing pattern guidance to regulate breathing pattern during exercise.
- conversations with the Health Guide to support changing diet if needed or keeping up with a healthy diet if they already eat healthily.
- conversations with Health Guide to support in becoming confident to exercise on their own and finding own ways of keeping physically active in the long run.
- conversations about emotional wellbeing and how to look after emotional health Participants will be asked to undergo some additional exercise-based tests, activity monitoring, assessment of nutritional wellbeing and complete some questionnaires before, after and during the intervention, with a total of 3 face to face study visits and 2 virtual visits at University Hospital Southampton.
It is safe to exercise and possible benefits include improved symptoms and quality of life. After exercising some people may feel achy or sore, but this should subside within a day or two. It is normal to feel short of breath during exercise. Occasionally, asthma symptoms are exacerbated briefly during exercise-this will be monitored for during the early supervised exercise sessions, and participants will be advised to take a dose of their reliever if needed.
During blood sampling, participants may feel discomfort due to the needle and may have bruising, bleeding or swelling at the blood sample site. Participants may feel faint and dizzy while blood is being drawn and there is a slight risk of infection.
Sometimes conversations about habits or emotional wellbeing might be a bit emotional but the Health Guide will be trained in how to provide support should this happen and to discuss further steps with participants if and when it is needed.
The study will open in the autumn of 2024, and will run for 18 months, with participants followed up for 12 months. The BMA James Trust is funding the study, with additional support from the NIHR
- Conditions
- Asthma, Multi Morbidity
- Being tested
- Behaviour change, Dietary support, Breathing pattern retraining, Exercise training
- Keywords
- exercise, behaviour change, multimorbidity, asthma
- Medical subject headings
- Asthma, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behaviour changeBehavioural
Also called healthy conversations
healthy conversations to support behaviour change
Dietary supportBehavioural
Guidance on healthy eating
Breathing pattern retrainingBehavioural
guidance on breathing pattern in exercise
Exercise trainingBehavioural
Exercise intervention prescribed to participant fitness level
| Study group | Role | What they receive |
|---|---|---|
| Multimodal Intervention (Exercise, breathing retraining nutritional and behaviour change support) | Experimental | Participants with difficult asthma and multimorbidity (more than 2 additional long term health conditions alongside asthma) will be invited to take part in the study. Participants will undertake in a 6-month/ 24 week supervised multimodal health improvement programme (combining exercise training, behavioural change support, breathing retraining and dietary and emotional self-management support. This programme will run alongside usual treatment.
Participants will be asked to undergo some additional exercise-based tests, activity monitoring, assessment of nutritional wellbeing and complete some questionnaires before, after and during the intervention, with a total of 3 face to face study visits and 2 virtual visits at University Hospital Southampton. Receives: Behavioral: Behaviour change; Behavioral: Dietary support; Behavioral: Breathing pattern retraining; Behavioral: Exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: pre and post intervention, at 12 month follow up
Secondary outcomes (3)
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.
Measured: pre and post intervention, at 12 month follow up
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
Measured: pre and post intervention, at 12 month follow up
Exacerbation frequency
number of asthma exacerbations requiring oral corticosteroid treatment
Measured: pre and post intervention, at 12 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2024
- Study startOct 2024 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pilot single arm trial of a structured responsive exercise program and psychological/behavioural support.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southampton
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Southampton NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Anna Freeman, MBBS PhD, Principal investigator, University of Southampton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06513117
- Sponsor's protocol ID
- RHM RSP 0002
- Acronym
- LIBERTY
- Status last verified
- Jul 2024
- First submitted
- 9 Jul 2024
- Last updated
- 26 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LIving BEtteR With asThma studY: A Multimodal Intervention to Address Multimorbidity in Difficult Asthma
- ClinicalTrials.gov ID
- NCT06513117
- Acronym / sponsor ID
- LIBERTY / RHM RSP 0002
- Conditions
- Asthma, Multi Morbidity
- Keywords
- exercise, behaviour change, multimorbidity, asthma
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of SouthamptonUniversity, hospital or other
- Collaborators
- University Hospital Southampton NHS Foundation Trust
- Study start
- Oct 2024 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 22 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 investigators want to find out if a personalised intervention (i.e. exercise training, behavioural change support, breathing retraining and dietary and emotional self-management support) to address mutimorbidity is feasible and tolerable and can improve asthma symptoms in difficult asthma. The investigators also want to find out if this intervention continues to benefit patients and help them to continue lifestyle changes after the intervention has finished.
The aim of this exercise training will be to improve fitness. The investigators believe that increases in physical fitness will improve symptom burden through reductions in inflammation and improved resilience. The aim of the dietary and emotional self-management support is to help participants develop their own solutions for healthy eating and keeping emotionally well. The aim of the behavioural change programme is to help participants continue these lifestyle changes post intervention and manage the challenges of living with difficult asthma alongside other multiple health conditions.
This is a pilot study, so all participants will receive the intervention.
Participants with difficult asthma and multimorbidity (more than 2 additional long term health conditions alongside asthma) will be invited to take part in the study. Participants will undertake in a 6-month/ 24 week supervised multimodal health improvement programme (combining exercise training, behavioural change support, breathing retraining and dietary and emotional self-management support. This programme will run alongside their treatment. The programme will be delivered by highly trained Health Guides, who are trained exercise professionals and have received additional training including how to support people to change their behaviour to be able to look after their own physical and emotional wellbeing by themselves in the long run. During the first 12 weeks, participants will take part in 2 community gym based sessions and 1 home based exercise session every week, all supervised by the Health Guide (in person in the gym and through a video or telephone call at home). For weeks 12-24, they will complete 1 community gym based session and 1 virtual/home based session, supervised by the Health Guide, and 1 session on their own. The sessions with the Health Guide will consist of:
- exercise programme, tailored to individual needs and abilities.
- breathing pattern guidance to regulate breathing pattern during exercise.
- conversations with the Health Guide to support changing diet if needed or keeping up with a healthy diet if they already eat healthily.
- conversations with Health Guide to support in becoming confident to exercise on their own and finding own ways of keeping physically active in the long run.
- conversations about emotional wellbeing and how to look after emotional health Participants will be asked to undergo some additional exercise-based tests, activity monitoring, assessment of nutritional wellbeing and complete some questionnaires before, after and during the intervention, with a total of 3 face to face study visits and 2 virtual visits at University Hospital Southampton.
It is safe to exercise and possible benefits include improved symptoms and quality of life. After exercising some people may feel achy or sore, but this should subside within a day or two. It is normal to feel short of breath during exercise. Occasionally, asthma symptoms are exacerbated briefly during exercise-this will be monitored for during the early supervised exercise sessions, and participants will be advised to take a dose of their reliever if needed.
During blood sampling, participants may feel discomfort due to the needle and may have bruising, bleeding or swelling at the blood sample site. Participants may feel faint and dizzy while blood is being drawn and there is a slight risk of infection.
Sometimes conversations about habits or emotional wellbeing might be a bit emotional but the Health Guide will be trained in how to provide support should this happen and to discuss further steps with participants if and when it is needed.
The study will open in the autumn of 2024, and will run for 18 months, with participants followed up for 12 months. The BMA James Trust is funding the study, with additional support from the NIHR
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pilot single arm trial of a structured responsive exercise program and psychological/behavioural support.
| Arm | Type | Receives |
|---|---|---|
| Multimodal Intervention (Exercise, breathing retraining nutritional and behaviour change support) | Experimental | Behavioral: Behaviour change, Behavioral: Dietary support, Behavioral: Breathing pattern retraining, Behavioral: Exercise trainingParticipants with difficult asthma and multimorbidity (more than 2 additional long term health conditions alongside asthma) will be invited to take part in the study. Participants will undertake in a 6-month/ 24 week supervised multimodal health improvement programme (combining exercise training, behavioural change support, breathing retraining and dietary and emotional self-management support. This programme will run alongside usual treatment. Participants will be asked to undergo some additional exercise-based tests, activity monitoring, assessment of nutritional wellbeing and complete some questionnaires before, after and during the intervention, with a total of 3 face to face study visits and 2 virtual visits at University Hospital Southampton. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behaviour changeAlso: healthy conversationshealthy conversations to support behaviour change | Behavioural | Multimodal Intervention (Exercise, breathing retraining nutritional and behaviour change support) |
| Dietary supportGuidance on healthy eating | Behavioural | Multimodal Intervention (Exercise, breathing retraining nutritional and behaviour change support) |
| Breathing pattern retrainingguidance on breathing pattern in exercise | Behavioural | Multimodal Intervention (Exercise, breathing retraining nutritional and behaviour change support) |
| Exercise trainingExercise intervention prescribed to participant fitness level | Behavioural | Multimodal Intervention (Exercise, breathing retraining nutritional and behaviour change support) |
Primary outcome
Improvement in Asthma Control Questionnaire score
Time frame: pre and post intervention, at 12 month follow up
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.
3 secondary outcomes
Improvement in exercise capacity, QoL scores, exacerbation frequency
Time frame: pre and post intervention, at 12 month follow up
Asthma Quality of Life Questionnaire (AQLQ)
Time frame: pre and post intervention, at 12 month follow up
Exacerbation frequency
Time frame: pre and post intervention, at 12 month follow up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2024.
- Individual participant dataSharing planned: No
Related trials for Asthma
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anna Freeman, MBBS PhD principal investigator
University of Southampton
Questions about this trial
What is this clinical trial studying?
A study testing Behaviour change, Dietary support and Breathing pattern retraining in people with Asthma and Multi Morbidity, run by University of Southampton.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anna Freeman, PhD MBBS (0238120 5232 ext. 6397, a.freeman@soton.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in Asthma Control Questionnaire score (time frame: pre and post intervention, at 12 month follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2024; AzTrials last refreshed its copy on 6 Nov 2026.