Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06513117
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-09
Brief Title:
LIving BEtteR With asThma studY A Multimodal Intervention to Address Multimorbidity in Difficult Asthma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
LIving BEtteR With asThma studY A Multimodal Intervention to Address Multimorbidity in Difficult Asthma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LIBERTY
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 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 ie 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 virtualhome 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
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 virtualhome 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None