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Effect of implementing a treatable traits approach on care of high risk chronic respiratory disease (the TAPPET trial)

Targeted Approach for Preventing Pulmonary and Extra-pulmonary Traits: the TAPPET trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12624001296527
Acronym
TAPPET
Enrollment
44
Registered
2024-10-25
Start date
2025-08-04
Completion date
Unknown
Last updated
2026-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Patients with chronic respiratory diseases are frequently hospitalised despite receiving the best available drug treatments. Systemic inflammation and frequent chest infections represent clinical signs (treatable traits) across multiple chronic respiratory diseases. These treatable traits are known to predict high risk of hospitalisations but are not routinely targeted by treatments. Non-drug treatments such as pulmonary rehabilitation and self-management are effective in reducing hospitalisations, but their potential to transform outcomes for high risk patients is unrealised, due to limited access and lack of guidance on optimal implementation. In this clinical trial we will implement a treatable traits approach that identifies patients at highest risk of hospitalisation, and targets personalised, safe, low-cost model of home pulmonary rehabilitation and self-management.

Interventions

Medical management of asthma, bronchiectasis or COPD according to local standard of care and receive an 8-week intervention consisting of home pulmonary rehabilitation and self-management. The 8-week intervention will include: Home visits: The program will commence with a home visit (within 2 weeks of study enrolment, 60 to 120 minutes) by a physiotherapist, exercise physiologist or nurse who will establish exercise goals and supervise the first exercise session. The home visit will also undert

Medical management of asthma, bronchiectasis or COPD according to local standard of care and receive an 8-week intervention consisting of home pulmonary rehabilitation and self-management. The 8-week intervention will include: Home visits: The program will commence with a home visit (within 2 weeks of study enrolment, 60 to 120 minutes) by a physiotherapist, exercise physiologist or nurse who will establish exercise goals and supervise the first exercise session. The home visit will also undertake a review of inhaler technique and airway clearance. Participants will complete a modified incremental step test (MIST) in the initial home visit to support exercise prescription. Participants will have a second home visit at 8 weeks where the physiotherapist will reassess exercise capacity using the MIST and discuss a long-term exercise plan including referral to local maintenance exercise programs. Unsupervised exercise training: The program will deliver an unsupervised aerobic and strength training program for 8 weeks to target key sources of systemic inflammation (skeletal muscle and adipose tissue). For the aerobic training, a walking program will be prescribed with participants set a walking distance to be completed in a given time, with distance measurement aided by pedometers. At least 30 minutes of aerobic exercise is recommended for each session, for at least 5 sessions per week. Strength training will utilise functional activities and equipment that are readily accessible at home (e.g. sit-to-stand from a dining chair), with at least two upper-limb and two lower-limb exercises prescribed for completion twice weekly (15 to 30 minutes total per session). Home exercise diary: Exercise goals and details of completed unsupervised exercise sessions will be documented in a home exercise diary each week. Prior to each unsupervised exercise session, participants will be prompted to complete a checklist (based on signs of a moderate or severe exacerbation e.g. increased dyspnoea, cough or sputum, using more reliever medication) in the diary to ensure clinical stability. Participants will be instructed to contact their local clinician if they have symptoms of an exacerbation to ensure appropriate exercise participation during and following chest infections. Weekly telephone calls: The initial home visit will be followed by seven once-weekly telephone calls (approximately 30 minutes each) by a physiotherapist. The physiotherapist will: (1) review symptoms and facilitate self-management of exacerbations as per the diary checklist; (2) review the home exercise diary; (3) progress the exercise prescription; and (4) deliver self-management education targeting systemic inflammation and chest infections including diet and weight management, understanding medications and infection control. Each physiotherapist will maintain a call log and complete a summary at the end of the intervention to report on intervention delivery including number and duration of telephone calls, exercise progression, goals set and achieved, self-management education, referrals to other treatments and services and long-term exercise plan. Action plans: Asthma Australia and Lung Foundation Australia have designed action plans that when completed with a health professional help people with asthma, bronchiectasis and COPD recognise early symptoms of an exacerbation and outline the actions to take. These action plans will be checked by the clinician during the initial home visit and re-visited during the telephone calls. If a participant does not have an action plan and/or existing rescue pack of antibiotics and/or oral corticosteroids to be used in conjunction with their action plan the local research team will coordinate an action plan and/or script to be prepared by the site principal Investigator or other local site physician where applicable. If any participants prefer for this to be completed in consultation with their local GP, the local research team will provide a letter for the participant to take to their GP confirming study participation and requirement for review of action plan and rescue pack script. Disease management checklists: Asthma Australia and Lung Foundation have designed checklists to optimise self-management of asthma, bronchiectasis or COPD. These cover aspects of exercise, inhaler technique, airway clearance, review of medications, comorbidities, smoking cessation, vaccinations, nutrition or mental health support. The local site team will review the relevant checklist with the participant during the second home visit including additional treatment referrals at the local health service partner or other services provided by Asthma Australia and Lung Foundation Australia. Educational resources: Our previous trials in COPD have provided printed educational resources of ‘Better Living with Exercise’ and ‘Better Living with COPD’ developed by Lung Foundation Australia. The provision of resources will be expanded to include written and printed educational material on asthma and bronchiectasis from Asthma Australia and Lung Foundation Australia respectively.

Sponsors

Monash University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

i. clinical diagnosis of asthma, bronchiectasis and/or chronic obstructive pulmonary disease (COPD) ii. two or more courses of systemic antibiotics and/or corticosteroids in the previous 12 months iii. white blood cell count > 9 × 10^9/L or plasma CRP concentration > 3 mg/L

Exclusion criteria

i. less than 4 weeks following an exacerbation of their respiratory disease (requiring hospitalisation or treatment with systemic antibiotics or corticosteroids) ii. comorbidities which preclude exercise training iii. inability to read, write or speak English iv. have undergone a pulmonary rehabilitation program in the previous 12 months

Outcome results

None listed

Source: ANZCTR · Data processed: Sep 19, 2026