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BREATH STUDY: Short and long-term effects of therapeutic exercise in children with bronchiectasis: a multi-centre randomised controlled trial

The effectiveness of a therapeutic, play-based exercise program in reducing acute exacerbations over a 12-month period in children aged 6 to less than 13 years with bronchiectasis compared to standard care: a multi-centre, observer-blinded randomised controlled trial

Status
Terminated
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12619001008112
Acronym
BREATH Study
Enrollment
47
Registered
2019-07-15
Start date
2021-02-17
Completion date
2023-08-31
Last updated
2026-06-15

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

Conditions

None listed

Brief summary

Children with bronchiectasis regularly experience exacerbations of their condition resulting in frequent hospitalisations and decreased of quality of life (QoL). Therapeutic exercise may reduce the incidence of acute exacerbations, which is a key predictor of future lung function decline and morbidity. This study aims to determine if a tailored, 8-week therapeutic exercise program delivered to children aged 6 to 12 years with bronchiectasis prevents acute respiratory exacerbations. The primary hypothesis is that children who undergo the exercise program will have fewer exacerbations over a 12-month period than children who do not receive the intervention.

Interventions

A tailored therapeutic exercise programme delivered by trained exercise therapists. The program focuses on developing and enhancing children’s confidence, motivation, functional motor skills (FMS) proficiency, and aerobic fitness through the use of developmentally-appropriate, play-based activity stations designed specifically to suit individual needs. It is comprised of a combination of supervised and unsupervised exercise therapy sessions. Therapists and parents will be required to follow a

A tailored therapeutic exercise programme delivered by trained exercise therapists. The program focuses on developing and enhancing children’s confidence, motivation, functional motor skills (FMS) proficiency, and aerobic fitness through the use of developmentally-appropriate, play-based activity stations designed specifically to suit individual needs. It is comprised of a combination of supervised and unsupervised exercise therapy sessions. Therapists and parents will be required to follow a detailed program manual and standard operating procedures. Sessions will be conducted in local community centres or at the Centre for Children's Health Research South Brisbane. The supervised component consists of 60-minute group sessions, completed on a weekly basis for 8 weeks, led by a clinical exercise physiologist or physiotherapist. During the supervised group sessions, children rotate through at least 6 activity stations where they complete developmentally appropriate games targeting specific FMS’s. The activity stations are sequenced so that a high intensity game is always followed by a low intensity game, thus ensuring that aerobic fitness is promoted in a safe and effective manner. Activities are tailored to the child’s fitness and skill level by modifying the intensity and duration of each session, and/or modifying the equipment. There will be up to six children each session. Children will participate in a warm up followed by a circuit of different activities and games targeting functional movement skills and cardiovascular fitness. There will be a group activity at the half way point and the session will end with a cool down. Children spend six minutes at each activity; 30s to switch stations, 30s to orientate to game, 5 minutes to complete activity (chosen from the FMS Activity Catalogue) before moving to the next activity. Each activity is designed to be tailored to the child’s individual fitness and skill level One group activity is incorporated per session to target social connection, work as a team and integrate into a bigger group. The group activity will be a modified game from the FMS Activity Catalogue. The group activity is 10 minutes long Heart rate will be monitored during the session using an upper arm monitor. Data collection will include a subjective rates from the instructor on the effectiveness of the game. Example outline of an 8-week program - Weeks 1-8 Warm up- 6 min FMS Activity - Kicking 6 min Strength 6 min Hit, strike, dribble 6 min Group Activity/Game 10 min FMS Activity Throwing & Catching 6 min Balance 6 min Agility & coordination 6 min Cool down 2 min The unsupervised component consists of a home-based, parent-led exercise program, completed 2 days per week (~ 20 minutes per session) for 8 weeks (the same 8 weeks in which the supervised session is taking place), during which children and parents complete 2 games or activity stations from their most recent 60-minute supervised group session. Examples of games targeting a range of FMS’s and fitness parameters, including kicking, underarm striking, throwing and catching, locomotion, strength, and balance. All sessions begin with a 5-minute warm up and end with a 5-minute cool down consisting of stretching and relaxation exercises. Exercise intensity during each program session is monitored continuously with a heart rate monitor. Fidelity is measure via parent report and parent records of heart rate and activities conducted at each session.

Sponsors

Queensland University of Technology
Lead SponsorUniversity

Study design

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

Eligibility

Sex/Gender
All
Age
4 Years to 12 Years
Healthy volunteers
No

Inclusion criteria

1. Aged 4 – 12 years 2. Bronchiectasis confirmed on high resolution computed tomography (HRCT), or if more than 5 years since HRCT, under the regular care of a respiratory paediatrician 3. Greater than or equal to 1 acute pulmonary exacerbation in the past 12-months 4. Medically able to complete an exercise program as determined by treating physician

Exclusion criteria

1. Medically unstable as determined by treating physician 2. Unstable emotional and/or behavioural problems 3. Recent musculoskeletal injury (e.g., muscle strain, sprains, fractures) 4. Underlying chronic illness other than BE (e.g., asthma, Cystic Fibrosis (CF), neurological or cardiac disorders) 5. Knowingly unable to attend any exercise sessions or follow-up clinical visits over the 12 months (eg. planned movement from the area) 6. Active participation in a clinical trial of another investigational drug/device or interventional therapy. 7. Other medical/psychosocial condition that the investigators/treating physicians consider should be excluded from the trial to prevent potential harm/risk to the subject or may adversely affect study outcomes.

Outcome results

None listed

Source: ANZCTR · Data processed: Jun 21, 2026