This is a prospective, single-center, two-arm (1:1), assessor-blinded, randomized controlled clinical trial that will be conducted in collaboration with the outpatient clinic of the third Pediatric Pulmonology Unit, "Attikon" University Hospital of Athens in Greece. The aim of the study is to investigate the effects of applying digital physiotherapy services in the management of specific clinical outcomes in children with chronic suppurative lung diseases, other than cystic fibrosis. The research question is whether airway clearance techniques and exercise training that are performed remotely using digital health services (DHSs) can improve functional and exercise capacity, as well as compliance with ACTs, compared to usual care. The intervention program includes airway clearance techniques (ACTs), as well as aerobic and strengthening exercises that can be implemented easily in an online setting at home with minimal equipment. The duration of the program will be 12 weeks, and the prescribed weekly regimen will consist of 50-minute remote sessions: two synchronous, supervised sessions conducted via the Vsee platform, and a minimum of one asynchronous, unsupervised session. Children will be encouraged to maintain daily adherence to the exercise protocol.
children aged 6 to 12 years old
clinically stable with an absence of pulmonary exacerbation four weeks prior to the study's recruitment
adherence to attend regular medical follow-up from a pediatric pulmonologist every three months
Cystic fibrosis
Immunodeficiency or asthma as their primary condition
Clinical evidence of cardiovascular, neuromuscular, metastatic, or psychiatric comorbidities, and neuromuscular or musculoskeletal impairments that affect mobility and the ability to follow instructions
Medical history of lung transplant
Parallel
Videoconferencing (Vsee platform)
DeviceThe prescribed weekly regimen will consist of 50-minute remote sessions: two synchronous, supervised sessions conducted via the Vsee platform, and a minimum of one asynchronous, unsupervised session. Children will perform ACTs (including individualized teaching and review of postural drainage, percussion, vibration, ACTs devices, huffing, coughing), diaphragmatic breathing, and blowing games. During the synchronous, supervised videoconference sessions, they will be monitored/supervised by the pediatric physiotherapist. The exercise program will be based on the 24-letter Greek alphabet, where each letter represents an individual aerobic or strengthening exercise. The exercise program consists of 16 exercises per session, varied on the four-letter words chosen at a time. At each session, a combination of four words will be performed. The exercise program will last 25 to 30 minutes per session. The exercise workload will be equal to 60 - 70% of maximum heart rate.
Specially designed website (FysΑΩ)
DeviceThe DHSG will be granted access to a website (www.fysao.gr) for disease management, including information about common symptoms, nutrition, pharmacological treatment, exercise, and ACTs performance. To facilitate adherence and longitudinal monitoring, the DHSG will receive automated weekly reminders for ACTs and exercise performance. Through the web portal's integrated evaluation forms, children can report daily symptomatology and track any clinical fluctuations. All the ACTs and the exercise program have been digitized as high-definition videos and images, ensuring asynchronous accessibility for the DHSG. Furthermore, the platform facilitates secure communication, enabling children and their parents/caregivers to communicate with healthcare professionals via integrated email or direct document transmission.
Exercise Capacity (modified Shuttle Walk test)
Maximal exercise capacity will be assessed through the modified shuttle walk test (MSWT). In the MSWT, participants will be asked to walk rapidly at gradually increasing speeds (15 levels total) along a 10-m corridor. An audio signal ("beep") will mark the transitions between levels, signaling a required increase in velocity. The protocol will commence at a baseline speed of 0.5 m/s (Level 1), with an incremental increase of 0.17 m/s for each subsequent level. The test will be terminated based on inability to continue, symptomatic fatigue, or the failure to reach the course marker before the auditory signal on two consecutive occasions. The walking distance (MSWD) will be recorded. Two trials will be performed, with at least a 30-minute rest.
Compliance with the airway clearance techniques and exercise program
Compliance with the ACTs will be recorded using a detailed diary that includes weekly symptoms, type, frequency, and duration of ACTs performed. For both groups, compliance will be assessed twice a month, following the completion of this diary. The DHSG will complete the diary through the website, while the CG will complete it in a paper version via a phone call from the physiotherapist. Furthermore, the DHSG's exercise program compliance will be assessed every second online session through a Microsoft Form diary.
Functional Capacity
The 6-minute walking test (6MWT) will be used to assess functional capacity. The participants will be asked to walk as far as possible in a 30-m corridor, and standardized encouragement will be given after each minute. The total walking distance (6MWD) will be recorded.
Exercise Capacity (Chester Step test)
CST is a multi-staged test that requires participants to step on and off a 20 or 25cm tall step with no handles at a rate set by a metronome beat, which is continuously increasing. Step heights were chosen to be optimal for children according to their age. It consists of 5 levels, each of two minutes duration. The total number of steps and the maximal level achieved will be recorded.
Respiratory muscle strength
Maximal inspiratory (MIP) and expiratory (MEP) pressure will be measured using a mouth pressure meter (MicroRPM; MicroMedical) to assess respiratory muscle strength. A maximum value of three efforts with a variation of less than 5% will be recorded for both inspiratory and expiratory pressures. There will be a minute rest between the efforts.
Peripheral muscle strength
Handgrip strength will be assessed using a hand dynamometer (JAMAR, Patterson Medical, IL, USA). Participants will hold the dynamometer at a 90o angle to their elbow. Three separate efforts for the dominant hand grip (DHG) and three for the non-dominant hand grip (NDHG) will be administered, with 30 seconds of rest between efforts. The highest value in kilograms (kg) for each hand will be recorded.
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University of Thessaly
Lead sponsor
Attikon Hospital
Collaborator
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