Digital Physiotherapy for Pediatric Chronic Suppurative Lung Diseases

Summary

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.

Conditions

• Chronic Suppurative Lung Disease
• Protracted Bacterial Bronchitis
• Primary Ciliary Dyskinesia (PCD)
• Non Cystic Fibrosis Bronchiectasis

Interventions

DEVICE

Videoconferencing (Vsee platform)

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 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.

DEVICE

Specially designed website (FysΑΩ)

The 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.

Sponsors & Collaborators

• Attikon Hospital

  collaborator OTHER

• University of Thessaly

  lead OTHER

Principal Investigators

• Eleni A Kortianou, Professor · Clinical Exercise Physiology and Rehabilitation Research Laboratory

• Eleni Kortianou, Professor · Clinical Exercise Physiology and Rehabilitation Research Laboratory

• Aspasia Mavronasou, PT, MSc, PhD candidate · Clinical Exercise Physiology and Rehabilitation Research Laboratory

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

6 Years

Max Age

12 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-05-01

Primary Completion

2027-12-31

Completion

2028-08-31

Countries

• Greece

Study Locations