Digital Physiotherapy for Pediatric Chronic Suppurative Lung Diseases

NCT07376187 | Not Yet Recruiting DMC

• 1 other identifier: 22510/25
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

chronic suppurative lung diseases; digital health services; pediatric; physiotherapy; remote; website

Outcome Measures

Primary Outcomes (2)

• 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.

  Change From Baseline in MSWT distance at 3 and 6 months

• 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.

  Change From Baseline at 3 and 6 months in: symptomatology, frequency, and duration of ACTs performance, as well as frequency and duration of exercise program performed

Secondary Outcomes (10)

• Functional Capacity

  Change From Baseline in 6MWT distance at 3 and 6 months

• Exercise Capacity (Chester Step test)

  Change From Baseline in CST steps at 3 and 6 months

• Respiratory muscle strength

  Change From Baseline in MIP and MEP scores at 3 and 6 months

• Peripheral muscle strength

  Change From Baseline in handgrip scores at 3 and 6 months

• Physical Activity (Physical Activity Questionnaire for Older Children)

  Change From Baseline in PAQ-C Score at 3 and 6 months

Study Arms (2)

Digital Health Services Group (DHSG)

ACTIVE COMPARATOR

The treatment arm will receive a home-based hybrid (synchronous and asynchronous) remotely administered exercise program and ACTs for 12 weeks. Children will perform ACTs daily and will participate in an exercise program. The exercise program will consist 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 and modified weekly. Additionally, they will have access to a website for disease management, including information about common symptoms, nutrition, pharmacological treatment, exercise, and ACTs performance. They will receive via website automated weekly reminders for ACTs and exercise performance, and can report daily symptomatology and track any clinical fluctuations.

Device: Videoconferencing (Vsee platform); Device: Specially designed website (FysΑΩ)

Control Group (CG)

NO INTERVENTION

Participants in the control group will receive usual care, typically comprising inhaled antibiotics and/or bronchodilators for respiratory infections as regular pharmacological treatment in clinically stable condition and a 40-minute, in-person, physiotherapy session where they will be taught ACTs to perform at home. A printed copy of a handbook, including information on their disease and symptoms, nutrition, pharmacological treatment, exercise, and how to perform airway clearance techniques, will be provided.

Interventions

Videoconferencing (Vsee platform) DEVICE

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.

Digital Health Services Group (DHSG)

Specially designed website (FysΑΩ) DEVICE

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.

Digital Health Services Group (DHSG)

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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
• Participation in other rehabilitation programs, or attendance at regular physiotherapy ACTs sessions (\>10 sessions in a 3-month period)
• Lack access to the internet (e.g., no smartphone, tablet, or laptop)
• Inability to use technological devices

Sponsors & Collaborators

• University of Thessaly: lead
• Attikon Hospital: collaborator

Study Sites (1)

Physiotherapy Department, University of Thessaly

Lamia, Fthiotis, 35100, Greece

Location

Related Publications (1)

• ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available.

  PMID: 12091180 BACKGROUND

MeSH Terms

Conditions

Ciliary Motility Disorders

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Ciliopathies; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn

Study Officials

• Eleni A Kortianou, Professor

  Clinical Exercise Physiology and Rehabilitation Research Laboratory

  STUDY DIRECTOR

• Eleni Kortianou, Professor

  Clinical Exercise Physiology and Rehabilitation Research Laboratory

  STUDY CHAIR

• Aspasia Mavronasou, PT, MSc, PhD candidate

  Clinical Exercise Physiology and Rehabilitation Research Laboratory

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eleni A Kortianou, Professor

CONTACT

+306944665856; ekortianou@uth.gr

Eleni Kapreli, Professor

CONTACT

+306972423374; ekapreli@uth.gr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Block Randomisation, Initial and final outcome assessors blinded to treatment arm
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PT, MSc, PhD candidate, Principal Investigator

Model Details: Two-arm (1:1), single blinded, randomized controlled clinical trial

Study Record Dates

• First Submitted: January 21, 2026
• First Posted: January 29, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): August 31, 2028
• Last Updated: January 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)