Chronic Suppurative Lung DiseaseNCT07376187

Digital Physiotherapy for Pediatric Chronic Suppurative Lung Diseases

A study testing Videoconferencing (Vsee platform) and Specially designed website (FysΑΩ) in people with Chronic Suppurative Lung Disease and Protracted Bacterial Bronchitis, run by University of Thessaly at 1 site in Greece.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 6 to 12 years
Conditions the study is for: Chronic Suppurative Lung Disease, Protracted Bacterial Bronchitis, Primary Ciliary Dyskinesia (PCD)
What is being tested?: Videoconferencing (Vsee platform) and Specially designed website (FysΑΩ)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 32 participants
Where: 1 siteGreece
Study dates: 1 May 2026to 31 Aug 2028
Phase: Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 6 to 12 years
All sexes
No healthy volunteers
Child

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Eleni A Kortianou, Professor contact

+306944665856

ekortianou@uth.gr

Eleni Kapreli, Professor contact

+306972423374

ekapreli@uth.gr

Greece1 site

Physiotherapy Department, University of Thessaly
Lamia, Fthiotis, 35100
Eleni A Kortianou, Professor, +306944665856, ekortianou@uth.gr
Eleni Kapreli, Professor, +306972423374, ekapreli@uth.gr

Other trials in Greece

About this study

Official title: Digital Physiotherapy Services in the Management of Pediatric Chronic Suppurative Lung Diseases: A Randomized Controlled Trial

Read the detailed description

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 collection of medical history will be conducted via a 40-minute synchronous videoconference session. Children will be randomized into parallel arms: the digital health services group (DHSG) and the control group (CG). All children will receive usual care, including inhaled antibiotics and/or bronchodilators for respiratory infections, alongside recommendations to maintain regular physical activity and to perform ACTs. Furthermore, all child-parent/caregiver dyads will attend a 40-minute, in-person session with the physiotherapist at the outpatient clinic. This session is designed to provide standardized training on airway clearance techniques (ACTs) for subsequent implementation at home. The DHSG will undergo a 12-week home-based hybrid (synchronous and asynchronous), remotely administered exercise program and ACTs. Likewise, the DHSG will have access to a specifically designed website about disease management (www.fysao.gr). 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 prescribed weekly regimen will consist of 50-minute remote sessions: two synchronous, 1:1 supervised sessions conducted via videoconferencing, and a minimum of one asynchronous, unsupervised session. All outcome measures will be assessed at the following time points: baseline (before the intervention), the end of the intervention (12 weeks), and follow-up (6 months after the intervention has ended). All clinical assessments will be conducted in-person at the outpatient clinic by blinded healthcare professionals. Changes from baseline in functional and exercise capacity, compliance with ACTs, respiratory and peripheral muscle strength, physical activity and sedentary behavior, as well as quality of life, will be assessed at 3 and 6 months for both groups.

Conditions: Chronic Suppurative Lung Disease, Protracted Bacterial Bronchitis, Primary Ciliary Dyskinesia (PCD), Non Cystic Fibrosis Bronchiectasis
Being tested: Videoconferencing (Vsee platform), Specially designed website (FysΑΩ)
Keywords: chronic suppurative lung diseases, digital health services, pediatric, physiotherapy, remote, website
Medical subject headings: Ciliary Motility Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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.
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.

Study groups in NCT07376187
Study group	Role	What they receive
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. Receives: 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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
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.
Measured: Change From Baseline in 6MWT distance at 3 and 6 months
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.
Measured: Change From Baseline in CST steps at 3 and 6 months
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.
Measured: Change From Baseline in MIP and MEP scores at 3 and 6 months
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.
Measured: Change From Baseline in handgrip scores at 3 and 6 months
Physical Activity (Physical Activity Questionnaire for Older Children)
The Physical Activity Questionnaire for Older Children (PAQ-C) is a ten-item self-administered questionnaire that intends to measure physical activity (PA). Nine of the ten items are scored on a five-point rating scale, where higher scores indicate a higher level of activity. The first item of the PAQ-C consists of 22 common sports and leisure activities for which the participants select the score based on the frequency of the activities performed during the preceding seven days on a five-point rating scale (1= no activity at all, 2= 1-2 times, 3= 3-4 times, 4= 5-6 times and 5= 7 times or more) after a mean composite score is calculated. The remaining eight items address PA performed during the day (e.g., physical education classes, recess time, lunchtime, as well as after-school activities on weekday evenings and weekends), and a summary for all days of the week. The mean score of the first nine items is the summary score of the PAQ-C.
Measured: Change From Baseline in PAQ-C Score at 3 and 6 months
Physical Activity and Sedentary Behavior (Youth Activity Profile)
The Youth Activity Profile (YAP) comprises 15 items in total, each scored on a 5-point scale designed to capture four components in youth behaviors: 1) PA in school, 2) PA out of school, 3) PA over the weekend, and 4) sedentary behaviors. Each YAP section is developed to be scored independently (ie, items for each dimension score would reflect a higher expected activity levels/sedentary time at that same dimension).
Measured: Change From Baseline in YAP Score at 3 and 6 months
Health-Related Quality of Life
Pediatric Quality of Life Inventory Version 4.0 (PedsQL) is a self-administrated questionnaire that includes 23 items divided into four subscales: Physical Functioning (PH), Emotional Functioning (EM), Social Functioning (SOC), and School Functioning (SCH). Responses are given on a five-point scale ranging from 0 (never a problem) to 4 (almost always a problem) and are reverse-scored so that lower scores reflect more negative functioning.
Measured: Change From Baseline in PedsQL Score at 3 and 6 months
Cough-specific Quality of Life
The Cough-specific Quality of Life (CC-QoL) is a 7-day recall questionnaire designed to reflect several domains related to a child's cough, including physical (e.g., coughing makes you feel tired), social (e.g., others staring at you), and psychological (e.g., feeling upset). The responses are rated on a 7-point Likert scale (1=all the time to 7=none of the time) with higher scores reflecting higher QoL.
Measured: Change From Baseline in CC-QoL Score at 3 and 6 months
Sleep Quality
The Pediatric Sleep Questionnaire (PSQ) is a tool used to assess sleep-related breathing disorders in children, such as snoring, daytime sleepiness, and related behavioral disturbances. It consists of 22 items with yes/no/don't know responses. Total score consists of the "yes" responses divided by the total number of items (excluding the "don't know" responses).
Measured: Change From Baseline in PSQ Score at 3 and 6 months
Digital Health Services Satisfaction
Satisfaction from the use of the Vsee platform and FysΑΩ website will be assessed using the Telemedicine Usability Questionnaire (TUQ). The TUQ consists of 21 questions, scored on a Likert scale from 1 (totally disagree) to 7 (totally agree). The total score is calculated by the mean of all 21 questions.
Measured: TUQ Score after 12 weeks (end of the intervention)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 May 202631 Aug 2028

First posted29 Jan 2026
Study start1 May 2026 (estimated)
Primary completion31 Dec 2027 (estimated)
Study completion31 Aug 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Chronic Suppurative Lung DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Two-arm (1:1), single blinded, randomized controlled clinical trial
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 32 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07376187
Sponsor's protocol ID: 22510/25
Status last verified: Jan 2026
First submitted: 21 Jan 2026
Last updated: 30 Jan 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 12091180