Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07376187

Digital Physiotherapy for Pediatric Chronic Suppurative Lung Diseases

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Exercise Capacity (modified Shuttle Walk test)

    Time frame: Change From Baseline in MSWT distance at 3 and 6 months

    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.

  2. Compliance with the airway clearance techniques and exercise program

    Time frame: 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

    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.

Secondary outcomes

  1. Functional Capacity

    Time frame: Change From Baseline in 6MWT distance at 3 and 6 months

    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.

  2. Exercise Capacity (Chester Step test)

    Time frame: Change From Baseline in CST steps at 3 and 6 months

    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.

  3. Respiratory muscle strength

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

    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.

  4. Peripheral muscle strength

    Time frame: Change From Baseline in handgrip scores at 3 and 6 months

    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.

  5. Physical Activity (Physical Activity Questionnaire for Older Children)

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

    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.

  6. Physical Activity and Sedentary Behavior (Youth Activity Profile)

    Time frame: Change From Baseline in YAP Score at 3 and 6 months

    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).

  7. Health-Related Quality of Life

    Time frame: Change From Baseline in PedsQL Score at 3 and 6 months

    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.

  8. Cough-specific Quality of Life

    Time frame: Change From Baseline in CC-QoL Score at 3 and 6 months

    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.

  9. Sleep Quality

    Time frame: Change From Baseline in PSQ Score at 3 and 6 months

    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).

  10. Digital Health Services Satisfaction

    Time frame: TUQ Score after 12 weeks (end of the intervention)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Eleni A Kortianou, Professor

CONTACT

[email protected]

+306944665856

Eleni Kapreli, Professor

CONTACT

[email protected]

+306972423374

Sponsors and collaborators

Lead sponsor

University of Thessaly

Other

Collaborators

  • Attikon Hospital

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jan 29, 2026
Registry last updated
Jan 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.