Digital Physiotherapy for Pediatric Chronic Suppurative Lung Diseases

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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 pe
• Устройство 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 pr

Первичные конечные точки

• Exercise Capacity (modified Shuttle Walk test) [Срок оценки: Change From Baseline in MSWT distance at 3 and 6 months]
• Compliance with the airway clearance techniques and exercise program [Срок оценки: 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]

Вторичные конечные точки (10)

• Functional Capacity [Срок оценки: Change From Baseline in 6MWT distance at 3 and 6 months]
• Exercise Capacity (Chester Step test) [Срок оценки: Change From Baseline in CST steps at 3 and 6 months]
• Respiratory muscle strength [Срок оценки: Change From Baseline in MIP and MEP scores at 3 and 6 months]
• Peripheral muscle strength [Срок оценки: Change From Baseline in handgrip scores at 3 and 6 months]
• Physical Activity (Physical Activity Questionnaire for Older Children) [Срок оценки: Change From Baseline in PAQ-C Score at 3 and 6 months]
• Physical Activity and Sedentary Behavior (Youth Activity Profile) [Срок оценки: Change From Baseline in YAP Score at 3 and 6 months]
• Health-Related Quality of Life [Срок оценки: Change From Baseline in PedsQL Score at 3 and 6 months]
• Cough-specific Quality of Life [Срок оценки: Change From Baseline in CC-QoL Score at 3 and 6 months]
• Sleep Quality [Срок оценки: Change From Baseline in PSQ Score at 3 and 6 months]
• Digital Health Services Satisfaction [Срок оценки: TUQ Score after 12 weeks (end of the intervention)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Греция · 1 центр

• Physiotherapy Department, University of Thessaly — Lamia

Публикации

• 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

Идентификаторы

NCT: NCT07376187 · 22510/25

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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