Digital Physiotherapy Services in the Management of Pediatric Chronic Suppurative Lung Diseases: A Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- University of Thessaly
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- Exercise Capacity (modified Shuttle Walk test)
Overview
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
Block Randomisation, Initial and final outcome assessors blinded to treatment arm
Eligibility Criteria
- Ages
- 6 Years to 12 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Digital Health Services Group (DHSG)
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.
Intervention: Specially designed website (FysΑΩ) (Device)
Digital Health Services Group (DHSG)
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.
Intervention: Videoconferencing (Vsee platform) (Device)
Control Group (CG)
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.
Outcomes
Primary Outcomes
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.
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
- 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)
- Physical Activity and Sedentary Behavior (Youth Activity Profile)(Change From Baseline in YAP Score at 3 and 6 months)
- Health-Related Quality of Life(Change From Baseline in PedsQL Score at 3 and 6 months)
- Cough-specific Quality of Life(Change From Baseline in CC-QoL Score at 3 and 6 months)
- Sleep Quality(Change From Baseline in PSQ Score at 3 and 6 months)
- Digital Health Services Satisfaction(TUQ Score after 12 weeks (end of the intervention))
Investigators
Aspasia Mavronasou
PT, MSc, PhD candidate, Principal Investigator
University of Thessaly