Effectiveness of Remote Respiratory Physiotherapy Using a Digital Platform on the Frequency of Exacerbations, Lung Function and Quality of Life, Assessed Before and After 6 Months of Intervention, in Children Aged 6-18 Years With Cystic Fibrosis at Dr. Luis Calvo Mackenna Hospital: a Pre-experimental Study.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 9
- Locations
- 1
- Primary Endpoint
- Exacerbations frequency
Study Overview
Brief Summary
Daily respiratory physiotherapy is a fundamental part of cystic fibrosis treatment, however, patients adherence is low. Thus, there is a need for studies that evaluate the impact of physiotherapy supervision in patients with cystic fibrosis (CF), with particular emphasis on the effectiveness of telemonitoring. A quantitative, pre-experimental, single-centre study was designed involving the universe of patients with CF from Dr. Luis Calvo Mackenna Hospital to measure frequency of exacerbations, pulmonary function and quality of life, before and after remote respiratory physiotherapy intervention via videoconference platform for 6 months.
Detailed Description
This study evaluated the effectiveness of remote respiratory physiotherapy delivered via a videoconferencing platform for children aged 6 to 18 years with cystic fibrosis, who were followed at Dr. Luis Calvo Mackenna Hospital. Cystic fibrosis is a chronic respiratory disease that requires interdisciplinary management from the time of diagnosis, with respiratory physiotherapy being a cornerstone of treatment. Despite its importance, adherence is often low, especially for home-based care. Therefore, the study aimed to determine whether remote supervision could improve key clinical outcomes such as exacerbation frequency, pulmonary function, and quality of life.
The study followed a quantitative, pre-experimental, single-center design, with a non-probabilistic convenience sample. Although the initial target sample size was 16, the final study population included 9 patients, all diagnosed through a sweat test and enrolled in the National Cystic Fibrosis Program. The intervention consisted of remote respiratory physiotherapy sessions, held three times per week for six months, led by a physiotherapist via videoconference. Each session included clinical assessment, airway clearance techniques, supervised use of inhaled medications, physical exercise, and general health education.
Outcomes were measured before and after the intervention. Primary outcomes included the frequency of respiratory exacerbations. Secondary outcomes were lung function (measured by FEV1 and FVC), health-related quality of life (assessed using the PedsQL™ questionnaire), exercise capacity (via the six-minute walk test), days of hospitalization and antibiotic use, treatment adherence, and adverse events. All measurements were performed by trained, blinded professionals according to established clinical standards.
Statistical analysis was conducted using STATA version 14.2. Data distribution was assessed to select appropriate tests: paired t-tests or Wilcoxon tests were used for continuous variables, and McNemar's test was applied to categorical variables. A significance level of 0.05 was used, and results were presented with 95% confidence intervals. All adverse events were documented, including their characteristics, resolution, severity, and potential relation to the intervention.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 6 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with a diagnosis of cystic fibrosis aged 6 to 18 years.
- •Patients admitted to the National Cystic Fibrosis Programme.
- •Patients followed at the pulmonology outpatient clinic of Dr. Luis Calvo Mackenna Hospital.
Exclusion Criteria
- •Patients currently undergoing pulmonary rehabilitation.
- •Patients undergoing lung transplantation.
- •Patients with severe comorbidity affecting survival.
Arms & Interventions
Remote physiotherapy group
Remote respiratory physiotherapy protocol supervised 3 times a week via digital video conference, based on Chilean national guidelines for cystic fibrosis.
Each 1-hour session (3×/week for 6 months) includes:
Evaluation: respiratory assessment, teaching and reinforcement of airway clearance techniques, inhaled medication use, physical activity, and adherence to non-physiotherapy care. Six checklists are used to guide and monitor weekly patient activities.
Respiratory physiotherapy: conducted on-screen by the patient or caregiver, guided remotely. Includes: short-acting bronchodilator (if indicated), 7% hypertonic saline nebulization (10 min), 5-min Flutter/Acapella, ELTGOL or ELPr (2×5 min), and assisted coughing.
Re-evaluation: reassessment with the initial checklist, Q&A, and scheduling the next session.
Participants continue their usual hospital-based care and receive baseline and post-intervention measurements.
Intervention: Remote respiratory physiotherapy (Other)
Outcomes
Primary Outcomes
Exacerbations frequency
Time Frame: Frequency of respiratory exacerbations will be assessed at the baseline, 2 weeks maximum before the beginning of the intervention, and at the end of the study, i.e. six months after the beginning of the intervention.
Frequency of respiratory exacerbations over six months expressed as proportion of subjects with \<1 exacerbation, 1-2 exacerbations, or \>2 exacerbations), using the medical record.
Secondary Outcomes
- FEV1(FEV1 will be assessed at the baseline, 2 weeks maximum before the beginning of the intervention, and at the end of the study, i.e. six months after the beginning of the intervention.)
- Adverse events(The occurrence of adverse events will be assessed from the beginning of the intervention up to six months after the beginning of the intervention.)
- FEV1/FVC(FEV1/FVC will be assessed at the baseline, 2 weeks maximum before the beginning of the intervention, and at the end of the study, i.e. six months after the beginning of the intervention.)
- Health-related quality of life(Health-related quality of life will be assessed at the baseline, 2 weeks maximum before the beginning of the intervention, and at the end of the study, i.e. six months after the beginning of the intervention.)
- Days of hospitalization(Days of hospitalization will be assessed at the baseline, 2 weeks maximum before the beginning of the intervention, and at the end of the study, i.e. six months after the beginning of the intervention.)
- Days on intravenous/oral antibiotic treatment for respiratory causes(Days on intravenous/oral antibiotic treatment will be assessed at the baseline, 2 weeks maximum before the beginning of the intervention, and at the end of the study, i.e. six months after the beginning of the intervention.)
- Exercise capacity(Exercise capacity will be assessed at the baseline, 2 weeks maximum before the beginning of the intervention, and at the end of the study, i.e. six months after the beginning of the intervention.)
- Treatment adherence(Treatment adherence will be assessed at the end of the study, i.e. six months after the beginning of the intervention.)
- FVC(FVC will be assessed at the baseline, 2 weeks maximum before the beginning of the intervention, and at the end of the study, i.e. six months after the beginning of the intervention.)
Investigators
Andrea Mendez
Full Professor, School of Physiotherapy, Faculty of Health and Social Sciences
University of Americas