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Completed

NCT Number: NCT07088614

Effectiveness of Respiratory Physiotherapy on Frequency of Exacerbations, Lung Function and Quality of Life After 6 Months in Children With Cystic Fibrosis

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.

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Key information

Conditions

Cystic Fibrosis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Pancreatic Diseases Respiratory Tract Diseases

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dr. Luis Calvo Mackenna Children's Hospital

Santiago, Santiago Metropolitan, 8370000, Chile

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Remote respiratory physiotherapy

Other

Remote respiratory physiotherapy protocol supervised 3 times a week via digital video conferencing, 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.

Primary outcomes

  1. 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

  1. Health-related quality of life

    Time frame: 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.

    Quality of life will be assessed using the PedsQL™ Generic Core Scales, a 23-item generic health-related quality of life questionnaire designed for healthy children and adolescents aged 2-18 years, as well as those with chronic health conditions. The PedsQL™ Young Child Report (ages 5-7), Child Report (8-12), Teen Report (13-18), and corresponding parent proxy reports will be used. The PedsQL™ evaluates four domains: physical, emotional, social, and school functioning, using a 5-point Likert scale, with scores ranging from 0 to 92, where lower scores indicate better health-related quality of life. The PedsQL™ is a valid and reliable instrument, with an internal consistency coefficient of 0.88, and has been used in studies of patients with cystic fibrosis.

  2. FEV1

    Time frame: 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.

    FEV1 as a percentage of predicted assessed by spirometry using a laboratory spirometer at Dr. Luis Calvo Mackenna Hospital, previously calibrated, following the American Thoracic Society/European Respiratory Society (ATS/ERS) clinical guidelines.

  3. Days of hospitalization

    Time frame: 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 of hospitalization will be assessed using the medical record as number of days

  4. Days on intravenous/oral antibiotic treatment for respiratory causes

    Time frame: 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.

    Days on intravenous/oral antibiotic treatment for respiratory causes will be assessed in the last 6 months, using the medical record.

  5. Exercise capacity

    Time frame: 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.

    Exercise capacity will be assessed using the 6-Minute Walk Test (6MWT), a reliable and valid test to measure exercise tolerance in children with cystic fibrosis. During the test, oxygen saturation (SpO₂) and heart rate (HR) will be continuously monitored and recorded at the beginning and end of the test, using the patient's own pulse oximeter or one provided by the study. Dyspnea will be assessed using the modified Borg scale at the beginning and end of the test. The exercise capacity will be expressed as distance walked, in meters,

  6. Treatment adherence

    Time frame: Treatment adherence will be assessed at the end of the study, i.e. six months after the beginning of the intervention.

    Treatment adherence will be determined as the percentage of compliance with the intervention guidelines.

  7. Adverse events

    Time frame: The occurrence of adverse events will be assessed from the beginning of the intervention up to six months after the beginning of the intervention.

    The occurrence of adverse events will be assessed using the medical record.

  8. FVC

    Time frame: 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.

    FVC as a percentage of predicted by spirometry using a laboratory spirometer at Dr. Luis Calvo Mackenna Hospital, previously calibrated, following the American Thoracic Society/European Respiratory Society (ATS/ERS) clinical guidelines.

  9. FEV1/FVC

    Time frame: 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.

    FEV1/FVC as a percentage assessed by spirometry using a laboratory spirometer at Dr. Luis Calvo Mackenna Hospital, previously calibrated, following the American Thoracic Society/European Respiratory Society (ATS/ERS) clinical guidelines.

Other outcomes

  1. Age

    Time frame: Age will be assessed at the baseline, 2 weeks maximum before the beginning of the intervention

    Age expressed in years will be determined using the medical record

  2. Sex

    Time frame: Sex will be assessed at the baseline, 2 weeks maximum before the beginning of the intervention

    Sex will be expressed as female or male, and it will be determined using the medical record

  3. Age at diagnosis

    Time frame: Age at diagnosis will be assessed at the baseline, 2 weeks maximum before the beginning of the intervention

    Age at diagnosis expressed in years will be determined using the medical record

  4. Body Mass Index (BMI)

    Time frame: Body Mass Index (BMI) will be assessed at the baseline, 2 weeks maximum before the beginning of the intervention

    Body Mass Index (BMI) will be calculated using the weight-to-height ratio (weight in kilograms/height in meters), both measured by stadiometer and scale.

  5. Co-morbidity

    Time frame: Co-morbidity will be assessed at the baseline, 2 weeks maximum before the beginning of the intervention

    Co-morbidity will be determined using the medical record

  6. Frequency of outpatient physiotherapy visits

    Time frame: Frequency of outpatient physiotherapy visits will be assessed at the baseline, 2 weeks maximum before the beginning of the intervention

    Frequency of outpatient physiotherapy visits will be expressed as times/month, and it will be determined using the medical record

Sponsors and collaborators

Lead sponsor

University of Americas

Other

Collaborators

  • Luis Calvo Mackenna Children´s Hospital

Registry information

Official study title

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.

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 28, 2025
Registry last updated
Jul 28, 2025

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.

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