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

NCT07088614 | Completed

• 1 other identifier: DI20/22
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Cystic Fibrosis

Keywords

Cystic fibrosis; Physiotherapy; Telehealth; Telemedicine; Children

Outcome Measures

Primary Outcomes (1)

• Exacerbations frequency

  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.

  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.

Secondary Outcomes (9)

• 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.

• 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.

• 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.

Other Outcomes (6)

• Age

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

• Sex

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

• Age at diagnosis

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

Study Arms (1)

Remote physiotherapy group

EXPERIMENTAL

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.

Other: Remote respiratory physiotherapy

Interventions

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.

Remote physiotherapy group

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Patients currently undergoing pulmonary rehabilitation.
• Patients undergoing lung transplantation.
• Patients with severe comorbidity affecting survival.

Sponsors & Collaborators

• University of Americas: lead
• Luis Calvo Mackenna Children´s Hospital: collaborator

Study Sites (1)

Dr. Luis Calvo Mackenna Children's Hospital

Santiago, Santiago Metropolitan, 8370000, Chile

Location

Related Publications (3)

• Lavie M, Vilozni D, Sokol G, Somech R, Szeinberg A, Efrati O. Hospital versus home treatment of respiratory exacerbations in cystic fibrosis. Med Sci Monit. 2011 Dec;17(12):CR698-703. doi: 10.12659/msm.882129.

  PMID: 22129901 BACKGROUND

• Goodfellow NA, Hawwa AF, Reid AJ, Horne R, Shields MD, McElnay JC. Adherence to treatment in children and adolescents with cystic fibrosis: a cross-sectional, multi-method study investigating the influence of beliefs about treatment and parental depressive symptoms. BMC Pulm Med. 2015 Apr 26;15:43. doi: 10.1186/s12890-015-0038-7.

  PMID: 25927329 BACKGROUND

• Thornton J, Elliott R, Tully MP, Dodd M, Webb AK. Long term clinical outcome of home and hospital intravenous antibiotic treatment in adults with cystic fibrosis. Thorax. 2004 Mar;59(3):242-6. doi: 10.1136/thx.2003.005876.

  PMID: 14985563 BACKGROUND

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor, School of Physiotherapy, Faculty of Health and Social Sciences

Model Details: Pre-experimental design, single-center

Study Record Dates

• First Submitted: July 11, 2025
• First Posted: July 28, 2025
• Study Start: October 28, 2022
• Primary Completion: June 1, 2023
• Study Completion: July 4, 2023
• Last Updated: July 28, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)