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

NCT ID: NCT07088614

Last Updated: 2025-07-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-28
• Study Completion Date: 2023-07-04

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.

Conditions

Cystic Fibrosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Remote respiratory physiotherapy

Intervention Type: 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.

Interventions

Remote respiratory physiotherapy

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Luis Calvo Mackenna Children´s Hospital

OTHER

Sponsor Role: collaborator

University of Americas

OTHER

Sponsor Role: lead

Responsible Party

Andrea Mendez

Full Professor, School of Physiotherapy, Faculty of Health and Social Sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Dr. Luis Calvo Mackenna Children's Hospital

Santiago, Santiago Metropolitan, Chile

Countries

Chile

References

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.

Reference Type: BACKGROUND

PMID: 22129901 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25927329 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 14985563 (View on PubMed)

Other Identifiers

DI20/22

Identifier Type: -

Identifier Source: org_study_id