e-Health Program to Prevent Exacerbations in the Cystic Fibrosis Population

Not Applicable

Recruiting

• Conditions: Cystic Fibrosis
• Interventions: Behavioral: Exercise Group (CG-1); Behavioral: Exercise plus monitoring and follow-up group (TGF-3); Behavioral: Exercise plus Monitoring Group (TG-2)

• Registration Number: NCT06313827
• Lead Sponsor: University of Valencia

Brief Summary

The goal of this clinical trial is to analyse the impact of a telematic assessment and monitoring protocol in people with cystic fibrosis, in order to identify exacerbations early, thus preventing loss of lung function and maintaining quality of life.

Participants will be assigned to one of 3 study groups:

Control group (CG-1): will receive their usual physiotherapy treatment; Treatment group (TG-2): will receive their usual physiotherapy treatment, plus explanation of the use of the monitoring equipment; Treatment and follow-up group (TGF-3): will receive their usual physiotherapy treatment, plus explanation of the use of the monitoring equipment, plus telematic control of exacerbations with feedback from the physiotherapist.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-03-01
• Study First Submitted QC: 2024-03-12
• Study First Posted: 2024-03-15
• Study Start: 2024-10-01
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-11
• Last Update Posted: 2025-02-13
• Primary Completion: 2026-01
• Study Completion: 2027-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Diagnosed cystic fibrosis
• Family access to an internet-enabled device
• Camera and microphone
• Absence of exacerbations in the last 30 days

Exclusion Criteria

• Patients with lung transplant or on the waiting list for lung transplantation
• Previous eye surgery (3 months)
• Hemothorax
• Active infection or inflammatory process
• Tumors
• Cognitive problems that make it impossible for them to use telematic devices.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control exercise group (CG-1)	Exercise Group (CG-1)	Participants will receive their usual physiotherapy treatment.
Exercise plus monitoring and follow-up group (TGF-3)	Exercise plus monitoring and follow-up group (TGF-3)	Participants will receive their usual physiotherapy treatment, plus explanation of the use of the monitoring equipment, plus telematic control (via 1:1 real-time videoconferencing) of exacerbations with feedback from the physiotherapist.
Exercise plus monitoring group (TG-2)	Exercise plus Monitoring Group (TG-2)	Participants will receive their usual physiotherapy treatment, plus explanation of the use of the monitoring equipment.

Primary Outcome Measures

Name	Time	Method
Clinical exacerbation	At baseline (T1), at 6 months (T2) and at 12 months(T3).	Presence of an exacerbation. To consider this the Escribano criteria will be followed, for which the presence of at least 3 of the criteria stablished (Clinical, spirometric, radiographic, analytical, and microbiological), collected by interviewing the patient

Secondary Outcome Measures

Name	Time	Method
Oxigenation	At baseline (T1), at 6 months (T2) and at 12 months(T3).	Oxyhemoglobin saturation in percent.
Functional capacity	At baseline (T1), at 6 months (T2) and at 12 months(T3).	30 seconds sit-to-stand test (in number of repetitions)
Spirometric function	At baseline (T1), at 6 months (T2) and at 12 months(T3).	Forced expiratory volume in the first second (FEV1) in L/sec
Dyspnea	At baseline (T1), at 6 months (T2) and at 12 months(T3).	Modified Medical Research Council (mMRC) scale (0 to 4 points). Higher scores are related to higher dyspnea.
Quality of life (QoL)	At baseline (T1) and at 12 months(T3).	Cystic fibrosis questionnaire-revised (in score points). It is a 0-100 scale with higher scores indicating better quality of life.

Trial Locations

Locations (1)

Instalaciones de la Universitat de Valencia; 🇪🇸 Valencia, Spain