An interventional study of Exercise plus Monitoring Group (TG-2) and Exercise plus monitoring and follow-up group (TGF-3) in Cystic Fibrosis, sponsored by University of Valencia. Recruiting at 1 site in Spain. Open to participants aged 6 Years and older. Per ClinicalTrials.gov, last updated 2025-02-13.
Sponsored by University of Valencia · Not applicable, Interventional, and Prevention
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.
1,581 studies on the registry are indexed under Cystic Fibrosis; 190 are open to participants now.
This study's planned enrollment of 60 is above the median of 36 across 1,034 interventional studies indexed under Cystic Fibrosis.
Browse Cystic Fibrosis studies →University of Valencia is the lead sponsor of 349 studies on the registry; 73 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will receive their usual physiotherapy treatment.
Behavioral: Exercise Group (CG-1)
Participants will receive their usual physiotherapy treatment, plus explanation of the use of the monitoring equipment.
Behavioral: Exercise plus Monitoring Group (TG-2)
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.
Behavioral: Exercise plus monitoring and follow-up group (TGF-3)
Participants will receive their usual physiotherapy treatment and user education on bronchial care and hygiene, plus a dossier on the use of monitoring equipment such as: pulse oximeter, thermometer, digital spirometer, Medical Research Council dyspnoea scale. If the patient detects an exacerbation (due to symptoms or monitoring of the equipment), they can contact a physiotherapist who can adjust the treatment.
Also known as: Exercise plus Monitoring Group
Participants who will receive their usual physiotherapy treatment and user education on bronchial care and hygiene, plus dossiers on the use of monitoring equipment ; plus telematic control of exacerbations (questionnaires and monitoring of the parameters of the aforementioned equipment). Depending on the follow-up, physiotherapy treatment will be adjusted. The questionnaire includes tracking of the following parameters: cough, secretions (quantity, colour, viscosity), chest tightness, dyspnoea, exercise tolerance, tiredness and appetite). The follow-up will consist of weekly filling the spreadsheet to which the physiotherapist will have access and who, by reviewing the parameters, will be able to adjust the treatment. The physiotherapist will systematically make videocalls to the participants and if the follow-up values require it, he/she will call every week.
Participants who will receive their usual physiotherapy treatment and user education on bronchial care and hygiene
Also known as: Exercise Group
Clinical exacerbation
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
Time frame: At baseline (T1), at 6 months (T2) and at 12 months(T3).
Dyspnea
Modified Medical Research Council (mMRC) scale (0 to 4 points). Higher scores are related to higher dyspnea.
Time frame: At baseline (T1), at 6 months (T2) and at 12 months(T3).
Spirometric function
Forced expiratory volume in the first second (FEV1) in L/sec
Time frame: At baseline (T1), at 6 months (T2) and at 12 months(T3).
Oxigenation
Oxyhemoglobin saturation in percent.
Time frame: At baseline (T1), at 6 months (T2) and at 12 months(T3).
Functional capacity
30 seconds sit-to-stand test (in number of repetitions)
Time frame: At baseline (T1), at 6 months (T2) and at 12 months(T3).
Quality of life (QoL)
Cystic fibrosis questionnaire-revised (in score points). It is a 0-100 scale with higher scores indicating better quality of life.
Time frame: At baseline (T1) and at 12 months(T3).
Motivation to engage in physical activity
A confidential online ad-hoc 13-item survey regarding their views, opinions and practices in relation to physical activity. This is a survey that is analyzed qualitatively.
Time frame: At baseline (T1)
Plan to share: No
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University of Valencia