NCT Number: NCT06313827
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.
Interested in participating?
Request Info6 year and older
All sexes
Interventional
Not applicable
Valencia, 46010, Spain
Location status: Recruiting
Anna Arnal Gomez, PhD
SUB_INVESTIGATOR
Carlos Gomez Chinesta, PT
SUB_INVESTIGATOR
Francisco Martinez Arnau, PhD
CONTACT
Francisco Martínez Arnau, PhD
SUB_INVESTIGATOR
Sara Cortes Amador, PhD
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: 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
Other names: Exercise Group
Time frame: 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
Time frame: 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.
Time frame: At baseline (T1), at 6 months (T2) and at 12 months(T3).
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).
Oxyhemoglobin saturation in percent.
Time frame: At baseline (T1), at 6 months (T2) and at 12 months(T3).
30 seconds sit-to-stand test (in number of repetitions)
Time frame: 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.
Time frame: At baseline (T1)
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.
Contact information is provided by the study sponsor or research team.
University of Valencia
Other
Effectiveness of an e-Health Program to Prevent Exacerbations in the Cystic Fibrosis Population: a Randomized Clinical Trial
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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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