Cystic FibrosisNCT06313827
e-Health Program to Prevent Exacerbations in the Cystic Fibrosis Population
A study testing Exercise plus Monitoring Group (TG-2), Exercise plus monitoring and follow-up group (TGF-3) and Exercise Group (CG-1) in people with Cystic Fibrosis, run by University of Valencia at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Exercise plus Monitoring Group (TG-2), Exercise plus monitoring and follow-up group (TGF-3) and Exercise Group (CG-1)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 1 Oct 2024to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosed cystic fibrosis
- Family access to an internet-enabled device
- Camera and microphone
- Absence of exacerbations in the last 30 days
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Instalaciones de la Universitat de Valencia
Valencia, 46010
Francisco Martinez Arnau, PhD
Anna Arnal Gomez, PhD
About this study
Official title: Effectiveness of an e-Health Program to Prevent Exacerbations in the Cystic Fibrosis Population: a Randomized Clinical Trial
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.
- Conditions
- Cystic Fibrosis
- Being tested
- Exercise plus Monitoring Group (TG-2), Exercise plus monitoring and follow-up group (TGF-3), Exercise Group (CG-1)
- Keywords
- e-Health, physiotherapy, Cystic fibrosis, exacerbation, quality of life
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise plus Monitoring Group (TG-2)Behavioural
Also called Exercise plus Monitoring Group
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.
Exercise plus monitoring and follow-up group (TGF-3)Behavioural
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.
Exercise Group (CG-1)Behavioural
Also called Exercise Group
Participants who will receive their usual physiotherapy treatment and user education on bronchial care and hygiene
| Study group | Role | What they receive |
|---|---|---|
| Control exercise group (CG-1) | Active comparator | Participants will receive their usual physiotherapy treatment. Receives: Behavioral: Exercise Group (CG-1) |
| Exercise plus monitoring group (TG-2) | Experimental | Participants will receive their usual physiotherapy treatment, plus explanation of the use of the monitoring equipment. Receives: Behavioral: Exercise plus Monitoring Group (TG-2) |
| Exercise plus monitoring and follow-up group (TGF-3) | Experimental | 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. Receives: Behavioral: Exercise plus monitoring and follow-up group (TGF-3) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At baseline (T1), at 6 months (T2) and at 12 months(T3).
Secondary outcomes (5)
Dyspnea
Modified Medical Research Council (mMRC) scale (0 to 4 points). Higher scores are related to higher dyspnea.
Measured: 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
Measured: At baseline (T1), at 6 months (T2) and at 12 months(T3).
Oxigenation
Oxyhemoglobin saturation in percent.
Measured: At baseline (T1), at 6 months (T2) and at 12 months(T3).
Functional capacity
30 seconds sit-to-stand test (in number of repetitions)
Measured: 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.
Measured: At baseline (T1) and at 12 months(T3).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start1 Oct 2024
- Primary completionJan 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Collaborators
- Asociación de Fibrosis Quística - Comunidad Valenciana
- Responsible party
- Principal investigator, SARA CORTES AMADOR, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06313827
- Sponsor's protocol ID
- UV-INV_3165929
- Status last verified
- Feb 2025
- First submitted
- 1 Mar 2024
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of an e-Health Program to Prevent Exacerbations in the Cystic Fibrosis Population: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06313827
- Acronym / sponsor ID
- UV-INV_3165929
- Conditions
- Cystic Fibrosis
- Keywords
- e-Health, physiotherapy, Cystic fibrosis, exacerbation, quality of life
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Collaborators
- Asociación de Fibrosis Quística - Comunidad Valenciana
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 15 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control exercise group (CG-1) | Active comparator | Behavioral: Exercise Group (CG-1)Participants will receive their usual physiotherapy treatment. |
| Exercise plus monitoring group (TG-2) | Experimental | Behavioral: Exercise plus Monitoring Group (TG-2)Participants will receive their usual physiotherapy treatment, plus explanation of the use of the monitoring equipment. |
| Exercise plus monitoring and follow-up group (TGF-3) | Experimental | Behavioral: 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. |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed cystic fibrosis
- Family access to an internet-enabled device
- Camera and microphone
- Absence of exacerbations in the last 30 days
Key exclusion criteria (6 listed)
- Patients with lung transplant or on the waiting list for lung transplantation
- Previous eye surgery (3 months)
- Hemothorax
- Active infection or inflammatory process
- Tumors
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise plus Monitoring Group (TG-2)Also: Exercise plus Monitoring GroupParticipants 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. | Behavioural | Exercise plus monitoring group (TG-2) |
| Exercise plus monitoring and follow-up group (TGF-3)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. | Behavioural | Exercise plus monitoring and follow-up group (TGF-3) |
| Exercise Group (CG-1)Also: Exercise GroupParticipants who will receive their usual physiotherapy treatment and user education on bronchial care and hygiene | Behavioural | Control exercise group (CG-1) |
Primary outcome
Clinical exacerbation
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
5 secondary outcomes
Dyspnea
Time frame: At baseline (T1), at 6 months (T2) and at 12 months(T3).
Spirometric function
Time frame: At baseline (T1), at 6 months (T2) and at 12 months(T3).
Oxigenation
Time frame: At baseline (T1), at 6 months (T2) and at 12 months(T3).
Functional capacity
Time frame: At baseline (T1), at 6 months (T2) and at 12 months(T3).
Quality of life (QoL)
Time frame: At baseline (T1) and at 12 months(T3).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise plus Monitoring Group (TG-2), Exercise plus monitoring and follow-up group (TGF-3) and Exercise Group (CG-1) in people with Cystic Fibrosis, run by University of Valencia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Francisco Martinez-Arnau, PhD (0034963983853 ext. 51327, francisco.m.martinez@uv.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical exacerbation (time frame: At baseline (T1), at 6 months (T2) and at 12 months(T3).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2025.