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| Name | Class |
|---|---|
| Asociación de Fibrosis QuÃstica - Comunidad Valenciana | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control exercise group (CG-1) | Active Comparator | Participants will receive their usual physiotherapy treatment. |
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| Exercise plus monitoring group (TG-2) | Experimental | 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 | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise plus Monitoring Group (TG-2) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | At baseline (T1), at 6 months (T2) and at 12 months(T3). |
| Measure | Description | Time Frame |
|---|---|---|
| Dyspnea | Modified Medical Research Council (mMRC) scale (0 to 4 points). Higher scores are related to higher dyspnea. | At baseline (T1), at 6 months (T2) and at 12 months(T3). |
| Spirometric function |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At baseline (T1) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Francisco Martinez-Arnau, PhD | Contact | 0034963983853 | 51327 | francisco.m.martinez@uv.es |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instalaciones de la Universitat de Valencia | Recruiting | Valencia | 46010 | Spain |
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| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| C088547 | KTN1 protein, human |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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Participants will be randomly assigned to one of three study groups by the person conducting the intervention.
All participants receive usual physiotherapy treatment, and both intervention groups receive monitoring and follow-up of their clinical situation.
The evaluators are unaware of the assignment at all times.
|
|
| Exercise plus monitoring and follow-up group (TGF-3) | Behavioral | 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) | Behavioral | Participants who will receive their usual physiotherapy treatment and user education on bronchial care and hygiene |
|
|
Forced expiratory volume in the first second (FEV1) in L/sec
| At baseline (T1), at 6 months (T2) and at 12 months(T3). |
| Oxigenation | Oxyhemoglobin saturation in percent. | At baseline (T1), at 6 months (T2) and at 12 months(T3). |
| Functional capacity | 30 seconds sit-to-stand test (in number of repetitions) | 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. | At baseline (T1) and at 12 months(T3). |
| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |