Bronchiectasis, Telerehabilitation
Conditions
Keywords
Bronchiectasis, Telerehabilitation, Quality of life, Inflammation
Brief summary
Background: Home-based telerehabilitation (TR) has demonstrated benefits comparable to conventional rehabilitation in patients with chronic obstructive pulmonary disease, asthma, and pulmonary fibrosis. However, TR has not been thoroughly investigated in patients with bronchiectasis, despite evidence suggesting improvements in exercise capacity and quality of life. Aims: To evaluate the effects of TR on functional capacity, quality of life, and inflammatory biomarkers, as well as its safety in patients with bronchiectasis. Study design: Single-center randomized controlled trial with a parallel-group design. Methods: Patients diagnosed with bronchiectasis will be recruited from the Surgical Medical Unit for Respiratory Diseases at Virgen del Rocío University Hospital. Participants will be randomly assigned to one of two groups: a control group receiving usual care, and a TR group undergoing supervised physical training for 12 weeks, three times per week. Outcome measures will include the 6-minute walk test, quality-of-life questionnaires, pulmonary function tests, symptom assessment, and adverse event recording, as well as sputum microbiology and analysis of inflammatory biomarkers. Assessments will be conducted at baseline and at the end of the intervention. Expected results: A 12-week TR program is expected to significantly improve exercise capacity and quality of life in the intervention group. Additionally, this study may contribute to the development of future clinical guidelines regarding the use of TR in patients with bronchiectasis.
Interventions
OTHERtelerehabilitation
3 days per week: supervised resistance training that includes upper and lower limb and core exercises, initially using with low weights, performed in 2 sets with 10 repetitions, with progressive weekly increases depending on symptoms. 4 days per week: endurance training. Patients will walk on days when they do not perform strength training, for at least 30 minutes, with the duration gradually increased each month depending on their symptoms.
Sponsors
Hospitales Universitarios Virgen del Rocío
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Bronchiectasis diagnosed by high resolution computed tomography (HRCT) of the chest. * Clinically stable patients (without hospitalizations, infection or changes in pharmacological treatment in the last month of the study beginning). * Both gender * Non smokers. * Internet connection available.
Exclusion criteria
* Inability to give informed consent to participate * Less of 18 years * With other lung related diseases (asthma, COPD and cystic fibrosis) * Decompensated cardiovascular and metabolic diseases, neuromuscular or musculoskeletal that impede the realization of the protocol. * Mental disorders that prevent the adequate participation in the tele-rehabilitation program. * Simultaneous participation in another clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 6-minute walk distance | Baseline, week 6, after 12 weeks of telerehabilitation program, and at 3 and 6 months after completing the telerehabilitation program. | Patients walk through a 30-meter corridor faster than they can for 6 minutes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The quality of life | Baseline, after 12 weeks of telerehabilitation program and at 3 and 6 months after completing the telerehabilitation program. | ST Georges respiratory questionnaire COPD assessment test. Scores range from 0 to 100, where 0 represents the best possible health (no limitations) and 100 the worst health status. |
| Pulmonary function tests | Baseline and after 12 weeks of telerehabilitation program. | pulmonary function tests (FEV1, FVC) |
| Respiratory Muscle Strength | Baseline and after 12 weeks of telerehabilitation program. | Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP). |
| Exahled Nitric Oxide Fraction (FeNO) | Baseline and after 12 weeks of telerehabilitation program. | Exahled Nitric Oxide Fraction (FeNO) |
| Sputum microbiology | Baseline, after 12 weeks of telerehabilitation program, and at 3 and 6 months after completing the telerehabilitation program. | The presence of Pseudomonas Aeruginosa through microbiological analysis of sputum |
| Biological markers of Biological markers of inflammation | Baseline and after 12 weeks of telerehabilitation program. | PCR, neutrophil/lymphocyte ratio, IL-1β, IL-6, TNF-α levels. |
| Dyspnoea | Baseline, week 6, after 12 weeks of telerehabilitation program, and at 3 and 6 months after completing the telerehabilitation program. | Modified Medical Research Council (mMRC) dyspnoea scale. Minimum value (Grade 0): Absence of dyspnea. Maximum value (Grade 4): Severe dyspnea. |
| Bronchiectasis severity | Baseline and after 12 weeks of telerehabilitation program. | The E-FACED questionnaire. Scores range from 0 to 9, where a score of 0-3 indicates mild severity, 4-6 indicates moderate severity, and ≥ 7 indicates severe disease. |
| Change from baseline in respiratory symptoms and adverse events. | Baseline, week 6, after 12 weeks of telerehabilitation program, and at 3 and 6 months after completing the telerehabilitation program. | Change from baseline in respiratory symptoms and adverse events. |
| Blood pressure | Baseline, week 6, after 12 weeks of telerehabilitation program, and at 3 and 6 months after completing the telerehabilitation program. | Measurement of blood pressure using a sphygmomanometer. Blood Pressure Ranges in Adults: Normal: Less than 120/80 mmHg. Elevated: 120-129 / \< 80 mmHg. Hypertension Grade 1: 130-139 / 80-89 mmHg. Hypertension Grade 2: ≥ 140 / ≥ 90 mmHg. |
| Heart rate | Baseline, week 6, after 12 weeks of telerehabilitation program, and at 3 and 6 months after completing the telerehabilitation program. | The heart rate value recorded by the sphygmomanometer will be documented. |
| Oxygen saturation (SpO2) | Baseline, week 6, after 12 weeks of telerehabilitation program, and at 3 and 6 months after completing the telerehabilitation program. | Oxygen saturation is measured using a pulse oximeter. Values between 95% and 100% are considered normal. Values below 90% are considered hypoxemia. Normal values range between 95% and 100%. |
| Exacerbation | Baseline, week 6, after 12 weeks of telerehabilitation program, and at 3 and 6 months after completing the telerehabilitation program. | Exacerbation rate |
| Telerehabilitation adherence | Baseline, week 6, after 12 weeks of telerehabilitation program, and at 3 and 6 months after completing the telerehabilitation program. | Number of sessions completed by participants who take part in the rehabilitation program and training parameters registration |
Countries
Spain
Outcome results
None listed