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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
80
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.
Hospital Universitario Virgen del Rocío
Seville, Sevilla, Spain
6-minute walk distance
Patients walk through a 30-meter corridor faster than they can for 6 minutes
Time frame: Baseline, week 6, after 12 weeks of telerehabilitation program, and at 3 and 6 months after completing the telerehabilitation program.
The quality of life
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.
Time frame: Baseline, after 12 weeks of telerehabilitation program and at 3 and 6 months after completing the telerehabilitation program.
Pulmonary function tests
pulmonary function tests (FEV1, FVC)
Time frame: Baseline and after 12 weeks of telerehabilitation program.
Respiratory Muscle Strength
Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP).
Time frame: Baseline and after 12 weeks of telerehabilitation program.
Exahled Nitric Oxide Fraction (FeNO)
Exahled Nitric Oxide Fraction (FeNO)
Time frame: Baseline and after 12 weeks of telerehabilitation program.
Sputum microbiology
The presence of Pseudomonas Aeruginosa through microbiological analysis of sputum
Time frame: Baseline, after 12 weeks of telerehabilitation program, and at 3 and 6 months after completing the telerehabilitation program.
Biological markers of Biological markers of inflammation
PCR, neutrophil/lymphocyte ratio, IL-1β, IL-6, TNF-α levels.
Time frame: Baseline and after 12 weeks of telerehabilitation program.
Dyspnoea
Modified Medical Research Council (mMRC) dyspnoea scale. Minimum value (Grade 0): Absence of dyspnea. Maximum value (Grade 4): Severe dyspnea.
Time frame: Baseline, week 6, after 12 weeks of telerehabilitation program, and at 3 and 6 months after completing the telerehabilitation program.
Bronchiectasis severity
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.
Time frame: Baseline and after 12 weeks of telerehabilitation program.
Change from baseline in respiratory symptoms and adverse events.
Change from baseline in respiratory symptoms and adverse events.
Time frame: Baseline, week 6, after 12 weeks of telerehabilitation program, and at 3 and 6 months after completing the telerehabilitation program.
Blood pressure
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.
Time frame: Baseline, week 6, after 12 weeks of telerehabilitation program, and at 3 and 6 months after completing the telerehabilitation program.
Heart rate
The heart rate value recorded by the sphygmomanometer will be documented.
Time frame: Baseline, week 6, after 12 weeks of telerehabilitation program, and at 3 and 6 months after completing the telerehabilitation program.
Oxygen saturation (SpO2)
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%.
Time frame: Baseline, week 6, after 12 weeks of telerehabilitation program, and at 3 and 6 months after completing the telerehabilitation program.
Exacerbation
Exacerbation rate
Time frame: Baseline, week 6, after 12 weeks of telerehabilitation program, and at 3 and 6 months after completing the telerehabilitation program.
Telerehabilitation adherence
Number of sessions completed by participants who take part in the rehabilitation program and training parameters registration
Time frame: Baseline, week 6, after 12 weeks of telerehabilitation program, and at 3 and 6 months after completing the telerehabilitation program.
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