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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual care group | No Intervention | Standard care for exacerbation and follow-up without rehabilitation. | |
| Exercise group | Experimental | Telerehabilitation: 12 weeks of supervised exercise interventions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| telerehabilitation | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 6-minute walk distance | Patients walk through a 30-meter corridor faster than they can for 6 minutes | Baseline, week 6, after 12 weeks of telerehabilitation program, and at 3 and 6 months after completing the telerehabilitation program. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, after 12 weeks of telerehabilitation program and at 3 and 6 months after completing the telerehabilitation program. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Virgen del Rocío | Seville | Sevilla | 41013 | Spain |
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| ID | Term |
|---|---|
| D001987 | Bronchiectasis |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000069350 | Telerehabilitation |
| D015444 | Exercise |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
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|
|
| Pulmonary function tests |
pulmonary function tests (FEV1, FVC) |
| Baseline and after 12 weeks of telerehabilitation program. |
| Respiratory Muscle Strength | Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP). | Baseline and after 12 weeks of telerehabilitation program. |
| Exahled Nitric Oxide Fraction (FeNO) | Exahled Nitric Oxide Fraction (FeNO) | Baseline and after 12 weeks of telerehabilitation program. |
| Sputum microbiology | The presence of Pseudomonas Aeruginosa through microbiological analysis of sputum | 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. | 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. | 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. | 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. | 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. | 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. | 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%. | Baseline, week 6, after 12 weeks of telerehabilitation program, and at 3 and 6 months after completing the telerehabilitation program. |
| Exacerbation | Exacerbation rate | 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 | Baseline, week 6, after 12 weeks of telerehabilitation program, and at 3 and 6 months after completing the telerehabilitation program. |
| D013812 |
| Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D017216 | Telemedicine |
| D003695 | Delivery of Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |