- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07539571
Telerehabilitation in Patients With Bronchiectasis
Effectiveness of a 12-week Telerehabilitation Training in Patients With Bronchiectasis: A Randomized Controlled Trial.
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Sevilla
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Seville, Sevilla, Spain, 41013
- Hospital Universitario Virgen del Rocio
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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No Intervention: Usual care group
Standard care for exacerbation and follow-up without rehabilitation.
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Experimental: Exercise group
Telerehabilitation: 12 weeks of supervised exercise interventions.
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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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
6-minute walk distance
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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Patients walk through a 30-meter corridor faster than they can for 6 minutes
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Baseline, week 6, after 12 weeks of telerehabilitation program, and at 3 and 6 months after completing the telerehabilitation program.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The quality of life
Time Frame: Baseline, after 12 weeks of telerehabilitation program and at 3 and 6 months after completing the telerehabilitation program.
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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.
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Baseline, after 12 weeks of telerehabilitation program and at 3 and 6 months after completing the telerehabilitation program.
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Pulmonary function tests
Time Frame: Baseline and after 12 weeks of telerehabilitation program.
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pulmonary function tests (FEV1, FVC)
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Baseline and after 12 weeks of telerehabilitation program.
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Respiratory Muscle Strength
Time Frame: Baseline and after 12 weeks of telerehabilitation program.
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Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP).
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Baseline and after 12 weeks of telerehabilitation program.
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Exahled Nitric Oxide Fraction (FeNO)
Time Frame: Baseline and after 12 weeks of telerehabilitation program.
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Exahled Nitric Oxide Fraction (FeNO)
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Baseline and after 12 weeks of telerehabilitation program.
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Sputum microbiology
Time Frame: Baseline, after 12 weeks of telerehabilitation program, and at 3 and 6 months after completing the telerehabilitation program.
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The presence of Pseudomonas Aeruginosa through microbiological analysis of sputum
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Baseline, after 12 weeks of telerehabilitation program, and at 3 and 6 months after completing the telerehabilitation program.
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Biological markers of Biological markers of inflammation
Time Frame: Baseline and after 12 weeks of telerehabilitation program.
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PCR, neutrophil/lymphocyte ratio, IL-1β, IL-6, TNF-α levels.
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Baseline and after 12 weeks of telerehabilitation program.
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Dyspnoea
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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Modified Medical Research Council (mMRC) dyspnoea scale.
Minimum value (Grade 0): Absence of dyspnea.
Maximum value (Grade 4): Severe dyspnea.
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Baseline, week 6, after 12 weeks of telerehabilitation program, and at 3 and 6 months after completing the telerehabilitation program.
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Bronchiectasis severity
Time Frame: Baseline and after 12 weeks of telerehabilitation program.
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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.
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Baseline and after 12 weeks of telerehabilitation program.
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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.
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Change from baseline in respiratory symptoms and adverse events.
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Baseline, week 6, after 12 weeks of telerehabilitation program, and at 3 and 6 months after completing the telerehabilitation program.
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Blood pressure
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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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.
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Heart rate
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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The heart rate value recorded by the sphygmomanometer will be documented.
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Baseline, week 6, after 12 weeks of telerehabilitation program, and at 3 and 6 months after completing the telerehabilitation program.
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Oxygen saturation (SpO2)
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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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.
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Exacerbation
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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Exacerbation rate
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Baseline, week 6, after 12 weeks of telerehabilitation program, and at 3 and 6 months after completing the telerehabilitation program.
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Telerehabilitation adherence
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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Number of sessions completed by participants who take part in the rehabilitation program and training parameters registration
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Baseline, week 6, after 12 weeks of telerehabilitation program, and at 3 and 6 months after completing the telerehabilitation program.
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Respiratory Tract Diseases
- Bronchial Diseases
- Pathological Conditions, Signs and Symptoms
- Inflammation
- Bronchiectasis
- Health Services Administration
- Delivery of Health Care
- Motor Activity
- Movement
- Musculoskeletal Physiological Phenomena
- Musculoskeletal and Neural Physiological Phenomena
- Therapeutics
- Patient Care
- Health Services
- Health Care Facilities Workforce and Services
- Rehabilitation
- Aftercare
- Continuity of Patient Care
- Telemedicine
- Patient Care Management
- Exercise
- Telerehabilitation
Other Study ID Numbers
- TRH-BQ
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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