Telerehabilitation in Patients With Bronchiectasis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHospitales Universitarios Virgen del Rocío
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
telerehabilitation
Other intervention3 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.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Usual care groupNo intervention 0 interventions
Group B: Exercise groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.Secondary outcomes
1
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.2
Pulmonary function tests
pulmonary function tests (FEV1, FVC)
Time frame
Baseline and after 12 weeks of telerehabilitation program.3
Respiratory Muscle Strength
Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP).
Time frame
Baseline and after 12 weeks of telerehabilitation program.4
Exahled Nitric Oxide Fraction (FeNO)
Exahled Nitric Oxide Fraction (FeNO)
Time frame
Baseline and after 12 weeks of telerehabilitation program.Sponsors and contacts
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Source ClinicalTrials.gov
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