Telerehabilitation in Patients With Bronchiectasis

Official title

Effectiveness of a 12-week Telerehabilitation Training in Patients With Bronchiectasis: A Randomized Controlled Trial.

Overview

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

• Other telerehabilitation
  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.

Primary outcome measures

• 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.]

Secondary outcome measures (12)

• The quality of life [Time frame: Baseline, after 12 weeks of telerehabilitation program and at 3 and 6 months after completing the telerehabilitation program.]
• Pulmonary function tests [Time frame: Baseline and after 12 weeks of telerehabilitation program.]
• Respiratory Muscle Strength [Time frame: Baseline and after 12 weeks of telerehabilitation program.]
• Exahled Nitric Oxide Fraction (FeNO) [Time frame: Baseline and after 12 weeks of telerehabilitation program.]
• Sputum microbiology [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 [Time frame: Baseline and after 12 weeks of telerehabilitation program.]
• Dyspnoea [Time frame: Baseline, week 6, after 12 weeks of telerehabilitation program, and at 3 and 6 months after completing the telerehabilitation program.]
• Bronchiectasis severity [Time frame: Baseline and after 12 weeks of telerehabilitation program.]
• 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 [Time frame: Baseline, week 6, after 12 weeks of telerehabilitation program, and at 3 and 6 months after completing the telerehabilitation program.]
• Heart rate [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) [Time frame: Baseline, week 6, after 12 weeks of telerehabilitation program, and at 3 and 6 months after completing the telerehabilitation program.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Spain · 1 center

• Hospital Universitario Virgen del Rocío — Seville

Identifiers

NCT: NCT07539571 · TRH-BQ

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗