BronchiectasisNCT07539571
Telerehabilitation in Patients With Bronchiectasis
A study testing telerehabilitation in people with Bronchiectasis and Telerehabilitation, run by Hospitales Universitarios Virgen del Rocío at 1 site in Spain.
Trial summary
Background: Home-based telerehabilitation (TR) has demonstrated benefits comparable to conventional rehabilitation in patients with chronic obstructive pulmonary disease, asthma, and pulmonary fibrosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bronchiectasis, Telerehabilitation
- What is being tested?
- telerehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2026to Dec 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read more
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.
- Conditions
- Bronchiectasis, Telerehabilitation
- Being tested
- telerehabilitation
- Keywords
- Bronchiectasis, Telerehabilitation, Quality of life, Inflammation
- Medical subject headings
- Bronchiectasis, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
telerehabilitationOther
Also called physical activity
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.
| Study group | Role | What they receive |
|---|---|---|
| Usual care group | No intervention | Standard care for exacerbation and follow-up without rehabilitation. |
| Exercise group | Experimental | Telerehabilitation: 12 weeks of supervised exercise interventions. Receives: Other: telerehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-minute walk distance
Patients walk through a 30-meter corridor faster than they can for 6 minutes
Measured: Baseline, week 6, after 12 weeks of telerehabilitation program, and at 3 and 6 months after completing the telerehabilitation program.
Secondary outcomes (14)
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.
Measured: 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)
Measured: Baseline and after 12 weeks of telerehabilitation program.
Respiratory Muscle Strength
Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP).
Measured: Baseline and after 12 weeks of telerehabilitation program.
Exahled Nitric Oxide Fraction (FeNO)
Exahled Nitric Oxide Fraction (FeNO)
Measured: Baseline and after 12 weeks of telerehabilitation program.
Sputum microbiology
The presence of Pseudomonas Aeruginosa through microbiological analysis of sputum
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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%.
Measured: Baseline, week 6, after 12 weeks of telerehabilitation program, and at 3 and 6 months after completing the telerehabilitation program.
Exacerbation
Exacerbation rate
Measured: 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
Measured: Baseline, week 6, after 12 weeks of telerehabilitation program, and at 3 and 6 months after completing the telerehabilitation program.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2026
- Study startSep 2026 (estimated)
- Primary completionDec 2031 (estimated)
- Study completionDec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BronchiectasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospitales Universitarios Virgen del Rocío
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana Ortega Moral, Hospitales Universitarios Virgen del Rocío
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07539571
- Sponsor's protocol ID
- TRH-BQ
- Status last verified
- Apr 2026
- First submitted
- 15 Dec 2025
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a 12-week Telerehabilitation Training in Patients With Bronchiectasis: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT07539571
- Acronym / sponsor ID
- TRH-BQ
- Conditions
- Bronchiectasis, Telerehabilitation
- Keywords
- Bronchiectasis, Telerehabilitation, Quality of life, Inflammation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Hospitales Universitarios Virgen del RocíoUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Dec 2031 (estimated)
- Study completion
- Dec 2032 (estimated)
- First posted
- 20 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care group | No intervention | –Standard care for exacerbation and follow-up without rehabilitation. |
| Exercise group | Experimental | Other: telerehabilitationTelerehabilitation: 12 weeks of supervised exercise interventions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| telerehabilitationAlso: physical activity3 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 | Exercise group |
Primary outcome
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.
Patients walk through a 30-meter corridor faster than they can for 6 minutes
14 secondary outcomes
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.
Exacerbation
Time frame: Baseline, week 6, after 12 weeks of telerehabilitation program, and at 3 and 6 months after completing the telerehabilitation program.
Telerehabilitation adherence
Time frame: Baseline, week 6, after 12 weeks of telerehabilitation program, and at 3 and 6 months after completing the telerehabilitation program.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing telerehabilitation in people with Bronchiectasis and Telerehabilitation, run by Hospitales Universitarios Virgen del Rocío at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026.