Non-cystic Fibrosis BronchiectasisNCT02614300
The Role of Pulmonary Rehabilitation and Airways Clearance Techniques in the Multidisciplinary Management of Non CF Bronchiectasis
A study testing Pulmonary Rehabilitation and Chest Physiotherapy, Pulmonary Rehabilitation and Chest Physiotherapy in people with Non-cystic Fibrosis Bronchiectasis, run by Hospital Clinic of Barcelona.
Trial summary
Pulmonary rehabilitation programs are part of the multidisciplinary treatment of some chronic respiratory diseases such as COPD (chronic obstructive pulmonary disease). Although clinical guidelines of other diseases such as non-cystic fibrosis bronchiectasis (nCFBE) discuss the benefits of these programs in quality of… Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Non-cystic Fibrosis Bronchiectasis
- What is being tested?
- Pulmonary Rehabilitation and Chest Physiotherapy, Pulmonary Rehabilitation and Chest Physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Nov 2015to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 50-80 years;
- No performing regular physiotherapy treatment or physical training (≤ 1 time/week);
- Stable disease [no changes in the chronic therapy (both inhaled and systematic) in the usual respiratory symptoms (according to the medical evaluation) and spirometry in the last 4 weeks prior to study recruitment];
- Regular cough and expectoration;
- Ability to follow the exercise program;
- Ability to perform all clinical tests, to understand the process and the purposes of the study;
- A history of at least 2 exacerbations during the previous year requiring antibiotic treatment and;
- Signed informed consent.
Who cannot join
- Active smokers, ex-smokers of less than 1 year prior to recruitment and/or a history of >20 smoking packs/year;
- FEV1 <30% or/and TLC<40% ;
- Diagnosis of cystic fibrosis, sarcoidosis, pulmonary fibrosis, active tuberculosis or non tuberculosis mycobacterial infection,
- Diagnosis of asthma or COPD as a primary respiratory disease and associated secondary bronchiectasis,
- Patients with unstable cardiac disease or locomotor difficulties that preclude exercise (eg, severe arthritis or severe peripheral vascular disease);
- Chronic respiratory failure and/or oxygen therapy;
Show all 12Show fewer
- Frequent haemoptysis (≥ 2 times/month);
- Participation in a PR program during the year prior to inclusion or during the study protocol;
- Participation in a CP program during 1 month prior to inclusion;
- Any physical and psychological disorder that interferes with protocol compliance;
- Participation in a clinical trial implying any change in usual pharmacological treatment in the last 6 months before recruitment;
- Being on the waiting list for lung transplantation or have been transplanted.
Trial locations and contacts
No sites are listed yet.
About this study
Pulmonary rehabilitation programs are part of the multidisciplinary treatment of some chronic respiratory diseases such as COPD (chronic obstructive pulmonary disease). Although clinical guidelines of other diseases such as non-cystic fibrosis bronchiectasis (nCFBE) discuss the benefits of these programs in quality of life and exercise tolerance, evidence of such intervention in nCFBE patients is insufficient. Longer studies are needed with larger sample sizes and optimized to maximize the response and maintain long-term benefits. The present study aims to examine the effects in exercise tolerance of a pulmonary rehabilitation program combined with respiratory physiotherapy in patients with nCFBE. It is a randomized controlled clinical trial with a total duration of 24 months. The intervention will be performed during 12 weeks and then will be a period of 12 months of maintenance. This is a multicenter study involving the following Hospitals: Hospital Clinic, Hospital la Plató and Hospital del Mar of Barcelona, Hospital Josep Trueta of Girona, Royal Infirmary of Edinburgh and Fondazione Maugeri di Lumezzane of Italy. Subjects will be randomized into three groups in a ratio (1: 1: 1) (1) Pulmonary Rehabilitation (2) Chest Physiotherapy and (3) Pulmonary Rehabilitation + Chest Physiotherapy. Hospital la Plató from Barcelona will be responsible for carrying out the Control Group. The primary endpoint will be the test of "endurance shuttle walk test".
- Conditions
- Non-cystic Fibrosis Bronchiectasis
- Being tested
- Pulmonary Rehabilitation and Chest Physiotherapy, Pulmonary Rehabilitation, Chest Physiotherapy
- Keywords
- pulmonary rehabilitation, chest physiotherapy, non-cystic fibrosis bronchiectasis, exercise tolerance, bronchiectasis, respiratory therapy
- Medical subject headings
- Bronchiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary Rehabilitation and Chest PhysiotherapyOther
The patient will come 3 times per week during 12 weeks Each session 1h15min
Pulmonary RehabilitationOther
The patient will come 3 times per week during 12 weeks Each session 45min
Chest PhysiotherapyOther
The patient will come 3 times per week during 12 weeks Each session 30min
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary Rehabilitation | Active comparator | These sessions will be individually designed and they will be a combination of global aerobic interval training using a cycloergometer. The aim is to achieve a training intensity of 80% HR or greater of the obtained during the ISWT. This intensity will be progressively increased during the firsts four weeks until achieving the target. The duration will be of about 45 minutes per session. Oxygen Saturation, HR and Borg scale for dyspnoea and fatigue will be measured before, during and at the end of the session in order to monitories the effort. Receives: Other: Pulmonary Rehabilitation |
| Chest Physiotherapy | Active comparator | The ELTGOL technique ("total slow expiration with glottis open in lateral decubitus") for airways clearance will be used in order to move respiratory secretions from the distal bronchial tree. It will be applied during 15 minutes each side (right and left lungs) assuming an approximate session length of 30 minutes. The patient could perform the cough technique when it's necessary. Receives: Other: Chest Physiotherapy |
| Pulmonary Rehabilitation and Chest Physiotherapy | Active comparator | This group will perform a combination of the two programs in the same session with a total duration of 1h and 15 minutes. The session will be divided in different parts: First, we will execute 15min of chest physiotherapy (7.5min for each side); second, the pulmonary rehabilitation session (45min) and finally, another 15min of chest physiotherapy (7.5min for each side). The patient will have a rest when it's necessary and we will continue with the session when there is a decrease of 2 points in the Borg scale.
Intensity of physiotherapy exercises and drainage techniques will be maintained similar to the PR and CP programs. Receives: Other: Pulmonary Rehabilitation and Chest Physiotherapy |
| Control Group | No intervention | For the control group, participants will attend educational sessions to improve patients' understanding and awareness of the respiratory diseases. These sessions will be performed at beginning and at 12 weeks by the physiotherapist and the pulmonologist. The physiotherapist will also do monthly telephone calls for patient's monitoring. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Exercise tolerance capacity measured as the distance walked in meters during the shuttle test at constant speed (ESWT) at 12 weeks.
Measured: At Screening and 12 weeks of intervention
Secondary outcomes (7)
Exacerbations incidence and symptoms
Measured: During all study (12 weeks of intervention)
Change from Baseline Health related quality of life at 12 weeks.
Measured: At Screening and 12 weeks of intervention with Quality of Life Questionnaire (QoL-B)
Change from Baseline Impact of expectoration on the quality of life at 12 weeks.
Measured: At Screening and 12 weeks of intervention with Leicester Cough Questionnaire (LCQ)
Sputum colour
Measured: During all study (12 weeks of intervention) with Murray's colour scale
Change from Baseline FEV1, FVC and FEV1/FVC at 12 weeks.
Measured: At Screening and 12 weeks of intervention with Pulmonary Function Tests
Change from Baseline Physical activity level measured by accelerometry at 12 weeks.
Measured: At Screening and 12 weeks of intervention with accelerometry
Sputum quantity
Measured: During all study (12 weeks of intervention) with weight of sputum containers in grams
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2015 (estimated)
- Study startNov 2015
- Primary completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-cystic Fibrosis BronchiectasisStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Collaborators
- Sociedad Española de Neumología y Cirugía Torácica
- Responsible party
- Principal investigator, Eva Polverino, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02614300
- Sponsor's protocol ID
- PulmRehab_NCFBE
- Status last verified
- Nov 2015
- First submitted
- 18 Nov 2015
- Last updated
- 25 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Herrero-Cortina B, Alcaraz-Serrano V, Torres A, Polverino E. Reliability and Minimum Important Difference of Sputum Weight in Bronchiectasis. Respir Care. 2020 Oct;65(10):1478-1487. doi: 10.4187/respcare.07175. Epub 2020 Feb 18.
PubMed 32071136
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Pulmonary Rehabilitation and Airways Clearance Techniques in the Multidisciplinary Management of Non CF Bronchiectasis
- ClinicalTrials.gov ID
- NCT02614300
- Acronym / sponsor ID
- PulmRehab_NCFBE
- Conditions
- Non-cystic Fibrosis Bronchiectasis
- Keywords
- pulmonary rehabilitation, chest physiotherapy, non-cystic fibrosis bronchiectasis, exercise tolerance, bronchiectasis, respiratory therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Collaborators
- Sociedad Española de Neumología y Cirugía Torácica
- Study start
- Nov 2015
- Primary completion
- Dec 2017 (estimated)
- First posted
- 25 Nov 2015 (estimated)
- 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.
Pulmonary rehabilitation programs are part of the multidisciplinary treatment of some chronic respiratory diseases such as COPD (chronic obstructive pulmonary disease). Although clinical guidelines of other diseases such as non-cystic fibrosis bronchiectasis (nCFBE) discuss the benefits of these programs in quality of life and exercise tolerance, evidence of such intervention in nCFBE patients is insufficient. Longer studies are needed with larger sample sizes and optimized to maximize the response and maintain long-term benefits. The present study aims to examine the effects in exercise tolerance of a pulmonary rehabilitation program combined with respiratory physiotherapy in patients with nCFBE. It is a randomized controlled clinical trial with a total duration of 24 months. The intervention will be performed during 12 weeks and then will be a period of 12 months of maintenance. This is a multicenter study involving the following Hospitals: Hospital Clinic, Hospital la Plató and Hospital del Mar of Barcelona, Hospital Josep Trueta of Girona, Royal Infirmary of Edinburgh and Fondazione Maugeri di Lumezzane of Italy. Subjects will be randomized into three groups in a ratio (1: 1: 1) (1) Pulmonary Rehabilitation (2) Chest Physiotherapy and (3) Pulmonary Rehabilitation + Chest Physiotherapy. Hospital la Plató from Barcelona will be responsible for carrying out the Control Group. The primary endpoint will be the test of "endurance shuttle walk test".
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Pulmonary Rehabilitation | Active comparator | Other: Pulmonary RehabilitationThese sessions will be individually designed and they will be a combination of global aerobic interval training using a cycloergometer. The aim is to achieve a training intensity of 80% HR or greater of the obtained during the ISWT. This intensity will be progressively increased during the firsts four weeks until achieving the target. The duration will be of about 45 minutes per session. Oxygen Saturation, HR and Borg scale for dyspnoea and fatigue will be measured before, during and at the end of the session in order to monitories the effort. |
| Chest Physiotherapy | Active comparator | Other: Chest PhysiotherapyThe ELTGOL technique ("total slow expiration with glottis open in lateral decubitus") for airways clearance will be used in order to move respiratory secretions from the distal bronchial tree. It will be applied during 15 minutes each side (right and left lungs) assuming an approximate session length of 30 minutes. The patient could perform the cough technique when it's necessary. |
| Pulmonary Rehabilitation and Chest Physiotherapy | Active comparator | Other: Pulmonary Rehabilitation and Chest PhysiotherapyThis group will perform a combination of the two programs in the same session with a total duration of 1h and 15 minutes. The session will be divided in different parts: First, we will execute 15min of chest physiotherapy (7.5min for each side); second, the pulmonary rehabilitation session (45min) and finally, another 15min of chest physiotherapy (7.5min for each side). The patient will have a rest when it's necessary and we will continue with the session when there is a decrease of 2 points in the Borg scale. Intensity of physiotherapy exercises and drainage techniques will be maintained similar to the PR and CP programs. |
| Control Group | No intervention | –For the control group, participants will attend educational sessions to improve patients' understanding and awareness of the respiratory diseases. These sessions will be performed at beginning and at 12 weeks by the physiotherapist and the pulmonologist. The physiotherapist will also do monthly telephone calls for patient's monitoring. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Aged between 50-80 years;
- No performing regular physiotherapy treatment or physical training (≤ 1 time/week);
- Stable disease [no changes in the chronic therapy (both inhaled and systematic) in the usual respiratory symptoms (according to the medical evaluation) and spirometry in the last 4 weeks prior to study recruitment];
- Regular cough and expectoration;
- Ability to follow the exercise program;
Key exclusion criteria (12 listed)
- Active smokers, ex-smokers of less than 1 year prior to recruitment and/or a history of >20 smoking packs/year;
- FEV1 <30% or/and TLC<40% ;
- Diagnosis of cystic fibrosis, sarcoidosis, pulmonary fibrosis, active tuberculosis or non tuberculosis mycobacterial infection,
- Diagnosis of asthma or COPD as a primary respiratory disease and associated secondary bronchiectasis,
- Patients with unstable cardiac disease or locomotor difficulties that preclude exercise (eg, severe arthritis or severe peripheral vascular disease);
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 |
|---|---|---|
| Pulmonary Rehabilitation and Chest PhysiotherapyThe patient will come 3 times per week during 12 weeks Each session 1h15min | Other | Pulmonary Rehabilitation and Chest Physiotherapy |
| Pulmonary RehabilitationThe patient will come 3 times per week during 12 weeks Each session 45min | Other | Pulmonary Rehabilitation |
| Chest PhysiotherapyThe patient will come 3 times per week during 12 weeks Each session 30min | Other | Chest Physiotherapy |
Primary outcome
Change from Baseline Exercise tolerance capacity measured as the distance walked in meters during the shuttle test at constant speed (ESWT) at 12 weeks.
Time frame: At Screening and 12 weeks of intervention
7 secondary outcomes
Exacerbations incidence and symptoms
Time frame: During all study (12 weeks of intervention)
Change from Baseline Health related quality of life at 12 weeks.
Time frame: At Screening and 12 weeks of intervention with Quality of Life Questionnaire (QoL-B)
Change from Baseline Impact of expectoration on the quality of life at 12 weeks.
Time frame: At Screening and 12 weeks of intervention with Leicester Cough Questionnaire (LCQ)
Sputum colour
Time frame: During all study (12 weeks of intervention) with Murray's colour scale
Change from Baseline FEV1, FVC and FEV1/FVC at 12 weeks.
Time frame: At Screening and 12 weeks of intervention with Pulmonary Function Tests
Change from Baseline Physical activity level measured by accelerometry at 12 weeks.
Time frame: At Screening and 12 weeks of intervention with accelerometry
Sputum quantity
Time frame: During all study (12 weeks of intervention) with weight of sputum containers in grams
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2015.
- Derived from this study: PubMed 32071136Herrero-Cortina B, Alcaraz-Serrano V, Torres A, Polverino E. Reliability and Minimum Important Difference of Sputum Weight in Bronchiectasis. Respir Care. 2020 Oct;65(10):1478-1487. doi: 10.4187/respcare.07175. Epub 2020 Feb 18.
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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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Pulmonary Rehabilitation and Chest Physiotherapy, Pulmonary Rehabilitation and Chest Physiotherapy in people with Non-cystic Fibrosis Bronchiectasis, run by Hospital Clinic of Barcelona.
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 8 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 25 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Victoria Alcaraz, Physiotherapist (+34 932275400 ext. 2333, victoriaalcarazserrano@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Exercise tolerance capacity measured as the distance walked in meters during the shuttle test at constant speed (ESWT) at 12 weeks. (time frame: At Screening and 12 weeks of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02614300, which also lists 1 linked publication.
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 25 Nov 2015.