Clinical trial NCT02614300: The Role of Pulmonary Rehabilitation and Airways Clearance Techniques in the Multidisciplinary Management of Non CF Bronchiectasis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Non-cystic Fibrosis Bronchiectasis
Keywords: pulmonary rehabilitation
chest physiotherapy
non-cystic fibrosis bronchiectasis
exercise tolerance
bronchiectasis
respiratory therapy
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
Collaborators: name: Sociedad Española de Neumología y Cirugía Torácica
First posted: 2015-11-25
Enrollment: 120
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SUPPORTIVE_CARE

Brief 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 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".


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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;
* 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.

Primary outcomes:
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.
timeFrame: At Screening and 12 weeks of intervention
Secondary outcomes:
measure: Exacerbations incidence and symptoms
timeFrame: During all study (12 weeks of intervention)
measure: Change from Baseline Health related quality of life at 12 weeks.
timeFrame: At Screening and 12 weeks of intervention with Quality of Life Questionnaire (QoL-B)
measure: Change from Baseline Impact of expectoration on the quality of life at 12 weeks.
timeFrame: At Screening and 12 weeks of intervention with Leicester Cough Questionnaire (LCQ)
measure: Sputum colour
timeFrame: During all study (12 weeks of intervention) with Murray's colour scale
measure: Change from Baseline FEV1, FVC and FEV1/FVC at 12 weeks.
timeFrame: At Screening and 12 weeks of intervention with Pulmonary Function Tests
measure: Change from Baseline Physical activity level measured by accelerometry at 12 weeks.
timeFrame: At Screening and 12 weeks of intervention with accelerometry
measure: Sputum quantity
timeFrame: During all study (12 weeks of intervention) with weight of sputum containers in grams
Other outcomes:
Locations:
Study officials:
References:
citation: 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.