The Role of Pulmonary Rehabilitation and Airways Clearance Techniques in the Multidisciplinary Management of Non CF Bronchiectasis

Sponsor

Hospital Clinic of Barcelona (Other)

Overall Status

Unknown status

CT.gov ID

NCT02614300

Collaborator

Sociedad Española de Neumología y Cirugía Torácica (Other)

120

Enrollment

Arms

Study Details

Study Description

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".

Condition or Disease	Intervention/Treatment	Phase
Non-cystic Fibrosis Bronchiectasis	Other: Pulmonary Rehabilitation and Chest Physiotherapy Other: Pulmonary Rehabilitation Other: Chest Physiotherapy	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Supportive Care

Study Start Date :

Nov 1, 2015

Anticipated Primary Completion Date :

Dec 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Pulmonary Rehabilitation 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.	Other: Pulmonary Rehabilitation The patient will come 3 times per week during 12 weeks Each session 45min
Active Comparator: Chest Physiotherapy 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.	Other: Chest Physiotherapy The patient will come 3 times per week during 12 weeks Each session 30min
Active Comparator: Pulmonary Rehabilitation and Chest Physiotherapy 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.	Other: Pulmonary Rehabilitation and Chest Physiotherapy The patient will come 3 times per week during 12 weeks Each session 1h15min
No Intervention: Control Group 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.

Outcome Measures

Primary Outcome Measures

Change from Baseline Exercise tolerance capacity measured as the distance walked in meters during the shuttle test at constant speed (ESWT) at 12 weeks. [At Screening and 12 weeks of intervention]

Secondary Outcome Measures

Exacerbations incidence and symptoms [During all study (12 weeks of intervention)]
Change from Baseline Health related quality of life at 12 weeks. [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. [At Screening and 12 weeks of intervention with Leicester Cough Questionnaire (LCQ)]
Sputum colour [During all study (12 weeks of intervention) with Murray's colour scale]
Change from Baseline FEV1, FVC and FEV1/FVC at 12 weeks. [At Screening and 12 weeks of intervention with Pulmonary Function Tests]
Change from Baseline Physical activity level measured by accelerometry at 12 weeks. [At Screening and 12 weeks of intervention with accelerometry]
Sputum quantity [During all study (12 weeks of intervention) with weight of sputum containers in grams]

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.