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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
120
The patient will come 3 times per week during 12 weeks Each session 1h15min
The patient will come 3 times per week during 12 weeks Each session 45min
The patient will come 3 times per week during 12 weeks Each session 30min
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
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
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