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

Non-cystic Fibrosis Bronchiectasis Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02614300
• Other study ID #: PulmRehab_NCFBE
• Status: Not yet recruiting
• Phase: N/A
• First received: November 18, 2015
• Last updated: November 23, 2015
• Start date: November 2015

Study information

• Verified date: November 2015
• Source: Hospital Clinic of Barcelona
• Contact: Victoria Alcaraz, Physiotherapist
• Phone: +34 932275400
• Email: victoriaalcarazserrano[@]gmail.com
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical 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 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".

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Bronchiectasis
• Non-cystic Fibrosis Bronchiectasis

Intervention

Other:
• Pulmonary Rehabilitation and Chest Physiotherapy
The patient will come 3 times per week during 12 weeks Each session 1h15min
• Pulmonary Rehabilitation
The patient will come 3 times per week during 12 weeks Each session 45min
• Chest Physiotherapy
The patient will come 3 times per week during 12 weeks Each session 30min

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona	Sociedad Española de Neumología y Cirugía Torácica

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Exacerbations incidence and symptoms		During all study (12 weeks of intervention)	Yes
Secondary	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)	No
Secondary	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)	No
Secondary	Sputum colour		During all study (12 weeks of intervention) with Murray's colour scale	No
Secondary	Change from Baseline FEV1, FVC and FEV1/FVC at 12 weeks.		At Screening and 12 weeks of intervention with Pulmonary Function Tests	No
Secondary	Change from Baseline Physical activity level measured by accelerometry at 12 weeks.		At Screening and 12 weeks of intervention with accelerometry	No
Secondary	Sputum quantity		During all study (12 weeks of intervention) with weight of sputum containers in grams	No