Back to resultsThe Role of Pulmonary Rehabilitation and Airways Clearance Techniques in the Multidisciplinary Management of Non CF Bronchiectasis
Primary Purpose
Non-cystic Fibrosis Bronchiectasis
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Pulmonary Rehabilitation and Chest Physiotherapy
Pulmonary Rehabilitation
Chest Physiotherapy
Sponsored by
About this trial
This is an interventional supportive care trial for Non-cystic Fibrosis Bronchiectasis focused on measuring pulmonary rehabilitation, chest physiotherapy, non-cystic fibrosis bronchiectasis, exercise tolerance, bronchiectasis, respiratory therapy
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
No Intervention
Arm Label
Pulmonary Rehabilitation
Chest Physiotherapy
Pulmonary Rehabilitation and Chest Physiotherapy
Control Group
Arm Description
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.
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.
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.
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.
Outcomes
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.
Secondary Outcome Measures
Exacerbations incidence and symptoms
Change from Baseline Health related quality of life at 12 weeks.
Change from Baseline Impact of expectoration on the quality of life at 12 weeks.
Sputum colour
Change from Baseline FEV1, FVC and FEV1/FVC at 12 weeks.
Change from Baseline Physical activity level measured by accelerometry at 12 weeks.
Sputum quantity
Full Information
NCT ID
NCT02614300
First Posted
November 18, 2015
Last Updated
November 23, 2015
Sponsor
Hospital Clinic of Barcelona
Collaborators
Sociedad Española de Neumología y Cirugía Torácica
1. Study Identification
Unique Protocol Identification Number
NCT02614300
Brief Title
The Role of Pulmonary Rehabilitation and Airways Clearance Techniques in the Multidisciplinary Management of Non CF Bronchiectasis
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Unknown status
Study Start Date
November 2015 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Clinic of Barcelona
Collaborators
Sociedad Española de Neumología y Cirugía Torácica
4. Oversight
Data Monitoring Committee
Yes
5. 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".
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-cystic Fibrosis Bronchiectasis
Keywords
pulmonary rehabilitation, chest physiotherapy, non-cystic fibrosis bronchiectasis, exercise tolerance, bronchiectasis, respiratory therapy
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pulmonary Rehabilitation
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Chest Physiotherapy
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Pulmonary Rehabilitation and Chest Physiotherapy
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Pulmonary Rehabilitation and Chest Physiotherapy
Intervention Description
The patient will come 3 times per week during 12 weeks Each session 1h15min
Intervention Type
Other
Intervention Name(s)
Pulmonary Rehabilitation
Intervention Description
The patient will come 3 times per week during 12 weeks Each session 45min
Intervention Type
Other
Intervention Name(s)
Chest Physiotherapy
Intervention Description
The patient will come 3 times per week during 12 weeks Each session 30min
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Exacerbations incidence and symptoms
Time Frame
During all study (12 weeks of intervention)
Title
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)
Title
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)
Title
Sputum colour
Time Frame
During all study (12 weeks of intervention) with Murray's colour scale
Title
Change from Baseline FEV1, FVC and FEV1/FVC at 12 weeks.
Time Frame
At Screening and 12 weeks of intervention with Pulmonary Function Tests
Title
Change from Baseline Physical activity level measured by accelerometry at 12 weeks.
Time Frame
At Screening and 12 weeks of intervention with accelerometry
Title
Sputum quantity
Time Frame
During all study (12 weeks of intervention) with weight of sputum containers in grams
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Victoria Alcaraz, Physiotherapist
Phone
+34 932275400
Ext
2333
Email
victoriaalcarazserrano@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Eva Polverino, Medical Doctor
Phone
+34 932275549
Email
epolveri@clinic.ub.es
12. IPD Sharing Statement
Citations:
PubMed Identifier
32071136
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.
Results Reference
derived
Learn more about this trial
The Role of Pulmonary Rehabilitation and Airways Clearance Techniques in the Multidisciplinary Management of Non CF Bronchiectasis
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