- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02614300
The Role of Pulmonary Rehabilitation and Airways Clearance Techniques in the Multidisciplinary Management of Non CF Bronchiectasis
Study Overview
Status
Conditions
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Victoria Alcaraz, Physiotherapist
- Phone Number: 2333 +34 932275400
- Email: victoriaalcarazserrano@gmail.com
Study Contact Backup
- Name: Eva Polverino, Medical Doctor
- Phone Number: +34 932275549
- Email: epolveri@clinic.ub.es
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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.
|
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.
|
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. |
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
At Screening and 12 weeks of intervention
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Exacerbations incidence and symptoms
Time Frame: During all study (12 weeks of intervention)
|
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)
|
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)
|
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
|
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
|
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
|
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
|
During all study (12 weeks of intervention) with weight of sputum containers in grams
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PulmRehab_NCFBE
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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