Relationship Between the Severity of Bronchiectasis and Exercise Capacity in a Pilot Home Pulmonary Rehabilitation Program at the Virgen Macarena University Hospital
Phase: NA
Conditions: Non-cystic Fibrosis Bronchiectasis, Pulmonary Rehabilitation
Sponsor: Hospital Universitario Virgen Macarena

Relationship between the Severity of 
Bronchiectasis and Exercise Capacity after a 
Pilot Program for Home Respiratory 
Rehabilitation at the Virgen Macarena University 
Hospital 
 
C.P. SCHNR15 - C.I. 1550-N-17 
May 07, 2018 
 

Relationship between the Severity of Bronchiectasis and Exercise 
Capacity after a Pilot Program for Home Respiratory Rehabilitation at the 
Virgen Macarena University Hospital 
 
BACKGROUND AND CURRENT STATE OF THE SUBJECT 
Bronchiectasis not associated with cystic fibrosis (non CF bronchiectasis) is 
bronchial dilatations characterized by inadequate mucociliary clearance, whose 
main clinical expression is cough with purulent expectoration and dyspnea, 
leading to exercise limitation. In order to try to quantify the severity of the 
disease and its prognosis, in recent years different scales have been developed 
that take into account clinical, radiological and functional parameters (FACED 
and BSI).  
The objective of the treatment of the disease lies in the prevention of 
exacerbations, reduction of symptoms, improvement in quality of life and 
stabilization of lung function (Polverino et al. 2017). Based on these objectives, 
we have tried to develop tools, until now not available in all media, such as the 
development of specific respiratory rehabilitation programs (PRR). Although the 
long-term benefits of PPRR have not been objectified or demonstrated, there is 
a common consensus on the need to include this type of intervention in the 
management of patients with bronchiectasis (strong level of recommendation) 
(Polverino et al. 2017), since they could stabilize lung function and exercise 
capacity, as well as influence exacerbations, although more studies are still 
needed in this regard. On the other hand, it is also not very clear where and 
when to carry out this type of program, and there is a need to implement and 
optimize respiratory rehabilitation programs in non-traditional settings, at home 
or in an exacerbation (Rochester et al. 2015) (Wedzicha et al. 2017)(Pasteur et 
al. 2010).  
Most of the studies carried out in relation to RR and non-CF bronchiectasis 
have focused on outcomes on quality of life and lung function with disparate 
results (Annemarie L Lee et al. 2014),however there are fewer data in relation 
home base rehabilitation program . To date, there are several clinical trials that 
analyze exercise capacity and tolerance in patients with bronchiectasis 
undergoing RP, with a clear improvement in these parameters after completion 
(Murray, Pentland, and Hill 2009)(Zanini et al. 2015)(Singh et al. 2014)(J. 
Bradley, Moran, and Greenstone 2002).  
The most recent meta-analysis (Annemarie L. Lee et al. 2017) includes four 
clinical trials with the aim of evaluating the effect of respiratory rehabilitation 
(RR) in terms of exercise capacity and tolerance, exacerbations, symptoms, 
quality of life and mortality.  
 

BIBLIOGRAPHY 
Bradley, J, F Moran, and M Greenstone. 2002. "Physical training for 
bronchiectasis (Cochrane review) [with consumer summary]." Cochrane 
Database of Systematic Reviews 2002 Issue 2 . 
Bradley, Judy M et al. 2015. "Sedentary behavior and physical activity in 
bronchiectasis: a cross-sectional study." BMC pulmonary medicine 15: 61. 
http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=4456779&tool=p
mcentrez&rendertype=abstract. 
Lee, AL et al. 2014. "Minimal important difference in field walking tests in non-
cystic fibrosis bronchiectasis following exercise training." Respiratory 
Medicine 108(9): 1303-9. 
Lee, Annemarie L et al. 2014. "The short and long term effects of exercise 
training in non-cystic fibrosis bronchiectasis--a randomized controlled trial." 
Respiratory 
research 
15(1): 
44. 
http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=3996132&tool=p
mcentrez&rendertype=abstract. 
Lee, Annemarie L., Catherine J. Hill, Christine F. McDonald, and Anne E. 
Holland. 2017. “Pulmonary Rehabilitation in Individuals With Non–Cystic 
Fibrosis Bronchiectasis: A Systematic Review.” Archives of Physical 
Medicine 
and 
Rehabilitation 
98(4): 
774-782.e1. 
http://dx.doi.org/10.1016/j.apmr.2016.05.017. 
Mandal, P. et al. 2012. "A pilot study of pulmonary rehabilitation and chest 
physiotherapy versus chest physiotherapy alone in bronchiectasis." 
Respiratory Medicine 106(12): 1647-54. 
Murray, MP et al. 2009. "Validation of the Leicester Cough Questionnaire in 
non-cystic fibrosis bronchiectasis." European Respiratory Journal 34(1): 
125-31. 
Murray, MP, JL Pentland, and AT Hill. 2009. "A randomized crossover trial of 
chest physiotherapy in non-cystic fibrosis bronchiectasis." European 
Respiratory Journal 34(5): 1086-92. 
NJ., Greening et al. 2014. "An early rehabilitation intervention to enhance 
recovery during hospital admission for an exacerbation of chronic 
respiratory disease: randomized controlled trial." BMJ (Clinical research 
ed.) 349(PG-g4315): g4315. 
Olveira, C, F Espíldora, a Padilla, and JL De la Cruz Rios. 2010. "Evaluation 
and treatment of the patient with non-CF bronchiectasis." Manual of 
diagnosis and therapy in Pulmonology . 2nd Edition. : 495-509. 
Olveira, Casilda, João Cordeiro da Costa, and Miguel Ángel Martínez-García. 
2016. "How to Assess the Severity and Prognosis of Bronchiectasis." 
Monographs from Archivos de Bronconeumología 3(1): 10-18. 
Pacheco, V Almadana. 2016. «Changes in physical activity after a respiratory 
rehabilitation program in COPD». 28(4): 214-21. 

Pasteur, MC, D Bilton, AT Hill, and British Thoracic Society Bronchiectasis non-
CF Guideline Group. 2010. "British Thoracic Society guideline for non-CF 
bronchiectasis." 
Thorax 
65 
Suppl 
1: 
i1-58. 
http://www.ncbi.nlm.nih.gov/pubmed/20627931. 
Polverino, Eva et al. 2017. «European Respiratory Society guidelines for the 
management of adult bronchiectasis». European Respiratory Journal 50(3): 
1700629. 
http://erj.ersjournals.com/lookup/doi/10.1183/13993003.00629-
2017. 
Rochester, Carolyn L. et al. 2015. "An official American Thoracic 
Society/European Respiratory Society policy statement: Enhancing 
implementation, use, and delivery of pulmonary rehabilitation." American 
Journal of Respiratory and Critical Care Medicine 192(11): 1373-86. 
Singh, Sally J. et al. 2014. «An official systematic review of the European 
Respiratory Society/American Thoracic Society: Measurement properties of 
field walking tests in chronic respiratory disease». European Respiratory 
Journal 44(6): 1447-78. 
Soto Campos, Jose. 2009. «Quality of life applied to Pulmonology». Diagnostic 
and Therapeutic Manual in Pulmonology : 105-14. 
Wedzicha, Jadwiga A. et al. 2017. «Management of COPD exacerbations: a 
European Respiratory Society/American Thoracic Society guideline». 
European 
Respiratory 
Journal 
49(3): 
1600791. 
http://erj.ersjournals.com/lookup/doi/10.1183/13993003.00791-2016. 
Zanini, Andrea et al. 2015. “Effects of Pulmonary Rehabilitation in Patients with 
Non-Cystic Fibrosis Bronchiectasis: A Retrospective Analysis of Clinical 
and Functional Predictors of Efficacy.” breathing; international review of 
thoracic 
diseases 
89(6): 
525-33. 
http://www.ncbi.nlm.nih.gov/pubmed/25924686. 
 
 
 

WORK HYPOTHESIS 
Exercise tolerance and capacity can be modified after completing a respiratory 
rehabilitation program with a decrease in the perception of symptoms, 
exacerbations and quality of life.  
 
SPECIFIC OBJECTIVES  
Primary  
To determine the capacity and tolerance to exercise by means of a 
cardiopulmonary test and to assess the effects and changes after a PRR in 
patients with BE without CF.  
Secondary  
 Assess the degree of baseline physical activity of patients with BE without CF 
and its changes after PR.  
 Know the severity through the prognostic scale E-FACED  
 Determine the impact of PR on health-related quality of life and 
anxious/depressive state, symptoms, exacerbations 
METHOD 
 
Population (inclusion and exclusion criteria). 
The study population will be the patients of the monographic consultation of 
Bronchiectasis of the Virgen Macarena University Hospital. 
 
 
Inclusion criteria 
 
Established radiological diagnosis of bronchiectasis (HRCT of the 
chest). 
 
Non-CF bronchiectasis older than 18 years. 
 
Non-CF bronchiectasis in a stable situation, who have not required 
antibiotic therapy in the last 6 weeks. 
 
Dyspnea greater than 1 according to the modified scale of the 
Medical Research Council (mMRC). 
Exclusion criteria 
 
Smokers or former smokers of less than 6 months or with a history 
of consumption of 15 packs/year. 
 
Cystic fibrosis. 
 
Active infections (bronchopulmonary aspergillosis, pulmonary 
tuberculosis). 
 
Active tuberculosis. 
 
poorly controlled asthma 

 
Chronic obstructive pulmonary disease. 
 
Diseases that prevent adequate performance of exercise 
(neuromuscular pathology or residual injuries) 
 
Medical 
diseases 
that 
put 
the 
individual at 
risk 
of a 
decompensation due to the performance of any physical activity or 
cardiopulmonary stress test (unstable ischemic heart disease, acute 
myocardial infarction less than 1 month). 
 
Pregnancy. 
 
Mental disorder that prevents the adequate interpretation of the 
indications or performance of the tests. 
  Study design. 
Prospective and randomized study with consecutive inclusion of patients 
from the Non-CF bronchiectasis BE monographic clinic of the Virgen Macarena 
Hospital (Seville). Patients who meet the inclusion criteria will be randomized 
into two groups: control and intervention, patients will be assigned to each 
group using a numerical sequence generated by computer until the sample size 
is obtained. 
The control group will receive basic recommendations on physical activity 
and the intervention group will be included in a mixed respiratory rehabilitation 
program (combining home and hospital sessions). 
 
Visit 1: inclusion of patients with BE who comply with inclusion. Signature 
of inform consent and randomization of patients. 
Visit 2: All patients will undergo an initial assessment of the degree of 
physical activity by means of accelerometers (®Sensewear arm band) for 3 
days including weekends, as well as pulmonary function and exercise tolerance 
tests, stratification of severity according to the E-FACED scales. 
* Control group: written recommendations on performing some physical 
activity for at least 30 minutes of moderate intensity according to the 
recommendations of the Spanish Society of Pulmonology and the Andalusian 
Society of Pulmonology and Thoracic Surgery. (Casilda Olveira, Costa, and 
Martínez-García 2016) , (C Olveira et al. 2010). A phone call every 15 days to 
assess the physical activity carried out without talking about exercise or 
physical activity.  
* Intervention group: Patients will be included in an 8-week outpatient 
program with recall sessions led by our physiotherapist once every 2 weeks in 
the hospital's Respiratory Rehabilitation gym. In the first session, patients will be 
instructed on how to perform home exercises as well as how to use the Borg 
scale. A phone calls weekly to provide support and general advice about 
exercise or physical activity. 
The program will combine isotonic strength and resistance exercises. 
Resistance training will consist of bicycle or walking exercises (depending on 
the availability of each patient), with a progressive increase in distance or time 
of completion depending on symptom control. 

The strength training program will include upper and lower limb exercises 
that will begin with no load and to which weights will be progressively added 
depending on the control of symptoms, in 2 sets of 6-8 repetitions: 
- Hanger (to work the latissimus dorsi muscle). 
-Butterfly (pectoralis major muscle work). 
- Neck press (brachial triceps and deltoid work). 
- Flexion of legs (work of biceps femoris and gastrocnemius). 
-Extension of legs (work of quadriceps femoris): place a weight or ballast. 
Stretch the leg and raise the thigh 
- Exercises with elastic bands: upper and lower limbs. Separate both ends 
of the tape as much as possible. 
- Walking: increase the walking time progressively. 
- Bicycle or treadmill: submaximal exercise. Constant pedaling at about 60 rpm 
with moderate intensity. 
Patients will be encouraged to maintain the exercises after the study. 
Visits 3, 4 and 5: at 8 weeks (time of completion of the rehabilitation 
programs), 6 months and 12 months, respectively. At the end-of-program and 
follow-up visits, all the measurements made at the baseline visit will be 
repeated, as well as the record of exacerbations. 
All patients will receive an educational program about their disease as well as 
an individualized respiratory physiotherapy program including relaxation 
techniques, secretion management and assessment of nutritional status. 
 
Measurement methods and variables 
 Assessment of exercise capacity with cycle ergometry. Cycle- 
ergometry will be performed in progressive steps of one minute up to its 
maximum. We will use a state-of-the-art Vyntus CPX ergospirometer 
from the firm Jaeger‐CareFusion. Maximum oxygen consumption, 
aerobic‐anaerobic thresholds, respiratory compensation point, ventilatory 
limitation study, calorimetry, forced spirometry F/V, slow spirometry + 
MVV, maximum voluntary ventilation, cardiac output and physiological 
dead space will be assessed. The subsequent evaluation of the data will 
be carried out through the Sentry program platform  
 6-minute walk test (6MWT): it is carried out in an absolutely flat corridor 
with a length equal to or greater than 30m, placing cones to mark the 
ends of the route. The distance traveled in a period of 6 minutes will be 

calculated according to the recommendations of the American Thoracic 
Society (ATS)  
 Physical activity level using the Multisensor ArmBand accelerometer. 
(SenseWear mini armband; BodyMedia,) as referenced in the study by 
Almadana et al (Pacheco 2016). It is placed on the right triceps and 
provides information on calorie consumption and physical activity levels, 
which are subsequently, analyzed using specific software (INNERVIEW 
professional version 8, BodyMedia, Pittsburgh, PA).  Quality of life in 
Saint George respiratory questionnaire (Soto Campos 2009). 50 items 
divided into three scales: symptoms, activity and impact. Symptom scale 
items refer to frequency and severity of respiratory symptoms 
 Cough 
Severity 
Questionnaire 
with 
LCQ 
(Murray 
et 
al. 
2009)(Annemarie L. Lee et al. 2017). The LCQ measures the physical, 
psychological, and social impact of chronic cough. It consists of 19 items. 
Validated in BQ not CF.  
 Severity and prognosis by E-FACED: number of exacerbations in the 
previous year; F: percentage of predicted FEV1; A: age; C: chronic 
colonization by Pseudomonas aeruginosa; E: Extension [number of lung 
lobes affected by bronchiectasis]; D: dyspnea) have been proposed to 
stratify BE patients according to their main dimensions (symptoms, lung 
function, imaging, and microbiology). 0-3 points: mild bronchiectasis. 4-6 
points: moderate bronchiectasis. 7-9 points: severe bronchiectasis  
 Pulmonary function test: measurements through a Jaeger Viasys 
Mastercope spirometer. Forced expiratory volume in 1 s (FEV1), Forced 
vital capacity (FVC).  
 Other variables: demographic (sex, age, weight, height, body mass 
index), comorbidities (hypertension, diabetes, dyslipidemia), smoking 
(packs/year): Modified dyspnea scale. Medical Research Council (MRC).  
 Other variables: demographic (Sex, age, weight, height, body mass index), 
comorbidities (HBP, Diabetes, Dyslipidemia), Smoking (packs/year): Modified 
dyspnea scale. Medical Research Council (MRC). 
 
 

Statistical analysis 
 
For the calculation of the sample size, a power of 95% is used, a 
hypothetical loss rate during the study of 15%, a total of 30 patients per group 
would be included, enough to demonstrate our hypothesis and find statistically 
significant differences in the capacity of exercise and the change in physical 
activity in the two populations. 
 
Statistical analysis was performed using the statistical analysis software 
IBM SPSS Statistics (SPSS v23, Chicago, IL, USA). For quantitative variables, 
the values are expressed as mean +/- standard deviation, while in the case of 
qualitative variables; their values are included as frequency and percentage. 
The comparison between groups was carried out using the T test for 
independent samples in the event that the data behaved according to a normal 
distribution. Otherwise, the Mann-Whitney U test was used for independent 
samples. The comparison of the effects of respiratory rehabilitation was 
performed with the Student's t test for related samples when the data follow a 
normal distribution and the Wilcoxon signed rank test for related samples. In all 
cases, the minimum level of significance was considered to be p <0.05. If 
statistically significant differences are identified between the different groups 
studied, "a posteriori" comparison tests will be carried out, such as the Mann-
Whitney U test according to application criteria, with the level of significance 
corrected. 
 
Ethical aspects 
 
All participants will sign the informed consent, the version of which is being 
evaluated by the ethics committee of our hospital. The rights of the subjects will 
be at all times protected by the Declaration of Helsinki. The data will be treated 
with absolute confidentiality and will be subject to the Data Protection Law 
15/1999 of December 13. The nature of the study, the voluntary nature of 
participation and the proposed objectives will be reported. They may leave the 
study at any time, if they wish. 
 
Potential Job Limitations 
Due to the natural history of the disease, we cannot foresee 
decompensations, so there may be losses in the development of the study, 
having to increase the sample size from the outset. 
In this study, since it is a home program, this may be greater due to the 
lack of stimulation generated by the groups to carry out physical activity. 
Work calendar 
Once the 3-month recruitment period has ended and the initial assessment 
tests have been completed, an 8-week rehabilitation program will begin with a 
subsequent 12-month follow-up from the start of the PRR. After this, the 
analysis, exploitation of the data and subsequent dissemination of the results 
will be carried out. 

- Data exploitation period: once the recruitment period has ended, the 
collected data will be analyzed and exploited, with the aim of subsequently 
disseminating the results. 
Experience of the research team on the subject 
 
Clinical experience having a monographic consultation of Bronchiectasis, 
in addition to the experience of more than almost a decade in carrying out 
respiratory rehabilitation programs (Dr. Almadana) with publications in the area 
of respiratory rehabilitation 
-Pacheco VA. Changes in physical activity after a respiratory rehabilitation 
program in COPD. 2016;28(4):214-21. 
-Almadana Pacheco V, Pavón Masa M, Gómez-Bastero Fernández AP, 
Muñíz Rodríguez AM, Tallón Moreno R, Montemayor Rubio T. Profile of 
patients who drop out of a respiratory rehabilitation program. Arch 
Bronconeumol. 2017;53(5):257-62. 
 
Potential practical applicability of the results 
  
The applicability of this project stems from the possibility of knowing the 
possible factors that may predispose to poor exercise tolerance and being able 
to take measures to improve this situation. In addition, determining if there is a 
relationship between effort tolerance and the severity of bronchiectasis 
according to the measurement scales could help us decide at what time to start 
a rehabilitation program. physical activity program, without this entailing 
additional economic costs. In addition, the development of the RR Program 
would provide an increase in exercise capacity and consequently an 
improvement in health-related quality of life, which would translate into a 
reduction in direct expenses such as hospitalizations or emergency visits (due 
to better control of exacerbations) or indirect, derived from social costs (due to 
the dependence and limitations of these patients in decompensation). 
 
For all these reasons, the interest of the work extends to the entire health 
system to promote a sustainable method and improve exercise tolerance and 
fundamentally the quality of life of patients and survival. 
 
Facilities and techniques already available for the project 
 
We have a Pulmonary Function Laboratory of the Pneumology UGC of the HUV 
Macarena where cycle ergometry and pulmonary function tests will be carried 
out, in addition to the space set aside for carrying out the 6-minute walk test. 
 
The recruitment of Non-CF Bronchiectasis patients will be carried out in the 
specialized bronchiectasis clinic of the Virgen Macarena Hospital. We also have 
research support staff; aimed at the initial assessment of patients, signing the 
consent, help with questions about the questionnaires and diagnostic tests.