Clinical trial NCT05369624: Exercise Capacity in Non-cystic Fibrosis Bronchiectasis After a Pulmonary Rehabilitation Home-based Program
Official title: Relationship Between the Severity of Bronchiectasis and Exercise Capacity in a Pilot Home Pulmonary Rehabilitation Program at the Virgen Macarena University Hospital
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-cystic Fibrosis Bronchiectasis
Pulmonary Rehabilitation
Lead sponsor: Hospital Universitario Virgen Macarena
Sponsor class: OTHER
First posted: 2022-05-11
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Clinical trial with parallel groups (Parallel treatment design):

Clinical trial in which one group of patients is assigned to receive the home pulmonary rehabilitation program (PHRP), while another group (control) does not receive PHRP
Primary purpose: OTHER

Brief summary: A number of studies have described low exercise capacity and physical activity in patients with non-cystic fibrosis bronchiectasis (non-CF Bronchiectasis), although little research exists on using the cardiopulmonary exercise test (CPET) to evaluate exercise capacity and its most relevant changes after a pulmonary rehabilitation home-based program (PRHP). In addition, few studies have addressed tolerance to exercise and physical activity in severe cases of the disease.

Aims:

To evaluate the exercise capacity of non-CF BQ patients using CPET and physical activity after a pulmonary rehabilitation home-based program.

Methodology:

Our study describes a non-pharmacological clinical trial in non-CF BQ patients at the Virgen Macarena University Hospital (Seville, Spain). The patients were randomized into two groups: the control group (who were provided with training instructions) and the intervention group (who took part in a specific pulmonary rehabilitation home-based program).

Detailed description: A signed informed consent form was provided prior to inclusion in the study. The data evaluated was obtained under strict confidentiality rules. All patients passed an initial assessment of the degree of physical activity by means of accelerometers, as well as pulmonary function tests and exercise tolerance (CPET) and 6MWT, stratification severity according to the E-FACED scales, quality of life using the saint george respiratory questionnaire.

Eligibility criteria: Inclusion Criteria:

* Certain diagnosis of non-CF bronchiectasis (chest HRCT)
* Over 18 years old, clinically stable in the previous 6 weeks (no need for antibiotic therapy due to exacerbations) and a dyspnea score over 1 according to the modified Medical Research Council (mMRC) dyspnea scale

Exclusion Criteria:

* Less of 18 years
* Other airway disease ( Asthma or COPD)
* Physical inability to perform a physical training program (neuromuscular pathology or residual injuries).
* 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.
* Medical illnesses 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.
* Attended pulmonary rehabilitation within 1 year.

Primary outcomes:
measure: Exercise capacity of Non-cystic Fibrosis Bronchiectasis ( Non-CF bronchiectasis) after pulmonary rehabilitation home-based program (PRHP). Change in VO2 (oxygen consumption, ml/min)
timeFrame: Baseline and week 8
Secondary outcomes:
measure: Level of physical activity (METS) of Non-CF bronchiectasis and its changes after PRHP
timeFrame: Baseline and week 8
measure: Impact of quality of life before and after PRHP
timeFrame: Baseline and week 8
measure: Dyspnoea
timeFrame: Baseline and week 8
measure: Exacerbations
timeFrame: Baseline, week 4 and week8
measure: Level of physical activity (number of steps) of Non-CF bronchiectasis and its changes after PRHP
timeFrame: Baseline and week 8
Other outcomes:
Locations:
city: Seville
country: Spain
facility: Virginia Almadana Pacheco
Study officials:
affiliation: Virgen Macarena University Hospital
name: Virginia Almadana, PhD
role: STUDY_DIRECTOR
References: