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Clinical Trials/NCT05369624
NCT05369624
Completed
Not Applicable

Relationship Between the Severity of Bronchiectasis and Exercise Capacity in a Pilot Home Pulmonary Rehabilitation Program at the Virgen Macarena University Hospital

Hospital Universitario Virgen Macarena1 site in 1 country34 target enrollmentMay 8, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Non-cystic Fibrosis Bronchiectasis
Sponsor
Hospital Universitario Virgen Macarena
Enrollment
34
Locations
1
Primary Endpoint
Exercise capacity of Non-cystic Fibrosis Bronchiectasis ( Non-CF bronchiectasis) after pulmonary rehabilitation home-based program (PRHP). Change in VO2 (oxygen consumption, ml/min)
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 8, 2018
End Date
March 14, 2020
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Hospital Universitario Virgen Macarena
Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

Exercise capacity of Non-cystic Fibrosis Bronchiectasis ( Non-CF bronchiectasis) after pulmonary rehabilitation home-based program (PRHP). Change in VO2 (oxygen consumption, ml/min)

Time Frame: Baseline and week 8

A measurement by cardiopulmonary exercise test (CPET) with oxygen consumption was performed at baseline and week 8 of the program.

Secondary Outcomes

  • Impact of quality of life before and after PRHP(Baseline and week 8)
  • Level of physical activity (number of steps) of Non-CF bronchiectasis and its changes after PRHP(Baseline and week 8)
  • Level of physical activity (METS) of Non-CF bronchiectasis and its changes after PRHP(Baseline and week 8)
  • Dyspnoea(Baseline and week 8)
  • Exacerbations(Baseline, week 4 and week8)

Study Sites (1)

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