Recruitment

Recruitment Status
Terminated
Estimated Enrollment
40

Exclusion Criteria

Recent myocardial infarction (within previous year)or unstable angina
Primary diagnosis of Chronic Obstructive Pulmonary Disease
Age <18 years
...
Recent myocardial infarction (within previous year)or unstable angina
Primary diagnosis of Chronic Obstructive Pulmonary Disease
Age <18 years
Aortic aneurysm
Inability to give informed consent to participate
Cystic Fibrosis
Significant comorbidity that would limit the ability to undertake pulmonary rehabilitation - i.e. Cerebrovascular, cardiovascular or musculoskeletal disease.

Summary

Conditions
Bronchiectasis
Type
Interventional
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

Background: Pulmonary rehabilitation is an effective treatment after exacerbations of COPD to prevent future exacerbations and to improve breathlessness and quality of life. Its effectiveness after exacerbations of bronchiectasis has never been demonstrated. Aims: To determine if a 6 week course of ...

Background: Pulmonary rehabilitation is an effective treatment after exacerbations of COPD to prevent future exacerbations and to improve breathlessness and quality of life. Its effectiveness after exacerbations of bronchiectasis has never been demonstrated. Aims: To determine if a 6 week course of pulmonary rehabilitation improves exercise capacity at 8 weeks after exacerbation. Study Design: Randomised controlled trial. Methods: The study will take place in NHS Tayside. 40 patients with a history of bronchiectasis confirmed by HRCT will be included. Patients will be monitored using diary cards for exacerbations. At the onset of an exacerbation patients will be treated with a standard 14 day course of antibiotic therapy and randomised to one of two arms: Pulmonary rehabilitation or standard care. Patients randomised to pulmonary rehabilitation will undergo a 6 week course of supervised pulmonary rehabilitation. Patients will undergo study assessments (6-minute walk test, Quality of life questionnaires, pulmonary function tests (FEV1, FVC, FEF 25-75), symptoms recorded by symptom diaries and sputum microbiology).Assessments will be performed at the start and end of exacerbations, at 6-8 weeks post exacerbation (after completion of pulmonary rehabilitation in patients randomised to rehabilitation) and at 12 weeks. Outcome: The primary outcome is 6 minute walk distance at 8 week post exacerbation Expected Conclusion: We will determine the effectiveness of pulmonary rehabilitation after exacerbations of bronchiectasis.

Exclusion Criteria

Recent myocardial infarction (within previous year)or unstable angina
Primary diagnosis of Chronic Obstructive Pulmonary Disease
Age <18 years
...
Recent myocardial infarction (within previous year)or unstable angina
Primary diagnosis of Chronic Obstructive Pulmonary Disease
Age <18 years
Aortic aneurysm
Inability to give informed consent to participate
Cystic Fibrosis
Significant comorbidity that would limit the ability to undertake pulmonary rehabilitation - i.e. Cerebrovascular, cardiovascular or musculoskeletal disease.

Locations

Dundee, DD1 9SY
Dundee, DD1 9SY

Tracking Information

NCT #
NCT02179983
Collaborators
Not Provided
Investigators
  • Principal Investigator: James D Chalmers, MBChB, PhD NHS Tayside Principal Investigator: Tom Fardon, MD NHS Tayside
  • James D Chalmers, MBChB, PhD NHS Tayside Principal Investigator: Tom Fardon, MD NHS Tayside