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Pulmonary Rehabilitation in Non Cystic Fibrosis Bronchiectasis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00868075
Recruitment Status : Completed
First Posted : March 24, 2009
Last Update Posted : November 8, 2011
Sponsor:
Information provided by (Responsible Party):
Adam Hill, NHS Lothian

Study Description
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Brief Summary:

The aim of our study is to ascertain whether chest physiotherapy + pulmonary rehabilitation is more efficacious than chest physiotherapy alone. The outcomes that will be used to assess effectiveness are relevant in terms of the direct benefit on the patient's health related quality of life.

PLANNED STUDY: This randomized study will compare 8 weeks chest physiotherapy with 8 weeks chest physiotherapy plus pulmonary rehabilitation.


Condition or disease Intervention/treatment Phase
Bronchiectasis Procedure: Chest physiotherapy Procedure: Chest Physiotherapy + Exercise Program Phase 4

Detailed Description:

PLANNED STUDY: This randomized study will compare 8 weeks chest physiotherapy with 8 weeks chest physiotherapy plus pulmonary rehabilitation.

PLAN OF INVESTIGATION: Patients will be recruited from NHS Lothian with 15 randomized to chest physiotherapy and 15 to chest physiotherapy plus pulmonary rehabilitation.

Protocols:

Chest physiotherapy Physiotherapy will be aided using a positive pressure airways device (Acapella) that aids sputum expectoration. They will be asked to do 10 breaths, followed by 3 huffs and a cough. This will be repeated 3 times and repeated twice a day. Expected tiime 10-15 minutes twice daily.

Pulmonary rehabiliation Will be an 8-week programme twice a week in hospital with a third session (unsupervised) at home. It will include both cardiovascular training and upper limb and lower limb strengthening exercises.

Each patient will have a baseline exercise test. Calculation of the patient's 80% peak heart rate will be recorded and then used to ensure that patients are working to this level during the pulmonary rehabilitation cardiovascular sections.

The session will include: 5 minute warm up; 10 minutes treadmill; 10 minutes bicycle; 10 minutes stepper; 10 minutes upper limb and lower limb strengthening exercises; 5 minutes cool down.

Throughout the 8-week programme the resistance and intensity of each activity will be increased as they improve.

Following commencement of their first class they will be provided with a diary for a walking programme at home, which they will do once a week unsupervised.

Endpoints: Assessments below will be done at baseline, 4 weeks, 8 weeks and 3 months.

Microbiology: A fresh sputum sample will be submitted for micobiological culture.

Systemic inflammatory markers: 10mls venous blood for full blood count, erythrocyte sedimentation rate, C reactive protein, urea, electrolytes and liver function tests.

Pulmonary physiology: Pre bronchodilator spirometry (FEV1, FVC and FEV1/FVC), mouth pressures, followed by an incremental shuttle walk test.

24 hour sputum volume: This will be collected the day before each clinic visit. Sputum colour: Graded as mucoid, mucopurulent or purulent. Health related quality of life: Leicester Cough Questionnaire and St George's Respiratory Questionnaire.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pulmonary Rehabilitation in Non Cystic Fibrosis Bronchiectasis
Study Start Date : March 2009
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arms and Interventions
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Arm Intervention/treatment
Experimental: Chest Physiotherapy
Twice daily chest physiotherapy
 Procedure: Chest physiotherapy
Twice daily for 8 weeks
Experimental: Chest Physiotherapy + Exercise Program
Chest Physiotherapy + Exercise Program
 Procedure: Chest Physiotherapy + Exercise Program
Twice daily chest physiotherapy and Three times weekly exercise program (two sessions supervised)for 8 weeks


Outcome Measures
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Primary Outcome Measures :
  1. The primary endpoint of this study is improvement in exercise tolerance from an incremental walk test. [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. These include pulmonary physiology, 24 hour sputum volume, sputum appearance, health related quality of life and systemic inflammation. [ Time Frame: 8 weeks ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with moderate and severe bronchiectasis aged 18-75 will be recruited. Severity will be assessed radiologically by HRCT of the chest using the scoring method by Bhalla et al.

Exclusion Criteria:

  • cystic fibrosis
  • emphysema on HRCT chest and FEV1<60% predicted
  • active allergic bronchopulmonary aspergillosis or tuberculosis
  • poorly controlled asthma
  • pregnancy or breast feeding
  • current smokers
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00868075


Locations
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United Kingdom
Royal Infirmary of Edinburgh
Edinburgh, Scotland, United Kingdom, EH164SA
Sponsors and Collaborators
NHS Lothian
Investigators
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Principal Investigator: Adam T Hill, MD, FRCPE NHS Lothian
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Adam Hill, Consultant Physician and Honorary Senior Lecturer, NHS Lothian
ClinicalTrials.gov Identifier: NCT00868075    
Other Study ID Numbers: 08/S1102/40
First Posted: March 24, 2009    Key Record Dates
Last Update Posted: November 8, 2011
Last Verified: November 2011
Keywords provided by Adam Hill, NHS Lothian:
Physiotherapy
Rehabilitation
Bronchiectasis
Additional relevant MeSH terms:
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Bronchiectasis
Bronchial Diseases
Respiratory Tract Diseases