Pulmonary Rehabilitation in Non Cystic Fibrosis Bronchiectasis
NCT ID: NCT00868075
Last Updated: 2011-11-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
27 participants
INTERVENTIONAL
2009-03-31
2011-08-31
Brief Summary
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PLANNED STUDY: This randomized study will compare 8 weeks chest physiotherapy with 8 weeks chest physiotherapy plus pulmonary rehabilitation.
Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Chest Physiotherapy
Twice daily chest physiotherapy
Chest physiotherapy
Twice daily for 8 weeks
Chest Physiotherapy + Exercise Program
Chest Physiotherapy + Exercise Program
Chest Physiotherapy + Exercise Program
Twice daily chest physiotherapy and Three times weekly exercise program (two sessions supervised)for 8 weeks
Interventions
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Chest physiotherapy
Twice daily for 8 weeks
Chest Physiotherapy + Exercise Program
Twice daily chest physiotherapy and Three times weekly exercise program (two sessions supervised)for 8 weeks
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* emphysema on HRCT chest and FEV1\<60% predicted
* active allergic bronchopulmonary aspergillosis or tuberculosis
* poorly controlled asthma
* pregnancy or breast feeding
* current smokers
18 Years
75 Years
ALL
No
Sponsors
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NHS Lothian
OTHER_GOV
Responsible Party
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Adam Hill
Consultant Physician and Honorary Senior Lecturer
Principal Investigators
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Adam T Hill, MD, FRCPE
Role: PRINCIPAL_INVESTIGATOR
NHS Lothian
Locations
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Royal Infirmary of Edinburgh
Edinburgh, Scotland, United Kingdom
Countries
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References
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Mandal P, Sidhu MK, Kope L, Pollock W, Stevenson LM, Pentland JL, Turnbull K, Mac Quarrie S, Hill AT. A pilot study of pulmonary rehabilitation and chest physiotherapy versus chest physiotherapy alone in bronchiectasis. Respir Med. 2012 Dec;106(12):1647-54. doi: 10.1016/j.rmed.2012.08.004. Epub 2012 Sep 1.
Other Identifiers
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08/S1102/40
Identifier Type: -
Identifier Source: org_study_id