Is Regular Chest Physiotherapy an Effective Treatment in Severe, Non Cystic Fibrosis Bronchiectasis?
Primary Purpose
Bronchiectasis
Status
Completed
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
Acapella Physiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Bronchiectasis focused on measuring physiotherapy, bronchiectasis
Eligibility Criteria
Inclusion Criteria:
- Moderate and Severe Bronchiectasis
- No regular chest physiotherapy
Exclusion Criteria:
- Moderate or Severe COPD
Sites / Locations
- Royal Infirmary of Edinburgh
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Acapella Physiotherapy
No physiotherapy
Arm Description
Physiotherapy with acapella versus no physiotherapy
Physiotherapy with acapella versus no physiotherapy
Outcomes
Primary Outcome Measures
24 hour sputum volume and assessment of cough severity (Leicester Cough Questionnaire)
Secondary Outcome Measures
spirometry (FEV1, FVC, FEF 25-75), incremental shuttle test, St George's Respiratory Questionnaire and Nottingham Health Profile NHP-2, quantitative bacteriology.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00816309
Brief Title
Is Regular Chest Physiotherapy an Effective Treatment in Severe, Non Cystic Fibrosis Bronchiectasis?
Official Title
Is Regular Chest Physiotherapy an Effective Treatment in Severe, Non Cystic Fibrosis Bronchiectasis?
Study Type
Interventional
2. Study Status
Record Verification Date
July 2010
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
March 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
NHS Lothian
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Bronchiectasis is a chronic chest condition which causes a persistent cough and frequent chest infections. One of the main forms of treatment is chest physiotherapy. Physiotherapy is thought to improve cough and help clear the airways of sticky sputum. Traditionally, physiotherapy techniques can be awkward, but recently a new device (a simple mouthpiece, called the Acapella device) has been developed to make physiotherapy practise easier. This study aims to assess how helpful regular physiotherapy using a new mouthpiece is in patients with severe bronchiectasis.
Detailed Description
Study being carried out in the Department of Respiratory Medicine, Royal Infirmary of Edinburgh.
The study is entitled "Is regular chest physiotherapy an effective treatment in severe, non cystic fibrosis bronchiectasis?" This is a small randomised controlled pilot crossover study assessing the efficacy of regular chest physiotherapy using an Acapella mouthpiece in severe non cystic fibrosis bronchiectasis. 10 patients will be randomised to receive full instruction in use of the Acapella device (twice daily therapy) and ten patients will continue with their standard treatment regimen. The study will be conducted over seven months.
At the beginning we will randomly allocate them to receive either the current standard treatment regimen for bronchiectasis or to receive instruction in the use of the Acapella physiotherapy device for the first 3 months.
After these 3 months all will receive the current standard treatment regimen for 1 month.
Following this, those that received current standard treatment will receive Acapella physiotherapy device for 3 months and those that received Acapella physiotherapy device will stop this and receive current standard treatment for 3 months.
All participants will be reviewed on 6 occasions (start of study and then at months 1, 2, 3, 4 and 6). At each review, sputum samples will be collected, routine bloods, spirometry and exercise testing performed and health related quality of life questionnaires be completed.
At the end of the study should patients have felt benefit with the physiotherapy with the Acapella device, they should continue using it regularly on a twice-daily basis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiectasis
Keywords
physiotherapy, bronchiectasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Acapella Physiotherapy
Arm Type
Experimental
Arm Description
Physiotherapy with acapella versus no physiotherapy
Arm Title
No physiotherapy
Arm Type
No Intervention
Arm Description
Physiotherapy with acapella versus no physiotherapy
Intervention Type
Device
Intervention Name(s)
Acapella Physiotherapy
Intervention Description
twice daily- around 20 minutes
Primary Outcome Measure Information:
Title
24 hour sputum volume and assessment of cough severity (Leicester Cough Questionnaire)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
spirometry (FEV1, FVC, FEF 25-75), incremental shuttle test, St George's Respiratory Questionnaire and Nottingham Health Profile NHP-2, quantitative bacteriology.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Moderate and Severe Bronchiectasis
No regular chest physiotherapy
Exclusion Criteria:
Moderate or Severe COPD
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adam T Hill, MBChB MD
Organizational Affiliation
NHS Lothian
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Infirmary of Edinburgh
City
Edinburgh
State/Province
Scotland
ZIP/Postal Code
EH16 4SA
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
19541717
Citation
Murray MP, Pentland JL, Hill AT. A randomised crossover trial of chest physiotherapy in non-cystic fibrosis bronchiectasis. Eur Respir J. 2009 Nov;34(5):1086-92. doi: 10.1183/09031936.00055509. Epub 2009 Jun 18.
Results Reference
derived
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Is Regular Chest Physiotherapy an Effective Treatment in Severe, Non Cystic Fibrosis Bronchiectasis?
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