Is Regular Chest Physiotherapy an Effective Treatment in Severe, Non Cystic Fibrosis Bronchiectasis?

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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?

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.
    

Study Phase

Phase 4

Study Type

Interventional


Primary Outcome

24 hour sputum volume and assessment of cough severity (Leicester Cough Questionnaire)

Secondary Outcome

 spirometry (FEV1, FVC, FEF 25-75), incremental shuttle test, St George's Respiratory Questionnaire and Nottingham Health Profile NHP-2, quantitative bacteriology.

Condition

Bronchiectasis

Intervention

Acapella Physiotherapy

Study Arms / Comparison Groups

 Acapella Physiotherapy
Description:  Physiotherapy with acapella versus no physiotherapy

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

20

Start Date

October 2007

Completion Date

March 2009

Primary Completion Date

December 2008

Eligibility Criteria

        Inclusion Criteria:

          -  Moderate and Severe Bronchiectasis

          -  No regular chest physiotherapy

        Exclusion Criteria:

          -  Moderate or Severe COPD
      

Gender

All

Ages

60 Years - 85 Years

Accepts Healthy Volunteers

No

Contacts

Adam T Hill, MBChB MD, , 

Location Countries

United Kingdom

Location Countries

United Kingdom

Administrative Informations


NCT ID

NCT00816309

Organization ID

AH003



Study Sponsor

NHS Lothian


Study Sponsor

Adam T Hill, MBChB MD, Principal Investigator, NHS Lothian


Verification Date

July 2010