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

NCT ID: NCT00816309

Last Updated: 2011-04-01

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2009-03-31

Brief Summary

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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

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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.

Conditions

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Bronchiectasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Acapella Physiotherapy

Physiotherapy with acapella versus no physiotherapy

Group Type EXPERIMENTAL

Acapella Physiotherapy

Intervention Type DEVICE

twice daily- around 20 minutes

No physiotherapy

Physiotherapy with acapella versus no physiotherapy

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Acapella Physiotherapy

twice daily- around 20 minutes

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Moderate and Severe Bronchiectasis
* No regular chest physiotherapy

Exclusion Criteria

* Moderate or Severe COPD
Minimum Eligible Age

60 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NHS Lothian

OTHER_GOV

Sponsor Role lead

Responsible Party

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NHS Lothian

Principal Investigators

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Adam T Hill, MBChB MD

Role: PRINCIPAL_INVESTIGATOR

NHS Lothian

Locations

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Royal Infirmary of Edinburgh

Edinburgh, Scotland, United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type DERIVED
PMID: 19541717 (View on PubMed)

Other Identifiers

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AH003

Identifier Type: -

Identifier Source: org_study_id

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