Pulmonary Rehabilitation in Non Cystic Fibrosis Bronchiectasis

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Brief Title

Pulmonary Rehabilitation in Non Cystic Fibrosis Bronchiectasis

Official Title

Pulmonary Rehabilitation in Non Cystic Fibrosis Bronchiectasis

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.
    

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 Phase

Phase 4

Study Type

Interventional


Primary Outcome

The primary endpoint of this study is improvement in exercise tolerance from an incremental walk test.

Secondary Outcome

 These include pulmonary physiology, 24 hour sputum volume, sputum appearance, health related quality of life and systemic inflammation.

Condition

Bronchiectasis

Intervention

Chest physiotherapy

Study Arms / Comparison Groups

 Chest Physiotherapy
Description:  Twice daily chest 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

Procedure

Estimated Enrollment

27

Start Date

March 2009

Completion Date

August 2011

Primary Completion Date

August 2011

Eligibility 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
      

Gender

All

Ages

18 Years - 75 Years

Accepts Healthy Volunteers

No

Contacts

Adam T Hill, MD, FRCPE, , 

Location Countries

United Kingdom

Location Countries

United Kingdom

Administrative Informations


NCT ID

NCT00868075

Organization ID

08/S1102/40


Responsible Party

Principal Investigator

Study Sponsor

NHS Lothian


Study Sponsor

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


Verification Date

November 2011