Pulmonary Rehabilitation in Non Cystic Fibrosis Bronchiectasis

Bronchiectasis Clinical Trial

Official title:

Pulmonary Rehabilitation in Non Cystic Fibrosis Bronchiectasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00868075
• Other study ID #: 08/S1102/40
• Status: Completed
• Phase: Phase 4
• First received: February 19, 2009
• Last updated: November 4, 2011
• Start date: March 2009
• Est. completion date: August 2011

Study information

• Verified date: November 2011
• Source: NHS Lothian
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bronchiectasis

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
United Kingdom	Royal Infirmary of Edinburgh	Edinburgh	Scotland

Sponsors (1)

Lead Sponsor	Collaborator
NHS Lothian

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary endpoint of this study is improvement in exercise tolerance from an incremental walk test.		8 weeks	No
Secondary	These include pulmonary physiology, 24 hour sputum volume, sputum appearance, health related quality of life and systemic inflammation.		8 weeks	No