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Pulmonary Rehabilitation in Non Cystic Fibrosis Bronchiectasis

Pulmonary Rehabilitation in Non Cystic Fibrosis Bronchiectasis

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00868075
Enrollment
27
Registered
2009-03-24
Start date
2009-03-31
Completion date
2011-08-31
Last updated
2011-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchiectasis

Keywords

Physiotherapy, Rehabilitation, 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.

Interventions

PROCEDUREChest physiotherapy

Twice daily for 8 weeks

PROCEDUREChest Physiotherapy + Exercise Program

Twice daily chest physiotherapy and Three times weekly exercise program (two sessions supervised)for 8 weeks

Sponsors

NHS Lothian
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
The primary endpoint of this study is improvement in exercise tolerance from an incremental walk test.8 weeks

Secondary

MeasureTime frame
These include pulmonary physiology, 24 hour sputum volume, sputum appearance, health related quality of life and systemic inflammation.8 weeks

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026