Clinical trial NCT00868075: Pulmonary Rehabilitation in Non Cystic Fibrosis Bronchiectasis
Official title: Pulmonary Rehabilitation in Non Cystic Fibrosis Bronchiectasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bronchiectasis
Keywords: Physiotherapy
Rehabilitation
Bronchiectasis
Lead sponsor: NHS Lothian
Sponsor class: OTHER_GOV
First posted: 2009-03-24
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The primary endpoint of this study is improvement in exercise tolerance from an incremental walk test.
timeFrame: 8 weeks
Secondary outcomes:
measure: These include pulmonary physiology, 24 hour sputum volume, sputum appearance, health related quality of life and systemic inflammation.
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Edinburgh
country: United Kingdom
facility: Royal Infirmary of Edinburgh
state: Scotland
Study officials:
affiliation: NHS Lothian
name: Adam T Hill, MD, FRCPE
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mandal P, Sidhu MK, Kope L, Pollock W, Stevenson LM, Pentland JL, Turnbull K, Mac Quarrie S, Hill AT. A pilot study of pulmonary rehabilitation and chest physiotherapy versus chest physiotherapy alone in bronchiectasis. Respir Med. 2012 Dec;106(12):1647-54. doi: 10.1016/j.rmed.2012.08.004. Epub 2012 Sep 1.