A single blind randomised controlled trial to determine the effectiveness and cost utility of manual chest physiotherapy techniques in the management of infective exacerbations of Chronic Obstructive Pulmonary Disease
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD)RespiratoryChronic obstructive pulmonary disease (COPD)
- Registration Number
- ISRCTN13825248
- Lead Sponsor
- niversity of East Anglia (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 550
Patients admitted to participating hospitals with infective exacerbations of COPD.
Inclusion Criteria:
1. Diagnosis of COPD as defined by the British Thoracic Society; namely
a. A forced expiratory volume in the first second (FEV1) of <80% of the predicted value, which is predominantly irreversible
b. Signs and symptoms of cough, breathlessness and +/- wheeze
c. In more severe disease there may be cyanosis and peripheral oedema
2. An infective exacerbation as set out by the British Thoracic Society; namely
a. A worsening of previous stable condition, a new respiratory event or complication imposed upon established COPD
b. Signs and symptoms of increased wheeze, dyspnoea, sputum volume and purulence, chest tightness and fluid retention
1. Cognitive impairment, rendering patients unable to give fully informed consent
2. Contraindications to the use of manual techniques; namely
a. Osteoporosis
b. Frank haemoptysis
c. Bronchial hyper-reactivity
d. Known respiratory system malignancy
3. No evidence of excess sputum production after examination (i.e. the patient does not report excess secretions and no signs of excess secretions on auscultation)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Quality of Life (St George?s Respiratory Questionnaire) at baseline, six weeks, three months, six months and one year post intervention.
- Secondary Outcome Measures
Name Time Method Quality of life, breathlessness and exercise tolerance:<br>1. Breathlessness, Cough and Sputum Scale (QOL) <br>2. EuroQol five dimensional instrument (EQ-5D)<br>3. Sputum volume and oxygen saturation during hospitalisation<br>4. Total number of days spent in hospital during 12 months period<br>5. Marginal cost-utility ratio for manual versus no manual chest physiotherapy