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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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN13825248
Enrollment
550
Registered
2005-03-16
Start date
2005-03-01
Completion date
Unknown
Last updated
2015-01-13

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

Conditions

Chronic Obstructive Pulmonary Disease (COPD) Respiratory Chronic obstructive pulmonary disease (COPD)

Interventions

Please note that, as of 10 January 2008, the anticipated start and end dates of this trial have been updated from 1 December 2004 and 31 August 2008 to 1 March 2005 and 30 April 2009, respectively.

Sponsors

University of East Anglia (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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)

Design outcomes

Primary

MeasureTime frame
Quality of Life (St George?s Respiratory Questionnaire) at baseline, six weeks, three months, six months and one year post intervention.

Secondary

MeasureTime frame
Quality of life, breathlessness and exercise tolerance: 1. Breathlessness, Cough and Sputum Scale (QOL) 2. EuroQol five dimensional instrument (EQ-5D) 3. Sputum volume and oxygen saturation during hospitalisation 4. Total number of days spent in hospital during 12 months period 5. Marginal cost-utility ratio for manual versus no manual chest physiotherapy

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 31, 2026