Condition category
Respiratory
Date applied
14/03/2005
Date assigned
16/03/2005
Last edited
29/10/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

http://www.hta.ac.uk/1416

Trial website

Contact information

Type

Scientific

Primary contact

Ms Jane Cross

ORCID ID

Contact details

School of Allied Health Professions
Queens Building
University of East Anglia
Norwich
NR4 7TJ
United Kingdom
+44 (0)1603 593315
j.cross@uea.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 03/13/06

Study information

Scientific title

Acronym

MATREX

Study hypothesis

This study proposes to look exclusively at COPD and compare a group of patients who do receive a chest physiotherapy intervention of manual techniques with a group of patients who receive no manual intervention but are given an information sheet, and to follow up all patients for one year.

Please note that, as of 11/05/2009, the anticipated start and end dates have been updated from 01/12/2004 and 31/08/2008 to 01/03/2005 and 30/04/2009, respectively.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Chronic Obstructive Pulmonary Disease (COPD)

Intervention

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.

Interventions:

Intervention arm:
Participants will receive the respiratory manual techniques of percussion, vibrations and chest shaking. A standard treatment protocol manual will be followed by all the participating hospitals. This manual will be developed with the clinical staff involved in order to represent current practice and optimise compliance. Treatment will be applied with the patient positioned according to an agreed protocol for optimal drainage of secretions. The chest will be percussed whilst the patient performs thoracic expansion exercises and vibrations and shaking will be applied on expiration. Treatment will be interspersed with periods of relaxed abdominal breathing, breathing control. Participants will also be given an information sheet giving advice on positioning, managing cough and mobilisation. The content, number and duration of treatments will be at the discretion of the physiotherapist applying treatment, within the bounds set by the manual and will be varied according to clinical need. This information will be recorded. Oxygen saturation will be monitored and recorded during treatment. Once the patient has returned to his/her normal stable saturation, monitoring will stop. Sputum produced in each 24 hour period will be collected and its volume measured throughout each hospital admission.

Control arm:
Participants will receive no manual chest physiotherapy. They will be given the same information sheet giving advice on positioning, managing coughing and mobilisation by a physiotherapist. 24 hour sputum volumes will be measured as for the intervention group. For patients in the control arm who show severe deterioration due to sputum retention, additional physiotherapy including manual techniques will be permitted. Such movement between trial arms will be monitored closely. Movement between arms will occur where there is clear clinical evidence of sputum retention (Auscultation/chest x-ray [CXR] evidence) in conjunction with a pH of less than 7.26, a rising CO2 in patients already receiving supportive treatment and controlled oxygen therapy. The primary analysis will be intention to treat. A per protocol analysis will be performed as a secondary analysis, with adjustment for baseline differences.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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

Secondary outcome measures

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

Overall trial start date

01/03/2005

Overall trial end date

30/04/2009

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

550

Participant 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)

Recruitment start date

01/03/2005

Recruitment end date

30/04/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

School of Allied Health Professions
Norwich
NR4 7TJ
United Kingdom

Sponsor information

Organisation

University of East Anglia (UK)

Sponsor details

-
Norwich
NR4 7TJ
United Kingdom

Sponsor type

University/education

Website

http://www1.uea.ac.uk/cm/home

Funders

Funder type

Government

Funder name

NIHR Health Technology Assessment Programme - HTA (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20487638
2. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22748085

Publication citations

  1. Results

    Cross J, Elender F, Barton G, Clark A, Shepstone L, Blyth A, Bachmann M, Harvey I, , A randomised controlled equivalence trial to determine the effectiveness and cost-utility of manual chest physiotherapy techniques in the management of exacerbations of chronic obstructive pulmonary disease (MATREX)., Health Technol Assess, 2010, 14, 23, 1-147, iii-iv, doi: 10.3310/hta14230.

  2. Results

    Cross JL, Elender F, Barton G, Clark A, Shepstone L, Blyth A, Bachmann MO, Harvey I, Evaluation of the effectiveness of manual chest physiotherapy techniques on quality of life at six months post exacerbation of COPD (MATREX): a randomised controlled equivalence trial., BMC Pulm Med, 2012, 12, 33, doi: 10.1186/1471-2466-12-33.

Additional files

Editorial Notes