Condition category
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Prof Susan Procter


Contact details

University of Northumbria at Newcastle
Faculty of Health
Social Work & Education
Coach Lane Campus (East)
Newcastle upon Tyne
United Kingdom
+44 (0)191 215 6039

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title


Study hypothesis

Two questions are being asked in this study. They are: What is the absolute and relative contribution to the reported outcomes of pulmonary rehabilitation of two of it's components: physical training and group cognitive behavioural therapy? Is the combined programme of pulmonary rehabilitation more clinically and cost effective than either of its two components delivered independently?

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet


Chronic Obstructive Pulmonary Disease (COPD)


1. Pulmonary Rehabilitation (combined intervention): The rehabilitation programme in this study will consist of a combination of a physical training programme, cognitive-behavioural programme and standard care. These components are described.
2. Physical training component: This approach involves a six week programme of twice weekly 2 hour sessions of aerobic exercise individually based on 80% of the participants' peak oxygen uptake as determined by the shuttle-walking test. The physical training will be carried out by a single trainer following standardised methods and using the same equipment in order to ensure that an equal level of training is provided to the whole sample. Additionally, participants will be provided with an individualised home exercise routine with a diary card to indicate completion.
3. Group cognitive behavioural therapy: the cognitive-behavioural approach aims to address issues relating to the impact of COPD on the individual and their life; facilitate adjustment to it and develop a range of appropriate physiological coping mechanisms. It requires active client participation, learning, discussion and practice of technique both within and between sessions. The sessions will be held once a week for 1.5 hours for six weeks. SD will lead the group. The maximum number of people recommended to attend would be 8-10 and partners and carers would be welcome.
4. Standard care control group: COPD management would be provided according to British Thoracic Society guidelines and would be comparable to the care participants would receive were this study not being carried out.

Intervention type



Not Specified

Drug names

Primary outcome measures

Outcome variables:
1. Physical Assessment Details: height and weight will be recorded and BMI will be calculated. A shuttle-walk test will be carried out. Forced expiratory volume and Forced vital capacity will be carried out.
2. Health status: The Chronic Respiratory Disease Questionnaire will be used.
3. Anxiety and Depression: HADS will be used.
4. Self-efficacy: The COPD Self-Efficacy Scale.
5. Resource Utilisation: Direct, indirect, personal and transfer resource utilisation will be assessed using the Health Service Utilisation and expenditure measurement.
Control variables: Demographic details: household composition specifically to include number of dependent children, number of habitable rooms per household, current or most recent occupation of head of household, marital status (where possible questions will match those used by the Office of National Statistics) collected on admission to the study only.
Disease characteristics: age at diagnosis, duration of disease, medication taken, use of domicillary oxygen and concurrent medical condition collected on admission to the study only.

Secondary outcome measures

Not provided at time of registration

Overall trial start date


Overall trial end date


Reason abandoned


Participant inclusion criteria

Patients with chronic obstructive pulmonary disease (COPD) recruited from general practice with diagnosis confirmed by spirometry

Participant type


Age group

Not Specified


Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Does not match inclusion criteria

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

University of Northumbria at Newcastle
Newcastle upon Tyne
United Kingdom

Sponsor information


NHS R&D Regional Programme Register - Department of Health (UK)

Sponsor details

The Department of Health
Richmond House
79 Whitehall
United Kingdom
+44 (0)20 7307 2622

Sponsor type




Funder type


Funder name

NHS Executive Northern and Yorkshire (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype


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

2004 results in

Publication citations

  1. Results

    Watson B, Procter S, Cochrana W, Using randomised controlled trials (RCTs) to test service interventions: issues of standardisation, selection and generalisability., Nurse Res, 2004, 11, 3, 28-42, doi: 10.7748/nr2004.

Additional files

Editorial Notes