A study of the effectiveness of individual components of a pulmonary rehabilitation programme when compared with the combined programme

ISRCTN	ISRCTN15645417
DOI	https://doi.org/10.1186/ISRCTN15645417
Protocol serial number	RRCC148LG PROCTER
Sponsor	NHS R&D Regional Programme Register - Department of Health (UK)
Funder	NHS Executive Northern and Yorkshire (UK)

Submission date: 23/01/2004
Registration date: 23/01/2004
Last edited: 18/01/2010

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Susan Procter
Scientific

University of Northumbria at Newcastle
Faculty of Health, Social Work & Education
Coach Lane Campus (East)
Newcastle upon Tyne
NE7 7XA
United Kingdom

Phone	+44 (0)191 215 6039

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Chronic Obstructive Pulmonary Disease (COPD)
Intervention	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	Other
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	01/01/2004

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Key inclusion criteria	Patients with chronic obstructive pulmonary disease (COPD) recruited from general practice with diagnosis confirmed by spirometry
Key exclusion criteria	Does not match inclusion criteria
Date of first enrolment	01/01/2001
Date of final enrolment	01/01/2004

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

University of Northumbria at Newcastle

Newcastle upon Tyne
NE7 7XA
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/01/2004		Yes	No