Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RRCC148LG PROCTER
Study information
Scientific title
Acronym
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
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measure
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
01/01/2001
Overall trial end date
01/01/2004
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients with chronic obstructive pulmonary disease (COPD) recruited from general practice with diagnosis confirmed by spirometry
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Does not match inclusion criteria
Recruitment start date
01/01/2001
Recruitment end date
01/01/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Northumbria at Newcastle
Newcastle upon Tyne
NE7 7XA
United Kingdom
Sponsor information
Organisation
NHS R&D Regional Programme Register - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NHS Executive Northern and Yorkshire (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
Basic results (scientific)
Publication list
2004 results in http://www.ncbi.nlm.nih.gov/pubmed/15065482
Publication citations
-
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/nr2004.04.11.3.28.c6203.