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 |
Secondary identifying numbers | RRCC148LG PROCTER |
- 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
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
Study design | Randomised controlled trial |
---|---|
Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Not Specified |
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 | 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 study start date | 01/01/2001 |
Completion date | 01/01/2004 |
Eligibility
Participant type(s) | Patient |
---|---|
Age group | Not Specified |
Sex | Not Specified |
Target number of participants | Not provided at time of registration |
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
- England
- United Kingdom
Study participating centre
University of Northumbria at Newcastle
Newcastle upon Tyne
NE7 7XA
United Kingdom
NE7 7XA
United Kingdom
Sponsor information
NHS R&D Regional Programme Register - Department of Health (UK)
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Phone | +44 (0)20 7307 2622 |
---|---|
dhmail@doh.gsi.org.uk | |
Website | http://www.doh.gov.uk |
Funders
Funder type
Government
NHS Executive Northern and Yorkshire (UK)
No information available
Results and Publications
Intention to publish date | |
---|---|
Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | 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 |