Plain English Summary
Background and study aims
Recent evidence has shown pulmonary rehabilitation (classes containing exercise and advice) for patients with chronic obstructive pulmonary disease (COPD) to be of benefit. However, only 3% of individuals with COPD have access to such a service. It may be more appropriate for patients to have access to a manual which covers issues such as drug and symptom management, exercise and nutrition at home. This would give help and advice concerning managing their own condition without having to travel to the hospital. This study is needed in order to inform the current delivery of the rehabilitation service, optimise patient care and aid in the development of new COPD rehabilitation programmes. The aim of the study is to to develop a novel, truly independent self-management rehabilitation programme specifically for patients with COPD and to evaluate the effectiveness of self-management rehabilitation programme compared to conventional out-patient rehabilitation
Who can participate?
Patients referred to pulmonary rehabilitation with an established diagnosis of COPD with an MRC breathlessness grade between 2 and 5.
What does the study involve?
320 participants will be randomly allocated to either receiving conventional outpatient pulmonary rehabilitation or the home-based self-management programme. For those assigned to the hospital based rehabilitation programme, they will complete the normal 7 week programme of exercise and educational advice by attending classes twice weekly. Participants will undergo a standard assessment, consisting of lung function tests, exercise capacity (walking tests) and completing some questionnaires about their health status. Participants will be assessed before commencing the hospital programme, immediately after the programme is completed and then 6 months after the hospital programme, as is routine. For those assigned to the self-management group, participants will undergo the same assessments at the same time points as the hospital group, however, they will introduced to a manual for people with lung disease. The manual will outline how participants can manage their condition and include information on drug and symptom management, exercise and nutrition. Included will be some home-based exercises for participants to carry out daily. Participants will receive 2 phone calls to review their progression with the manual. This group will not participate in the exercise and educational sessions at the hospital.
What are the possible benefits and risks of participating?
We hope that the research will aid participants' understanding of their disease, its consequences, exercise and rehabilitation and inform both present and future pulmonary rehabilitation programmes therefore benefiting patients with COPD. For those placed in the self-management group, they will not participate in the routine 7 weeks of rehabilitation at the hospital. We do not yet know if the self-management manual is as effective as the hospital-based rehabilitation, however, if the self-management manual has proved to be ineffective for any patients, they will be offered the conventional rehabilitation at the end of the study.
Where is the study run from?
Pulmonary Rehabilitation Department, Glenfield Hospital, University Hospitals of Leicester NHS Trust (UK)
When is the study starting and how long is it expected to run for?
The study started in 2007 and is expected to be completed mid-2013
Who is funding the study?
Pulmonary Rehabilitation Research Group - University Hospitals of Leicester NHS Trust (UK)
Who is the main contact?
Prof Sally Singh
sally.singh@uhl-tr.nhs.uk
Trial website
Contact information
Type
Scientific
Primary contact
Prof Sally Singh
ORCID ID
Contact details
Pulmonary Rehabilitation Department
University Hospitals of Leicester NHS Trust
Glenfield Hospital
Groby Road
Leicester
LE3 9QP
United Kingdom
+44 (0)116 250 2535
sally.singh@uhl-tr.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
10196
Study information
Scientific title
A Self-management Programme of Activity, Coping and Education for Chronic Obstructive Pulmonary Disease (COPD): is it a feasible alternative to conventional rehabilitation? A randomised study
Acronym
SPACE for COPD
Study hypothesis
The Self-management Programme of Activity, Coping and Education (SPACE) will be as effective at increasing quality of life (as measured by the Chronic Respiratory Quesionnaire-Dyspnoea domain) as conventional Pulmonary Rehabilitation.
Ethics approval
Leicester, Northamptonshire and Rutland Research Ethics Committee, 15/02/2007, ref: 07/Q2501/6
Study design
Randomised single-blind single-centre interventional study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Chronic Obstructive Pulmonary Disease (COPD)
Intervention
Self-management intervention:
A Self-management Programme of Activity, Coping and Education (SPACE) for COPD. Participants in this group will receive a 171-page A4 workbook comprising sections on disease education, stress management strategies, breathing control advice and techniques to improve exercise capacity and levels of domestic physical activity. It also includes an individual action plan designed to help cope with exacerbations. Motivational telephone calls will be made at 2 and 4 weeks to encourage participants to complete the manual and pursue an active lifestyle. It is anticipated that participants will have worked through the manual in approximately seven weeks.
Pulmonary Rehabilitation intervention:
Participants in this group will attend classes (consisiting of exercise and education) at the hospital, twice weekly for 7 weeks.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Quality of life as determined by the Chronic Respiratory Questionnaire (self-reported) - Dyspnoea domain, measured at baseline, after the intervention at 7 weeks and 6 months later
Secondary outcome measures
Measured at the initial assessment, and at 7 weeks and 6 months after this assessment:
1. Chronic Respiratory Quesionnaire (Self-reported) - fatigue, emotion and mastery domains
2. Pulmonary Rehabilitation Adapted Index of Self-Efficacy (PRAISE)
3. Hospital Anxiety and Depression Scale (HADS)
4. Exercise tolerance (Incremental and Endurance Shuttle Walk Tests)
5. Daily physical activity (measured by wearing SenseWear accelerometers for 5 days)
Overall trial start date
15/02/2007
Overall trial end date
30/06/2013
Reason abandoned
Eligibility
Participant inclusion criteria
1. Adults with an establised diagnosis of Chronic Obstructive Pulmonary Disease [ratio of the forced expiratory volume in the first one second to the forced vital capacity of the lungs (FEV1/FVC ratio <70%)]
2. Medical Research Council (MRC) dyspnoea grade of 2-5
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
320
Participant exclusion criteria
1. Patients with significant neurological, locomotive, cardiac or psychological conditions which would exclude them from exercising
2. Those unwilling to participate
3. Who have participated in Pulmonary Rehabilitation in the previous 12 months
Recruitment start date
15/02/2007
Recruitment end date
30/06/2013
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Glenfield Hospital
Leicester
LE3 9QP
United Kingdom
Funders
Funder type
Hospital/treatment centre
Funder name
Pulmonary Rehabilitation Research Group at University Hospitals of Leicester NHS Trust (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
2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/28756402