Chronic obstructive pulmonary disease Respiratory Chronic obstructive pulmonary disease, unspecified
Conditions
Interventions
the content will be largely guided by the focus groups in stage 1.
The exercise component consists of a combination of resistance and aerobic training, using minimal equipment, individually adjusted
Sponsors
University of Leicester
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Stage 1 (patient): 1. Aged =18 years 2. Physician diagnosis of COPD Stage 1 (staff): 1. Healthcare staff that would typically refer patients to a clinical PR programme, such as physicians & clinicians. Stage 2: 1. Age =18 years 2. Spirometry confirmed COPD, based on GOLD criteria, with FEV1/FVC<0/7, and FEV1<80% predicted. 3. Physician diagnosed COPD 4. Medical Research Council (MRC) dyspnoea score grade 2 or higher 5. Patients willing to participate and attend the PR program
Exclusion criteria
Exclusion criteria: Stage 1 (patients): 1. Unable or unwilling to provide informed consent Stage 2 (staff): 1. Unable or unwilling to provide informed consent Stage 2: 1. Co-morbidities or significant respiratory, cardiovascular, hepatic, renal, neurological, orthopaedic, neoplastic diseases that may hamper the participation of the patient and outcome of the program. 2. Active pulmonary Tuberculosis 3. COPD patients unable or unwilling to provide informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary aim of this study is to establish the feasibility of a future definitive trial; as such its aims are: 1. To inform the recruitment and timeline of a future fully-powered trial, by establishing the number of participants identified, approached, consented, randomised and completed. 2. To refine future trial procedures by establishing the acceptability and experience of the trial process to participants, including randomisation and completion of outcome measures. 3. To determine the optimal primary outcome measure in a future trial by assessing the performance of selected candidate primary outcome measures with respect to level of acceptability to participants (completion rates, perceived burden) 4. To inform estimation of sample size for a future trial by measuring data completeness at follow up (participant attrition), standard deviation of the likely primary outcome measure, and the variability of the comparator condition, treatment as usual. 5. To inform the measurement of health economic outcomes in a future trial through piloting the use of a tool for identifying resource use and costs associated with delivery of the intervention. 6. To further assess the acceptability of the treatment via qualitative interviews and focus groups and, based on input from trial participants and clinicians, to further refine and develop the intervention and the procedures for training, supervising and assessing the competence of intervention deliverers. We will also evaluate whether the following continuation criteria have been met, prior to planning a future definitive trial: 1. Trial participation does not lead to serious negative consequences (unexpected serious adverse reaction) for our participants. 2. Any serious concerns about the acceptability and feasibility of the trial procedures can be rectified prior to a full trial. | — |
Secondary
| Measure | Time frame |
|---|---|
| Completed at baseline, and 4 weeks and 8 weeks post-baseline: 1. Anxiety and depression level, measured using Hospital Anxiety and Depression Scale (HADS). 2. Breathlessness, measured using Medical Research Council (MRC) Dyspnea scale. 3. Health status, measured using COPD Assessment Test (CAT) and Clinical COPD Questionnaire (CCQ). 4. Economic impact, measured using Work Productivity and Activity impairment (WPAI) Questionnaire Bodyweight, measured using scales. 5. Lung health, assessed by spirometry, impulse oscillometry and diffusing capacity for carbon monoxide. 6. Exercise capacity, measured by incremental shuttle walking test (ISWT) and the endurance shuttle walking test (ESWT). 7. Physical activity, measured by ActiGraph wGT3x-BT accelerometer. 8. Strength, measured by quadriceps strength test and 5x sit-to-stand test. | — |
Countries
India
Contacts
Public ContactMark Orme
Outcome results
None listed