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| Name | Class |
|---|---|
| Guy's and St Thomas' NHS Foundation Trust | OTHER |
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The purpose of this study is to investigate whether pulmonary rehabilitation (PR) is effective in increasing level of (a) physical activity (PA) and (b) self-efficacy in patients with chronic obstructive pulmonary disease (COPD).
PR is an evidence-based multidisciplinary approach consisting primarily of a supervised exercise program with educational components. It has demonstrated high efficacy in improving dyspnoea, health-related quality of life (HRQoL) and functional exercise capacity in patients with COPD. Despite these improvements, there is no conclusive evidence that these benefits translate to an increase in PA in patient's day-to-day life. This is of concern as low PA is a predictor of all cause mortality, correlated with lower HRQoL, increased level of dyspnoea and higher number of hospital admissions in this group of patients.
Self-efficacy is found to be an instigating force in forming intention to exercise and in maintaining practice for an extended time. Self-efficacy may be the key in determining whether a patient translates the improvement in exercise tolerance to actually being more physically active. Based on current knowledge, there is insufficient evidence that self-efficacy increases after pulmonary rehabilitation and no correlation has been made between level of self-efficacy and level of PA in these group of patients.
Hence this study aims to find out whether the existing PR program increases level of PA and self-efficacy. Correlation between level of PA and self-efficacy will be made.
The intervention group will consist of all patients with chronic obstructive pulmonary disease (COPD) referred to Guy's and St Thomas' Hospital (GSTT) pulmonary rehabilitation. A sample of 30 is anticipated as this is the maximum number of patients who could be enrolled in the 3 month recruitment period in Guy's and St. Thomas' Hospital.
No changes will be made to the current pulmonary rehabilitation program.
No control group is present in the study as pulmonary rehabilitation is the standard of care and it is not ethical to withhold pulmonary rehabilitation from patients with COPD.
The null hypothesis would be that there is no difference in physical activity and self-efficacy before and after pulmonary rehabilitation. The statistical test used will be a paired sample t-test to determine the change in a) physical activity and b)self-efficacy after pulmonary rehabilitation.
Correlation analysis will be made between self-efficacy and physical activity with a) Anxiety and depression (Hospital anxiety and depression scale), b)Functional exercise capacity (6 minute walk test) and c) COPD Assessment test.
A Pearson or Spearman correlations will be done depending on whether or not the data is normally distributed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with COPD | This is an observational study of patients with chronic obstructive pulmonary disease (COPD) who attend pulmonary rehabilitation, which is the routine standard of care in Guy's and St. Thomas' Hospital, London. It lasts for 14 sessions, twice a week and primarily consists of a supervised exercise program and educational sessions. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in physical activity level after pulmonary rehabilitation | Physical activity is measured using the Actigraph accelerometer, which is a small light weight device clipped onto a waist belt. Its output is vector magnitude units, steps, energy expenditure and activity intensity level. Patients will wearing the device for 5 to 7 days, before and after the program. The pulmonary rehabilitation program consists of 14 sessions, twice a week. | Baseline measurement and after the program (approx Week 10) |
| Change in level of Self-Efficacy using the Pulmonary Rehabilitation Adapted Index of Self-Efficacy (PRAISE) questionnaire scores | Pulmonary Rehabilitation Adapted Index of Self-Efficacy (PRAISE) questionnaire is a questionnaire measuring the level of self-efficacy. It consists of 15 questions on a 4-point scale. It takes less than 10 minutes to complete. | Baseline, and after pulmonary rehabilitation program (approx Week 10) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in 6-Minute Walk Test distance after pulmonary rehabilitation | The 6-Minute Walk Test is a test of functional exercise capacity which is routinely used in pulmonary rehabilitation programs. | Baseline, and after pulmonary rehabilitation program (approx Week 10) |
| Change in Hospital Anxiety and Depression Scale (HADS) questionnaire score |
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Inclusion Criteria:
Patients who fulfill the current inclusion criteria for referral to pulmonary rehabilitation in Guy's and St Thomas' Hospital.
A diagnosis of COPD confirmed by spirometry (Forced Expiratory Volume in 1 second/Forced Vital Capacity < 0.70 after bronchodilator) (GOLD, 2014)
Exclusion Criteria:
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This study involves patients with chronic obstructive pulmonary disease (COPD), whose diagnosis is confirmed by spirometry
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Noor Diana Mohamed Sani | Contact | 4407852599168 | noor.sani.13@ucl.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| Noor Diana Mohamed Sani | University College, London | Principal Investigator |
| Leyla Osman, Dr | University College London, Guy's and St. Thomas' Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Thomas' Hospital | Recruiting | City of Westminster | London | SE1 7EH | United Kingdom |
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| Label | URL |
|---|---|
| The use of accelerometers to measure level of physical activity in patients with COPD | View source |
| Determinants and outcomes of physical activity in patients with COPD: a systematic review | View source |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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HADS consists of 14 questions and takes less than 10 minutes to complete. It measures the level of anxiety and depression. |
| Baseline, and after pulmonary rehabilitation program (approx Week 10) |
| Change in COPD Assessment Test score | The COPD Assessment Test is an 8-item questionnaire which determines the impact of chronic obstructive pulmonary disease on the patient's wellbeing and daily life. It takes less than 5 minutes to complete. | Baseline, and after pulmonary rehabilitation program (approx Week 10) |
| Lynn McDonnell, MSc |
| Guy's and St Thomas' NHS Foundation Trust |
| Study Director |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |