Chronic Obstructive Pulmonary Disease Respiratory Chronic obstructive pulmonary disease, unspecified
Conditions
Interventions
Group 1: Standard treatment: exercise and oxygen (If SpO2 < 90%)
Group 2: Exercise with NIV (average PS 20) and oxygen (If SpO2 < 90%)
Group 3: Continued supervised exe
Sponsors
Bristol Royal Infirmary (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female subjects, aged 40 and above (no upper age limit) 2. Primary diagnosis of COPD 3. Admission for an acute exacerbation on chronic respiratory failure requiring non-invasive ventilation (NIV) 4. Able to mobilize following admission 5. Able to use NIV within the hospital setting during exercise 6. Not attending Pulmonary Rehabilitation or planned to within the study period of three months post discharge
Exclusion criteria
Exclusion criteria: 1. Unable to tolerate/use NIV 2. Unable to mobilize following admission 3. Currently undertaking pulmonary rehabilitation 4. Primary diagnosis is not COPD
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Health related quality of life (QoL) is measured using the EuroQol questionnaire (EQ-5D) (Brooks R, et al, 1996), will be used. The EQ-5D is a patient-completed questionnaire giving a single index value for health status and has been used in COPD patients (Cleland J, et al, 2007; Gonzalez-Moro J, et al, 2009; Harper R, et al, 1997; Heyworth I, et al, 2009; Nilsson E, et al, 2007; Pickard A, et al, 2008; Stahl E, et al, 2003; Stahl et al, 2005; Szende A, et al, 2009;). The EQ-5D will be completed as follows ? 1. On admission to the study 2. At point of discharge home 3. At 1, 2 and 3 months of the study. Completion of the EQ-5D at time points 1 and 2 will be supervised by the researcher. In all three groups, following discharge, the questionnaire will be posted out to the patients. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Breathlessness during Daily Activity: This will be measured using the London Chest Activity of Daily Living questionnaire (Garrod R, et al, 2002). If NIV improves the ability to exercise and results in the patients being less breathless during exercise, daily activity should increase (Pitta et al, 2008). 2. Subjective Breathlessness: The MRC Dyspnoea scale (Burdon JG et al, 1982) will be used to assess the level of perceived breathlessness. The normal scale of 1 ? 5 will be reduced to 3 levels ? Grade 1 and 2 ? those who are ?troubled by breathlessness on strenuous exertion? or ?short of breath when hurrying?; Grades 3 and 4 ? patient who need to ?walk slower than most people of their own age on level ground? or to ?stop for breath after walking about 100 yards on the level?; and Grade 5 ? those who were ?too breathless to leave the house? or were ?breathless after undressing? 3. Diary Card: We will give patients an optional symptom diary card to indicate changes in symptoms over time. It will also allow us to monitor drug usage and changes in therapy as prescribed. We will ask patients to assess cough, sputum production, breathlessness, wheeze, sputum colour, sleepiness, and activity levels, and will allow us to monitor reported and unreported exacerbations (Vijayasaratha K, et al, 2008). 4. Compliance with NIV on Exercise: Usage of NIV during exercise will be obtained from the integrated monitor from the Trilogy that records date, time, duration and other physiological data during each treatment session. 5. Activity Levels: From the ActiCal software, the levels of activity over a predefined period of time will be assessed, giving mean activity, number of steps and energy expenditure levels. 6. Demographics: In addition to recording gender, age, standing height and weight, we will ask the following information at baseline: living situation, education level, smoking history, alcohol u | — |
Countries
United Kingdom
Outcome results
None listed