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21 March 2013
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| [ Print-friendly version ] |
| The application of non-invasive ventilation during pulmonary rehabilitation in patients with Chronic Obstructive Pulmonary Disease (COPD) |
| ISRCTN | ISRCTN15832381 |
| DOI | 10.1186/ISRCTN15832381 |
| ClinicalTrials.gov identifier | |
| EudraCT number | |
| Public title | The application of non-invasive ventilation during pulmonary rehabilitation in patients with Chronic Obstructive Pulmonary Disease (COPD) |
| Scientific title | A randomized control trial of non-invasive ventilation during an exercise programme following acute acidotic exacerbation of COPD in hospital and follow-up use at home: feasibility of using the Trilogy Ventilator |
| Acronym | N/A |
| Serial number at source | EAME2011Trilogy01 |
| Study hypothesis | The use of the Trilogy Ventilator will improve health related Quality of Life in patients with Chronic Obstructive Pulmonary Disease following an acute acidotic exacerbation. |
| Lay summary | Lay summary under review 3 |
| Ethics approval | NRES Committee South West - Central Bristol. Bristol Research Ethics Committee Centre, 24th September 2012, REC Reference: 12/SW/0228 |
| Study design | Randomized non-blinded controlled trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Chronic Obstructive Pulmonary Disease |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 01/02/2013 |
| Anticipated end date | 01/02/2015 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 45 |
| 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 exercise program, with NIV, and Oxygen if indicated at home Visit 1. (Baseline) (All Groups) 1. Inclusion/Exclusion 2. Demographic Data (gender, age, height, weight, living situation, education level, smoking history, alcohol use and disease co-morbidity) 3. The EuroQol questionnaire (EQ-5D) 4. The St Georges Respiratory Questionnaire 5. The London Chest Activity of Daily Living Questionnaire 6. The MRC Dyspnoea scale 7. 6 Minute Walk Test 8. Actical monitoring of exercise programme (according to randomization group) 9) Issue Diary Card Pre-Discharge Assessment. (Baseline) (All Groups) 1. Demographic Data 2. The EuroQol questionnaire (EQ-5D) 3. The St Georges Respiratory Questionnaire 4. The London Chest Activity of Daily Living Questionnaire 5. The MRC Dyspnoea scale 6. 6 Minute Walk Test 7. Actical monitoring of exercise programme (according to randomization group) Visit 2. Month 1 (Group 3) 1. The EuroQol questionnaire (EQ-5D) 2. The St Georges Respiratory Questionnaire 3. The London Chest Activity of Daily Living Questionnaire 4. The MRC Dyspnoea scale 5. 6 Minute Walk Test 6. Actical monitoring of exercise programme 7. Check Diary Card Visit 2. Month 1 (Group 1 and 2 - Questionnaires via post) 1. The EuroQol questionnaire (EQ-5D) 2. The St Georges Respiratory Questionnaire 3. The London Chest Activity of Daily Living Questionnaire 4. The MRC Dyspnoea scale 5. 6 Minute Walk Test 6. Check Actical Monitor being used 7. Check Diary Card Visit 3. Month 2 (Group 3). 1. The EuroQol questionnaire (EQ-5D) 2. The St Georges Respiratory Questionnaire 3. The London Chest Activity of Daily Living Questionnaire 4. The MRC Dyspnoea scale 5. 6 Minute Walk Test 6. Actical monitoring of exercise programme 7. Check Diary Card Visit 3. Month 2 (Group 1 and 2 Questionnaires via post). 1. The EuroQol questionnaire (EQ-5D) 2. The St Georges Respiratory Questionnaire 3. The London Chest Activity of Daily Living Questionnaire 4. The MRC Dyspnoea scale 5. 6 Minute Walk Test 6. Check Actical Monitor being used 7. Check Diary Card Visit 4. Month 3 (All Groups - patients either visited by researcher or reviewed in out patient clinic). 1. The EuroQol questionnaire (EQ-5D) 2. The St Georges Respiratory Questionnaire 3. The London Chest Activity of Daily Living Questionnaire 4. The MRC Dyspnoea scale 5. 6 Minute Walk Test 6. Actical monitoring of exercise programme 7. Retrieve Diary Card 8. Retrieve Equipment |
| Primary outcome measure(s) |
Change in health related quality of life (QoL), as COPD is known to have a strong negative impact on QoL (Heyworth I, et al, 2009). 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 outcome measure(s) |
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 use and disease co-morbidity. |
| Sources of funding | Philips Home Healthcare Solutions (UK) |
| Trial website | |
| Publications | |
| Contact name | Dr Adrian Kendrick |
| Address |
The Sleep Unit
Level 4 Old Building Bristol Royal Infirmary Upper Maudlin Street |
| City/town | Bristol |
| Zip/Postcode | BS2 8HW |
| Country | United Kingdom |
| Adrian.Kendrick@UHBristol.nhs.uk | |
| Sponsor | Bristol Royal Infirmary (UK) |
| Address |
c/o Dr Adrian Kendrick
The Sleep Unit Level 4 Old Building Bristol Royal Infirmary Upper Maudlin Street |
| City/town | Bristol |
| Zip/Postcode | BS2 8HW |
| Country | United Kingdom |
| Adrian.Kendrick@UHBristol.nhs.uk | |
| Sponsor website: | http://www.uhbristol.nhs.uk/your-hospitals/bristol-royal-infirmary.html |
| Date applied | 07/02/2013 |
| Last edited | 15/02/2013 |
| Date ISRCTN assigned | 15/02/2013 |
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