Introduction: Patients with COPD are characterised by symptoms of dyspnoea, limited exercise tolerance and low levels of physical activity which can lead to reduced quality of life. Pulmonary rehabilitation (PR) is recommended, however, not all are able to participate and there is a large dropout rate from this service. Home-based programmes aiming to enhance self-management skills can potentially provide an alternative model of delivery, allowing increased options for treatment. As one of the key components of PR is to enhance exercise endurance and physical activity, valid and reliable measures are needed to determine programme effectiveness. Therefore, the first aim of this thesis is to determine the validity, reproducibility and sensitivity of the SenseWear Pro 2 Armband, activity monitor (SWM) to be used in the main trial. The primary aim of this thesis is to describe the noninferiority randomised control trial of the effectiveness of the home based Self-management Programme of Activity Coping and Education (SPACE for COPD) in comparison to PR in patients with COPD.
Methods: Validation of methods; One subject (EH) completed a battery of repeated walking tests using the speeds from the endurance shuttle walk test. Minute by minute energy expenditure (EE) and step counts were recorded from 9 SWM and indirect calorimetry was used as the criterion measure to determine the validity of EE output from the monitor.
Noninferiority randomised controlled trial; 287 (187 male: mean (SD) age 67 (9) yrs; FEV1 1.25 (0.55); BMI 27.63 (6.22) kg/m2) patients with COPD were recruited from referral to PR and randomised to either the SPACE for COPD programme or conventional PR. The primary outcome was the self-reported measure of dyspnoea from the chronic respiratory questionnaire. Secondary measures included exercise performance (incremental and endurance shuttle walk tests (ISWT and ESWT), anxiety, depression and self-efficacy. Daily physical activity was measured over five days using the SWM in a subgroup of 154 patients. Outcome measures were taken at baseline, post intervention (seven weeks) and six months.
Results: The SWM was shown to be acceptable at measuring slow standardised walking speeds. However, reproducibility and sensitivity was more acceptable when using step count rather than EE.
There was a significant improvement in dyspnoea (mean (95% CI) 0.58 (0.28 to 0.88) units; p<0.001) and endurance capacity (ISWT 18 (3 to 32) m, p=0.015; ESWT 212 (139 to 284) sec, p<0.001), at seven weeks in the SPACE for COPD group that was to a similar level in the PR group (dyspnoea between group difference (95% CI) -0.032 (-0.71 to 0.08), p0.113), although it remains unclear as to the level of noninferiority. At six months some of the initial benefits in the ESWT were maintained in the SPACE for COPD group. However the other outcome measures (dyspnoea and ISWT) declined to baseline levels which were also evident in the PR group.
Daily PA was low at baseline in those recruited to the trial and reduced as dyspnoea symptoms increased (mean (SD) steps; MRC 2 5824 (3027); MRC 3 3908 (2162); MRC 4 3278 (2351); MRC 5 2382 (2046)). 51 patients had complete data sets at each measurement time point from the main trial. Those in the SPACE group significantly increased their PA above the PR group at seven weeks (mean (SD) between group difference for step count 1463 (280 to 2645) p0.020). By six months PA had decreased towards baseline levels in both groups.
Conclusion: SPACE for COPD does provide a number of health benefits so has the potential to be offered as an alternative to those who decline PR. As these benefits were not sustained at six months future work needs to be focussed on strategies to provide continued support for these patients.
|Date of Award||2014|
|Supervisor||Sally Singh (Supervisor)|