Challenges of undertaking a clinical trial using bubble-PEP in an acute exacerbation of chronic obstructive pulmonary disease: A feasibility study

Abstract

The aims of this study were to compare the effect of bubble-positive expiratory pressure with a commercial positive expiratory pressure device and standardised physiotherapy in patients with an acute exacerbation of chronic obstructive pulmonary disease, and to assess the feasibility of inpatient research methods. Patients admitted to a medical ward at Middlemore Hospital, Auckland, New Zealand, with an acute exacerbation of chronic obstructive pulmonary disease were randomly assigned to a treatment group. Participants undertook one supervised treatment, then independently completed two further sessions. Participants' symptoms and ease of sputum expectoration were measured using the Breathlessness, Cough and Sputum Scale. Health-related quality of life and length of hospital stay were also recorded. Only eleven participants were recruited, over ten months. The study was, therefore, underpowered to show differences in end points. Useful findings were uncovered relating to the feasibility of the protocol. Limitations to the recruitment process were identified, including staffing issues and the assessment schedule. Findings from this study will enable revision of the study protocol to allow a modified trial to be performed in the future. B, Jepsen N, Coulter K, Wong C, Zeng I (2016) Challenges of undertaking a clinical trial using bubble-PEP in an acute exacerbation of chronic obstructive pulmonary disease: A feasibility study. Eastwood

Design of pulmonary rehabilitation programmes during acute exacerbations of COPD: a systematic review and network meta-analysis

“…Most frequent timings to begin intervention were 24-48 h after hospital admission (n=10) [22,30,31,40,41,45,46,49,53,57], after hospital discharge (n=5) [28,33,35,38,56], at the moment of hospital discharge (n=4) [18,19,36,47] and at hospital admission (n=3) [25,43,55]. [27,45,46,53], positive expiratory pressure therapy performed with noninvasive ventilation [22,54] or devices (n=3) [49], home diaries (n=2) [35,36], respiratory muscle training (n=1) [37], nutrition (n=1) [28] and whole body vibration (n=1) [30]. Only 16 (38.1%) of the included studies [18, 21-24, 26, 28, 29, 31, 34, 35, 38, 39, 44, 46, 56] used pulmonary rehabilitation as an intervention if the pulmonary rehabilitation definition is taken into account [4].…”

“…Aerobic training was prescribed at 40-85% of the maximal or submaximal test result [24, 31-33, 37, 40, 44] and strength training at 40-80% of 1-repetition maximum [24,26,40,43,44]. Additional components used were: electrostimulation, which was applied using a range of frequencies from 12-50 Hz [27,30,45,53], with 50 Hz being the most used frequency; positive expiratory pressure therapy which was performed using 10-20 cmH 2 O [22,49]; and respiratory muscle training which was set at 50% of maximal inspiratory pressure [37].…”

The effectiveness of additional long-term use of bottle-positive expiratory pressure in chronic obstructive pulmonary disease: A single-blind, randomized study

“…Bottle-PEP is easily assembled by a physician and can be administered as an alternative to commercially available devices, therefore, constituting a valuable choice. [ 20 ] Previous surveys among physical therapists showed that it was used daily in a variety of situations. [ 21 ] A recent review demonstrated that there were only seven articles that implemented bottle-PEP, and most of the existing literature was about the technical properties of the device rather than long-term results.…”

Outcome Measures Used in Pulmonary Rehabilitation in Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease: A Systematic Review

“…2016. Most studies were randomized control trials (n = 31) 15,16, conducted with inpatients (n = 27), 15,16,29,30,33,35,[37][38][39][40][41]43,[45][46][47][48][51][52][53][54][55][56][57][58][59][60][61] followed by hospital outpatient departments (n = 6), 15,37,38,42,44,49 inpatients plus patients' homes (n = 3), 31,32,50 community settings (n = 3), 34,62,63 and patients' homes (n = 1) 36 (Tabs. 1 and 2).…”