Implementation of supplemental physiotherapy following hip fracture surgery: a protocol for the process evaluation of a randomised controlled trial.

BACKGROUND: Patient outcomes following low-trauma hip fracture are suboptimal resulting in increased healthcare costs and poor functional outcomes at 1 year. Providing early and intensive in-hospital physiotherapy could help improve patient outcomes and reduce costs following hip fracture surgery. The HIP fracture Supplemental Therapy to Enhance Recovery (HIPSTER) trial will compare usual care physiotherapy to intensive in-hospital physiotherapy for patients following hip fracture surgery. The complex environments in which the intervention is implemented present unique contextual challenges that may impact intervention effectiveness. This study aims to complete a process evaluation to identify barriers and facilitators to implementation and explore the patient, carer and clinician experience of intensive therapy following hip fracture surgery. METHODS AND ANALYSIS: The process evaluation is embedded within a two-arm randomised, controlled, assessor-blinded trial recruiting 620 participants from eight Australian hospitals who have had surgery for a hip fracture sustained via a low-trauma injury. A theory-based mixed method process evaluation will be completed in tandem with the HIPSTER trial. Patient and carer semi-structured interviews will be completed at 6 weeks following hip fracture surgery. The clinician experience will be explored through online surveys completed pre- and post-implementation of intensive therapy and mapped to domains of the Theoretical Domains Framework (TDF). Translation and behaviour change success will be assessed using the Reach Effectiveness-Adoption Implementation Maintenance (RE-AIM) framework and a combination of qualitative and quantitative data collection methods. These data will assist with the development of an Implementation Toolkit aiding future translation into practice. DISCUSSION: The embedded process evaluation will help understand the interplay between the implementation context and the intensive therapy intervention following surgery for low-trauma hip fracture. Understanding these mechanisms, if effective, will assist with transferability into other contexts and wider translation into practice. TRIAL REGISTRATION: ACTRN 12622001442796.

HIP fracture Supplemental Therapy to Enhance Recovery (HIPSTER): a protocol for a randomised controlled trial.

INTRODUCTION: Hip fractures result in substantial health impacts for patients and costs to health systems. Many patients require prolonged hospital stays and up to 60% do not regain their prefracture level of mobility within 1 year. Physical rehabilitation plays a key role in regaining physical function and independence; however, there are no recommendations regarding the optimal intensity. This study aims to compare the clinical efficacy and cost-effectiveness of early intensive in-hospital physiotherapy compared with usual care in patients who have had surgery following a hip fracture. METHODS AND ANALYSIS: This two-arm randomised, controlled, assessor-blinded trial will recruit 620 participants who have had surgery following a hip fracture from eight hospitals. Participants will be randomised 1:1 to receive usual care (physiotherapy according to usual practice at the site) or intensive physiotherapy in the hospital over the first 7 days following surgery (two additional sessions per day, one delivered by a physiotherapist and the other by an allied health assistant). The primary outcome is the total hospital length of stay, measured from the date of hospital admission to the date of hospital discharge, including both acute and subacute hospital days. Secondary outcomes are functional mobility, health-related quality of life, concerns about falling, discharge destination, proportion of patients remaining in hospital at 30 days, return to preadmission mobility and residence at 120 days and adverse events. Twelve months of follow-up will capture data on healthcare utilisation. A cost-effectiveness evaluation will be undertaken, and a process evaluation will document barriers and facilitators to implementation. ETHICS AND DISSEMINATION: The Alfred Hospital Ethics Committee has approved this protocol. The trial findings will be published in peer-reviewed journals, submitted for presentation at conferences and disseminated to patients and carers. TRIAL REGISTRATION NUMBER: ACTRN12622001442796.

The AWESCORE, a patient-reported outcome measure: development, feasibility, reliability, validity and responsiveness for adults with cystic fibrosis.

BACKGROUND: Quality of life has improved dramatically over the past two decades in people with cystic fibrosis (CF). Quantification has been enabled by patient-reported outcome measures (PROMs); however, many are lengthy and can be challenging to use in routine clinical practice. We propose a short-form PROM that correlates well with established quality-of-life measures. METHODS: We evaluated the utility of a 10-item score (AWESCORE) by measuring reliability, validity and responsiveness in adults with CF. The questions were developed by thematic analysis of survey questions to patients in a single adult CF centre. Each question was scored using a numerical rating scale 0 to 10. Total scores ranged from 0 to 100. Test-retest reliability was assessed over 24 h. To determine validity, comparisons were sought between stable subjects and those in pulmonary exacerbation, and between AWESCORE and Cystic Fibrosis Questionnaire - Revised (CFQ-R). Responsiveness to pulmonary exacerbation in individual subjects was evaluated. RESULTS: Five domains, each with two questions, were identified for respiratory, physical, nutritional, psychological and general health. A total of 246 consecutive adults attending the outpatient clinic completed the AWESCORE. Scores were higher during clinical stability compared to pulmonary exacerbation (mean± sd): 73±11 versus 48±11 (p<0.001). Each domain scored worse during an acute exacerbation (p<0.001). No differences in reliability were observed in scores on retesting using Bland-Altman comparison. The CFQ-R scores (mean±sd: 813±125) and AWESCORE (81±13) were moderately correlated (Pearson's r=0.649; p=0.002). CONCLUSIONS: The AWESCORE is valid, reliable and responsive to altered health status in CF.

Application of the Modified Incremental Step Test for Pulmonary Rehabilitation.

OBJECTIVE: A Modified Incremental Step Test (MIST) performed in the home may facilitate entirely home-based pulmonary rehabilitation programs. The aims of this study were to investigate the reliability and responsiveness, and the utility of the MIST for exercise prescription in people with stable chronic lung disease. METHODS: The MIST was undertaken at the center and home in random order, before and after pulmonary rehabilitation, with 2 tests at each time point. Reliability was assessed using intraclass correlation coefficient. Responsiveness was evaluated as effect size. The minimal important difference was appraised using distribution and anchor-based methods. In a substudy, physiological responses to MIST were measured by a portable metabolic system, followed by a constant step rate test at 60% of peak oxygen uptake (VO2peak), to evaluate utility for exercise prescription. RESULTS: Forty-six participants were recruited (29% of eligible candidates). There was excellent reliability for number of steps recorded in home- and center-based settings (intraclass correlation coefficient = 0.954, 95% CI = 0.915-0.976). A small-moderate effect size was demonstrated following pulmonary rehabilitation (0.34), and the minimal detectable change was 7 steps. All participants in the substudy achieved 60% of VO2peak and achieved steady state by the fourth minute, with 60% of VO2peak corresponding to a mean 37% (95% CI = 29-44) of the MIST final level. CONCLUSIONS: The MIST is reliable and responsive to pulmonary rehabilitation in people with stable chronic respiratory disease. It provides new opportunities to assess exercise capacity, prescribe exercise training, and reassess exercise program outcomes in environments where established field walking tests are not feasible. IMPACT: Pulmonary rehabilitation is a highly effective treatment that is underutilized worldwide. Home-based pulmonary rehabilitation may improve access for patients and deliver equivalent clinical outcomes but is limited by the availability of a robust exercise test that can be used at home to assess exercise capacity and prescribe training intensity. This study tested the clinimetric properties of the MIST and demonstrated a new way to assess exercise capacity, prescribe exercise training of an appropriate intensity, and reassess exercise capacity in environments where established field walking tests are not feasible.

Interventions for promoting physical activity in people with chronic obstructive pulmonary disease (COPD).

BACKGROUND: Escalating awareness of the magnitude of the challenge posed by low levels of physical activity in people with chronic obstructive pulmonary disease (COPD) highlights the need for interventions to increase physical activity participation. The widely-accepted benefits of physical activity, coupled with the increasing availability of wearable monitoring devices to objectively measure participation, has led to a dramatic rise in the number and variety of studies that aimed to improve the physical activity of people with COPD. However, little was known about the relative efficacy of interventions tested so far. OBJECTIVES: In people with COPD, which interventions are effective at improving objectively-assessed physical activity? SEARCH METHODS: We identified trials from the Cochrane Airways Trials Register Register, which contains records identified from bibliographic databases including the Cochrane Central Register of Controlled Trials, MEDLINE, Embase, CINAHL, AMED, and PsycINFO. We also searched PEDro, ClinicalTrials.gov, the World Health Organization International Clinical Trials Registry Platform portal and the Australian New Zealand Clinical Trials Registry (from inception to June 2019). We checked reference lists of all primary studies and review articles for additional references, as well as respiratory journals and respiratory meeting abstracts, to identify relevant studies. SELECTION CRITERIA: We included randomised controlled trials of interventions that used objective measures for the assessment of physical activity in people with COPD. Trials compared an intervention with no intervention or a sham/placebo intervention, an intervention in addition to another standard intervention common to both groups, or two different interventions. DATA COLLECTION AND ANALYSIS: We used standard methods recommended by Cochrane. Subgroup analyses were possible for supervised compared to unsupervised pulmonary rehabilitation programmes in clinically-stable COPD for a range of physical activity outcomes. Secondary outcomes were health-related quality of life, exercise capacity, adverse events and adherence. Insufficient data were available to perform prespecified subgroup analyses by duration of intervention or disease severity. We undertook sensitivity analyses by removing studies that were at high or unclear risk of bias for the domains of blinding and incomplete outcome data. MAIN RESULTS: We included 76 studies with 8018 participants. Most studies were funded by government bodies, although some were sponsored by equipment or drug manufacturers. Only 38 studies had physical activity as a primary outcome. A diverse range of interventions have been assessed, primarily in single studies, but improvements have not been systematically demonstrated following any particular interventions. Where improvements were demonstrated, results were confined to single studies, or data for maintained improvement were not provided. Step count was the most frequently reported outcome, but it was commonly assessed using devices with documented inaccuracy for this variable. Compared to no intervention, the mean difference (MD) in time in moderate- to vigorous-intensity physical activity (MVPA) following pulmonary rehabilitation was four minutes per day (95% confidence interval (CI) -2 to 9; 3 studies, 190 participants; low-certainty evidence). An improvement was demonstrated following high-intensity interval exercise training (6 minutes per day, 95% CI 4 to 8; 2 studies, 275 participants; moderate-certainty evidence). One study demonstrated an improvement following six months of physical activity counselling (MD 11 minutes per day, 95% CI 7 to 15; 1 study, 280 participants; moderate-certainty evidence), but we found mixed results for the addition of physical activity counselling to pulmonary rehabilitation. There was an improvement following three to four weeks of pharmacological treatment with long-acting muscarinic antagonist and long-acting beta2-agonist (LAMA/LABA) compared to placebo (MD 10 minutes per day, 95% CI 4 to 15; 2 studies, 423 participants; high-certainty evidence). These interventions also demonstrated improvements in other measures of physical activity. Other interventions included self-management strategies, nutritional supplementation, supplemental oxygen, endobronchial valve surgery, non-invasive ventilation, neuromuscular electrical stimulation and inspiratory muscle training. AUTHORS' CONCLUSIONS: A diverse range of interventions have been assessed, primarily in single studies. Improvements in physical activity have not been systematically demonstrated following any particular intervention. There was limited evidence for improvement in physical activity with strategies including exercise training, physical activity counselling and pharmacological management. The optimal timing, components, duration and models for interventions are still unclear. Assessment of quality was limited by a lack of methodological detail. There was scant evidence for a continued effect over time following completion of interventions, a likely requirement for meaningful health benefits for people with COPD.

Pulmonary Rehabilitation does not Improve Objective Measures of Sleep Quality in People with Chronic Obstructive Pulmonary Disease.

Abnormal sleep duration is associated with poor health. Upwards of 50% of people with chronic obstructive pulmonary disease (COPD) report poor sleep quality. The effect of pulmonary rehabilitation on self-reported sleep quality is variable. The aim of this study was to assess the effect of pulmonary rehabilitation on objectively measured sleep quality (via actigraphy) in people with COPD. Sleep quality was assessed objectively using the SenseWear Armband (SWA, BodyMedia, Pittsburgh, PA), worn for ≥4 days before and immediately after completing an 8-week pulmonary rehabilitation program. Sleep characteristics were derived from accelerometer positional data and registration of sleep state by the SWA, determined from energy expenditure. Forty-eight participants (n = 21 male) with COPD (mean (SD), age 70 (10) years, mean FEV1 55 (20) % predicted, mean 45 (24) pack year smoking history) contributed pre and post pulmonary rehabilitation sleep data to this analysis. No significant differences were seen in any sleep parameters after pulmonary rehabilitation (p = 0.07-0.70). There were no associations between sleep parameters and measures of quality of life or function (all p > 0.30). Sleep quality, measured objectively using actigraphy, did not improve after an 8-week pulmonary rehabilitation program in individuals with COPD. Whether on-going participation in regular exercise training beyond the duration of pulmonary rehabilitation may influence sleep quality, or whether improving sleep quality could enhance rehabilitation outcomes, is yet to be determined.

Promoting Physical Activity Using the Internet: Is It Feasible and Acceptable for Patients With Chronic Obstructive Pulmonary Disease and Bronchiectasis?

Older people with chronic lung diseases and with low physical activity participation rates are at higher risk of morbidity and mortality. This study assessed the feasibility and acceptability of a purpose-designed Internet-based program (ActivOnline) to monitor and encourage exercise and physical activity. Twelve participants with chronic obstructive pulmonary disease or bronchiectasis were recruited (54-84 years). Primary outcome measures were feasibility measured by frequency of program access, and acceptability measured by semistructured interview, system usability scores, and participant perception of benefit. The results suggest regular participation in physical activity and exercise during the 8-week study period and high usability scores (mean = 90% ± 9%). Major themes were the importance of regular exercise and how sustained lifestyle changes were essential to be physically active, regular contact with clinicians assisted with motivation, and aspects of ActivOnline facilitated individual behavior change and confidence to continue exercising. Most participants (82%) reported a benefit from using ActivOnline, and 55% wished to remain on the program indefinitely.

Positive expiratory pressure therapy versus other airway clearance techniques for bronchiectasis.

BACKGROUND: People with bronchiectasis experience chronic cough and sputum production and require the prescription of airway clearance techniques (ACTs). A common type of ACT prescribed is positive expiratory pressure (PEP) therapy. A previous review has suggested that ACTs including PEP therapy are beneficial compared to no treatment in people with bronchiectasis. However, the efficacy of PEP therapy in a stable clinical state or during an acute exacerbation compared to other ACTs in bronchiectasis is unknown. OBJECTIVES: The primary aim of this review was to determine the effects of PEP therapy compared with other ACTs on health-related quality of life (HRQOL), rate of acute exacerbations, and incidence of hospitalisation in individuals with stable or an acute exacerbation of bronchiectasis.Secondary aims included determining the effects of PEP therapy upon physiological outcomes and clinical signs and symptoms compared with other ACTs in individuals with stable or an acute exacerbation of bronchiectasis. SEARCH METHODS: We searched the Cochrane Airways Group Specialised Register of Trials, PEDro and clinical trials registries from inception to February 2017 and we handsearched relevant journals. SELECTION CRITERIA: Randomised controlled parallel and cross-over trials that compared PEP therapy versus other ACTs in participants with bronchiectasis. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures as outlined by Cochrane. MAIN RESULTS: Nine studies involving 213 participants met the inclusion criteria, of which seven were cross-over in design. All studies included adults with bronchiectasis, with eight including participants in a stable clinical state and one including participants experiencing an acute exacerbation. Eight studies used oscillatory PEP therapy, using either a Flutter or Acapella device and one study used Minimal PEP therapy. The comparison intervention differed between studies. The methodological quality of studies was poor, with cross-over studies including suboptimal or no washout period, and a lack of blinding of participants, therapists or personnel for outcome measure assessment in most studies. Clinical heterogeneity between studies limited meta-analysis.Daily use of oscillatory PEP therapy for four weeks was associated with improved general health according to the Short-Form 36 questionnaire compared to the active cycle of breathing technique (ACBT). When applied for three sessions over one week, minimal PEP therapy resulted in similar improvement in cough-related quality of life as autogenic drainage (AD) and L'expiration Lente Totale Glotte Ouverte en Decubitus Lateral (ELTGOL). Oscillatory PEP therapy twice daily for four weeks had similar effects on disease-specific HRQOL (MD -0.09, 95% CI -0.37 to 0.19; low-quality evidence). Data were not available to determine the incidence of hospitalisation or rate of exacerbation in clinically stable participants.Two studies of a single session comparison of oscillatory PEP therapy and gravity-assisted drainage (GAD) with ACBT had contrasting findings. One study found a similar sputum weight produced with both techniques (SMD 0.54g (-0.38 to 1.46; 20 participants); the other found greater sputum expectoration with GAD and ACBT (SMD 5.6 g (95% CI 2.91 to 8.29: 36 participants). There was no difference in sputum weight yielded between oscillatory PEP therapy and ACBT with GAD when applied daily for four weeks or during an acute exacerbation. Although a single session of oscillatory PEP therapy was associated with less sputum compared to AD (median difference 3.1 g (95% CI 1.5 to 4.8 g; one study, 31 participants), no difference between oscillatory PEP therapy and seated ACBT was evident. PEP therapy had a similar effect on dynamic and static measures of lung volumes and gas exchange as all other ACTs. A single session of oscillatory PEP therapy (Flutter) generated a similar level of fatigue as ACBT with GAD, but greater fatigue was noted with oscillatory PEP therapy compared to ACBT alone. The degree of breathlessness experienced with PEP therapy did not differ from other techniques. Among studies exploring adverse events, only one study reported nausea with use of oscillatory PEP therapy. AUTHORS' CONCLUSIONS: PEP therapy appears to have similar effects on HRQOL, symptoms of breathlessness, sputum expectoration, and lung volumes compared to other ACTs when prescribed within a stable clinical state or during an acute exacerbation. The number of studies and the overall quality of the evidence were both low. In view of the chronic nature of bronchiectasis, additional information is needed to establish the long-term clinical effects of PEP therapy over other ACTs for outcomes that are important to people with bronchiectasis and on clinical parameters which impact on disease progression and patient morbidity in individuals with stable bronchiectasis. In addition, the role of PEP therapy during an acute exacerbation requires further exploration. This information is necessary to provide further guidance for prescription of PEP therapy for people with bronchiectasis.

The evidence of benefits of exercise training in interstitial lung disease: a randomised controlled trial.

BACKGROUND: Uncertainty exists regarding the clinical relevance of exercise training across the range of interstitial lung diseases (ILDs). OBJECTIVE: To establish the impact of exercise training in patients with ILDs of differing aetiology and severity. METHODS: 142 participants with ILD (61 idiopathic pulmonary fibrosis (IPF), 22 asbestosis, 23 connective tissue disease-related ILD (CTD-ILD) and 36 with other aetiologies) were randomised to either 8 weeks of supervised exercise training or usual care. Six-minute walk distance (6MWD), Chronic Respiratory Disease Questionnaire (CRDQ), St George Respiratory Questionnaire IPF-specific version (SGRQ-I) and modified Medical Research Council dyspnoea score were measured at baseline, 9 weeks and 6 months. MEASUREMENTS AND MAIN RESULTS: Exercise training significantly increased 6MWD (25 m, 95% CI 2 to 47 m) and health-related quality of life (CRDQ and SGRQ-I) in people with ILD. Larger improvements in 6MWD, CRDQ, SGRQ-I and dyspnoea occurred in asbestosis and IPF compared with CTD-ILD, but with few significant differences between subgroups. Benefits declined at 6 months except in CTD-ILD. Lower baseline 6MWD and worse baseline symptoms were associated with greater benefit in 6MWD and symptoms following training. Greater gains were seen in those whose exercise prescription was successfully progressed according to the protocol. At 6 months, sustained improvements in 6MWD and symptoms were associated with better baseline lung function and less pulmonary hypertension. CONCLUSIONS: Exercise training is effective in patients across the range of ILDs, with clinically meaningful benefits in asbestosis and IPF. Successful exercise progression maximises improvements and sustained treatment effects favour those with milder disease. TRIAL REGISTRATION NUMBER: Results, ACTRN12611000416998.

A randomised controlled trial of CPAP versus non-invasive ventilation for initial treatment of obesity hypoventilation syndrome.

BACKGROUND: Obesity hypoventilation syndrome (OHS) is the most common indication for home ventilation, although the optimal therapy remains unclear, particularly for severe disease. We compared Bi-level and continuous positive airways pressure (Bi-level positive airway pressure (PAP); CPAP) for treatment of severe OHS. METHODS: We conducted a multicentre, parallel, double-blind trial for initial treatment of OHS, with participants randomised to nocturnal Bi-level PAP or CPAP for 3 months. The primary outcome was frequency of treatment failure (hospital admission, persistent ventilatory failure or non-adherence); secondary outcomes included health-related quality of life (HRQoL) and sleepiness. RESULTS: Sixty participants were randomised; 57 completed follow-up and were included in analysis (mean age 53 years, body mass index 55 kg/m2, PaCO2 60 mm Hg). There was no difference in treatment failure between groups (Bi-level PAP, 14.8% vs CPAP, 13.3%, p=0.87). Treatment adherence and wake PaCO2 were similar after 3 months (5.3 hours/night Bi-level PAP, 5.0 hours/night CPAP, p=0.62; PaCO2 44.2 and 45.9 mm Hg, respectively, p=0.60). Between-group differences in improvement in sleepiness (Epworth Sleepiness Scale 0.3 (95% CI -2.8, 3.4), p=0.86) and HRQoL (Short Form (SF)36-SF6d 0.025 (95% CI -0.039, 0.088), p=0.45) were not significant. Baseline severity of ventilatory failure (PaCO2) was the only significant predictor of persistent ventilatory failure at 3 months (OR 2.3, p=0.03). CONCLUSIONS: In newly diagnosed severe OHS, Bi-level PAP and CPAP resulted in similar improvements in ventilatory failure, HRQoL and adherence. Baseline PaCO2 predicted persistent ventilatory failure on treatment. Long-term studies are required to determine whether these treatments have different cost-effectiveness or impact on mortality. TRIAL REGISTRATION NUMBER: ACTRN12611000874910, results.

Airway clearance techniques for bronchiectasis.

BACKGROUND: People with non-cystic fibrosis bronchiectasis commonly experience chronic cough and sputum production, features that may be associated with progressive decline in clinical and functional status. Airway clearance techniques (ACTs) are often prescribed to facilitate expectoration of sputum from the lungs, but the efficacy of these techniques in a stable clinical state or during an acute exacerbation of bronchiectasis is unclear. OBJECTIVES: Primary: to determine effects of ACTs on rates of acute exacerbation, incidence of hospitalisation and health-related quality of life (HRQoL) in individuals with acute and stable bronchiectasis. Secondary: to determine whether:• ACTs are safe for individuals with acute and stable bronchiectasis; and• ACTs have beneficial effects on physiology and symptoms in individuals with acute and stable bronchiectasis. SEARCH METHODS: We searched the Cochrane Airways Group Specialised Register of trials from inception to November 2015 and PEDro in March 2015, and we handsearched relevant journals. SELECTION CRITERIA: Randomised controlled parallel and cross-over trials that compared an ACT versus no treatment, sham ACT or directed coughing in participants with bronchiectasis. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures as expected by The Cochrane Collaboration. MAIN RESULTS: Seven studies involving 105 participants met the inclusion criteria of this review, six of which were cross-over in design. Six studies included adults with stable bronchiectasis; the other study examined clinically stable children with bronchiectasis. Three studies provided single treatment sessions, two lasted 15 to 21 days and two were longer-term studies. Interventions varied; some control groups received a sham intervention and others were inactive. The methodological quality of these studies was variable, with most studies failing to use concealed allocation for group assignment and with absence of blinding of participants and personnel for outcome measure assessment. Heterogeneity between studies precluded inclusion of these data in the meta-analysis; the review is therefore narrative.One study including 20 adults that compared an airway oscillatory device versus no treatment found no significant difference in the number of exacerbations at 12 weeks (low-quality evidence). Data were not available for assessment of the impact of ACTs on time to exacerbation, duration or incidence of hospitalisation or total number of hospitalised days. The same study reported clinically significant improvements in HRQoL on both disease-specific and cough-related measures. The median difference in the change in total St George's Respiratory Questionnaire (SGRQ) score over three months in this study was 7.5 units (P value = 0.005 (Wilcoxon)). Treatment consisting of high-frequency chest wall oscillation (HFCWO) or a mix of ACTs prescribed for 15 days significantly improved HRQoL when compared with no treatment (low-quality evidence). Two studies reported mean increases in sputum expectoration with airway oscillatory devices in the short term of 8.4 mL (95% confidence interval (CI) 3.4 to 13.4 mL) and in the long term of 3 mL (P value = 0.02). HFCWO improved forced expiratory volume in one second (FEV1) by 156 mL and forced vital capacity (FVC) by 229.1 mL when applied for 15 days, but other types of ACTs showed no effect on dynamic lung volumes. Two studies reported a reduction in pulmonary hyperinflation among adults with non-positive expiratory pressure (PEP) ACTs (difference in functional residual capacity (FRC) of 19%, P value < 0.05; difference in total lung capacity (TLC) of 703 mL, P value = 0.02) and with airway oscillatory devices (difference in FRC of 30%, P value < 0.05) compared with no ACTs. Low-quality evidence suggests that ACTs (HFCWO, airway oscillatory devices or a mix of ACTs) reduce symptoms of breathlessness and cough and improve ease of sputum expectoration compared with no treatment (P value < 0.05). ACTs had no effect on gas exchange, and no studies reported effects of antibiotic usage. Among studies exploring airway oscillating devices, investigators reported no adverse events. AUTHORS' CONCLUSIONS: ACTs appear to be safe for individuals (adults and children) with stable bronchiectasis and may account for improvements in sputum expectoration, selected measures of lung function, symptoms and HRQoL. The role of these techniques in acute exacerbation of bronchiectasis is unknown. In view of the chronic nature of bronchiectasis, additional data are needed to establish the short-term and long-term clinical value of ACTs for patient-important outcomes and for long-term clinical parameters that impact disease progression in individuals with stable bronchiectasis, allowing further guidance on prescription of specific ACTs for people with bronchiectasis.

Field Walking Tests Are Reliable and Responsive to Exercise Training in People With Non-Cystic Fibrosis Bronchiectasis.

PURPOSE: The 6-Minute Walk Test (6MWT) and Incremental Shuttle Walk Test (ISWT) are used to assess exercise capacity, but the reliability and responsiveness of these tests in individuals with non-cystic fibrosis (CF) bronchiectasis have not been determined. This study aimed to determine the reliability and responsiveness of both tests in adults with non-CF bronchiectasis. METHODS: Eighty-five participants completed 2 6MWTs and 2 ISWTs in random order. Testing was repeated at the conclusion of an 8-week intervention period of exercise training. Reliability was assessed using intraclass correlation coefficients (ICC) and Bland-Altman analysis. Responsiveness was measured by effect size (ES) and standardized response mean (SRM). RESULTS: At baseline, test-retest reliability was high for both tests (ICC ≥ 0.95). The mean (95% CI) increase in the 6MWT from test 1 to test 2 was 20 m (13-26 m): 3% (0-5%) change. The mean (95% CI) increase in the ISWT was 15 m (4-25m): 4% (2-6%) change. A significant learning effect persisted after 8 weeks for the 6MWT (P = .04), but not the ISWT (P = .61). The 6MWT ES was 0.32 and SRM was 0.68; for the ISWT, ES was 0.42 with SRM of 0.71. CONCLUSION: The 6MWT and ISWT are reliable measures of exercise capacity in non-CF bronchiectasis and responsive to exercise training. The small learning effect in both measures at baseline suggests that 2 of each test are necessary to correctly assess exercise capacity. Completion of 2 6MWTs at followup may minimize the risk of underestimating a treatment effect.

Validity and Reliability of the Chronic Respiratory Disease Questionnaire in Elderly Individuals with Mild to Moderate Non-Cystic Fibrosis Bronchiectasis.

BACKGROUND: The chronic respiratory disease questionnaire (CRDQ) is designed to assess health-related quality of life (HRQOL) in chronic respiratory conditions, but its reliability, validity and responsiveness in individuals with mild to moderate non-cystic fibrosis (CF) bronchiectasis are unclear. OBJECTIVES: This study aimed to determine measurement properties of the CRDQ in non-CF bronchiectasis. METHODS: Participants with non-CF bronchiectasis involved in a randomised controlled trial of exercise training were recruited. Internal consistency was assessed using Cronbach's α. Over 8 weeks, reliability was evaluated using intra-class correlation coefficients and Bland-Altman analysis for measures of agreement. Convergent and divergent validity was assessed by correlations with the other HRQOL questionnaires and the Hospital Anxiety and Depression Scale (HADS). The responsiveness to exercise training was assessed using effect sizes and standardised response means. RESULTS: Eighty-five participants were included (mean age ± SD, 64 ± 13 years). Internal consistency was adequate (>0.7) for all CRDQ domains and the total score. Test-retest reliability ranged from 0.69 to 0.85 for each CRDQ domain and was 0.82 for the total score. Dyspnoea (CRDQ) was related to St George's respiratory questionnaire (SGRQ) symptoms only (r = 0.38), with no relationship to the Leicester cough questionnaire (LCQ) or HADS. Moderate correlations were found between the total score of the CRDQ, the SGRQ (rs = -0.49) and the LCQ score (rs = 0.51). Lower CRDQ scores were associated with higher anxiety and depression (rs = -0.46 to -0.56). The responsiveness of the CRDQ was small (effect size 0.1-0.24). CONCLUSIONS: The CRDQ is a valid and reliable measure of HRQOL in mild to moderate non-CF bronchiectasis, but responsiveness was limited.

Prevalence and impact of urinary incontinence in men with cystic fibrosis.

OBJECTIVES: To determine the prevalence and impact of urinary incontinence (UI) in men with cystic fibrosis (CF). DESIGN: Prospective observational study. SETTING: Adult CF clinics at tertiary referral centres. PARTICIPANTS: Men with CF (n=80) and age-matched men without lung disease (n=80). INTERVENTIONS: Validated questionnaires to identify the prevalence and impact of UI. MAIN OUTCOME MEASURES: Prevalence of UI and relationship to disease specific factors, relationship of UI with anxiety and depression. RESULTS: The prevalence of UI was higher in men with CF (15%) compared to controls (10%) (p=0.339). Men with CF and UI had higher scores for anxiety than those without UI (mean 9.1 (SD 4.8) vs 4.7 (4.1), p=0.003), with similar findings for depression (6.8 (4.6) vs 2.8 (3.4), p=0.002) using the Hospital Anxiety and Depression Scale. CONCLUSIONS: Incontinence is more prevalent in adult men with CF than age matched controls, and may have an adverse effect on mental health. The mechanisms involved are still unclear and may differ from those reported in women.

The short and long term effects of exercise training in non-cystic fibrosis bronchiectasis--a randomised controlled trial.

BACKGROUND: Exercise training is recommended for non-cystic fibrosis (CF) bronchiectasis, but the long-term effects are unclear. This randomised controlled trial aimed to determine the effects of exercise training and review of airway clearance therapy (ACT) on exercise capacity, health related quality of life (HRQOL) and the incidence of acute exacerbations in people with non-CF bronchiectasis. METHODS: Participants were randomly allocated to 8 weeks of supervised exercise training and review of ACT, or control. Primary outcomes of exercise capacity and HRQOL (Chronic respiratory disease questionnaire) and secondary outcomes of cough-related QOL (Leicester cough questionnaire) and psychological symptoms (Hospital anxiety and depression scale) were measured at baseline, following completion of the intervention period and at 6 and 12 months follow up. Secondary outcomes of the exacerbation rate and time to first exacerbation were analysed over 12 months. RESULTS: Eighty-five participants (mean FEV1 74% predicted; median Modified Medical Research Council Dyspnoea grade of 1 (IQR [1-3]) were included. Exercise training increased the incremental shuttle walk distance (mean difference to control 62 m, 95% CI 24 to 101 m) and the 6-minute walking distance (mean difference to control 41 m, 95% CI 19 to 63 m), but these improvements were not sustained at 6 or 12 months. Exercise training reduced dyspnoea (p = 0.009) and fatigue (p = 0.01) but did not impact on cough-related QOL or mood. Exercise training reduced the frequency of acute exacerbations (median 1[IQR 1-3]) compared to the control group (2[1-3]) over 12 months follow up (p = 0.012), with a longer time to first exacerbation with exercise training of 8 months (95% CI 7 to 9 months) compared to the control group (6 months [95% CI 5 to 7 months], p = 0.047). CONCLUSIONS: Exercise training in bronchiectasis is associated with short term improvement in exercise capacity, dyspnoea and fatigue and fewer exacerbations over 12 months. TRIAL REGISTRY: ClinicalTrials.gov (NCT00885521).