End-of-life preferences of people with advanced chronic obstructive pulmonary disease.

OBJECTIVES: To identify end-of-life preferences of people with advanced chronic obstructive pulmonary disease (COPD) and to compare characteristics between those who wish to discuss the end-of-life and those who do not. METHODS: An analysis of the baseline data of a randomised controlled trial was performed including people with COPD GOLD stages III-IV or former quadrant D with modified Medical Research Council questionnaire grade ≥2, after hospital discharge following an exacerbation. Participants were interviewed using the End-of-Life Preferences Interview. RESULTS: A total of 165 individuals (53% men; 68±9 years old; 55% care dependent) were included. Most participants wished to take part in shared decision-making (78%), to be informed about a short life expectancy (82%), to discuss the end-of-life (82%), to have loved ones around at death (87%) and to choose when to die (70%). They also reported accepting opioids (74%). Preferences for who to provide physical care, the place, consciousness and atmosphere at death as well as life-sustaining treatments were heterogeneous. Participants who wanted to discuss the end-of-life had a significantly higher educational level (p=0.030) and worse health status than participants who did not (p=0.007). CONCLUSIONS: End-of-life preferences of people with advanced COPD were heterogeneous, however, most wished to discuss it, especially those with higher educational level and worse health status. TRIAL REGISTRATION NUMBER: NTR3940.

Development of a core outcome set for physiotherapy trials in adults with bronchiectasis (the COS-PHyBE study): A Delphi study and consensus meeting.

Background: Physiotherapy is recommended for bronchiectasis management, but there is disparity in evidence supporting its use. This is partly because of inconsistency and poor reporting of outcomes in available studies. A Core Outcome Set (COS) may improve trial consistency and decrease reporting bias. This study aimed to develop a COS for physiotherapy clinical trials in adults with bronchiectasis. Methods: A comprehensive list of outcomes was developed using a systematic review and qualitative semi-structured interviews with patients with bronchiectasis and physiotherapists.An international two-round online Delphi survey was conducted. Outcomes scored 7-9 (crucial) by ≥ 70 % of participants and 1-3 (not that important) by ≤ 15 % of participants from each stakeholder in the Likert scale were nominated for inclusion in the COS. Nominated outcomes and those considered crucial by only one of the stakeholders' groups were further discussed and voted in an international consensus meeting. Results: A list of 137 outcomes was generated; 104 from literature and 33 from interviews. A Delphi survey containing 59 outcomes was completed by 171 participants from 20 countries. After the consensus meeting, representatives agreed on seven outcomes: health-related quality of life, respiratory symptoms, physical functioning, emotional and psychological functioning, fatigue, adherence to treatment, and functional exercise capacity. Conclusion: A minimum set of seven outcomes are recommended to be included as measurements in future trials evaluating physiotherapy interventions for bronchiectasis.

Pulmonary rehabilitation with balance training for fall reduction in chronic obstructive pulmonary disease: a randomized controlled trial.

BACKGROUND AND OBJECTIVES: Available evidence suggests that adults with chronic obstructive pulmonary disease (COPD) performed substantially worse than healthy controls on many balance measures and balance training can improve the balance measures in this population. We conducted this study to determine the effects of incorporating balance training into pulmonary rehabilitation (PR) on the incidence of falls at 12 months follow-up in high fall risk adults with COPD. METHODS: We conducted a prospective international multi-center randomized controlled trial. Eligible participants were adults with COPD at a high risk of future falls and were randomly assigned (1:1) to the intervention or control group. The intervention included personalized balance training for a targeted total of 90 min per week. Both the intervention and control groups received usual PR (2-3 times per week for 8-12 weeks). The primary outcome was the incidence of falls at 12-month follow-up using monthly fall diary calendars. Negative binomial regression or recurrent events models were used to examine the effects of the intervention on fall events. Multiple imputations were performed to deal with missing values. RESULTS: Of 258 participants who were enrolled in the trial, 178 provided falls information (intervention group = 91, control group = 87) and were included in the main analysis. Forty-one participants (45%) experienced at least one fall event in the intervention group and 33 (38%) in the control group (p = 0.34). The mean incidence of falls at 12 months was similar between the two groups (128 versus 128 per 100 person-years; mean difference: 0.30, 95% CI: -0.76 to 1.36 per 100 person-years). The results are robust after multiple imputations for missing data (n = 67). CONCLUSIONS: PR incorporating balance training compared to PR alone did not reduce the incidence of falls over the 12-month period in high fall risk adults with COPD. TRIAL REGISTRATION: The study was registered with ClinicalTrials.gov (NCT02995681) on 14/12/2016.

InspireGBs - Inspiratory muscle training in people with Guillain-Barré syndrome: A feasibility study.

BACKGROUND: Guillain-Barré syndrome (GBS) is a rare immune-mediated peripheral nerve disease often preceded by infections. Respiratory muscle weakness is a common complication in this population, leading to decreased vital capacity, weakened coughing ability, atelectasis, and pulmonary infections. Inspiratory muscle training (IMT) has been widely used to enhance inspiratory muscle strength and pulmonary function in various diseases; however, its application in GBS is unknown. OBJECTIVE: To assess the safety, feasibility, and preliminary effectiveness of an IMT protocol-InspireGBs-in people with GBS. METHODS: A pre/post feasibility study was conducted. Feasibility was determined by participant recruitment/retention, adherence, time spent in each session, and adverse events. Secondary outcome was inspiratory muscle strength. InspireGBs consisted of twice daily sessions 5 times/week, three sets of 10 breaths in each session, for 6 weeks. Initial resistance was set at 50% of participant's baseline maximal inspiratory pressure (MIP) and with a weekly increase of 10% calculated from the previous week's training intensity, if tolerated, otherwise the increase was 5%. RESULTS: Eleven patients (63% male; 63 ± 9 years) were recruited from inpatient rehabilitation and 10 completed the study. Recruitment and retention rates were high (79% and 91%, respectively). Excellent adherence rate (96%) was obtained with no reported adverse effects or safety issues. Sessions lasted from 4 to 6 minutes. The MIP improved (pretraining: 39 [26.5-50] cm H2O vs. posttraining: 61 [56.3-64.5] cm H2O, p = .005 and pretraining: 38 [30.5-53.8] % of predicted vs. posttraining: 60 [54.28-71.58] % of predicted, p = .009) with the InspireGBs. CONCLUSION: InspireGBs is safe, feasible, and may be effective in improving inspiratory muscle strength in individuals with GBS. A randomized controlled trial is now needed to strengthen these findings.

Reflections on the challenges of conducting an international multicentre randomized controlled trial of balance training in addition to pulmonary rehabilitation and its impact on fall incidence in people with COPD.

BACKGROUND: Pulmonary rehabilitation (PR) is accepted as standard care for individuals with COPD. We conducted an international, multi-centred randomized controlled trial (RCT) to determine if adding balance training to PR would reduce the incidence of falls in people with COPD. While there have been many trials investigating the effectiveness of PR, few have involved international collaboration. Successful execution of rehabilitation trials requires a significant investment of time, staffing, and resources. With the recent completion of the Balance Training for Fall Reduction in COPD RCT, we report on the design, implementation, and execution of our trial using project management phases. We also highlight our lessons learned for consideration in future multi-centre rehabilitation trials. METHODS: This was a retrospective review of the planning, preparation, timelines, and personnel training involved in the execution of this study using four of the five project management phases described by Farrell et al. in 2010: (1) initiation, (2) planning, (3) execution, and (4) monitoring and controlling. We report descriptive statistics as percentages and counts and summarize our lessons learned. RESULTS: Ten outpatient PR programs in three continents participated. Thirty-one personnel worked on the trial across all sites. Enrolment began in January 2017 and was suspended in March 2020 due to the COVID-19 pandemic. Approximately 1275 patients were screened, 455 (36%) were eligible, 258 (57%) consented, 243 (53%) participated, and 130 (61%) completed the 12-month follow-up assessment. Lessons learned through our experience included (1) ensuring awareness of funder policies and considering the impact on collaborating sites; (2) preparing for the possibility of human resource and program disruptions; (3) anticipating site dropout and having a contingency plan in place; (4) planning and monitoring process measure data before, during, and after trial initiation; (5) ensuring frequent and consistent communication with and between collaborating sites; (6) maximizing features of database platform to ensure data set completeness and controlled data access; and (7) identifying strategies for increasing patient engagement in a high-demand study. CONCLUSIONS: We identify seven lessons learned through our experience conducting an international, multicentre rehabilitation-based RCT. These lessons can provide guidance to other trialists conducting studies with similar logistics and may assist with future trial planning and implementation.

Unravelling the complex interplay of factors behind exercise limitations and physical inactivity in COPD.

Exercise limitation and physical inactivity are known treatable traits for people with COPD. Maximising exercise capacity and keeping people physically active improves health status and survival rates among people with COPD. However, managing these two treatable traits can be extremely challenging for clinicians due to the complex intersectionality of factors influencing an individual's capacity, opportunity and motivation to engage in physical activity. This review presents the complex factors influencing exercise capacity ("can do"), levels of physical activity ("do do") and sedentary behaviours amongst people with COPD and provides practical recommendations on how clinicians can address some of these factors in practice. Most importantly, it highlights the importance of referring to pulmonary rehabilitation as a way to improve exercise capacity among people with COPD.

Functional capacity using sit-to-stand tests in people with chronic obstructive pulmonary disease and its relationship with disease severity-a cross-sectional study with matched controls.

BACKGROUND: Functional capacity impairment is a crucial consequence of chronic obstructive pulmonary disease (COPD). Although it can be identified with simple tests, such as the sit-to-stand tests, its prevalence, relation with disease severity, and the characteristics of people presenting this impairment remain unknown. OBJECTIVE: To explore the functional capacity of people with COPD. METHODS: A cross-sectional study with people with COPD and age-/sex-matched healthy controls was conducted. Functional capacity was assessed with the 5-repetitions (5-STS) and the 1-minute (1-minSTS) sit-to-stand tests. People with COPD were grouped according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) classifications. Comparisons between people with COPD and healthy controls, and among GOLD groups were established. Associations between symptoms, muscle strength, quality of life, and measures of functional capacity were explored. RESULTS: 302 people with COPD [79% male; mean (SD) 68 (10) years old] and 304 healthy controls [75% male; 66 (9) years old] were included. 23% of people with COPD presented impairment in the 5-STS and 33% in the 1-minSTS. People with COPD from all GOLD classifications presented significantly lower functional capacity than healthy controls (5-STS: COPD median [1st quartile; 3rd quartile] 8.4 [6.7; 10.6] versus healthy 7.4 [6.2; 9.3] s; 1-minSTS: COPD 27 [21; 35] vs healthy 35 [29; 43] reps). Correlations with symptoms, muscle strength, and quality of life were mostly weak (5-STS: rs [-0.34; 0.33]; 1-minSTS: rs [-0.47; 0.40]). CONCLUSION: People with COPD have decreased functional capacity independently of their GOLD classifications. The prevalence of functional impairment is 23-33%. Because impaired functional capacity is a treatable trait not accurately reflected by other outcomes, comprehensive assessment and management is needed.

Balance measures for fall risk screening in community-dwelling older adults with COPD: A longitudinal analysis.

BACKGROUND: Chronic obstructive pulmonary disease (COPD) increases fall risk, but consensus is lacking on suitable balance measures for fall risk screening in this group. We aimed to evaluate the reliability and validity of balance measures for fall risk screening in community-dwelling older adults with COPD. METHODS: In a secondary analysis of two studies, participants, aged ≥60 years with COPD and 12-month fall history or balance issues were tracked for 12-month prospective falls. Baseline balance measures - Brief Balance Evaluation Systems Test (Brief BESTest), single leg stance (SLS), Timed Up and Go (TUG), and TUG Dual-Task (TUG-DT) test - were assessed using intra-class correlation (ICC2,1) for reliability, Pearson/Spearman correlation with balance-related factors for convergent validity, t-tests/Wilcoxon rank-sum tests with fall-related and disease-related factors for known-groups validity, and area under the receiver operator characteristic curve (AUC) for predictive validity. RESULTS: Among 174 participants (73 ± 8 years; 86 females) with COPD, all balance measures showed excellent inter-rater and test-retest reliability (ICC2,1 = 0.88-0.97) and moderate convergent validity (r = 0.34-0.77) with related measures. Brief BESTest and SLS test had acceptable known-groups validity (p < 0.05) for 12-month fall history, self-reported balance problems, and gait aid use. TUG test and TUG-DT test discriminated between groups based on COPD severity, supplemental oxygen use, and gait aid use. All measures displayed insufficient predictive validity (AUC<0.70) for 12-month prospective falls. CONCLUSION: Though all four balance measures demonstrated excellent reliability, they lack accuracy in prospectively predicting falls in community-dwelling older adults with COPD. These measures are best utilized within multi-factorial fall risk assessments for this population.

Validation of "CENTR(AR)" walking trails: Different field criteria do not lead to different physical activity intensities in people with COPD.

BACKGROUND: Validating walking trails is essential to promote physical activity (PA) safely and confidently in people with COPD. OBJECTIVES: We aimed to validate predetermined light, moderate, and vigorous intensities of walking trails in people with COPD. METHODS: This cross-sectional study included individuals with COPD walking in predetermined light, moderate and vigorous intensity trails. Activity intensity and volume outcomes were collected. Dyspnoea and fatigue (modified Borg scale), energy expenditure (EE, Sensewear), heart rate (HR, HR monitor), time spent in different PA intensities, and cadence (ActiGraph) were recorded and used to classify PA intensity. RESULTS: Twenty people with COPD [71(7) years, 80 % male, FEV1%predicted 65.6(11.6)] were included. Fatigue differed significantly between light and moderate [3.0(2.0;4.0) vs 3.4(2.5;4.5), p = 0.01], but not vigorous (3.5[2.5-4.0]) tracks. Dyspnoea [2.3(1.5) vs 2.7(1.6) vs 2.6(1.4)], EE [5.1(0.8) vs 4.9(0.5) vs 4.6(0.8) METs], HR [92.5(11.1) vs 93.7(18.6) vs 95.4(15.0) beats/min] and cadence [115.1(104.0;120.3) vs 104.7(99.6;117.6) vs 111.2(99.9;118.5) steps/min] were similar across trails (p > 0.05). Time spent in light and moderate PA, EE volume, walking time, and step count increased along with the proposed intensity levels (p < 0.01). Walking trails were categorised as moderate intensity in most participants. CONCLUSION: Walking trails were safe and valid for practising moderate-intensity PA in people with COPD. Participants adjusted their physiological responses and perceived symptoms to match a moderate intensity.

Association of inadequate social support and clinical outcomes in patients with chronic obstructive pulmonary disease - A cross-sectional study.

INTRODUCTION: In patients with chronic obstructive pulmonary disease (COPD), loneliness and social isolation are associated with increased morbidity and decreased mobility, self-reliance, and health-related quality of life. Social support has been shown to improve these outcomes. AIMS: This cross-sectional study aimed to investigate the level of experienced social support and the clinical outcomes associated with inadequate social support among patients with COPD with a resident loved one. METHODS: Level of social support was assessed with the Medical Outcomes Study - Social Support Survey (MOS-SSS) in patients with COPD with a resident loved one. Patients were sub-grouped into adequate or inadequate social support. Multiple clinical outcomes were assessed, including lung function, degree of dyspnoea, health status, symptoms of anxiety and depression, the degree of care dependency, functional status, and mobility. RESULTS: The study included 191 Dutch patients with COPD (53.4% men, age: 65.6 ± 8.9 years, FEV1: 47.3 ± 17.7% predicted). Eighteen percent of the patients reported inadequate social support. Patients with inadequate social support reported a significantly symptom severity of COPD (p = 0.004), a higher care dependency level (p = 0.04) and a higher level of depression (p = 0.004) compared to patients with adequate social support. Other traits were comparable for both groups. CONCLUSION: Patients with COPD with a resident loved one who perceive an inadequate level of social support are more likely to report a higher impact of COPD, a higher care dependency and symptoms of depression. Other characteristics are comparable with patients who perceive adequate social support.