Background Clinical trials are the best method for evaluating new treatments for people with interstitial lung disease (ILD). However, recruitment in ILD clinical trials is often challenging. Certain trial characteristics may influence willingness to participate but this has not been investigated in people with ILD. This study aims to identify the factors that influence participation in clinical trials in people with ILD. Methods This is a qualitative study using thematic analysis. Participants with ILD were recruited from a tertiary hospital in Melbourne, Australia between 2023 and 2024. Interviews were conducted over the phone, recorded and transcribed. The study was approved by the Alfred Hospital Ethics Committee (598/22). Results 17 participants with mild-to-moderate ILD were included. Overarching themes were: 1) reasons for participation, including development of new treatments, acceptable burden of participation and positive relationship with the research team; 2) reasons for refusing participation, consisting of disruption to daily life including financial burden, impact on health and uncertainty of benefits; and 3) experience when participating, including lack of communication and poor relationship with the research team. Participants described positive experiences (care and support from the research team) and negative experiences (discontinuation of treatment, insufficient information on trial outcomes) of trial participation. Discussion People with ILD prefer trials that offer clear information and minimise disruption to their daily routines. A unique finding in this population is the importance placed on communication and support from the research team, as well as the desire to receive feedback about the trial's outcomes.
Background Although physical exercise is largely recommended, sedentary lifestyle is common in people with asthma. Understanding the motivation to exercise in adolescents with asthma may help to promote exercise-related behavior change. Objectives To identify clusters based on Motivational Regulations (MR) and Basic Psychological Needs (BPN) for exercise and compare quality of life, asthma control, and disease severity across these clusters. Methods A cross-sectional and multicenter study in which adolescents with asthma were assessed for anthropometric measures, MR, and self-determination for exercise, as well as their perceptions regarding the fulfillment of autonomy, competence, and relatedness to exercise, quality of life, asthma control, and severity. Participants were classified by hierarchical cluster analysis based on MR and BPN. In addition, clusters were compared. Results A total of 144 participants with asthma aged 14 (SD: 2) years participated. Self-determination for physical exercise was 7.13 (7.88) points. Two clusters were identified: 1) More autonomous behavior and High Perceived Support (n=56) and 2) Less autonomous behavior and Low Perceived Support (n=88). Participants in Cluster 2 had worse quality of life than those in Cluster 1 [71 (SD: 15) vs 83 (SD: 15) points, respectively, P<0.0001] and a higher proportion of girls [50 (57%) vs 18 (32%); P=0.006, respectively). No significant differences were observed in the other variables between clusters. Conclusions The behavioral profile based on MR and BPN was identified in adolescents with asthma through cluster analysis. Females showed a greater association with Cluster 2, characterized by less autonomous behavior and low perceived support, and this cluster can negatively impact quality of life.
OBJECTIVES:To assess the safety, reliability and acceptability of the modified incremental step test (MIST) supervised remotely via videoconferencing in adults with chronic respiratory disease. METHODS:Adults with chronic respiratory disease undertaking pulmonary rehabilitation were invited to undertake the MIST under two testing conditions: in-person supervision and remote supervision via video-conferencing. Test order was randomised. RESULTS:38 participants (n = 18 Female; mean (SD) age 68 (10) years; 56% chronic obstructive pulmonary disease) undertook two MIST evaluations. There was excellent agreement between tests for total step count (ICC2,1 0.93, 95%CI 0.86 to 0.96), despite higher counts with in-person supervision (MD 12 steps, 95%CI 1 to 24). There was very good agreement, and no difference between tests, for nadir oxygen saturation (ICC2,1 0.797, 95%CI 0.643 to 0.889) and peak heart rate (ICC2,1 0.782, 95%CI 0.620 to 0.880). Participant satisfaction with telehealth was high, and confidence was not different between testing conditions. There were no adverse events and remote testing was acceptable to participants. DISCUSSION:In this single centre cohort study MIST supervised remotely via video-conferencing was safe, reliable and acceptable to people with chronic respiratory disease.
BackgroundBronchodilators (BDs) have been used therapeutically to improve exercise capacity in patients with other chronic respiratory diseases. However, the effect of BDs on the exercise capacity of individuals with non-cystic fibrosis bronchiectasis (NCFB) is poorly understood. ObjectiveThe aim of this study was to evaluate the effects of BDs on exercise capacity and thoracoabdominal kinematics in patients with NCFB. MethodsThis crossover randomized controlled trial will involve 45 outpatients with NCFB aged 18 to 59 years. They will be evaluated in 3 visits. On day 1, the maximal exercise capacity (cardiopulmonary exercise test; peak work rate [Wpeak]) will be assessed. On day 2, individuals will be randomized to receive either BD (ipratropium bromide 160 µg and fenoterol hydrobromide 400 µg) or a placebo and then undergo simultaneous endurance exercise capacity (constant work-rate exercise test) and thoracoabdominal kinematics (optoelectronic plethysmography) assessments. After at least 1-week washout (day 3), the individuals will repeat the same assessments as on day 2 in the reverse order. The time to the limit of tolerance will be obtained in both groups (BD and placebo groups) as the primary outcome. Thoracoabdominal kinematics will be assessed at 3 time points: at rest, during unloaded exercise, and at 75% Wpeak. The total chest wall and compartmental volumes as well as thoracoabdominal asynchrony will be assessed. The assessors and patients will be blinded to the interventions (BDs or placebo). Data will be compared using 1-sided t tests or Wilcoxon tests and repeated-measures analysis of variance or Friedman tests. Categorical data will be analyzed using the chi-square test or Fisher test. The associations among variables will be analyzed using Pearson or Spearman correlation. The significance level will be set at 5% (P<.05). ResultsThe ethics approval was granted in November 2018, and a pilot study was commenced in April 2019 but was interrupted due to the COVID-19 pandemic. The study restarted in April 2022, and data collection is anticipated to continue until November 2025. The publication of the results is anticipated to be in 2025 or 2026. ConclusionsThere is no evidence that BDs can improve the exercise capacity of patients with NCFB. This trial will compare the endurance exercise capacity of the same individual with and without dual bronchodilation. If successful, this study will demonstrate that exercise capacity can be improved with the use of BDs in adults with NCFB. Trial RegistrationClinicalTrials.gov NCT05183841; https://clinicaltrials.gov/study/NCT05183841 International Registered Report Identifier (IRRID)DERR1-10.2196/68582
Purpose: Oral corticosteroids (OCS) are recommended for the treatment of exacerbations in people with COPD; however, high cumulative lifetime doses (>= 1000mg prednisolone-equivalent) are associated with adverse health effects. This issue is well defined in asthma but is less well understood in COPD. The aim of this study was to examine cumulative OCS dispensed to people with COPD over 12 months. Patients and Methods: This was a secondary analysis of data from two randomised controlled trials involving people with COPD followed up for 12 months following pulmonary rehabilitation. Clinical and administrative (respiratory-related hospital admissions and emergency presentations, dispensed OCS and COPD maintenance medications) data were examined to determine cumulative OCS dose relative to the 1000mg threshold and the relationship with clinical features. Results: Of 232 participants (126 females, age mean 68 +/- SD 9 years, FEV1 53 +/- 22% predicted), 48% (n = 112) were dispensed OCS at least once over 12 months. Sixty-two participants (26%) were dispensed >= 1000mg. Participants with a high cumulative dose were more likely to have had a respiratory admission (OR 4.1, 95% CI 2.3 to 8.7) and greater breathlessness (modified Medical Research Council scale >= 2, OR 2.5, 95% CI 1.3 to 5.0); no relationship with disease severity or maintenance medications was demonstrated. Conclusion: One in four people with COPD were dispensed unsafe lifetime cumulative OCS doses over a period of only 12 months. Further work is needed to determine the magnitude of this issue in COPD and strategies to address exposure to high doses of OCS.
Introduction: Pulmonary Fibrosis (PF) clinical trials are important to confirm efficacy and safety of new treatments. However, poor recruitment in clinical trials is still a reality and patient related factors can contribute to this scenario. This research aims to identify factors that influence participation in clinical trials in people with PF. Methods: This is a qualitative study that used thematic analysis. Participants with PF were recruited from the Alfred Hospital in Melbourne between 2023 and 2024. Interviews were conducted over the phone, recorded and transcribed verbatim. Two researchers analysed the transcripts and consensus on themes was reached after data interpretation and discussions. Results: Seventeen participants (4 female) with mild to severe PF were included; 15 (88%) had been invited to participate in clinical trials (2 refused and 13 consented). Three major themes were identified. (1) Reasons to participate, including the opportunity to improve one's symptoms; helping to improve future treatments; helping others with same condition; minimal impact to daily life; convenient study location/information; good relationship with the research team. (2) Reasons to refuse, including disruption of daily life, expected financial burden, impact on health and current condition; uncertainty of the personal benefits; lack of communication with the research team. (3) Experience while participating, including the importance of communication with research team and trial coordinator; support for disease management and post-trial experiences including continuity use of the trial intervention and follow-up recommendations. Conclusion: People with PF are likely to participate in clinical trials if enough information about the trial is provided at the time of recruitment, and research participation has lower interference with their daily routine. Participants prefer trials with fewer number of research assessments, shorter travel distance to the research centre and minor financial costs.
INTRODUCTION:The 6-Minute Walk Test (6MWT) is recommended for assessing the functional exercise capacity of the elderly. It was hypothesized that faster functional tests could identify low exercise capacity in this population. OBJECTIVE:To investigate which simple functional test are associated with the performance in the 6MWT of fully functional adults above 60 years of age and to determine the cutoff points that discriminate the worst functional capacity. METHODS:The Sit-to-stand test, usual and maximum gait speed, usual and maximum Timed-up-and-go test and the 6MWT were performed. RESULTS:A total of 113 elderly people aged 67(64-73) years were analyzed. The ROC curve identified the cutoff point of each functional test, which discriminated the worst exercise capacity. The area under the curve were satisfatory (0.549<AUC<0.860), with variable sensitivity (0.092<S<0.885) and specificity (0.240<E<1.000). CONCLUSION:Cutoff points of simple functional tests can be used to identify elderly people with low exercise capacity.
BACKGROUND:Dysfunctional breathing is common and leads to worse asthma outcomes. OBJECTIVE:To describe the characteristics of nonpharmacological interventions to treat dysfunctional breathing, and evidence for their efficacy. METHODS:We searched electronic databases (MEDLINE, Embase, Cumulative Index to Nursing and Allied Health Literature, Cochrane Central Register of Controlled Trials, and Physiotherapy Evidence Database) to identify studies that involved nonpharmacological interventions for people with the diagnosis of dysfunctional breathing. The primary aim was to determine the characteristics of intervention protocols according to the Template for Intervention Description and Replication checklist. Secondary aims included the assessment tools used, outcomes measured, and the clinical impact of the intervention. We assessed the risk of bias using the Cochrane Risk of Bias 1.0 tool or the Standard Quality Assessment Criteria, depending on the study design. RESULTS:A total of 68 trials met review criteria (26 cohort studies, 20 case series, 19 randomized trials, and three nonrandomized trials), with 2,119 participants. Most studies had a high or unclear risk of bias across multiple domains. Five groups of nonpharmacological interventions were identified: breathing retraining with or without biofeedback, psychological therapy, acupoint therapy, manual therapy, and exercise therapy. Intervention components were highly variable and inadequately reported. Breathing retraining was the most reported intervention and showed positive effects across biochemical (29 of 34 studies; 85%), biomechanical (10 of 10 studies; 100%), and psychophysiological (15 of 19; 79%) domains of dysfunctional breathing. There was marked heterogeneity across studies and outcomes. CONCLUSIONS:A variety of nonpharmacological interventions have been applied in people with dysfunctional breathing. Breathing retraining was frequently studied, with low-quality evidence for efficacy. Future studies should report intervention components in sufficient detail to allow replication and use consistent objective measurements to assess outcomes.
INTRODUCTION:Some scales evaluate the self-efficacy of asthmatic adolescents, but do not consider issues related to age and the correct use of medication. GOAL:To translate to cross-culturally adapt to Portuguese and to test the psychometric properties of the Adolescent Asthma Self-Efficacy Questionnaire (AASEQ). METHODS:The questionnaire was translated and adapted to Portuguese. The final version was applied in two moments with an interval between seven and fourteen days. Asthma-related Quality of Life Questionnaires (PedsQL and PAQLQA) were also applied. Reliability, agreement, construct validity, ceiling and floor effect, and confirmatory factor analysis were evaluated. RESULTS:A total of 135 adolescents (median age 14 (interquartile range 12‒16) were evaluated, and the severity of asthma was mild in 63 (47 %), with controlled symptoms in 90 (67 %). The internal consistency of the AASEQ was adequate (Cronbach's alpha 0.70). The standard error of measurement was very good (SEM = 5.82 points and MDC90 % = 6.68), with moderate reliability (ICC3,1: 0.68 [95 % CI: 0.55-0.77], p < 0.0001. The validity of the AASEQ construct was poor with PedsQL (r = 0.28 and p < 0.05) and PAQLQA (r = 0.27 and p > 0.05). The floor and ceiling effects were adequate. CONCLUSION:AASEQ is a reliable tool to assess self-efficacy in Brazilian adolescents with asthma.
OBJECTIVE:We investigated the measurement properties of the incremental step test in subjects with moderate to severe asthma. METHODS:Subjects with moderate to severe persistent asthma were recruited from a tertiary university hospital specializing in treating severe asthma. All subjects performed one cardiopulmonary exercise test (CPET) and two incremental step tests (IST) in random sequences. Pulmonary gas exchange was measured during all exercise tests. The measurement properties investigated were reliability by intraclass correlation coefficient (ICC), measurement error by the standard error of measurement and minimum detectable difference, construct validity by Pearson's correlation, and interpretability by the ceiling and floor effects. RESULTS:Fifty subjects (38 females, mean [SD], age 43.7 [11.6] yr, % FEV1 70 [14.3], BMI 28.5 [5.3] kg/m2) completed the study. The peak oxygen uptake (peak VO2) for the CPET was 27.6 [±6.8] ml/kg/min, for the first IST was 22.3 [±5.3] ml/kg/min and for the second IST was 23.3 [±5.3] ml/kg/min. The IST presented excellent reliability (ICC=0.93, CI95% 0.88-0.96), very good measurement error (2.5%), and construct validity for peak VO2 measurement compared to the CPET (r = 0.85; p < 0.001) to assess exercise capacity in subjects with moderate to severe asthma, with appropriate ceiling (10%) and floor (0%) effects. CONCLUSION:The IST presented excellent reliability and very good measurement error and validity to assess exercise capacity in subjects with moderate to severe asthma, without ceiling or floor effects.
PurposeThe six-minute walk test (6MWT) is extensively employed to evaluate gait impairment in patients with symptomatic peripheral artery disease (PAD) and has been associated with different health outcomes. However, various approaches exist for calculating and interpreting the six-minute test in order to address the needs of patients more effectively. Therefore, we investigated how these different approaches correlate with functional capacity and cardiovascular health in patients with symptomatic PAD.MethodsIn total, 227 PAD patients [65.2% men and 67 (13) y.o.] were included in this cross-sectional study. The 6MWT was performed along a 30-meter corridor and the distance was expressed in three ways: absolute (described as the meters walked during the test), relativized (based on the results of the 6MWT in healthy individuals), and DW (multiplying the body weight in kilograms by the absolute distance in the 6MWT). A functional capacity z-score was calculated using the results of the handgrip strength test, 4-meter walking test, and sit-and-stand test. A cardiovascular parameter z-score was calculated with data on brachial and central blood pressure, the low-frequency component/high-frequency component ratio, and carotid-femoral pulse wave velocity.ResultsThe absolute (b = 0.30, 95%CI: 18-0.43, R² = 0.11, p < 0.001) and DW (b = 0.40, 95%CI: 27-0.53, R² = 0.17, p < 0.001) measures were related to functional capacity, independently of sex, age, and the ankle-arm index of the patients. Neither absolute nor DW were related to cardiovascular health. The relativized measure was not associated with either functional capacity or cardiovascular health.ConclusionIn patients with symptomatic PAD, absolute and DW measures are related to functional capacity, but not cardiovascular function.
Abstract Introduction Heart Rate (HR) and Heart Rate Variability (HRV) are both indicators of the autonomic nervous system. Both low HR and high HRV indicate greater vagal/sympathetic ratio consistent with better sleep quality. However, high HRV may also reflect untreated OSA due to the large negative intra-thoracic pressure swings. Thus, effects of CPAP treatment of OSA on HR and HRV are poorly described. Aim To assess HRV and HR in patients with OSA before and after CPAP controlled for sleep stage (SS) and body position. Methods 15 Patients (age 33-75, (8M/7F), average BMI 33.7kg/m2) with a confirmed diagnosis of sleep-disordered breathing, mean AHI of 42.9 (range: 23.8-118.0), underwent a diagnostic and CPAP in-laboratory polysomnography. HR and HRV were measured using 5-10min blocks in each SS (wake, N2, N3, REM) in lateral, prone and supine positions using ProfusionTM PSG4 (Compumedics, Abbotsford). LabChart® (ADInstruments, Dunedin) was used for HRV analysis. HRV was measured using the non-linear metrics of SD1 and SD2, derived from Poincaré plots. HRV and HR were then compared off and on CPAP. Results Preliminary results in 5 patients (age 33-72, 4M/1F, average BMI 30.5kg/m2) show HR decreased 9.6±2.4% and R-R interval increased 12.2±2.3% with CPAP. Preliminary analysis does not show that HRV decreased with CPAP (Diagnostic vs CPAP, SD1: 33.3 + 10.5ms vs 34.5 + 12.9ms and SD2: 76.3 + 18.6ms vs 73.6 + 22.1ms, respectively). Conclusion CPAP treatment of OSA is associated with a fall in HR representing a rise in vagal/sympathetic ratio. Further analysis may be needed to determine whether there is a rise in HRV.
PURPOSE:To develop and assess the Bed Bridge Test's (BBT) feasibility, safety, and clinimetric properties and evaluate functional capacity in hospitalised patients. MATERIALS AND METHODS:This feasibility and measurement study examined four BBT versions, including the timed-limited at 30 and 60 s and repetition-limited at 5 and 10 times, in hospitalised patients in a university hospital in Brazil. Ninety-two functionally stable patients with respiratory, gastrointestinal, or post-surgical conditions participated. Participants completed the BBT versions in a random order. BBT concurrent criterion validity was evaluated using the Short Physical Performance Battery (SPPB), Sit-to-Stand (STS) test, and Functional Status Score (FSS). RESULTS:The participants were 51 ± 17 years old, 60% female, and 66% with clinical conditions. All participants completed the BBT versions without adverse events. Test-retest reliability was good-excellent (intraclass correlation coefficient >0.87) for all BBT versions, with acceptable agreement parameters and minimal detectable changes. The time-limited versions of the BBT might be affected by a ceiling effect. Floor effects were minimal for all BBT versions. BBT showed moderate associations with SPPB and STS and weak associations with FSS. CONCLUSIONS:The BBT is feasible and has promising measurement properties.
OBJECTIVES:To determine the uptake of the Alfred Health Post-COVID service among people hospitalised with coronavirus disease 2019 (COVID-19) or referred by general practitioners; to describe their characteristics and symptoms at eight weeks and the clinical services they required.STUDY DESIGN:Observational cohort study.SETTING:Outpatient post-COVID-19 follow-up service in a tertiary Melbourne hospital.PARTICIPANTS:All people admitted to Alfred Health (inpatients, hospital-in-the-home) with COVID-19, 19 March 2020 - 28 December 2022; people with persistent symptoms referred by general practitioners in the Alfred Health catchment area during 2022.INTERVENTION:Questionnaire-based symptom assessment eight weeks after onset of COVID-19. Dyspnoea, fatigue, depression, anxiety, and post-traumatic stress disorder were assessed with standardised tools, as were health status and health-related quality of life; return to work or study, weight loss, and altered cognition and memory were also assessed. Screening was followed by physical assessment and management at the service (specialist general medicine review, physiotherapist, allied health assistant, neuropsychologist) and referral to other specialist medical services as required.MAIN OUTCOME MEASURES:Proportion of eligible people who used the service for follow-up at eight weeks; proportions of service users who reported symptoms and return to pre-COVID-19 employment or study; clinical services required by service users.RESULTS:Of 6712 people invited for screening, 726 completed questionnaires (11%). At least one persistent symptom was reported by 385 of 642 respondents (60% of respondents, 5.7% of invitees), most frequently memory (371 of 656, 57%) or concentration problems (431 of 656, 66%), dyspnoea (197 of 703, 28%), and extreme fatigue (189 of 673, 28%). Sixty-seven of 453 respondents had not returned to pre-COVID-19 work or study (15%). People were referred to a variety of medical and non-medical services for management, including specialist medical clinics, allied health, and rehabilitation. Among 71 people who also completed questionnaires at twelve months, the proportions who reported fatigue, anxiety, and memory and concentration changes were similar at both assessments.CONCLUSIONS:After acute COVID-19 that required hospital admission or was followed by persistent symptoms in community care, a small proportion of people (5.7%) reported symptoms that required medical and allied health specialist assessment and management. Our findings may assist planning services for people with long COVID.
Family history of hypertension is associated with early autonomic dysfunction and increased oxidative stress. These alterations have been found to be reinforced by the overweight factor. Conversely, an active lifestyle is effective in improving the mechanisms regulating blood pressure control. Hence, we ought to investigate the effects of an active lifestyle on the hemodynamic, autonomic and oxidative stress parameters in individuals carrying both family history of hypertension and overweight risk factors. Fifty-six normotensive males were divided into four groups: eutrophic offspring of normotensive parents (EN, n = 12), eutrophic and inactive with hypertensive parents (EH, n = 14), overweight and inactive with hypertensive parents (OH, n = 13), and overweight and physically active with hypertensive parents (OAH, n = 17). Cardiovascular autonomic modulation was assessed by heart rate (HRV) and blood pressure (BPV) variability indexes. Oxidative stress included pro/antioxidant markers and nitrite concentration. Inactive offspring of hypertensive parents (EH and OH) showed higher LFSBP (vs EN), an indicator of sympathetic outflow to the vasculature and reduced anti-oxidant activity (vs EN), while higher pro-oxidant markers were found exclusively in OH (vs EN and EH). Conversely, the OAH group showed bradycardia, higher vagally-mediated HFabs index (vs OH and EN), lower sympathovagal balance (vs OH) and preserved LFSBP. Yet, the OAH showed preserved pro/antioxidant markers and nitrite levels. Our findings indicates that overweight offspring of hypertensive parents with an active lifestyle have improved hemodynamic, cardiac autonomic modulation and oxidative stress parameters compared to their inactive peers.