Investigation of exertional dyspnoea by cardiopulmonary exercise testing with continuous laryngoscopy.

OBJECTIVES: Abnormal breathlessness at maximal exercise may be caused by a range of conditions, including exercise-induced bronchospasm, breathing pattern disorder, or exercise-induced laryngeal obstruction. These three disorders may not be detected on standard cardiopulmonary exercise testing. The aim of this study was to describe diagnostic outcomes of an expanded protocol during cardiopulmonary exercise testing. DESIGN: Retrospective cohort study. METHODS: Patients presenting with abnormal breathlessness on maximal exercise underwent continuous laryngoscopy with cardiopulmonary exercise testing on a stationary cycle ergometer. Breathing pattern disorder was evaluated by video and ventilatory data. Pre- and post-exercise spirometry was performed. RESULTS: 24 adult patients were evaluated; 10 were professional athletes. Mean age was 40 years (range 18-73). Nine of 24 (38 %) were diagnosed with exercise-induced laryngeal obstruction and referred for speech pathology. Six of these had supraglottic exercise-induced laryngeal obstruction; all were aged <30 years; 5/6 were professional athletes. One patient had breathing pattern disorder and was referred for physiotherapy; one had exercise-induced bronchospasm, requiring escalation of asthma medication; one had muscle tension dysphonia resulting in referral to an otolaryngologist who administered a laryngeal injection of botulinum toxin. A further four patients had unexplained lower maximal oxygen consumption with cardiac limitation and were referred for further cardiac investigation. CONCLUSIONS: In patients reporting abnormal breathlessness at maximal exercise, this expanded exercise protocol provided diagnostic information in 66.7 % cases which contributed to further personalised management.

Characterizing pulmonary rehabilitation referrals from primary care.

BACKGROUND: Supporting referral to pulmonary rehabilitation (PR) from primary care for people with chronic lung disease could improve equity of access. Understanding who is referred to PR from primary care, and by whom, could inform development of strategies to increase awareness of and referral to PR for people with chronic respiratory disease. We aimed to quantify the proportion of patients referred to PR from primary care in an Australian metropolitan setting; and to identify characteristic features of patients and referrers. METHODS: A retrospective, single-site, audit of referrals was undertaken. Corresponding patient medical records were reviewed for referral details, patient demographics and baseline PR assessment measures. RESULTS: Between January 2020 and December 2023 658 referrals to PR were received of which 6.2 % (n = 41) originated from a primary care source (98 % general practice; 2 % allied health). People referred to PR from primary care were typically diagnosed with COPD (71 %), were female (59 %), had moderate disease severity (mean(SD) forced expiratory volume in 1 s 70(26) %predicted) and had mild symptoms (53 % modified Medical Research Council dyspnoea score 0 or 1) and modest functional impairment (6-min walk distance 410(121) meters). Just 4 of 36 primary care practitioners referred more than one patient. CONCLUSION: In this audit the proportion of people referred to PR from primary care was very low. Processes to support the referral of more patients from primary care to PR, across the spectrum of chronic respiratory disease, remain a priority for improving access to this well-established treatment.

A self-management package for pulmonary fibrosis: A feasibility study.

Background and objective: There is currently no self-management package designed to meet the needs of people with pulmonary fibrosis (PF). This study evaluated the feasibility and acceptability of a PF-specific self-management package. Methods: Adults with PF were randomly allocated (1:1) to either receive the self-management package with healthcare professional (HCP) support or standardised PF information. Primary outcomes were feasibility and acceptability of the intervention. Secondary outcomes included health-related quality of life, self-efficacy, breathlessness, daily steps, use of PF-related treatments, and healthcare utilisation. Participants' experiences of using the package were explored using qualitative interviews. Results: Thirty participants were included. Recruitment rate was 91% and 100% of those recruited were randomised. Eighty-seven percent of participants who received the package read ≥1 module and set a goal. Secondary outcomes were feasible to collect with high assessment completion rates (87%). Most participants reported the package was easy to use and enhanced knowledge, but suggested some improvements, while HCP support was highly valued. Conclusion: A PF-specific self-management package was feasible to deliver and requires further testing in a trial powered to detect changes in clinical outcomes. Innovation: This is the first self-management package designed specifically for people with PF, informed by patient experience and expert consensus.

Telerehabilitation Compared to Center-based Pulmonary Rehabilitation for People with Chronic Respiratory Disease: Economic Analysis of a Randomized, Controlled Clinical Trial.

RATIONALE: New pulmonary rehabilitation models can improve access to this effective but underutilised treatment for people with chronic respiratory disease, however cost effectiveness has not been determined. OBJECTIVE: To compare the cost effectiveness of telerehabilitation, including videoconferencing and synchronous supervision, to standard center-based pulmonary rehabilitation. METHODS: Prospective economic analyses were undertaken from a societal perspective alongside a randomised controlled equivalence trial in which adults with stable chronic respiratory disease undertook an 8-week outpatient center-based program or telerehabilitation. Clinical assessment for effectiveness (Chronic Respiratory Disease Questionnaire dyspnoea domain [CRQ-D] score) was undertaken at baseline, following pulmonary rehabilitation and 12-month follow-up. Individual-level administrative and self-report healthcare cost data were collected over 12 months following the program (Australian dollars, 2020) Results: There were no between-group differences for effectiveness (CRQ-D MD -0.2 [SE 1.0], p=0.61) or total costs ($565 [5452], p=0.92) over 12 months. On the cost effectiveness plane, 97.4% of estimates fell between the equivalence margins for effectiveness. Application of a range of values for cost margin demonstrated a 95% probability that telerehabilitation was equivalent to center-based pulmonary rehabilitation when the threshold was $11,000. Results were robust to approach, sensitivity and subgroup analyses. The internal rate of return was 134% over 5 years. Program completion (regardless of model) was associated with a significant reduction in total costs in the following 12 months (ß $-17,960, 95%CI -29,967 to -5952). Conclusions This study supports delivery of telerehabilitation as a cost-effective alternative model of pulmonary rehabilitation for people with chronic respiratory disease.

Clinically important changes and adverse events with centre-based or home-based pulmonary rehabilitation in chronic respiratory disease: A systematic review and meta-analysis.

Objectives: To determine the proportion of people who achieve minimal clinically important differences (MCID) with centre-based or home-based pulmonary rehabilitation and to synthesise data on adverse events.Methods: Cochrane reviews and electronic databases were searched to identify randomised trials comparing centre-based to home-based pulmonary rehabilitation, or either model to usual care, in people with chronic respiratory disease. Primary outcomes were the proportion of participants achieving MCIDs in exercise capacity and disease-specific quality of life. Secondary outcomes were symptoms and adverse events. Cochrane Risk of Bias 1.0 and GRADE were used to assess the risk of bias and certainty of evidence respectively.Results: Forty-nine trials were eligible. Compared to usual care, a higher proportion of pulmonary rehabilitation participants achieved the MCID for exercise capacity (6MWT: 47% vs 20%, p = 0.11), dyspnoea (43% vs 29%, p = 0.0001), fatigue (48% vs 27%, p = 0.0002) and emotional function (37% vs 25%, p = 0.02), with all of these between group differences statistically significant except for exercise capacity. There were no differences between centre-based and home-based pulmonary rehabilitation in the proportion of participants who achieved MCIDs (34%- 58% across studies). Ninety percent of trials reported no adverse events. Certainty of evidence was low-to- moderate with all outcomes except for CRQ-mastery (centre-based vs home-based pulmonary rehabilitation, or pulmonary rehabilitation vs usual care in COPD), ESWT (pulmonary rehabilitation vs usual care in COPD) and 6MWT (pulmonary rehabilitation vs usual care in bronchiectasis) where evidence was very uncertain.Discussion: Clinically meaningful outcomes are achieved by similar proportions of participants in centre-based and home-based pulmonary rehabilitation, with few adverse events. Reporting of trial outcomes according to MCIDs is necessary for informed decision making regarding pulmonary rehabilitation models.

Breathing control training for functional seizures: A multi-site, open-label pilot study.

There are no well-validated treatments for functional seizures. While specialist psychotherapy is usually recommended, the evidence for its benefit is qualified, and it can be difficult to obtain. Given the association between hyperventilation and functional seizures we explored an alternative modality, breathing control training, in a multi-site open label pilot trial. Participants with functional seizures over the age of 16 received an hour of breathing training from a respiratory physiotherapist, with a half-hour booster session a month later. Seizure frequency and Nijmegen scores (a measure of hyperventilation) were reported at baseline and follow-up, 3-4 months later. Eighteen subjects were recruited, and 10 completed follow-up. Seven of these 10 had improved seizure frequency, and 3 did not (Wilcoxon signed rank test, p = 0.09), with seizure frequency correlating with Nijmegen score (Spearman's rank correlation = 0.75, p = 0.034). The intervention was well tolerated, with no adverse events reported. These preliminary results support a potentially new approach to treating functional seizures that should prove cost-effective and acceptable, though require confirmation by a randomised controlled trial.

Rapid real-world implementation of pulmonary telerehabilitation: good fortune or COVID-19 luck?

"Real-world" telerehabilitation achieves clinically meaningful outcomes for patients and may improve access to pulmonary rehabilitation, but implementation into practice may have been aided by COVID-19-related support for telehealth https://bit.ly/3NqYdCC.

Impact of Test Instructions on 6-min Walk Distance in Adults With Chronic Respiratory Disease: A RANDOMIZED CONTROLLED TRIAL.

PURPOSE: The 6-min walk test (6MWT) is commonly used to assess functional exercise capacity in people with chronic respiratory disease in both clinical and research settings. However, two tests are required to achieve accurate results, due to a well-documented learning effect for the 6-min walk distance (6MWD). Whether it is possible to reduce or eliminate the learning effect by optimizing 6MWT instructions is not known. METHODS: People with chronic respiratory disease referred to pulmonary rehabilitation undertook two 6MWT with random allocation to modified instructions ( fast -walk as fast as possible; n = 46) or usual instructions ( far -walk as far as possible; n = 49). The primary outcome was the learning effect, defined as the difference in the 6MWD between test one and test two. Subgroup analyses investigated whether effects varied in those who were naïve to the 6MWT or according to diagnosis (chronic obstructive pulmonary disease, interstitial lung disease, and bronchiectasis). RESULTS: A learning effect was present in both groups, with a mean improvement in the 6MWD on the second test of 14 m in the fast (modified) group (95% CI, 6-22) and 11 m in the far (usual) group (95% CI, 4-19). There was no statistically or clinically significant difference between groups in the magnitude of the learning effect (between-group difference -3 m, 95% CI, -14 to 8). There was no significant effect of naivety to the 6MWT or diagnosis. CONCLUSION: The current recommended procedures for the 6MWT, including standardized instructions and performance of two tests on each occasion, should be retained.

The Alfred Health post-COVID-19 service, Melbourne, 2020-2022: an observational cohort study.

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.

Trait profiles in difficult-to-treat asthma: Clinical impact and response to systematic assessment.

BACKGROUND: Multidisciplinary systematic assessment improves outcomes in difficult-to-treat asthma, but without clear response predictors. Using a treatable-traits framework, we stratified patients by trait profile, examining clinical impact and treatment responsiveness to systematic assessment. METHODS: We performed latent class analysis using 12 traits on difficult-to-treat asthma patients undergoing systematic assessment at our institution. We examined Asthma Control Questionnaire (ACQ-6) and Asthma Quality of Life Questionnaire (AQLQ) scores, FEV1 , exacerbation frequency, and maintenance oral corticosteroid (mOCS) dose, at baseline and following systematic assessment. RESULTS: Among 241 patients, two airway-centric profiles were characterized by early-onset with allergic rhinitis (n = 46) and adult onset with eosinophilia/chronic rhinosinusitis (n = 60), respectively, with minimal comorbid or psychosocial traits; three non-airway-centric profiles exhibited either comorbid (obesity, vocal cord dysfunction, dysfunctional breathing) dominance (n = 51), psychosocial (anxiety, depression, smoking, unemployment) dominance (n = 72), or multi-domain impairment (n = 12). Compared to airway-centric profiles, non-airway-centric profiles had worse baseline ACQ-6 (2.7 vs. 2.2, p < .001) and AQLQ (3.8 vs. 4.5, p < .001) scores. Following systematic assessment, the cohort showed overall improvements across all outcomes. However, airway-centric profiles had more FEV1 improvement (5.6% vs. 2.2% predicted, p < .05) while non-airway-centric profiles trended to greater exacerbation reduction (1.7 vs. 1.0, p = .07); mOCS dose reduction was similar (3.1 mg vs. 3.5 mg, p = .782). CONCLUSION: Distinct trait profiles in difficult-to-treat asthma are associated with different clinical outcomes and treatment responsiveness to systematic assessment. These findings yield clinical and mechanistic insights into difficult-to-treat asthma, offer a conceptual framework to address disease heterogeneity, and highlight areas responsive to targeted intervention.

Perceived Autonomy Support in Telerehabilitation by People With Chronic Respiratory Disease: A Mixed Methods Study.

BACKGROUND: Autonomy-supportive health environments can assist patients in achieving behavior change and can influence adherence positively. Telerehabilitation may increase access to rehabilitation services, but creating an autonomy-supportive environment may be challenging. RESEARCH QUESTION: To what degree does telerehabilitation provide an autonomy-supportive environment? What is the patient experience of an 8-week telerehabilitation program? STUDY DESIGN AND METHODS: Individuals undertaking telerehabilitation or center-based pulmonary rehabilitation within a larger randomized controlled equivalence trial completed the Health Care Climate Questionnaire (HCCQ; short form) to assess perceived autonomy support. Telerehabilitation participants were invited 1:1 to undertake semistructured interviews. Interviews were transcribed verbatim and coded thematically to identify major themes and subthemes. RESULTS: One hundred thirty-six participants (n = 69 telerehabilitation) completed the HCCQ and 30 telerehabilitation participants (42%) undertook interviews. HCCQ summary scores indicated that participants strongly agreed that the telerehabilitation environment was autonomy supportive, which was similar to center-based participants (HCCQ summary score, P = .6; individual HCCQ items, P ≥ .3). Telerehabilitation interview data supported quantitative findings identifying five major themes, with subthemes, as follows: (1) making it easier to participate in pulmonary rehabilitation, because telerehabilitation was convenient, saved time and money, and offered flexibility; (2) receiving support in a variety of ways, including opportunities for peer support and receiving an individualized program guided by expert staff; (3) internal and external motivation to exercise as a consequence of being in a supervised group, seeing results for effort, and being inspired by others; (4) achieving success through provision of equipment and processes to prepare and support operation of equipment and technology; and (5) after the rehabilitation program, continuing to exercise, but dealing with feelings of loss. INTERPRETATION: Telerehabilitation was perceived as an autonomy-supportive environment, in part by making it easier to undertake pulmonary rehabilitation. Support for behavior change, understanding, and motivation were derived from clinicians and patient-peers. The extent to which autonomy support translates into ongoing self-management and behavior change is not clear. TRIAL REGISTRY: Australian and New Zealand Clinical Trials Registry; No.: ACTRN12616000360415; URL: https://anzctr.org.au/.

Long-term Telerehabilitation or Unsupervised Training at Home for Patients with Chronic Obstructive Pulmonary Disease: A Randomized Controlled Trial.

Rationale: Despite the benefits of pulmonary rehabilitation in chronic obstructive pulmonary disease (COPD), many patients do not access or complete pulmonary rehabilitation, and long-term maintenance of exercise is difficult. Objectives: To compare long-term telerehabilitation or unsupervised treadmill training at home with standard care. Methods: In an international randomized controlled trial, patients with COPD were assigned to three groups (telerehabilitation, unsupervised training, or control) and followed up for 2 years. Telerehabilitation consisted of individualized treadmill training at home supervised by a physiotherapist and self-management. The unsupervised training group performed unsupervised treadmill exercise at home. The control group received standard care. The primary outcome was the combined number of hospitalizations and emergency department presentations. Secondary outcomes included time free from the first event; exercise capacity; dyspnea; health status; quality of life; anxiety; depression; self-efficacy; and subjective impression of change. Measurements and Main Results: A total of 120 participants were randomized. The incidence rate of hospitalizations and emergency department presentations was lower in telerehabilitation (1.18 events per person-year; 95% confidence interval [CI], 0.94-1.46) and unsupervised training group (1.14; 95% CI, 0.92-1.41) than in the control group (1.88; 95% CI, 1.58-2.21; P < 0.001 compared with intervention groups). Telerehabilitation and unsupervised training groups experienced better health status for 1 year. Intervention participants reached and maintained clinically significant improvements in exercise capacity. Conclusions: Long-term telerehabilitation and unsupervised training at home in COPD are both successful in reducing hospital readmissions and can broaden the availability of pulmonary rehabilitation and maintenance strategies.

Telerehabilitation for chronic respiratory disease: a randomised controlled equivalence trial.

RATIONALE: Pulmonary rehabilitation is an effective treatment for people with chronic respiratory disease but is delivered to <5% of eligible individuals. This study investigated whether home-based telerehabilitation was equivalent to centre-based pulmonary rehabilitation in people with chronic respiratory disease. METHODS: A multicentre randomised controlled trial with assessor blinding, powered for equivalence was undertaken. Individuals with a chronic respiratory disease referred to pulmonary rehabilitation at four participating sites (one rural) were eligible and randomised using concealed allocation to pulmonary rehabilitation or telerehabilitation. Both programmes were two times per week for 8 weeks. The primary outcome was change in Chronic Respiratory Disease Questionnaire Dyspnoea (CRQ-D) domain at end-rehabilitation, with a prespecified equivalence margin of 2.5 points. Follow-up was at 12 months. Secondary outcomes included exercise capacity, health-related quality of life, symptoms, self-efficacy and psychological well-being. RESULTS: 142 participants were randomised to pulmonary rehabilitation or telerehabilitation with 96% and 97% included in the intention-to-treat analysis, respectively. There were no significant differences between groups for any outcome at either time point. Both groups achieved meaningful improvement in dyspnoea and exercise capacity at end-rehabilitation. However, we were unable to confirm equivalence of telerehabilitation for the primary outcome ΔCRQ-D at end-rehabilitation (mean difference (MD) (95% CI) -1 point (-3 to 1)), and inferiority of telerehabilitation could not be excluded at either time point (12-month follow-up: MD -1 point (95% CI -4 to 1)). At end-rehabilitation, telerehabilitation demonstrated equivalence for 6-minute walk distance (MD -6 m, 95% CI -26 to 15) with possibly superiority of telerehabilitation at 12 months (MD 14 m, 95% CI -10 to 38). CONCLUSION: telerehabilitation may not be equivalent to centre-based pulmonary rehabilitation for all outcomes, but is safe and achieves clinically meaningful benefits. When centre-based pulmonary rehabilitation is not available, telerehabilitation may provide an alternative programme model. TRIAL REGISTRATION NUMBER: ACtelerehabilitationN12616000360415.

Survival after inpatient or outpatient pulmonary rehabilitation in patients with fibrotic interstitial lung disease: a multicentre retrospective cohort study.

BACKGROUND: The impact of pulmonary rehabilitation (PR) on survival in patients with fibrotic interstitial lung disease (ILD) is unknown. Given the challenges conducting a large randomised controlled trial, we aimed to determine whether improvement in 6-minute walk distance (6MWD) was associated with better survival. METHODS: This retrospective, international cohort study included patients with fibrotic ILD participating in either inpatient or outpatient PR at 12 sites in 5 countries. Multivariable models were used to estimate the association between change in 6MWD and time to death or lung transplantation accounting for clustering by centre and other confounders. RESULTS: 701 participants (445 men and 256 women) with fibrotic ILD were included. The mean±SD ages of the 196 inpatients and 505 outpatients were 70±11 and 69±12 years, respectively. Baseline/changes in 6MWD were 262±128/55±83 m for inpatients and 358±125/34±65 m for outpatients. Improvement in 6MWD during PR was associated with lower hazard rates for death or lung transplant on adjusted analysis for both inpatient (HR per 10 m 0.94, 95% CI 0.91 to 0.97, p<0.001) and outpatient PR (HR 0.97, 95% CI 0.95 to 1.00, p=0.042). Participation in ≥80% of planned outpatient PR sessions was associated with a 33% lower risk of death (95% CI 0.49% to 0.92%). CONCLUSIONS: Patients with fibrotic ILD who improved physical performance during PR had better survival compared with those who did not improve performance. Confirmation of these hypothesis-generating findings in a randomised controlled trial would be required to definitely change clinical practice, and would further support efforts to improve availability of PR for patients with fibrotic ILD.

The clinical impact of self-reported symptoms of chronic rhinosinusitis in people with bronchiectasis.

BACKGROUND: Chronic rhinosinusitis affects 62% of adults with bronchiectasis and is linked to greater bronchiectasis severity. However, the impact of symptoms of chronic rhinosinusitis on disease-specific and cough-related quality of life is unknown. METHODS: In this cross-sectional study, adults with stable bronchiectasis and chronic rhinosinusitis symptoms completed the sinonasal outcome test-22 (SNOT-22), quality of life-bronchiectasis questionnaire, and Leicester cough questionnaire. Bronchiectasis severity was assessed using the bronchiectasis severity index (BSI) and chest high-resolution computed tomography (HRCT). RESULTS: Sixty participants with bronchiectasis (mean [SD] forced expiratory volume in 1 s of 73.2 [25.5] %predicted) were included. Greater severity of chronic rhinosinusitis symptoms (based on SNOT-22) was moderately associated with impaired cough-related quality of life (according to the Leicester cough questionnaire; all r > -.60) and impaired bronchiectasis-specific quality of life (based on the quality of life-bronchiectasis questionnaire), with impaired physical function (r = -.518), less vitality (r = -.631), reduced social function (r = -.546), greater treatment burden (r = -.411), and increased severity of respiratory symptoms (r = -.534). Chronic rhinosinusitis symptoms were unrelated to disease severity according to the BSI (r = .135) and HRCT scoring (all r < .200). The severity of chronic rhinosinusitis symptoms was not affected by sputum color (p = .417) or the presence of Pseudomonas aeruginosa colonization (p = .73). CONCLUSIONS: In adults with bronchiectasis, chronic rhinosinusitis has a consistent and negative impact on both cough-related and bronchiectasis-specific quality of life.

Home-based pulmonary rehabilitation early after hospitalisation in COPD (early HomeBase): protocol for a randomised controlled trial.

INTRODUCTION: Chronic obstructive pulmonary disease (COPD) is characterised by exacerbations of respiratory disease, frequently requiring hospital admission. Pulmonary rehabilitation can reduce the likelihood of future hospitalisation, but programme uptake is poor. This study aims to compare hospital readmission rates, clinical outcomes and costs between people with COPD who undertake a home-based programme of pulmonary rehabilitation commenced early (within 2 weeks) of hospital discharge with usual care. METHODS: A multisite randomised controlled trial, powered for superiority, will be conducted in Australia. Eligible patients admitted to one of the participating sites for an exacerbation of COPD will be invited to participate. Participants will be randomised 1:1. Intervention group participants will undertake an 8-week programme of home-based pulmonary rehabilitation commencing within 2 weeks of hospital discharge. Control group participants will receive usual care and a weekly phone call for attention control. Outcomes will be measured by a blinded assessor at baseline, after the intervention (week 9-10 posthospital discharge), and at 12 months follow-up. The primary outcome is hospital readmission at 12 months follow-up. ETHICS AND DISSEMINATION: Human Research Ethics approval for all sites provided by Alfred Health (Project 51216). Findings will be published in peer-reviewed journals, conferences and lay publications. TRIAL REGISTRATION NUMBER: ACTRN12619001122145.

High intensity interval training versus moderate intensity continuous training for people with interstitial lung disease: protocol for a randomised controlled trial.

BACKGROUND: Interstitial lung disease is a debilitating condition associated with significant dyspnoea, fatigue, and poor exercise tolerance. Pulmonary rehabilitation is an effective and key intervention in people with interstitial lung disease. However, despite the best efforts of patients and clinicians, many of those who participate are not achieving clinically meaningful benefits. This assessor-blinded, multi-centre, randomised controlled trial aims to compare the clinical benefits of high intensity interval exercise training versus the standard pulmonary rehabilitation method of continuous training at moderate intensity in people with fibrotic interstitial lung disease. METHODS: Eligible participants will be randomised to either a standard pulmonary rehabilitation group using moderate intensity continuous exercise training or high intensity interval exercise training. Participants in both groups will undertake an 8-week pulmonary rehabilitation program of twice-weekly supervised exercise training including aerobic (cycling) and strengthening exercises. In addition, participants in both groups will be prescribed a home exercise program. Outcomes will be assessed at baseline, upon completion of the intervention and at six months following the intervention by a blinded assessor. The primary outcome is endurance time on a constant work rate test. Secondary outcomes are functional capacity (6-min walk distance), health-related quality of life (Chronic Respiratory Disease Questionnaire (CRQ), St George's Respiratory Questionnaire idiopathic pulmonary fibrosis specific version (SGRQ-I), breathlessness (Dyspnoea 12, Modified Medical Research Council Dyspnoea Scale), fatigue (fatigue severity scale), anxiety (Hospital Anxiety and Depression Scale), physical activity level (GeneActiv), skeletal muscle changes (ultrasonography) and completion and adherence to pulmonary rehabilitation. DISCUSSION: The standard exercise training strategies used in pulmonary rehabilitation may not provide an optimal exercise training stimulus for people with interstitial lung disease. This study will determine whether high intensity interval training can produce equivalent or even superior changes in exercise performance and symptoms. If high intensity interval training proves effective, it will provide an exercise training strategy that can readily be implemented into clinical practice for people with interstitial lung disease. Trial registration ClinicalTrials.gov Registry (NCT03800914). Registered 11 January 2019, https://clinicaltrials.gov/ct2/show/NCT03800914 Australian New Zealand Clinical Trials Registry ACTRN12619000019101. Registered 9 January 2019, https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=376050&isReview=true.