Preoperative physiotherapy is cost-effective for preventing pulmonary complications after major abdominal surgery: a health economic analysis of a multicentre randomised trial.

QUESTION: Is preoperative physiotherapy cost-effective in reducing postoperative pulmonary complications (PPC) and improving quality-adjusted life years (QALYs) after major abdominal surgery? DESIGN: Cost-effectiveness analysis from the hospitals' perspective within a multicentre randomised controlled trial with concealed allocation, blinded assessors and intention-to-treat analysis. PARTICIPANTS: Four hundred and forty-one adults awaiting elective upper abdominal surgery attending pre-anaesthetic clinics at three public hospitals in Australia and New Zealand. INTERVENTIONS: The experimental group received an information booklet and a 30-minute face-to-face session, involving respiratory education and breathing exercise training, with a physiotherapist. The control group received the information booklet only. OUTCOME MEASURES: The probability of cost-effectiveness and incremental net benefits was estimated using bootstrapped incremental PPC and QALY cost-effectiveness ratios plotted on cost-effectiveness planes and associated probability curves through a range of willingness-to-pay amounts. Cost-effectiveness modelling utilised 21-day postoperative hospital cost audit data and QALYs estimated from Short Form-Six Domain health utilities and mortality to 12 months. RESULTS: Preoperative physiotherapy had 95% probability of being cost-effective with an incremental net benefit to participating hospitals of A$4,958 (95% CI 10 to 9,197) for each PPC prevented, given that the hospitals were willing to pay $45,000 to provide the service. Cost-utility for QALY gains was less certain. Sensitivity analyses strengthened cost-effectiveness findings. Improved cost-effectiveness and QALY gains were detected when experienced physiotherapists delivered the intervention. CONCLUSIONS: Preoperative physiotherapy aimed at preventing PPCs was highly likely to be cost-effective from the hospitals' perspective. For each PPC prevented, preoperative physiotherapy is likely to cost the hospitals less than the costs estimated to treat a PPC after surgery. Potential QALY gains require confirmation. TRIAL REGISTRATION: ACTRN12613000664741.

Rumination syndrome: Assessment of vagal tone during and after meals and during diaphragmatic breathing.

BACKGROUND: Pathophysiology of rumination syndrome (RS) is not well understood. Treatment with diaphragmatic breathing improves rumination syndrome. The aim of the study was to characterize vagal tone in patients with rumination syndrome during and after meals and during diaphragmatic breathing. METHODS: We prospectively recruited 10 healthy volunteers (HV) and 10 patients with RS. Subjects underwent measurement of vagal tone using heart rate variability. Vagal tone was measured during baseline, test meal and intervention (diaphragmatic (DiaB), slow deep (SlowDB), and normal breathing). Vagal tone was assessed using mean values of root mean square of successive differences (RMSSD), and area under curves (AUC) were calculated for each period. We compared baseline RMSSD, the AUC and meal-induced discomfort scores between HV and RS. Furthermore, we assessed the effect of respiratory exercises on symptom scores, and number of rumination episodes. KEY RESULTS: There was no significant difference in baseline vagal tone between HV and RS. During the postprandial period, there was a trend to higher vagal tone in RS, but not significantly (P > .2 for all). RS had the higher total symptom scores than HV (P < .011). In RS, only DiaB decreased the number of rumination episodes during the intervention period (P = .028), while both DiaB and SlowDB increased vagal tone (P < .05 for both). The symptom scores with the 3 breathing exercises showed very similar trends. CONCLUSIONS AND INFERENCES: Patients with RS do not have decreased vagal tone related to meals. DiaB reduced number of rumination events by a mechanism not related to changes in vagal tone.

Body Temperature and Energy Expenditure During and After Yoga Breathing Practices Traditionally Described as Cooling.

BACKGROUND In traditional yoga texts, sheetali and sitkari pranayamas are described as cooling. The present study was aimed at recording the surface body temperature, oxygen consumed, and carbon dioxide eliminated before, during, and after performance of sheetali and sitkari pranayamas. MATERIAL AND METHODS Seventeen healthy male volunteers with ages between 19 to 25 years (average age 20.7±1.8 years) were assessed in 4 sessions, viz. sheetali pranayama, sitkari pranayama, breath awareness and quiet lying, on 4 separate days, in random sequence. The axillary surface body temperature (TRUSCOPE II, Schiller, China) and metabolic variables (Quark CPET, COSMED, Italy) were recorded in 3 periods: before (5 minutes), during (18 minutes), and after (5 minutes), in each of the 4 sessions. The heat index was calculated in the before and after periods, based on recordings of ambient temperature and humidity. Data were analyzed using SPSS (Version 24.0). RESULTS Body temperature increased significantly during sheetali and sitkari (p<0.05, p<0.01; respectively) while it decreased after breath awareness and quiet lying down (p<0.01, p<0.001; respectively) when compared with respective post-exercise states. Oxygen consumption increased by 9.0% during sheetali (p<0.05) and by 7.6% during sitkari (p<0.01) while it decreased significantly during (p<0.05) and after (p<0.01) quiet lying down compared to respective pre-exercise states. CONCLUSIONS The results do not support the description of these yoga breathing practices as cooling. These yoga breathing practices may be used to induce a mild hypermetabolic state.

Beyond inspiratory muscle strength: Clinical utility of single-breath work capacity assessment in veterans with COPD.

BACKGROUND: Inspiratory muscle function in COPD has been traditionally described in terms of maximal inspiratory pressure (MIP). Arguably, however, is the day-to-day relevance of MIP, given that individuals rarely need maximal inspiratory forces to perform general tasks, but rather repeated breathing muscle contractions which demand endurance. The sustained maximal inspiratory pressure (SMIP) reflects the ability of the respiratory muscles to maintain force over time (i.e. single-breath work capacity). We investigated the relationships between SMIP and COPD-related clinical outcomes, hypothesizing that SMIP would have superior correlational and discriminatory value when compared to MIP. METHODS: 61 males with mild-to-very severe airflow obstruction underwent measures of spirometry, whole-body plethysmography, symptomatology, comorbidity, quality of life, exacerbations and mental health. MIP and SMIP were obtained via the Test of Incremental Respiratory Endurance. RESULTS: The mean ±â€¯SD MIP and SMIP were 77.2 ±â€¯22.9 cmH2O and 407.9 ±â€¯122.8 PTU. Both MIP and SMIP positively correlated with pulmonary function, with SMIP displaying the highest correlations. We found significant differences in spirometry, hyperinflation, symptomatology, exacerbation frequency, comorbidity, quality of life and anxiety in subjects grouped as having reduced or normal single-breath work capacity. Finally, significantly lower SMIP values were found in individuals with an IC/TLC ratio ≤25%. CONCLUSIONS: The assessment of SMIP appears to have superior clinical value than MIP in COPD. Our analyses revealed that subjects whose SMIP was reduced experienced more severe airflow obstruction, greater hyperinflation, as well as worse health and mental status with increased symptomatology and impaired quality of life.

The impact on health status in short- and long-terms of a novel and non-orthodox real-world COPD rehabilitation effort in rural India: an appraisal.

BACKGROUND: Rehabilitation has been an integral part of management of COPD. Since the implementation of the standard rehabilitation protocol is hardly possible in the rural developing world, aiming to make a feasible alternate effort may be worthwhile. METHODS: COPD patients diagnosed through spirometry were first stabilized with 6 weeks of uniform pharmacotherapy. Subsequently, they were subjected to a curriculum-based intensive single-session intervention with education, bronchial hygiene, and exercise training. The latter involved whole body exercise, pursed lip breathing, and diaphragmatic exercise. The participants continued to practice the exercises under real-world encouragement and supervision from trained volunteers. The impact was appraised in terms of change in health status through COPD assessment test (CAT) score measurements at stabilization, and after 6 weeks and 1 year of the intensive training and education. RESULTS: At stabilization, 70 out of 96 selected COPD subjects (73%) turned up (with mean age 62±9 years and mean FEV1 as 1.16±0.39 L) showing improvement as per CAT score (p=0.0001) from pharmacotherapy. After practicing the imparted education and training for 6 weeks, all these 70 participants had further significant improvement in the health status (n=70, p=0.00001). This improvement, been reinforced and supervised, continued to last even at 1 year (n=54, p=0.0001). CONCLUSION: The self-managed practice of a single-session education and training under real-world supervision can bring forth significant long-term improvement in the health status of COPD sufferers. Such simple and feasible intervention may substitute formal COPD rehabilitation programs in resource constraint situations.

The effectiveness of a health promotion and stress-management intervention program in a sample of obese children and adolescents.

OBJECTIVE: Our study aimed to evaluate the effectiveness of an 8-week stress management intervention program that included progressive muscle relaxation, diaphragmatic breathing, guided imagery, and cognitive restructuring in obese Greek children and adolescents. DESIGN: Thirty-six patients were prospectively recruited to participate in this randomized controlled study. Of these, 16 participants formed the intervention group and 20 participants the control group. Anthropometric measurements and salivary cortisol, determined serially 3 times a day, were assessed at the beginning and at the end of the study. Participants also completed the state-trait anxiety in children questionnaire (STAIC), the stress in children questionnaire (SiC), and the child behavior checklist (CBCL). RESULTS: The intervention resulted in a significant reduction of waist-hip ratio (p = 0.008) in the intervention group compared with the control group. Moreover, school performance was improved in the intervention group (p = 0.025), while both the intervention and the control group adopted healthier daily habits (p = 0.020 and 0.011, respectively). However, there was no statistically significant difference between body mass index (BMI) z-score, stress, anxiety, and diurnal patterns in salivary cortisol. CONCLUSIONS: The present study supports the effectiveness of stress management intervention programs on waist-hip ratio reduction. Further research is required to investigate biomarkers able to predict and evaluate the effectiveness of stress management intervention programs.

A randomised controlled trial of three or one breathing technique training sessions for breathlessness in people with malignant lung disease.

BACKGROUND: About 90 % of patients with intra-thoracic malignancy experience breathlessness. Breathing training is helpful, but it is unknown whether repeated sessions are needed. The present study aims to test whether three sessions are better than one for breathlessness in this population. METHODS: This is a multi-centre randomised controlled non-blinded parallel arm trial. Participants were allocated to three sessions or single (1:2 ratio) using central computer-generated block randomisation by an independent Trials Unit and stratified for centre. The setting was respiratory, oncology or palliative care clinics at eight UK centres. Inclusion criteria were people with intrathoracic cancer and refractory breathlessness, expected prognosis ≥3 months, and no prior experience of breathing training. The trial intervention was a complex breathlessness intervention (breathing training, anxiety management, relaxation, pacing, and prioritisation) delivered over three hour-long sessions at weekly intervals, or during a single hour-long session. The main primary outcome was worst breathlessness over the previous 24 hours ('worst'), by numerical rating scale (0 = none; 10 = worst imaginable). Our primary analysis was area under the curve (AUC) 'worst' from baseline to 4 weeks. All analyses were by intention to treat. RESULTS: Between April 2011 and October 2013, 156 consenting participants were randomised (52 three; 104 single). Overall, the 'worst' score reduced from 6.81 (SD, 1.89) to 5.84 (2.39). Primary analysis [n = 124 (79 %)], showed no between-arm difference in the AUC: three sessions 22.86 (7.12) vs single session 22.58 (7.10); P value = 0.83); mean difference 0.2, 95 % CIs (-2.31 to 2.97). Complete case analysis showed a non-significant reduction in QALYs with three sessions (mean difference -0.006, 95 % CIs -0.018 to 0.006). Sensitivity analyses found similar results. The probability of the single session being cost-effective (threshold value of £20,000 per QALY) was over 80 %. CONCLUSIONS: There was no evidence that three sessions conferred additional benefits, including cost-effectiveness, over one. A single session of breathing training seems appropriate and minimises patient burden. TRIAL REGISTRATION: Registry: ISRCTN; TRIAL REGISTRATION NUMBER: ISRCTN49387307; http://www.isrctn.com/ISRCTN49387307 ; registration date: 25/01/2011.

Management of the respiratory distress symptom cluster in lung cancer: a randomised controlled feasibility trial.

BACKGROUND: Breathlessness, cough and fatigue are distressing symptoms for patients with lung cancer. There is evidence that these three symptoms form a discreet symptom cluster. This study aimed to feasibly test a new non-pharmacological intervention for the management of the Respiratory Distress Symptom Cluster (breathlessness-cough-fatigue) in lung cancer. METHOD: This was a multi-centre, randomised controlled non-blinded parallel group feasibility trial. Eligible patients (patients with primary lung cancer and 'bothered' by at least two of the three cluster symptoms) received usual care plus a multicomponent intervention delivered over two intervention training sessions and a follow-up telephone call or usual care only. Follow-up was for 12 weeks, and end-points included six numerical rating scales for breathlessness severity, Dyspnoea-12, Manchester Cough in Lung Cancer scale, FACIT-Fatigue scale, Hospital Anxiety and Depression scale, Lung Cancer Symptom Scale and the EQ-5D-3L, collected at baseline, week 4 and week 12. RESULTS: One hundred seven patients were randomised over 8 months; however, six were removed from further analysis due to protocol violations (intervention group n = 50 and control group n = 51). Of the ineligible patients (n = 608), 29 % reported either not experiencing two or more symptoms or not being 'bothered' by at least two symptoms. There was 29 % drop-out by week 4, and by week 12, a further two patients in the control group were lost to follow-up. A sample size calculation indicated that 122 patients per arm would be needed to detect a clinically important difference in the main outcome for breathlessness, cough and fatigue. CONCLUSIONS: The study has provided evidence of the feasibility and acceptability of a new intervention in the lung cancer population and warrants a fully powered trial before we reach any conclusions. The follow-on trial will test the hypothesis that the intervention improves symptom cluster of breathlessness, cough and fatigue better than usual care alone. Full economic evaluation will be conducted in the main trial.

Mechanisms, assessment and therapeutic implications of lung hyperinflation in COPD.

The main complaint of patients with chronic obstructive pulmonary disease (COPD) is shortness of breath with exercise, that is usually progressive. The principal mechanism that explains this symptom is the development of lung hyperinflation (LH) which is defined by an increase of functional residual capacity (FRC) above predicted values. Patients with COPD may develop static LH (sLH) because of destruction of pulmonary parenchyma and loss of elastic recoil. In addition, dynamic LH (dLH) develops when patients with COPD breathe in before achieving a full exhalation and, as a consequence, air is trapped within the lungs with each further breath. Dynamic LH may also occur at rest but it becomes clinically relevant during exercise and exacerbation. Lung hyperinflation may have an impact beyond the lungs and the effects of LH on cardiovascular function have been extensively analysed. The importance of LH makes its identification and measurement crucial. The demonstration of LH in COPD leads to the adoption of strategies to minimise its impact on the daily activities of patients. Several strategies reduce the impact of LH; the use of long-acting bronchodilators has been shown to reduce LH and improve exercise capacity. Non pharmacologic interventions have also been demonstrated to be useful. This article describes the pathophysiology of LH, its impact on the lungs and beyond and reviews the strategies that improve LH in COPD.

Controlled-frequency breath swimming improves swimming performance and running economy.

Respiratory muscle fatigue can negatively impact athletic performance, but swimming has beneficial effects on the respiratory system and may reduce susceptibility to fatigue. Limiting breath frequency during swimming further stresses the respiratory system through hypercapnia and mechanical loading and may lead to appreciable improvements in respiratory muscle strength. This study assessed the effects of controlled-frequency breath (CFB) swimming on pulmonary function. Eighteen subjects (10 men), average (standard deviation) age 25 (6) years, body mass index 24.4 (3.7) kg/m(2), underwent baseline testing to assess pulmonary function, running economy, aerobic capacity, and swimming performance. Subjects were then randomized to either CFB or stroke-matched (SM) condition. Subjects completed 12 training sessions, in which CFB subjects took two breaths per length and SM subjects took seven. Post-training, maximum expiratory pressure improved by 11% (15) for all 18 subjects (P < 0.05) while maximum inspiratory pressure was unchanged. Running economy improved by 6 (9)% in CFB following training (P < 0.05). Forced vital capacity increased by 4% (4) in SM (P < 0.05) and was unchanged in CFB. These findings suggest that limiting breath frequency during swimming may improve muscular oxygen utilization during terrestrial exercise in novice swimmers.

The effects of respiratory muscle training on respiratory mechanics and energy cost.

Resistance respiratory muscle training (RRMT) increases respiratory muscle strength and can increase swimming endurance time by as much as 85%. The purpose of this study was to examine potential mechanisms by which RRMT improves exercise endurance. Eight healthy adult male scuba divers underwent experiments in a hyperbaric chamber at sea level (1 atmosphere absolute (ATA)), 2.7 ATA and 4.6 ATA, both dry and fully submersed. Subjects rested, exercised, and rested while mimicking their own exercise breathing (ISEV). Airway resistance (R(aw)), exhaled nitric oxide output (V˙(NO)), and respiratory duty cycle (T(I)/T(Tot)) were determined before and after four weeks of RRMT. RRMT decreased T(I)/T(Tot) (-10% at rest at 1 ATA), V˙(O2) (-17% at 2.7 ATA during submersed exercise), V˙(E) (-6% at 2.7 ATA during submersed exercise), and R(aw) (-34% inspiratory at 4.6 ATA submersed, -38% expiratory at 2.7 ATA dry), independent of changes in V˙(NO). Most importantly, respiratory muscle efficiency increased (+83% at 2.7 ATA submersed).