The effect of respiratory muscle training on respiratory muscle strength, diaphragm thickness/mobility, and exercise capacity in patients with systemic lupus erythematosus and associated shrinking lung syndrome.

Systemic lupus erythematosus (SLE) is a chronic autoimmune disorder that can impact any organ in the body. The pathophysiology of shrinking lung syndrome (SLS), a rare pulmonary complication of SLE, remains unknown. The objective of the current case series was to investigate the effects of inspiratory muscle training (IMT) on diaphragm thickness/mobility, respiratory muscle strength, peripheral muscle thickness/strength, and functional exercise capacity in patients with SLE and associated SLS. Three patients with SLE were included in the case series. Respiratory muscle strength, peripheral muscle strength, peripheral muscle thickness, diaphragm muscle thickness, diaphragm muscle mobility, functional exercise capacity, and pulmonary function test were assessed. A significant improvement has been determined in respiratory muscle strength, functional exercise capacity, peripheral muscle strength, peripheral muscle thickness, diaphragm muscle thickness, and diaphragm muscle mobility. This is the first case series showing the beneficial effects of IMT on respiratory muscle strength, diaphragm thickness/mobility, peripheral muscle thickness/strength, and exercise capacity in patients with SLE.

A temporal examination of inspiratory muscle strength and endurance in hospitalized COVID-19 patients.

BACKGROUND: The two most common symptoms associated with COVID-19 are dyspnea and fatigue. One possible cause of such symptoms may be inspiratory muscle weakness. OBJECTIVES: The purpose of this study was to examine inspiratory muscle performance (IMP) from intensive care unit discharge (ICUD) to hospital discharge (HD) in patients with COVID-19 hypothesizing that IMP would be markedly depressed at both ICUD and HD. METHODS: IMP was examined at ICUD and HD via the PrO2 device (PrO2 Health, Smithfield, RI) which provided the maximal inspiratory pressure (MIP), sustained MIP (SMIP), inspiratory duration (ID), and fatigue index test (FIT). Patient symptoms were assessed at ICUD, HD, and 1-month post-HD. RESULTS: 30 patients (19 men, 11 women) with COVID-19 were included. The mean±SD age, BMI, and length of ICU and hospital stay was 71±11 yrs, 27.9 ± 6.3 kg/m, 9 ± 6 days, and 26±16 days, respectively. The mean±SD MIP, SMIP, ID, and FIT of the entire cohort at ICUD vs HD were 36±21 vs 40±20 cm H2O, 231±157 vs 297±182 PTU, 8.8 ± 4.2 vs 9.5 ± 4.6 s, and 9.0 ± 9.4 vs 13.1 ± 12.3, respectively, with only SMIP and FIT significantly greater at HD (p=.006 and 0.03, respectively). SMIP at HD was significantly related to resting dyspnea at HD (r=-0.40; p=.02). The SMIP and FIT of men were found to increase significantly from ICUD to HD, but no measure of IMP in the women increased significantly from ICUD to HD. At least one COVID-19-related symptom was present 1 month after HD with the most persistent symptoms being fatigue, cough, and dyspnea in 47%, 40%, and 37% of the patients, respectively. CONCLUSIONS: A significant reduction in IMP exists in patients with COVID-19 at both ICUD and HD and no measure of IMP in women was observed to increase significantly from ICUD to HD. Impaired inspiratory muscle endurance rather than strength was associated with greater dyspnea at HD.

Effect of eight weeks respiratory muscle training on respiratory capacity, functional capacity and quality of life on subjects with mild to moderate relapsing-remitting multiple sclerosis: A single-blinded randomized controlled trial.

BACKGROUND: Multiple Sclerosis (MS) is a chronic inflammatory disease of the nervous system leading to muscle weakness, including the respiratory muscles that cause pulmonary complications, impair functional capacity, increased fatigue, and as a result decreases the quality of life. AIM: The purpose of the present study is to examine the influence of 8 weeks of respiratory muscle training (RMT) on pulmonary function and respiratory muscle strength in MS patients. METHODS: The present study was a single-blind, randomized controlled trial that was conducted on 36 (27 Female, 9 Male) relapsing-remitting MS patients who were definitively diagnosed by a neurologist and randomly were divided into intervention and control groups. Both groups were educated on lifestyle modification with an emphasis on regular physical activity. In addition, the intervention group was prescribed eight weeks of respiratory muscle training with a threshold resistance device, daily, twice a day for three sets of 15 repetitions per set. Maximal expiratory pressure (PImax), maximal expiratory pressure (PEmax), spirometric indices, functional tests (six-minute walk test, timed up and go test), fatigue questionnaire, and questionnaire of quality of life were assessed before and after trials. RESULTS: A total of 36 patients (75% female; mean age 38.00(8.86) years; BMI 26.56(2.64) kg/m2) were included in the study. The strength of inspiratory and expiratory muscles, respiratory function, fatigue, and quality of life were significantly improved in the intervention group (p<0.005). In addition, there was a significant improvement in the rate of fatigue and quality of life in all their dimensions (p<0.005). Only in the six-minute walk test, no significant improvement was seen in the intervention group compared to the control group (p = 0.262). CONCLUSION: Findings could help therapists to provide MS patients with more effective respiratory muscle training protocols to maximize the benefits of rehabilitation.

Effects of the Combination of Continuous Nursing Care and Breathing Exercises on Respiratory Function, Self-Efficacy, and Sleep Disorders in Patients with Lung Cancer Discharged from Hospital.

The purpose of this study was to explore the effect of respiratory function and self-efficacy of patients with lung cancer after surgery by the combination of continuing nursing care and breathing exercises and to assess its clinical value in improving the quality of patients' sleep. 120 cases of lung cancer patients were divided into the control group (n = 60 cases) and the experimental group (n = 60 cases) randomly. The control group used conventional care methods for postoperative lung cancer patients, while the experimental group used continuous care combined with a respiratory exercise care model on the basis of conventional care, comparing the differences in the recovery of lung function, self-efficacy, sleep quality, incidence of sleep disorders, and other indicators between the two groups. The average indicator of recovery condition in patients of experimental groups FEV1 (L), FEV1% pred (%), and FEV1/FVC (%) was higher than patients in control groups with lower symptom scores and complication rates (P < 0.05). The self-efficacy score of patients in the experimental group was higher than that in the control group (P < 0.05) during sixty days of follow-up. The sleeping time of the experimental group was significantly shorter than that of the control group (P < 0.05) and the sleep time was longer than that of the control group (P < 0.05), but the incidence of sleep disorders and drug use rate were lower than that of the control group (P < 0.05) before discharge. Continuous nursing care combined with respiratory exercises can significantly accelerate the recovery of lung function and respiratory function reconstruction in patients with lung cancer after surgery, improve the self-efficacy score of patients, improve the sleep quality of patients, and be conducive to postoperative rehabilitation of patients.

Pre and postoperative nurse-guided incentive spirometry versus physiotherapist-guided pre and postoperative breathing exercises in patients undergoing cardiac surgery: An evaluation of postoperative complications and length of hospital stay.

Atelectasis is the most occurring postoperative complication after cardiac surgeries. Postoperative respiratory exercises and incentive spirometry led to decrease in postoperative complications, especially atelectasis and hospital stay. The objectives of the study were to evaluate postoperative complications and length of hospital stay of patients who received pre and postoperative nurse-guided incentive spirometry against those of patients who received pre and postoperative breathing exercises by the physiotherapist in patients who underwent cardiac surgery. Data of patients who received 2 days preoperative and 2 days postoperative nurse-guided incentive spirometry with a spirometer (PPN cohort, n = 102) or received 2 days preoperative and 2 days postoperative breathing exercises by physiotherapist without spirometer (PPP cohort, n = 105), or 2 days postoperative physiotherapist-guided breathing exercises only without spirometer (PPB cohort, n = 114) were collected and analyzed. The acute or chronic collapse of part or entire lung was defined as atelectasis. The length of stay in the hospital was from the day of admission to discharge. Patients of the PPN cohort had fewer numbers of incidences of atelectasis, dyspnea, and sweating >1 day after operations compared to those of the PPB and the PPP cohorts (P < .05 for all). The partial pressure of oxygen and oxygen saturation of arterial blood ≥6 hours after operations reported higher, the duration of ventilation was shorter, and numbers of re-intubation processes reported fewer for patients of the PPN cohort than those of the PPB and the PPP cohorts (P < .05 for all). The hospital length of the stay of patients in the PPN cohort was fewer than those of the PPB and the PPP (P < .0001 for both) cohorts. Pre and postoperative nurse-guided incentive spirometry with a spirometer following cardiac surgeries would have better postoperative pulmonary outcomes and fewer hospital stays than those of postoperative-only or pre and postoperative physiotherapist-guided breathing exercises (level of evidence: IV; technical efficacy stage: 5).

Impacto Clínico da Fisioterapia Pré-Operatória nas Complicações Pulmonares Pós-Operatórias de Pacientes Oncológicos / Clinical Impact of Preoperative Physiotherapy on Postoperative Pulmonary Complications of Oncological Patients / Impacto Clínico de la Fisioterapia Preoperatoria sobre las Complicaciones Pulmonares Postoperatorias de Pacientes Oncológicos

Introdução: A fisioterapia pré-operatória em pacientes oncológicos tem papel fundamental para redução das complicações pós-operatórias. Sabe-se que a avaliação pré-operatória identifica os fatores de risco e é decisiva na redução do desenvolvimento de tais complicações. Objetivo: Verificar o efeito da cinesioterapia pré-operatória e do treino muscular inspiratório nas complicações pulmonares pós-operatórias em pacientes oncológicos. Método: Trinta pacientes foram divididos aleatoriamente em grupo cinesioterapia, grupo treinamento muscular inspiratório e grupo controle, com dez participantes em cada grupo. Foram realizadas avaliação da força muscular respiratória, teste de caminhada de seis minutos e força muscular periférica. Foi utilizado o teste de Wilcoxon para comparação pré e pós-tratamento. Também foi realizado o teste Kruskal Wallis para comparação do resultado pós-tratamento e o teste qui-quadrado para variáveis categóricas. Utilizou--se o teste de Cohen (d) para identificação do tamanho do efeito. Resultados: Nove (90%) indivíduos do grupo controle apresentaram complicações, enquanto, nos grupos cinesioterapia e de treinamento muscular inspiratório, as complicações foram observadas em dois (20%) e três (30%) pacientes, respectivamente. As pressões inspiratória máxima (PImáx) e expiratória máxima (PEmáx) no treinamento muscular inspiratório e a PImáx no grupo cinesioterapia demonstraram impacto clínico quando comparados ao grupo controle. Conclusão: A cinesioterapia e o treinamento muscular inspiratório impactaram na redução das complicações pós-operatórias das cirurgias oncológicas.

Introduction: Preoperative physiotherapy in cancer patients plays a fundamental role in reducing postoperative complications. It is known that the preoperative assessment identifies risk factors and is critical in reducing the development of such complications. Objective: Identify the effect of preoperative kinesiotherapy and inspiratory muscle training on postoperative pulmonary complications in cancer patients. Method: Thirty patients were randomly divided into a kinesiotherapy group, inspiratory muscle training group and control group, with 10 participants in each group. Respiratory muscle strength assessment, 6-minute walk test and peripheral muscle strength were performed. The Wilcoxon test was used for comparison before and after treatment. The Kruskal Wallis test was also performed to compare the post-treatment result and the Chi-square test for categorical variables. The Cohen test (d) was also performed to identify the effect size. Results: Nine (90%) individuals in the control group had complications, while in the kinesiotherapy and inspiratory muscle training groups, complications were observed in two (20%) and three (30%) patients, respectively. Maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP) in inspiratory muscle training and MIP in the kinesiotherapy group demonstrated clinical impact when compared to the control group. Conclusion: Kinesiotherapy and inspiratory muscle training impacted the reduction of postoperative complications of oncology surgeries.

Introducción: La fisioterapia preoperatoria en pacientes oncológicos tiene un papel fundamental en la reducción de las complicaciones posoperatorias. Se sabe que la evaluación preoperatoria identifica factores de riesgo y es decisiva para reducir el desarrollo de tales complicaciones. Objetivo: Verificar el efecto de la kinesioterapia preoperatoria y el entrenamiento de los músculos inspiratorios sobre las complicaciones pulmonares postoperatorias en pacientes con cáncer. Método: Treinta pacientes fueron divididos aleatoriamente en un grupo de kinesioterapia, un grupo de entrenamiento de los músculos inspiratorios y un grupo de control, con diez participantes en cada grupo. Se realizó una evaluación de la fuerza de los músculos respiratorios, la prueba de marcha de seis minutos y la fuerza de los músculos periféricos. Se utilizó la prueba de Wilcoxon para comparar antes y después del tratamiento. También se realizó la prueba de Kruskal Wallis para comparar el resultado postratamiento y la prueba de chi-cuadrado para variables categóricas. También se realizó la prueba de Cohen (d) para identificar el tamaño del efecto. Resultados: Nueve (90%) individuos en el grupo de control tuvieron complicaciones, mientras, en los grupos de kinesioterapia y entrenamiento de los músculos inspiratorios, se observaron complicaciones en dos (20%) y tres (30%) pacientes, respectivamente. Las presiones inspiratorias (MIP) y espiratorias máximas (MEP) en el entrenamiento de los músculos inspiratorios y MIP en el grupo de kinesioterapia demostraron un impacto clínico en comparación con el grupo de control. Conclusión: La kinesioterapia y el entrenamiento de los músculos inspiratorios impactaron en la reducción de las complicaciones posoperatorias de las cirugías oncológicas

Can respiratory muscle training therapy effectively manage obstructive sleep apnea syndrome after stroke?: A protocol of systematic review and meta-analysis.

BACKGROUND: This study will explore the effectiveness and safety of respiratory muscle training therapy (RMTT) for the treatment of patients with obstructive sleep apnea syndrome (OSAS) after stroke. METHODS: In this study, we will systematically and comprehensively search Cochrane Library, PubMed, EMBASE, WANGFANG, VIP, Chinese Biomedical Literature Database, and China National Knowledge Infrastructure for relevant literature from their inception to March 1, 2020 without any limitations to language and publication status. We will consider any randomized controlled trials focusing on the effectiveness and safety of RMTT for the treatment of patients with OSAS after stroke. The study quality will be checked using Cochrane risk of bias tool, and statistical analysis will be performed utilizing RevMan 5.3 software. RESULTS: This study will summarize and synthesize the current evidence of RMTT for the treatment of patients with OSAS following stroke. CONCLUSION: The findings of this study will assess the present evidence for the benefits and harms of RMTT for treating OSAS after stroke, and will inform clinical practice and future research. PROSPERO REGISTRATION NUMBER: PROSPERO CRD42020170355.

Safety and efficacy of short- and long-term inspiratory muscle training in late-onset Pompe disease (LOPD): a pilot study.

BACKGROUND: In patients with late-onset Pompe disease, progressive respiratory muscle weakness with predominantly diaphragmatic involvement is a frequent finding at later stages of the disease. Respiratory muscle training (RMT) is an established therapy option for patients with several neuromuscular disorders including Duchenne muscular dystrophy. Forced voluntary muscle contractions of inspiration and/or expiration muscles enhance ventilation by increasing respiratory coordination, endurance, and strength. Efficacy of RMT in LOPD is rarely examined, and the clinical studies performed are difficult to compare because of different training programs and protocols. This impedes a useful statement and recommendation about the safety and efficacy of respiratory muscle training. METHODS: We conducted a monocentric unblinded single-arm pilot study in patients with LOPD to evaluate the safety and efficacy of inspiratory muscle training (IMT). The primary objective was to determine the efficacy of a 6-week repetitive IMT with a gradual increase of inspiratory resistance, measured by MIP (maximum inspiratory pressure) in the upright position. For statistical analysis, we used an A-B-C single subject design. The 6-week training-period A was followed by a 6-week non-training period B and an optional training period of 40 weeks in period C. The total study duration for the periods A, B and C was 52 weeks. Throughout the study, spirometry assessments (FCV, FEV1) and measurements of respiratory strength (MIP, MEP) were performed at defined time points, as well as capillary oximetry and capnometry, motor function test and patient's questionnaires for quality of life and dyspnea, measured by St. George's Respiratory Questionnaire (SGRQ) and MMRC-Dyspnea scale. For the cross-sectional comparison, a paired two-sided t test, and for the longitudinal comparison, a two-sample, two-sided t test were used. When data were not normally distributed, a Wilcoxon-Mann-Whitney test was added. Finally, the annual decline in FVC and FEV1 before and after IMT was compared. FINDINGS: 11 subjects were included in this pilot study. Overall, IMT was well tolerated. In four subjects, a total of six adverse events related to the study procedures were noticed. Training compliance was excellent in the first weeks of training, but declined continuously in the extension period. There was a significant increase in our primary outcome measure MIP within the 6-week period of frequent IMT with a mean of 15.7% (p =0.024; d =0.402). A significant increase was also seen after week 52 by a mean of + 26.4% (mean + 13.4 cmH2O, p =0.001, d =0.636). In the 6-week non-training interim-period (period B), the values remained stable, and there was no clinically meaningful decline in secondary outcome measures. The increase in MIP did not have any effect on secondary outcome measures like spirometry tests (FVC, FEV1), capillary blood gas analysis, motor function tests, patient's perceived quality of life or any significant change in dyspnea score. CONCLUSIONS: Frequent IMT improves MIP and thereby stabilizes and decelerates the decline of the diaphragm strength. The gradual increase of inspiratory resistance is well tolerated without any increase of side effects, as long as IMT is supervised and resistance is individually adjusted to the patient's perceived grade of exhaustion. Although we could not detect a significant impact on secondary outcome measures, IMT should be offered to all LOPD patients, especially to those who demonstrate a progressive decline in respiratory muscle function or are unable to receive ERT.

Yoga and breathing technique training in patients with heart failure and preserved ejection fraction: study protocol for a randomized clinical trial.

BACKGROUND: Current therapies for heart failure (HF) are followed by strategies to improve quality of life and exercise tolerance, besides reducing morbidity and mortality. Some HF patients present changes in the musculoskeletal system and inspiratory muscle weakness, which may be restored by inspiratory muscle training, thus increasing respiratory muscle strength and endurance, maximal oxygen uptake (VO2), functional capacity, respiratory responses to exercise, and quality of life. Yoga therapies have been shown to improve quality of life, inflammatory markers, and peak VO2 mostly in HF patients with a reduced ejection fraction. However, the effect of different yoga breathing techniques in patients showing HF with a preserved ejection fraction (HFpEF) remain to be assessed. METHODS/DESIGN: A PROBE (prospective randomized open blinded end-point) parallel-group trial will be conducted at two specialized HF clinics. Adult patients previously diagnosed with HFpEF will be included. After signing informed consent and performing a pre-test intervention, patients will be randomized into three groups and provided with either (1) active yoga breathing techniques; (2) passive yoga breathing techniques (pranayama); or and (3) control (standard pharmacological treatment). Follow-up will last 8 weeks (16 sessions). The post-intervention tests will be performed at the end of the intervention period for analysis of outcomes. Interventions will occur continuously according to patients' enrollment. The main outcome is respiratory muscular resistance. A total of 33 enrolled patients are expected. The present protocol followed the SPIRIT guidelines and fulfilled the SPIRIT checklist. DISCUSSION: This trial is probably the first to assess the effects of a non-pharmacological intervention, namely yoga and specific breathing techniques, to improve cardiorespiratory function, autonomic system, and quality of life in patients with HFpEF. TRIAL REGISTRATION: REBEC Identifier: RBR-64mbnx (August 19, 2012). Clinical Trials Register: NCT03028168 . Registered on 16 January 2017).

Noninvasive ventilation and respiratory physical therapy reduce exercise-induced bronchospasm and pulmonary inflammation in children with asthma: randomized clinical trial.

BACKGROUND: Asthma is characterized by hyperresponsiveness of the airways, and exercise-induced bronchospasm (EIB) is a symptom that limits a large proportion of asthmatic patients, especially children. Continuous positive airway pressure (CPAP) leads to a reduction in the reactivity of the airways. The aim of this study was to evaluate the effect of outpatient treatment with CPAP and bilevel pressure combined with respiratory physical therapy for children and adolescents with asthma following bronchial hyperresponsiveness caused by an exercise bronchoprovocation test. METHODS: A randomized, controlled, blind, clinical trial was conducted involving 68 asthmatic children and adolescents aged 4 to 16 years divided into three groups: G1, treated with bilevel pressure (inspiratory positive airway pressure: 12 cm H2O; expiratory positive airway pressure: 8 cm H2O), G2, treated with CPAP (8 cm H2O) and G3, treated with respiratory muscle training (RMT), considered as the control group. All groups were treated at an outpatient clinic and submitted to 10 1-hour sessions, each of which also included respiratory exercises. Evaluations were performed before and after treatment and involved spirometry, an exercise bronchoprovocation test, respiratory pressures, fraction of nitric oxide (FeNO), the Asthma Control Questionnaire (ACQ6) and anthropometric variables. This study received approval from the local ethics committee (certificate number: 1487225/2016) and is registered with ClinicalTrials [ ClinicalTrials.gov identifier: NCT02939625]. RESULTS: A total of 64 patients concluded the protocol; the mean age of the patients was 10 years. All were in the ideal weight range and had adequate height ( z score: -2 to +2). The three groups demonstrated improved asthma control after the treatments, going from partial to complete control. A significant increase in maximal inspiratory pressure occurred in the three groups, with the greatest increase in the RMT group. A reduction in FeNO in the order of 17.4 parts per billion (effect size: 2.43) and a reduction in bronchial responsiveness on the exercise bronchoprovocation test occurred in the bilevel group. An improvement in FeNO on the order of 15.7 parts per billion (effect size: 2.46) and a reduction in bronchial responsiveness occurred in the CPAP group. No changes in lung function or responsiveness occurred in the RMT group. CONCLUSION: Positive pressure and respiratory exercises were effective in reducing pulmonary inflammation, exercise-innduced bronchoespasm (EIB), and increased the clinical control of asthma, as well as RMT, which also resulted in improved clinical control.

Acute effects of glossopharyngeal insufflation in people with cervical spinal cord injury.

OBJECTIVES: To evaluate acute effects of glossopharyngeal insufflation (GI) on lung function, airway pressure (Paw), blood pressure and heart rate (HR) in people with cervical spinal cord injury (CSCI). DESIGN: Case-control design. SETTING: Karolinska Institutet, Stockholm, Sweden. PARTICIPANTS: Ten participants with CSCI suffering from lesions between C4 and C8, and ASIA classification of A or B were recruited. Ten healthy particpants familiar with GI were recruited as a reference group. OUTCOME MEASURES: Spirometry, mean arterial blood pressure (MAP), Paw, and HR were measured in a sitting and a supine position before, during, and after GI. RESULTS: GI in the study group in a sitting position increased total lung capacity (TLC) by 712 ml: P < 0.001, vital capacity (VC) by 587 ml: P < 0.0001, Paw by 13 cm H2O: P < 0.01, and HR by 10 beats/min: P < 0.001. MAP decreased by 25 mmHg, P < 0.0001. Significant differences were observed between groups comparing baseline with GI. The reference group had a higher increase in; TLC (P < 0.01), VC (P < 0.001), Paw (P < 0.001) and HR (P < 0.05) and a higher decrease in MAP (P < 0.001). With GI in a sitting compared to a supine position, TLC, MAP, HR, Paw remained unchanged in the study group, while residual volume decreased in the supine position (P < 0.01). CONCLUSION: There was a difference between the groups in the increase in TLC; VC; Paw, HR and in the decrease in MAP with GI, however MAP, HR and Paw responded in similar way in both groups in a sitting as well as a supine position. If performed correctly, the risks of GI resulting in clinically significant hemodynamic changes is low, although syncope may still occur.

Safety and efficacy of inspiratory muscle training for preventing adverse outcomes in patients at risk of prolonged hospitalisation.

BACKGROUND: The early institution of inspiratory muscle training on hospitalised patients with no established respiratory deficits could prevent in-hospital adverse outcomes that are directly or indirectly associated to the loss of respiratory muscle mass inherent to a prolonged hospital stay. The objective of the clinical trial is to assess the impact of inspiratory muscle training on hospital inpatient complications. METHODS: This is a double-blind randomised controlled trial. Subjects in the intervention group underwent an inspiratory muscle training loaded with 50% maximum inspiratory pressure twice daily for 4 weeks from study enrolment. Patients were randomly assigned to an inspiratory muscle training group or a sham inspiratory muscle training group. All patients received conventional physiotherapy interventions. Baseline and post-intervention respiratory and peripheral muscle strength, functionality (performance of activities of daily living), length of hospital stay, and death were evaluated. Clinical outcomes were assessed until hospital discharge. This study was approved by the Institutional Hospital Ethics Committee (03/2014). RESULTS: Thirty-one patients assigned to the inspiratory muscle training group and 34 to the sham inspiratory muscle training group were analysed. Patients in the inspiratory muscle training group had a shorter mean length of hospital stay (35.3 ± 2.7 vs. 41.8 ± 3.5 days, p < 0.01) and a lower risk of endotracheal intubation (relative risk (RR) = 0.36; 95% confidence interval (CI) 0.27-0.97; p = 0.03) as well as muscle weakness (RR = 0.36; 95% CI 0.19-0.98; p = 0.02) and mortality (RR = 0.23; 95% CI 0.2-0.94; p = 0.04). The risk of adverse events did not differ significantly between groups. CONCLUSION: Inspiratory muscle training was a protective factor against endotracheal intubation, muscle weakness, and mortality. TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT02459444 . Registered on 19 May 2015.

The effect of pre- and post-operative physical activity on recovery after colorectal cancer surgery (PHYSSURG-C): study protocol for a randomised controlled trial.

BACKGROUND: Surgery for colorectal cancer is associated with a high risk of post-operative adverse events, re-operations and a prolonged post-operative recovery. Previously, the effect of prehabilitation (pre-operative physical activity) has been studied for different types of surgery, including colorectal surgery. However, the trials on colorectal surgery have been of limited methodological quality and size. The aim of this trial is to compare the effect of a combined pre- and post-operative intervention of moderate aerobic physical activity and inspiratory muscle training (IMT) with standard care on post-operative recovery after surgery for colorectal cancer. METHODS/DESIGN: We are conducting a randomised, controlled, parallel-group, open-label, multi-centre trial with physical recovery within 4 weeks after cancer surgery as the primary endpoint. Some 640 patients planned for surgery for colorectal cancer will be enrolled. The intervention consists of pre- and post-operative physical activity with increased daily aerobic activity of moderate intensity as well as IMT. In the control group, patients will be advised to continue their normal daily exercise routine. The primary outcome is patient-reported physical recovery 4 weeks post-operatively. Secondary outcomes are length of sick leave, complication rate and severity, length of hospital stay, re-admittances, re-operations, post-operative mental recovery, quality of life and mortality, as well as changes in insulin-like growth factor 1 and insulin-like growth factor-binding protein 3, perception of pain and a health economic analysis. DISCUSSION: An increase in moderate-intensity aerobic physical activity is a safe, cheap and feasible intervention that would be possible to implement in standard care for patients with colorectal cancer. If shown to be effective, this lifestyle intervention could be a clinical parallel to pre-operative smoke cessation that has already been implemented with good clinical results. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02299596 . Registered on 17 November 2014.

Inspiratory Muscle Training and Functional Electrical Stimulation for Treatment of Heart Failure With Preserved Ejection Fraction: Rationale and Study Design of a Prospective Randomized Controlled Trial.

Heart failure with preserved ejection fraction (HFpEF) has become the most prevalent form of heart failure in developed countries. Regrettably, there is no evidence-based effective therapy for HFpEF. We seek to evaluate whether inspiratory muscle training, functional electrical stimulation, or a combination of both can improve exercise capacity as well as left ventricular diastolic function, biomarker profile, quality of life (QoL), and prognosis in patients with HFpEF. A total of 60 stable symptomatic patients with HFpEF (New York Heart Association class II-III/IV) will be randomized (1:1:1:1) to receive a 12-week program of inspiratory muscle training, functional electrical stimulation, a combination of both, or standard care alone. The primary endpoint of the study is change in peak exercise oxygen uptake; secondary endpoints are changes in QoL, echocardiogram parameters, and prognostic biomarkers. As of March 21, 2016, thirty patients have been enrolled. Searching for novel therapies that improve QoL and autonomy in the elderly with HFpEF has become a health care priority. We believe that this study will add important knowledge about the potential utility of 2 simple and feasible physical interventions for the treatment of advanced HFpEF.

Effect of inspiratory muscle training with load compared with sham training on blood pressure in individuals with hypertension: study protocol of a double-blind randomized clinical trial.

BACKGROUND: Hypertension is a complex chronic condition characterized by elevated arterial blood pressure. Management of hypertension includes non-pharmacologic strategies, which may include techniques that effectively reduce autonomic sympathetic activity. Respiratory exercises improve autonomic control over cardiovascular system and attenuate muscle metaboreflex. Because of these effects, respiratory exercises may be useful to lower blood pressure in subjects with hypertension. METHODS/DESIGN: This randomized, double-blind clinical trial will test the efficacy of inspiratory muscle training in reducing blood pressure in adults with essential hypertension. Subjects are randomly allocated to intervention or control groups. Intervention consists of inspiratory muscle training loaded with 40 % of maximum inspiratory pressure, readjusted weekly. Control sham intervention consists of unloaded exercises. Systolic and diastolic blood pressures are co-primary endpoint measures assessed with 24 h ambulatory blood pressure monitoring. Secondary outcome measures include cardiovascular autonomic control, inspiratory muscle metaboreflex, cardiopulmonary capacity, and inspiratory muscle strength and endurance. DISCUSSION: Previously published work suggests that inspiratory muscle training reduces blood pressure in persons with hypertension, but the effectiveness of this intervention is yet to be established. We propose an adequately sized randomized clinical trial to test this hypothesis rigorously. If an effect is found, this study will allow for the investigation of putative mechanisms to mediate this effect, including autonomic cardiovascular control and metaboreflex. TRIAL REGISTRATION: ClinicalTrials.gov NCT02275377 . Registered on 30 September 2014.

Efeitos Agudos da Estimulação Elétrica Funcional e do Treinamento Muscular Inspiratório em Pacientes com Insuficiência Cardíaca: Ensaio Clínico Randomizado Cruzado / Acute Effects of Functional Electrical Stimulation and Inspiratory Muscle Training in Patients With Heart Failure: A Randomized Crossover Clinical Trial

Fundamentos: A insuficiência cardíaca é uma doença multissistêmica que inclui disfunção autonômica. Objetivo: Avaliar os efeitos agudos da Estimulação Elétrica Funcional (EEF) e do Treinamento Muscular Inspiratório (TMI) sobre o controle autonômico, a função endotelial e os níveis de citocinas inflamatórias em pacientes portadores de IC. Métodos: Estudo randomizado cruzado que incluiu 12 pacientes submetidos a três intervenções randomizadas: EEF, TMI, e EEF + TMI, com intervalo de 1 semana entre as sessões. O TMI foi realizado durante 15 minutos, com 30% da pressão inspiratória máxima. A EEF foi realizada nos músculos vasto lateral e vasto medial, a uma frequência de 20Hz durante 30 minutos. O controle autonômico foi medido através de monitorização de pressão batimento por batimento (Finapres); a função endotelial, através da técnica de dilatação mediada por fluxo (DMF); e os níveis de citocinas inflamatórias foram medidos antes e depois de cada sessão. Resultados: O controle autonômico após EEF diminuiu em termos de BF/AF (p=0,01) e BFn.u (p=0,03), e aumentou em termos de RR médio (p=0,005). Observou-se um aumento do RR médio após o TMI (p=0,005) e após EEF+TMI (p=0,02). Não houve diferenças na DMF e na concentração de lactato sérico. Quanto às citocinas, a EEF promoveu uma redução nos níveis de TNF-α (pré versus pós 24 horas, p = 0,05). O TMI resultou em níveis aumentados de IL-10 (pré versus 24 horas pós, p=0,05) e em níveis diminuídos de TNF-α (1 hora pós versus 24 horas pós, p = 0,03). Não houve diferenças quando as duas intervenções foram associadas. Conclusão: EEF, TMI, e EEF + TMI alteraram o controle autonômico, mas não a função endotelial. A EEF e o TMI isoladamente alteraram os níveis de citocinas inflamatórias. Ensaios Clínicos: NCT01325597

Background: Heart Failure is a multisystem disorder, which includes autonomic dysfunction. Objective: To evaluate the acute effects of Functional Electrical Stimulation (FES) and Inspiratory Muscle Training (IMT) on autonomic control, endothelial function and inflammatory cytokine levels in patients with HF. Methods: Randomized crossover trial including 12 patients undergoing three randomized interventions: FES, IMT, and FES+IMT, with a 1-week interval between sessions. IMT was performed for 15 minutes with 30% of the maximal inspiratory pressure. FES was performed in the vastus lateralis and vastus medialis muscles, at 20Hz for 30 minutes. The autonomic control was measured using beat-to-beat blood pressure monitoring (Finapres); the endothelial function, using the flow-mediated dilation technique (FMD); and inflammatory cytokine levels were assessed before and after the sessions. Results: Autonomic control after FES decreased regarding LF/HF (p=0.01) and LFn.u (p=0.03), and increased regarding mean RR (p=0.005). Increased mean RR was observed after IMT (p=0.005) and after FES+IMT (p=0.02). No differences were found in FMD and blood lactate concentration. As regards the cytokines, FES led to a decrease in TNF-α levels (pre vs. 24 hours post, p = 0.05). IMT resulted in increased IL-10 levels (pre vs. 24 hours post, p=0.05) and decreased TNF-α levels (1 hour post vs. 24 hours post, p = 0.03). No difference was observed when the two interventions were associated. Conclusion: FES, IMT, and FES+IMT changed the autonomic control without changing the endothelial function. FES and IMT separately changed inflammatory cytokine levels. Clinical Trials: NCT01325597

"Functional" Respiratory Muscle Training During Endurance Exercise Causes Modest Hypoxemia but Overall is Well Tolerated.

A novel commercial training mask purportedly allows for combined respiratory muscle training and altitude exposure during exercise. We examined the mask's ability to deliver on this claim. Ten men completed three bouts of treadmill exercise at a matched workload (60%VO2peak) in a controlled laboratory environment. During exercise, the mask was worn in 2 manufacturer-defined settings (9,000 ft [9K] and 15,000 ft [15K]) and a Sham configuration (∼3,500 ft). Ventilation (V(E)), tidal volume (V(T)), respiratory rate (R(R)), expired oxygen (F(E)O2) and carbon dioxide (F(E)CO2), peripheral oxygen saturation (S(P)O2), heart rate, and RPE were measured each minute during exercise, and subjects completed the Beck Anxiety Inventory (BAI) immediately after. The mask caused a reduction in V(E) of ∼20 L/min in both the 9K and 15K configurations (p < 0.001). This was due to a reduction in R(R) of ∼10 b·min, but not V(T), which was elevated by ∼250 ml (p < 0.001). F(E)O2 was reduced and F(E)CO2 was elevated above Sham in both 9K and 15K (p < 0.001). VO2 was not different across conditions (p = 0.210), but VCO2 trended lower at 9K (p = 0.093) and was reduced at 15K (p = 0.016). V(E)/VO2 was 18.3% lower than Sham at 9K and 19.2% lower at 15K. V(E)/VCO2 was 16.2% lower than Sham at 9K and 18.8% lower at 15K (all p < 0.001). Heart rate increased with exercise (p < 0.001) but was not different among conditions (p = 0.285). S(P)O2 averaged 94% in Sham, 91% at 9K, and 89% at 15K (p < 0.001). RPE and BAI were also higher in 9K and 15K (p < 0.010), but there was no difference among mask conditions. The training mask caused inadequate hyperventilation that led to arterial hypoxemia and psychological discomfort, but the magnitude of these responses were small and they did not vary across mask configurations.

Stress Management in Patients Undergoing Carotid Endarterectomy for Carotid Artery Stenosis: A Pilot Randomized Controlled Trial.

BACKGROUND: Psychological stress is common to patients submitted to cardiovascular operations. The purpose of this pilot, single-center, open-label, randomized controlled trial was to investigate the effects of a stress management program (SMP) on patients undergoing carotid endarterectomy (CEA). METHODS: A sample of 24 patients with significant (>70%) carotid stenosis was finally randomized to SMP (intervention group; n = 12) or no-stress management intervention (control group; n = 12) before CEA. SMP consisted of 2 relaxation techniques (relaxation-breathing and guided imagery) before and 8 weeks after CEA. Measurements included Perceived Stress Scale (PSS), Hospital Anxiety and Depression Scale (HADS), Health Locus of Control Scale (HLC), and blood pressure and heart rate. RESULTS: The 2 groups did not differ in terms of demographic characteristics, vascular risk factors, and baseline psychometric measurements. No delay on the time of surgery was caused by the practice of the relaxation techniques. Both perceived stress and anxiety improved within the intervention group at the end of the program (P = 0.005 and P = 0.007, respectively). No improvement in PSS-14, HLC, and HADS scores were documented in control group at the end of the 8-week follow-up period. The intervention group had lower PSS-14 scores at 8 weeks after CEA (median PSS-14 score, 20 points; range, 10-28) compared with control group (median PSS, 25 points; range, 11-47; P = 0.026). No significant effect of SMP was found for blood pressure and heart rate measurements. CONCLUSIONS: Our results indicate that relaxation techniques appear to be beneficial in terms of stress and anxiety reduction in patients undergoing CEA. These findings require independent confirmation in the setting of a larger, double-blind randomized controlled trial.

Breathing practices for treatment of psychiatric and stress-related medical conditions.

Neurophysiological studies may explain how breathing techniques normalize stress response, emotion regulation, and autonomic and neuroendocrine system function. Breath practices have been shown to reduce symptoms of stress, anxiety, insomnia, post-traumatic stress disorder, mass disasters, depression, and attention deficit disorder. Technology-assisted breathing interventions facilitate therapeutic breathing by using either static cues such as a breath pacer or real-time feedback based on physiological parameters such as heart rate variability. The empirical literature indicates that technology-assisted breathing can be beneficial in mental health treatment, though it may not be appropriate for all individuals. Initial in-person training and evaluation can improve results.

Inspiratory muscle training in heart disease and heart failure: a review of the literature with a focus on method of training and outcomes.

Evidence to date strongly suggests that poor inspiratory muscle performance is associated with dyspnea, poor exercise tolerance and poor functional status in patients with heart failure (HF). A growing body of literature has examined the effects of inspiratory muscle training (IMT) in HF patients with the majority of studies reporting favorable effects on several of the above limitations and a substantial number of related deficiencies due to inadequate inspiration and inspiratory muscle strength and endurance. The domains and manifestations of HF, which were significantly improved by IMT in one or more of the 18 out of 19 studies of IMT, included dyspnea, quality of life, balance, peripheral muscle strength and blood flow, peripheral muscle sympathetic nervous activity, heart rate, respiratory rate, peak VO2, 6-min walk test distance, ventilation, VE/VCO2 slope, oxygen uptake efficiency, circulatory power, recovery oxygen kinetics and several indices of cardiac performance. This paper will also review the available IMT literature with a focus on methods of IMT and clinical outcomes. Key differences between available IMT methods will be highlighted with a goal to improve IMT efforts and decrease the pathophysiological manifestations of heart disease and HF.