Effects of different modalities of inspiratory muscle training as an add-on to conventional treatment of patients with chronic obstructive pulmonary disease (COPD): study protocol for a randomized controlled trial.
ABSTRACT: BACKGROUND:Chronic obstructive pulmonary disease (COPD) leads to peripheral and respiratory muscle dysfunctions. Nowadays, inspiratory muscle training can be geared toward strength or endurance gains. This study aims to investigate the effects of an inspiratory muscle training (IMT) protocol using different therapeutic modalities to be implemented in pulmonary rehabilitation programs. The effects of IMT on exercise capacity were considered as the primary endpoint, and the effects of IMT on inspiratory muscle function, health-related quality of life, and daily physical activity level were considered as the secondary outcomes. METHODS:This study is a blinded-investigator randomized controlled clinical trial. Sixty subjects will be randomly allocated into three groups: (1) pulmonary rehabilitation (PR) associated with inspiratory muscle training without any load (PRWIMT), (2) PR associated with inspiratory muscle training with a linear load (PRIMTLL), and (3) PR associated with inspiratory muscle training with isocapnic voluntary hyperpnea (PRIMTIVH). The protocol will be performed 5 days a week (3 days with supervision) for 10 weeks. The study will assess anthropometric data, lung function, respiratory muscle strength, and functional capacity by the Incremental Shuttle Walking Test and the Six-Minute Walk Test, lung volumes during the submaximal endurance test, peripheral muscle strength of the upper and lower limbs, dyspnea, and quality of life related to health, before and after the training protocol. Normality will be tested using the Kolmogorov-Smirnov test, and variables will be compared by two-way analysis of variance. The significance level was set at p < 0.05. Ethics approval was obtained from the Institutional Ethics Committee in Research (1.663.411). The study results will be disseminated through presentation at specific scientific conferences and publication in peer-reviewed journals. DISCUSSION:The different IMT protocols used in our study will be able to guide respiratory therapists to understand and to include in conventional PR programs the most effective respiratory muscle training type in subjects with COPD. TRIAL REGISTRATION:Brazilian Clinical Trials Registry, RBR-94v6kd . Registered on 11 March 2017.
Project description:BACKGROUND:Inspiratory muscle training (IMT) has brought great benefits in terms of improving physical performance in healthy individuals. However, there is no consensus regarding the best training load, as in most cases the maximal inspiratory pressure (MIP) is used, mainly the intensity of 60% of MIP. Therefore, prescribing an IMT protocol that takes into account inspiratory muscle strength and endurance may bring additional benefits to the commonly used protocols, since respiratory muscles differ from other muscles because of their greater muscular resistance. Thus, IMT using critical inspiratory pressure (PThC) can be an alternative, as the calculation of PThC considers these characteristics. Therefore, the aim of this study is to propose a new IMT protocol to determine the best training load for recreational cyclists. METHODS:Thirty recreational cyclists (between 20 and 40?years old) will be randomized into three groups: sham (SG), PThC (CPG) and 60% of MIP, according to age and aerobic functional capacity. All participants will undergo the following evaluations: pulmonary function test (PFT), respiratory muscle strength test (RMS), cardiopulmonary exercise test (CPET), incremental inspiratory muscle endurance test (iIME) (maximal sustained respiratory pressure for 1?min (PThMAX)) and constant load test (CLT) (95%, 100% and 105% of PThMÁX) using a linear load inspiratory resistor (PowerBreathe K5). The PThC will be calculated from the inspiratory muscle endurance time (TLIM) and inspiratory loads of each CLT. The IMT will last 11?weeks (3 times/week and 55?min/session). The session will consist of 5-min warm-up (50% of the training load) and three sets of 15-min breaths (100% of the training load), with a 1-min interval between them. RMS, iIME, CLT and CPET will be performed beforehand, at week 5 and 9 (to adjust the training load) and after training. PFT will be performed before and after training. The data will be analyzed using specific statistical tests (parametric or non-parametric) according to the data distribution and their respective variances. A p value <0.05 will be considered statistically significant. DISCUSSIONS:It is expected that the results of this study will enable the training performed with PThC to be used by health professionals as a new tool to evaluate and prescribe IMT. TRIAL REGISTRATION:ClinicalTrials.gov, NCT02984189 . Registered on 6 December 2016.
Project description:Background:Subjects with COPD frequently develop considerable weakness and deconditioning of the inspiratory musculature, which can be corrected with inspiratory muscle training (IMT). While rehabilitation centers may be able to provide IMT as part of the rather complex management of COPD, there is currently a lack of rehabilitation services in the Czech Republic. Remote IMT may then benefit subjects with COPD who are unable to attend or do not have access to rehabilitation programs. We aim at evaluating the utility of the test of incremental respiratory endurance (TIRE) as an at-home IMT method in subjects with COPD, while comparing the effectiveness of this novel training approach to the outcomes of traditional, threshold loading IMT protocols. Methods/Design:This prospective, randomized controlled trial will comprise 8 weeks of at-home IMT sessions with remote supervision followed by 4 months of unsupervised, independent IMT. Eligible subjects will be randomly assigned to one of the following three distinct home-based IMT protocols: (1) TIRE, (2) Threshold loading, and (3) Sham training. Subjects allocated to the TIRE group will train once daily using an advanced IMT electronic system (PrO2), while the other two groups will receive threshold devices. Study outcomes will include measures of inspiratory muscle strength and endurance, pulmonary function, COPD-specific symptomatology, functional exercise capacity, surrogate markers of mortality risk, mental health status and health-related quality of life. Discussion:While we acknowledge the value of threshold loading IMT protocols, we believe that the TIRE training method has the potential to provide additional clinical benefits in COPD given its sophisticated remote tracking system and ability to modulate all aspects of muscular performance, including not only strength but also endurance, power and work capacity, allowing users to achieve considerably higher inspiratory pressures throughout the full range of inspiration when compared to other more traditionally used IMT methods.
Project description:PURPOSE:The purpose of the present review was to assess the quality of evidence in the literature regarding the specific benefits of inspiratory muscle training (IMT) with an emphasis on training intensity and the relationships between changes in inspiratory muscle function and other clinical outcome measures. METHODS:Articles were found by searching CINAHL, PubMed, Medline via First Search, and ProQuest databases. Articles used in the review were randomized trials of IMT vs. sham IMT or no intervention, published in English in a peer-reviewed journal, included patients with chronic obstructive pulmonary disease (COPD), and specified the intensity of training. The quality of the studies was evaluated by 2 independent reviewers using the methodological rigor scale described by Medlicott and Harris as well as Sackett's levels of evidence. Fifteen articles met the inclusion criteria and were used in this review. RESULTS:Consistent improvements in maximal inspiratory pressures (ranging from -11 to -30 cm H(2)O) and inspiratory muscle endurance were found. Improvements in dyspnea and health-related quality of life were also observed. Inspiratory muscle training may result in improved exercise tolerance as measured using walking tests. High-intensity IMT resulted in improved training efficiency with respect to inspiratory muscle strength, but evidence of the effect of high-intensity IMT on other clinical outcomes is lacking. CONCLUSION:Despite research spanning decades, there are numerous limitations in the literature regarding IMT. IMT appears to improve dyspnea, waking test distance, and health-related quality of life in individuals with COPD, but it is not clear whether this improvement is mediated through improved inspiratory muscle strength and endurance. This review discussed several considerations critical to the design of future trials.
Project description:Cycle ergometer training (CET) has been shown to improve exercise performance of the quadriceps muscles in patients with COPD, and inspiratory muscle training (IMT) may improve the pressure-generating capacity of the inspiratory muscles. However, the effects of combined CET and IMT remain unclear and there is a lack of comprehensive assessment.Eighty-one patients with COPD were randomly allocated to three groups: 28 received 8 weeks of CET + IMT (combined training group), 27 received 8 weeks of CET alone (CET group), and 26 only received 8 weeks of free walking (control group). Comprehensive assessment including respiratory muscle strength, exercise capacity, pulmonary function, dyspnea, quality of life, emotional status, nutritional status, and body mass index, airflow obstruction, and exercise capacity index were measured before and after the pulmonary rehabilitation program.Respiratory muscle strength, exercise capacity, inspiratory capacity, dyspnea, quality of life, depression and anxiety, and nutritional status were all improved in the combined training and CET groups when compared with that in the control group (P<0.05) after pulmonary rehabilitation program. Inspiratory muscle strength increased significantly in the combined training group when compared with that in the CET group (ΔPImax [maximal inspiratory pressure] 5.20±0.89 cmH2O vs 1.32±0.91 cmH2O; P<0.05). However, there were no significant differences in the other indices between the two groups (P>0.05). Patients with weakened respiratory muscles in the combined training group derived no greater benefit than those without respiratory muscle weakness (P>0.05). There were no significant differences in these indices between the patients with malnutrition and normal nutrition after pulmonary rehabilitation program (P>0.05).Combined training is more effective than CET alone for increasing inspiratory muscle strength. IMT may not be useful when combined with CET in patients with weakened inspiratory muscles. Nutritional status had slight impact on the effects of pulmonary rehabilitation. A comprehensive assessment approach can be more objective to evaluate the effects of combined CET and IMT.
Project description:BACKGROUND:Difference between combined inspiratory and expiratory muscle training in same respiratory cycle or different cycles remained unclarified. We explored the difference between both patterns of combined trainings in patients with COPD. METHODS:In this randomized, open-label, controlled trial, stable COPD subjects trained for 48 minutes daily, for 8 weeks, using a monitoring device for quality control. Ninety-two subjects were randomly and equally assigned for sham training, inspiratory muscle training(IMT), combined inspiratory and expiratory muscle training in same cycle(CTSC) or combined inspiratory and expiratory muscle training in different cycles(CTDC). Respiratory muscle strength, as the primary endpoint, was measured before and after training. Registry: ClinicalTrials.gov (identifier: NCT02326181). RESULTS:Respiratory muscle training improved maximal inspiratory pressure(PImax), while no significant difference was found in PImax among IMT, CTSC and CTDC. Maximal expiratory pressure(PEmax) in CTSC and CTDC was greater than IMT(P = 0.026, and P=0.04, respectively) and sham training (P = 0.001). IMT, CTSC, and CTDC shortened inhalation and prolonged exhalation(P < 0.01). Subjects with respiratory muscle weakness in IMT and CTDC exhibited greater increase in PImax than those without. IMT, CTSC and CTDC showed no difference in symptoms and quality of life scales among themselves(P > 0.05). CONCLUSION:Both patterns of CTSC and CTDC improved inspiratory and expiratory muscle strength, while IMT alone only raised PImax. Respiratory muscle training might change the respiratory cycles, and be more beneficial for COPD patients with inspiratory muscle weakness.
Project description:Dynamic hyperinflation has important clinical consequences in patients with chronic obstructive pulmonary disease (COPD). Given that most of these patients have respiratory and peripheral muscle weakness, dyspnea and functional exercise capacity may improve as a result of inspiratory muscle training (IMT). The aim of the study was to analyze the effects of IMT on exercise capacity, dyspnea, and inspiratory fraction (IF) during exercise in patients with COPD. Daily inspiratory muscle strength and endurance training was performed for 8 weeks in 10 patients with COPD GOLD II and III. Ten patients with COPD II and III served as a control group. Maximal inspiratory pressure (Pimax) and endurance time during resistive breathing maneuvers (tlim) served as parameter for inspiratory muscle capacity. Before and after training, the patients performed an incremental symptom limited exercise test to maximum and a constant load test on a cycle ergometer at 75% of the peak work rate obtained in the pretraining incremental test. ET was defined as the duration of loaded pedaling. Following IMT, there was a statistically significant increase in inspiratory muscle performance of the Pimax from 7.75 ± 0.47 to 9.15 ± 0.73 kPa (P < 0.01) and of tlim from 348 ± 54 to 467 ± 58 seconds (P < 0.01). A significant increase in IF, indicating decreased dynamic hyperinflation, was observed during both exercise tests. Further, the ratio of breathing frequency to minute ventilation (bf/V'(E)) decreased significantly, indicating an improved breathing pattern. A significant decrease in perception of dyspnea was also measured. Peak work rate during the incremental cycle ergometer test remained constant, while ET during the constant load test increased significantly from 597.1 ± 80.8 seconds at baseline to 733.6 ± 74.3 seconds (P < 0.01). No significant changes during either exercise tests were measured in the control group. The present study found that in patients with COPD, IMT results in improvement in performance, exercise capacity, sensation of dyspnea, and improvement in the IF prognostic factor.
Project description:BACKGROUND:Respiratory muscle weakness and its relation to other impairments in children with cerebral palsy (CP) have been shown in the latest studies. The effects of inspiratory muscle training (IMT) in this population have not been comprehensively investigated so far. OBJECTIVES:To investigate the effects of IMT on trunk control, pulmonary functions, respiratory muscle strength, daily living activities, exercise capacity and quality of life in children with CP. METHODS:This was a prospective-randomized controlled trial. Twenty-five children with CP were randomly assigned to the treatment (n=13) or the control group (n=12). The treatment group received IMT at 30% of maximal inspiratory pressure (MIP) and the control group received sham therapy (5% of MIP) for 6 weeks. Also, both groups received routine conventional physical therapy (stretching, strengthening, and functional exercises, etc.) for 6 weeks. The primary outcome measure was trunk control. Secondary outcome measures were pulmonary function, respiratory muscle strength, daily living activities, functional exercise capacity and quality of life. RESULTS:The treatment group had better outcome for trunk control (3.87, 95% CI 3.72-4.02). Also, respiratory muscle strength, daily living activities, functional exercise capacity and quality of life were significantly improved in the treatment group compared with controls. No improvements were observed in the pulmonary function test scores between the groups. CONCLUSION:Inspiratory muscle training improves trunk control, respiratory muscle strength, daily living activities, functional exercise capacity and quality of life in children with CP and it can be included in the physiotherapy and rehabilitation programs.
Project description:RATIONALE:Respiratory muscle weakness is common in critically ill patients; the role of targeted inspiratory muscle training (IMT) in intensive care unit rehabilitation strategies remains poorly defined. OBJECTIVES:The primary objective of the present study was to describe the range and tolerability of published methods for IMT. The secondary objectives were to determine whether IMT improves respiratory muscle strength and clinical outcomes in critically ill patients. METHODS:We conducted a systematic review to identify randomized and nonrandomized studies of physical rehabilitation interventions intended to strengthen the respiratory muscles in critically ill adults. We searched the MEDLINE, Embase, HealthSTAR, CINAHL, and CENTRAL databases (inception to September Week 3, 2017) and conference proceedings (2012 to 2017). Data were independently extracted by two authors and collected on a standardized report form. RESULTS:A total of 28 studies (N = 1,185 patients) were included. IMT was initiated during early mechanical ventilation (8 studies), after patients proved difficult to wean (14 studies), or after extubation (3 studies), and 3 other studies did not report exact timing. Threshold loading was the most common technique; 13 studies employed strength training regimens, 11 studies employed endurance training regimens, and 4 could not be classified. IMT was feasible, and there were few adverse events during IMT sessions (nine studies; median, 0%; interquartile range, 0-0%). In randomized trials (n = 20), IMT improved maximal inspiratory pressure compared with control (15 trials; mean increase, 6 cm H2O; 95% confidence interval [CI], 5-8 cm H2O; pooled relative ratio of means, 1.19; 95% CI, 1.14-1.25) and maximal expiratory pressure (4 trials; mean increase, 9 cm H2O; 95% CI, 5-14 cm H2O). IMT was associated with a shorter duration of ventilation (nine trials; mean difference, 4.1 d; 95% CI, 0.8-7.4 d) and a shorter duration of weaning (eight trials; mean difference, 2.3 d; 95% CI, 0.7-4.0 d), but confidence in these pooled estimates was low owing to methodological limitations, including substantial statistical and methodological heterogeneity. CONCLUSIONS:Most studies of IMT in critically ill patients have employed inspiratory threshold loading. IMT is feasible and well tolerated in critically ill patients and improves both inspiratory and expiratory muscle strength. The impact of IMT on clinical outcomes requires future confirmation.
Project description:Respiratory/inspiratory muscle training (RMT/IMT) has been proposed to improve the endurance performance of athletes in normoxia. In recent years, due to the increased use of hypoxic training method among athletes, the RMT applicability has also been tested as a method to minimize adverse effects since hyperventilation may cause respiratory muscle fatigue during prolonged exercise in hypoxia. We performed a review in order to determine factors potentially affecting the change in endurance performance in hypoxia after RMT in healthy subjects. A comprehensive search was done in the electronic databases MEDLINE and Google Scholar including keywords: "RMT/IMT," and/or "endurance performance," and/or "altitude" and/or "hypoxia." Seven appropriate studies were found until April 2018. Analysis of the studies showed that two RMT methods were used in the protocols: respiratory muscle endurance (RME) (isocapnic hyperpnea: commonly 10-30', 3-5 d/week) in three of the seven studies, and respiratory muscle strength (RMS) (Powerbreathe device: commonly 2 × 30 reps at 50% MIP (maximal inspiratory pressure), 5-7 d/week) in the remaining four studies. The duration of the protocols ranged from 4 to 8 weeks, and it was found in synthesis that during exercise in hypoxia, RMT promoted (1) reduced respiratory muscle fatigue, (2) delayed respiratory muscle metaboreflex activation, (3) better maintenance of SaO2 and blood flow to locomotor muscles. In general, no increases of maximal oxygen uptake (VO2max) were described. Ventilatory function improvements (maximal inspiratory pressure) achieved by using RMT fostered the capacity to adapt to hypoxia and minimized the impact of respiratory stress during the acclimatization stage in comparison with placebo/sham. In conclusion, RMT was found to elicit general positive effects mainly on respiratory efficiency and breathing patterns, lower dyspneic perceptions and improved physical performance in conditions of hypoxia. Thus, this method is recommended to be used as a pre-exposure tool for strengthening respiratory muscles and minimizing the adverse effects caused by hypoxia related hyperventilation. Future studies will assess these effects in elite athletes.
Project description:Background:According to the literature, 20-30% of intubated patients are difficult to wean off mechanical ventilation and have a prolonged intensive care unit (ICU) stay with detrimental effects on muscle strength, functional ability and quality of life. Inspiratory muscle training (IMT) via a threshold device has been proposed as an effective exercise for minimising the effects of mechanical ventilation on respiratory muscles of critically ill patients with prolonged weaning. In addition, high-flow nasal cannula (HFNC) oxygen has been proved to provide efficient support for both high- and low-risk patients after extubation, thus preventing re-intubation. Material and methods:A randomised controlled trial was designed to assess the efficacy of combining IMT and HFNC as therapeutic strategies for patients with high risk for weaning failure. Once patients with prognostic factors of difficult weaning are awake, ventilated with support settings and cooperative, they will be randomised to one of the two following study groups: intervention group (IMT and HFNC) and control group (IMT and Venturi mask). IMT will start as soon as possible. Each allocated oxygen delivery device will be applied immediately after extubation. IMT intervention will continue until patients' discharge from ICU. The primary outcome is the rate of weaning failure. Secondary outcomes are maximal inspiratory and expiratory strength, endurance of respiratory muscles, global muscle strength, functional ability and quality of life along with duration of ventilation (days) and ICU and hospital length of stay. Conclusion:The present study could significantly contribute to knowledge of how best to treat patients with difficult weaning and high risk of re-intubation.