Dataset Information

Protocol: inspiratory muscle training for promoting recovery and outcomes in ventilated patients (IMPROVe): a randomised controlled trial.

ABSTRACT:

Introduction

Inspiratory muscle weakness is a known consequence of mechanical ventilation and a potential contributor to difficulty in weaning from ventilatory support. Inspiratory muscle training (IMT) reduces the weaning period and increases the likelihood of successful weaning in some patients. However, it is not known how this training affects the residual inspiratory muscle fatigability following successful weaning nor patients' quality of life or functional outcomes.

Methods and analysis

This dual centre study includes two concurrent randomised controlled trials of IMT in adult patients who are either currently ventilator-dependent (>7 days) (n=70) or have been recently weaned from mechanical ventilation (>7 days) in the past week (n=70). Subjects will be stable, alert and able to actively participate and provide consent. There will be concealed allocation to either treatment (IMT) or usual physiotherapy (including deep breathing exercises without a resistance device). Primary outcomes are inspiratory muscle fatigue resistance and maximum inspiratory pressures. Secondary outcomes are quality of life (Short Form-36v2, EQ-5D), functional status (Acute Care Index of Function), rate of perceived exertion (Borg Scale), intensive care length of stay (days), post intensive care length of stay (days), rate of reintubation (%) and duration of ventilation (days).

Ethics and dissemination

Ethics approval has been obtained from relevant institutions, and results will be published with a view to influencing physiotherapy practice in the management of long-term ventilator-dependent patients to accelerate weaning and optimise rehabilitation outcomes.

Trial registration number

ACTRN12610001089022.

SUBMITTER: Bissett BM

PROVIDER: S-EPMC3293141 | biostudies-literature | 2012

REPOSITORIES: biostudies-literature

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Publications

Protocol: inspiratory muscle training for promoting recovery and outcomes in ventilated patients (IMPROVe): a randomised controlled trial.

Bissett Bernie M BM Leditschke I Anne IA Paratz Jennifer D JD Boots Robert J RJ

BMJ open 20120302 2

<h4>Introduction</h4>Inspiratory muscle weakness is a known consequence of mechanical ventilation and a potential contributor to difficulty in weaning from ventilatory support. Inspiratory muscle training (IMT) reduces the weaning period and increases the likelihood of successful weaning in some patients. However, it is not known how this training affects the residual inspiratory muscle fatigability following successful weaning nor patients' quality of life or functional outcomes.<h4>Methods and ...[more]

PMID: 22389363

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Project description:INTRODUCTION:Respiratory muscle dysfunction has been associated with failure to wean from mechanical ventilation. It has therefore been hypothesised that these patients might benefit from inspiratory muscle training (IMT). Evidence, however, is thus far limited to data from small, single-centre studies with heterogeneity in inclusion criteria, training modalities and outcomes. The aim of this study is to evaluate the effects of a novel IMT method on weaning outcomes in selected patients with weaning difficulties. METHODS:This study is designed as a double-blind, parallel-group, randomised controlled superiority trial with 1:1 allocation ratio. Patients with weaning difficulties will be randomly allocated into either an IMT group (intervention) or a sham-IMT group (control). Ninetypatients (45 in each group) will be needed to detect a 28% difference in the proportion of weaning success between groups (estimated difference in primary outcome based on previous studies) with a risk for type I error (?) of 5% and statistical power (1-?) of 80%. Patients will perform four sets of 6-10 breaths daily against an external load using a tapered flow resistive loading device (POWERbreathe KH2, HaB International, UK). Training intensity in the intervention group will be adjusted to the highest tolerable load. The control group will train against a low resistance that will not be modified during the training period. Training will becontinued until patients are successfully weaned or for a maximum duration of 28 days. Pulmonary and respiratory muscle function, weaning duration, duration of mechanical ventilation, ventilator-free days and length of stay in the intensive care unit will be evaluated as secondary outcomes. ?2 tests and analysis of covariance with adjustments for baseline values of respective outcomesas covariates will be used to compare results after the intervention period between groups. ETHICS AND DISSEMINATION:Ethics approval was obtained from the local ethical committee (Ethische Commissie Onderzoek UZ/KU Leuven protocol ID: S60516). Results from this randomised controlled trial will be presented at scientific meetings as abstracts for poster or oral presentations and published in peerreviewed journals. TRIAL STATUS:Enrolment into the study have started in August 2017. Data collection and data analysis are expected to be completed in September 2021. TRIAL REGISTRATION NUMBER:NCT03240263.

Project description:BackgroundStroke results in varying physical, cognitive, emotional and/or social disabilities in the short and long term alike. Motor impairments are important, persistent consequences of stroke and include, among others, decreased respiratory muscle function, decreased ability to expand the thorax and postural dysfunction. These deficits affect the patient's ability to perform daily activities, produce fatigue and reduce endurance and quality of life. Inspiratory muscle training (IMT) aims to improve the strength and endurance of the diaphragm and the external intercostal muscles. The objectives of this study are to investigate the effect of 3 weeks of IMT on (i) maximal inspiratory pressure (MIP) in adults having suffered a stroke, as well as (ii) functional activities and expiratory measurements.Methods/designThis is a randomised controlled trial (RCT) comparing IMT with conventional neurorehabilitation (usual practice). The trial will include 80 patients with reduced MIP hospitalised at a specialised neurorehabilitation hospital in Denmark. The intervention group will receive IMT sessions, exercising at 30% of MIP. Patients in the intervention group will perform two daily sessions (one session of IMT with Threshold IMT consisting of two times 15 inspirations at normal breathing rhythm (5-10 min)), 7 days a week for 3 weeks. Training can be with or without physiotherapist supervision.Study outcomesMIP assessed by the Power Breath, Functional Independence Measurement, The 6-min walk test, the Fatigue Severity Scale and average voice volume. Expiratory function will be assessed using spirometry. All assessments will be conducted at baseline and 3 weeks (at termination of the intervention) and 3 months after the intervention has concluded.DiscussionIMT is a promising and partly self-managed tool for rehabilitation to improve respiratory function. The introduction of IMT in combination with traditional physical therapy may enhance faster recovery after stroke and may at the same time demand little personnel resources to increase training intensity. This trial will provide further evidence of IMT to clinicians, patients and health managers. Hereby, this study accepts the call for further research.Trial registrationClinicalTrials.gov NCT04686019 . Registered on 28 December 2020.

Project description:BackgroundDiaphragmatic dysfunction is well documented in patients receiving mechanical ventilation. Inspiratory muscle training (IMT) has been used to facilitate weaning by strengthening the inspiratory muscles, yet the optimal approach remains uncertain. Whilst some data on the metabolic response to whole body exercise in critical care exist, the metabolic response to IMT in critical care is yet to be investigated. This study aimed to quantify the metabolic response to IMT in critical care and its relationship to physiological variables.MethodsWe conducted a prospective observational study on mechanically ventilated patients ventilated for ≥ 72 h and able to participate in IMT in a medical, surgical, and cardiothoracic intensive care unit. 76 measurements were taken on 26 patients performing IMT using an inspiratory threshold loading device at 4 cmH2O, and at 30, 50 and 80% of their negative inspiratory force (NIF). Oxygen consumption (VO2) was measured continuously using indirect calorimetry.ResultsFirst session mean (SD) VO2 was 276 (86) ml/min at baseline, significantly increasing to 321 (93) ml/min, 333 (92) ml/min, 351(101) ml/min and 388 (98) ml/min after IMT at 4 cmH2O and 30, 50 and 80% NIF, respectively (p = 0.003). Post hoc comparisons revealed significant differences in VO2 between baseline and 50% NIF and baseline and 80% NIF (p = 0.048 and p = 0.001, respectively). VO2 increased by 9.3 ml/min for every 1 cmH2O increase in inspiratory load from IMT. Every increase in P/F ratio of 1 decreased the intercept VO2 by 0.41 ml/min (CI - 0.58 to - 0.24 p < 0.001). NIF had a significant effect on the intercept and slope, with every 1 cmH2O increase in NIF increasing intercept VO2 by 3.28 ml/min (CI 1.98-4.59 p < 0.001) and decreasing the dose-response slope by 0.15 ml/min/cmH2O (CI - 0.24 to - 0.05 p = 0.002).ConclusionsIMT causes a significant load-dependent increase in VO2. P/F ratio and NIF impact baseline VO2. The dose-response relationship of the applied respiratory load during IMT is modulated by respiratory strength. These data may offer a novel approach to prescription of IMT.Take home messageThe optimal approach to IMT in ICU is uncertain; we measured VO2 at different applied respiratory loads to assess whether VO2 increased proportionally with load and found VO2 increased by 9.3 ml/min for every 1 cmH2O increase in inspiratory load from IMT. Baseline NIF has a significant effect on the intercept and slope, participants with a higher baseline NIF have a higher resting VO2 but a less pronounced increase in VO2 as the inspiratory load increases; this may offer a novel approach to IMT prescription. Trial registration ClinicalTrials.gov, registration number: NCT05101850. Registered on 28 September 2021, https://clinicaltrials.gov/ct2/show/NCT05101850.

Project description:IntroductionInspiratory muscle training (IMT) has been applied during pulmonary rehabilitation in patients with chronic obstructive pulmonary disease (COPD). However, it remains unclear if the addition of IMT to a general exercise training programme leads to additional clinically relevant improvements in patients with COPD. In this study, we will investigate whether the addition of IMT to a general exercise training programme improves 6 min walking distance, health-related quality of life, daily physical activity and inspiratory muscle function in patients with COPD with inspiratory muscle weakness.Methods and analysisPatients with COPD (n=170) with inspiratory muscle weakness (Pi,max <60 cm H2O or <50%pred) will be recruited to a multicentre randomised placebo controlled trial of IMT and allocated into one of the two groups. Patients in both groups will follow a 3 month general exercise training programme, in combination with home-based IMT. IMT will be performed with a recently developed device (POWERbreathe KH1). This device applies an inspiratory load that is provided by an electronically controlled valve (variable flow resistive load). The intervention group (n=85) will undertake an IMT programme at a high intensity (?50% of their Pi,max), whereas the placebo group (n=85) will undertake IMT at a low training intensity (?10% of Pi,max). Total daily IMT time for both groups will be 21 min (6 cycles of 30 breaths). Improvement in the 6 min walking distance will be the primary outcome. Inspiratory muscle function, health-related quality of life and daily physical activity will be assessed as secondary outcomes.Ethics and disseminationEthics approval has been obtained from relevant centre committees and the study has been registered in a publicly accessible clinical trial database. The results will be easily interpretable and should immediately be communicated to healthcare providers, patients and the general public.ResultsThis can be incorporated into evidence-based treatment recommendations for clinical practice.ClinicaltrialsgovNCT01397396.

Project description:IntroductionInspiratory muscle training (IMT) protocols are typically performed using pressure threshold loading with inspirations initiated from residual volume (RV). We aimed to compare effects of three different IMT protocols on maximal inspiratory pressures (PImax) and maximal inspiratory flow (V̇Imax) at three different lung volumes. We hypothesized that threshold loading performed from functional residual capacity (FRC) or tapered flow resistive loading (initiated from RV) would improve inspiratory muscle function over a larger range of lung volumes in comparison with the standard protocol.Methods48 healthy volunteers (42% male, age: 48 ± 9 years, PImax: 110 ± 28%pred, [mean ± SD]) were randomly assigned to perform three daily IMT sessions of pressure threshold loading (either initiated from RV or from FRC) or tapered flow resistive loading (initiated from RV) for 4 weeks. Sessions consisted of 30 breaths against the highest tolerable load. Before and after the training period, PImax was measured at RV, FRC, and midway between FRC and total lung capacity (1/2 IC). V̇Imax was measured at the same lung volumes against a range of external threshold loads.ResultsWhile PImax increased significantly at RV and at FRC in the group performing the standard training protocol (pressure threshold loading from RV), it increased significantly at all lung volumes in the two other training groups (all p < 0.05). No significant changes in V̇Imax were observed in the group performing the standard protocol. Increases of V̇Imax were significantly larger at all lung volumes after tapered flow resistive loading, and at higher lung volumes (i.e., FRC and 1/2 IC) after pressure threshold loading from FRC in comparison with the standard protocol (all p < 0.05).ConclusionOnly training with tapered flow resistive loading and pressure threshold loading from functional residual capacity resulted in consistent improvements in respiratory muscle function at higher lung volumes, whereas improvements after the standard protocol (pressure threshold loading from residual volume) were restricted to gains in PImax at lower lung volumes. Further research is warranted to investigate whether these results can be confirmed in larger samples of both healthy subjects and patients.

Dataset Information

Protocol: inspiratory muscle training for promoting recovery and outcomes in ventilated patients (IMPROVe): a randomised controlled trial.

Introduction

Methods and analysis

Ethics and dissemination

Trial registration number

Publications

Protocol: inspiratory muscle training for promoting recovery and outcomes in ventilated patients (IMPROVe): a randomised controlled trial.

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