Background
Methods
Results
MIP as an endpoint in clinical trials
Reference | MIP Endpoint | Treatment Group | N | MIP Result |
---|---|---|---|---|
Golparvar M et al., 2005 [30] | Primary | Progesterone administration in adult trauma patients during partial support ventilation | 40 | MIP significantly increased (P < 0.05) 3 h after administration |
Gontijo-Amaral C et al., 2012 [26] | Primary | Oral magnesium supplementation in adolescent cystic fibrosis patients | 44 | Significant increase in MIP between intervention and placebo period (P < 0.001) |
Mackersie RC et al., 1991 [31] | Primary | Continuous epidural or continual IV infusions of fentanyl in patients with multiple rib fractures | 32 | Significant increase in MIP in epidural and fentanyl epidural groups compared with pre-analgesia (P < 0.05) |
Sosis M et al., 1987 [32] | Primary | Atracurium treatment in patients requiring intubation | 39 | Significant decrease in MIP in patients receiving atracurium compared with placebo (P < 0.05) |
Andreas S et al., 2006 [35] | Primary | Irbesartan treatment in COPD patients | 60 | No significant difference in MIP after 4 months of treatment (P = 0.16). Reporting a large standard deviation of MIP. |
Skorodin MS et al., 1995 [33] | Primary | Magnesium sulphate administration in COPD patients | 72 | No significant difference in MIP after 20 and 45 min of treatment (P = NS) |
Weisberg J et al., 2002 [34] | Primary | Megestrol acetate administration in COPD patients | 128 | No significant difference in MIP (P = NS). Reporting a large standard deviation of MIP. |
Buyse GM et al., 2013 [36] | Secondary | Idebenone treatment in Duchenne muscular dystrophy patients | 21 | MIP improved in idebenone group but deteriorated in placebo group (P = NS) |
NCT number | Study Title | Study Design | Primary or Secondary Endpoint | Estimated Study Completion Date | Estimated Enrollment |
---|---|---|---|---|---|
Neuromuscular diseases | |||||
Amyotrophic lateral sclerosis | |||||
NCT02478450 | Study to Investigate the Safety of the Transplantation (by Injection) of Human Glial Restricted Progenitor Cells (hGRPs; Q-Cells®) Into Subjects With Amyotrophic Lateral Sclerosis (ALS) | Nonrandomized, open-label, parallel group study | Secondary | December 2017 | 12 |
Duchenne muscular dystrophy | |||||
NCT02310906 | Phase I/II Study of SRP-4053 in DMD Patients | Randomized, placebo-controlled, double-blind, parallel group study | Secondary | December 2016 | 48 |
NCT01999075 | Stacking Exercises Aid the Decline in FVC and Sick Time (STEADFAST) | Randomized, single-blind, parallel group study | Secondary | August 2016 | 110 |
NCT02255552 | Confirmatory Study of Eteplirsen in DMD Patients (PROMOVI) | Nonrandomized, open-label, parallel group study | Secondary | May 2016 | 160 |
Myasthenia gravis | |||||
NCT01047761 | Exercise for Stable Myasthenia Gravis | Nonrandomized, open-label, single group study | Secondary | December 2015 | 30 |
Parkinson’s disease | |||||
NCT02202057 | Respiratory Load Magnitude Estimation in PD | Prospective, case control study | Secondary | August 2015 | 80 |
Pompe disease | |||||
NCT02357225 | A Pilot Study of Pyridostigmine in Pompe Disease | Nonrandomized, open-label, single group study | Primary | June 2017 | 16 |
NCT02354651 | Response to Diaphragmatic Pacing in Subjects With Pompe Disease | Prospective, observational study | Secondary | February 2017 | 12 |
NCT01924845 | BMN 701 Phase 3 in rhGAA Exposed Subjects With Late Onset Pompe Disease (INSPIRE Study) | Nonrandomized, open-label, single group study | Primary | June 2020 | 50 |
Pulmonary hypertension | |||||
NCT02288442 | Whole Muscle Exercise Training (WHOLEi + 12) in Pulmonary Hypertension | Randomized, single-blind, parallel group study | Secondary | September 2016 | 20 |
Sarcopenia | |||||
NCT02120586 | Preventive Physiotherapy Intervention in Elderly People With Sarcopenia | Randomized, single-blind, parallel group study | Primary | July 2015 | 70 |
X-linked myotubular myopathy | |||||
NCT02453152 | Respiratory Muscle Function in Untreated X-Linked Myotubular Myopathy (XLMTM) | Prospective, observational study | Secondary | December 2016 | 12 |
Other disorders (non-NMDs) | |||||
Back pain | |||||
NCT02429752 | Low Back Pain and Breathing Pattern Dysfunction (LBP & BPD) | Open-label, single group study | Secondary | June 2016 | 75 |
Breast disease | |||||
NCT02491762 | The Effect of Breast Reconstruction Surgery Using Tissue Expanders on Respiratory Functions | Nonrandomized, open-label, parallel group study | Primary | August 2017 | 45 |
NCT02165696 | Compression Bandaging and Manual Lymph Drainage in Women With Lymphedema (LYMPHATIC) | Randomized, single-blind, parallel group study | Secondary | December 2015 | 44 |
COPD | |||||
NCT01655199 | Sensitivity of the Step Test to Detect Improvement in Dyspnea Following Bronchodilation in Patients With Chronic Obstructive Pulmonary Disease (CODEx) | Double-blind, single group study | Secondary | July 2014 | 40 |
NCT01903772 | Effects of Inspiratory Muscle Training in Chronic Obstructive Pulmonary Disease (COPD) (IMTCO) | Randomized, double-blind, parallel group study | Secondary | December 2015 | 72 |
NCT01956565 | Feasibility of Inspiratory Muscle Training in People With COPD Who Decline Pulmonary Rehabilitation | Nonrandomized, open-label, single group study | Secondary | November 2015 | 20 |
NCT02392715 | Inspiratory Muscle Training Combined With General Exercise Training in COPD (IMTGET) | Randomized, double-blind, parallel group study | Secondary | October 2016 | 80 |
NCT02007772 | Effectiveness of TNI vs. BiPAP in Chronic Global Insufficiency in COPD Patients (TIBICO) | Randomized, open-label, crossover study | Secondary | August 2015 | 85 |
NCT01582958 | The Effect of OMT on Patients With COPD: Correlating Pulmonary Function Tests With Biochemical Alterations | Randomized, single-blind, parallel group study | Primary | August 2015 | 60 |
NCT01037387 | Effect of Noninvasive Ventilation on Physical Activity and Inflammation in COPD Patients | Randomized, open-label, parallel group study | Secondary | June 2016 | 50 |
COPD or asthma | |||||
NCT02233114 | Do Yogic Exercises (12 weeks) Increase Respiratory Function in Patients with Obstructive Lung Diseases? | Randomized, single-blind, parallel group study | Secondary | December 2017 | 40 |
Chronic respiratory insufficiency | |||||
NCT01458314 | Non Invasive Mechanical Ventilation in Chronic Respiratory Insufficiency Patients During Rehabilitation | Randomized, open-label, parallel group study | Secondary | June 2015 | 50 |
Chronic respiratory failure | |||||
NCT00994552 | Comparison of Pressure Support and Pressure Control Ventilation in Chronic Respiratory Failure | Randomized, single-blind crossover study | Secondary | April 2010 | 20 |
Congenital heart disease | |||||
NCT02438293 | The Impact of Rhinovirus Infections in Paediatric Cardiac Surgery’ (RISK) | Prospective, observational study | Secondary | June 2016 | 250 |
Intraventricular hemorrhage | |||||
NCT02231411 | Neonatal Resuscitation With Intact Cord (NRIC) | Randomized, single-blind, parallel group study | Secondary | August 2016 | 150 |
Lung cancer | |||||
NCT02493114 | Functional Status in Patients Undergoing Curative Treatment for Lung Cancer | Prospective, observational study | Secondary | November 2017 | 80 |
Mechanically ventilated patients | |||||
NCT02003053 | A Randomized, Controlled Trial of Inspiratory Muscle Training (IMT) in the ICU and CCU | Randomized, single-blind, parallel group study | Primary | September 2015 | 40 |
Obstructive sleep apnea | |||||
NCT02259660 | Airway Muscle Training for Obstructive Sleep Apnea (OSA) | Randomized, double-blind, parallel group study | Secondary | September 2016 | 60 |
Stroke | |||||
NCT02400138 | Home-based Respiratory Training After Stroke | Randomized, double-blind, parallel group study | Primary | November 2016 | 20 |
Relationship between MIP and survival in patients with NMD
Reference | Therapy Area/Population | Study Type | N | MIP and Survival |
---|---|---|---|---|
Correlation between MIP and survival | ||||
Schmidt EP et al., 2006 [37] | ALS | Cohort study | 95 | MIP was an important predictor of 1-year survival (P < 0.05) after controlling for nonpulmonary factors known to predict survival in ALS |
Baumann F et al., 2010 [38] | ALS | Cohort study | 80 | MIP was significantly associated with survival (P < 0.05); survival time was increased in patients with normal MIP |
Gay PC et al., 1991 [39] | ALS | Prospective study | 21 | MIP was 100% sensitive for predicting 18-months survival (r = 0.57; P < 0.007) |
Chaudri MB et al., 2002 [40] | MND (ALS) | Single-center cohort study | 53 | Survivors had a higher percentage of predicted MIP than nonsurvivors (37.83 ± 24.32% vs 20.13 ± 18.43%; P < 0.01) |
Lopes Almeida JP, et al., 2012 [41] | ALS | Prospective, comparative study | 60 | There was a significant correlation between MIP and 5-years survival (P = 0.02) in patients with ALS using NIV |
Benzo R et al., 2013 [42] | COPD | Analysis of clinical data from NETT | 1218 | Decrease in MIP > 11 cm H2O was a predictor of 1-year mortality (OR, 2.19; P = 0.0217) |
Gray-Donald K et al., 1996 [43] | COPD | 3 to 5-years follow-up of a double-blind RCT | 348 | Low MIP was a significant independent predictor of respiratory (HR, 0.64; 95% CI, 0.44–0.95) and all-cause mortality (HR, 0.67; 95% CI, 0.47–0.95) |
Schols AMWJ et al., 1998 [44] | COPD | RCT | 203 | Improvement in MIP during rehabilitation decreased the risk of death |
Hodgev VA et al., 2006 [45] | COPD | Prospective cohort study | 63 | A Cox proportional hazards analysis showed that MIP was a significant predictor of mortality (r = 0.91; 95% CI, 0.85–0.97; P = 0.005) |
Meyer FJ et al., 2001 [47] | Heart failure | Prospective study | 244 | In a univariate Cox regression analysis, MIP was found to be a significant prognostic indicator of survival (P = 0.001) |
Frankenstein L et al., 2009 [48] | Heart failure | Prospective, observational study | 686 | MIP was identified as a significant predictor of survival by univariate analysis; survivors had a significantly higher MIP and percentage of predicted MIP than nonsurvivors |
Ionescu AA et al., 1998 [49] | Cystic fibrosis | Single-center study | 49 | Mean % predicted MIP (SD) for survivors was 85.5% (28.4) compared with 64.1% (23.9) for nonsurvivors |
Marroni CA et al., 2014 [50] | Liver cirrhosis | Prospective cohort study | 86 | Sixty-two percent of patients with MIP < −70 cm H2O survived compared with 93% of patients with MIP > −70 cm H2O (P = 0.0001) |
Budweiser S et al., 2007 [46] | Chronic hypercapnic respiratory failure | Cohort study | 464 | MIP was a significant predictor of long-term survival; according to stepwise multivariate Cox regression analysis, P0.1/MIP was identified as an independent predictor of survival (P < 0.05) |
van der Palen J et al., 2004 [51] | Elderly with a mean age of 72.5 years | Cohort study | 3839 | Subjects in the lowest quintile of MIP had a 1.5-fold increased risk of cardiovascular-related death (HR, 1.54; 95% CI, 1.09–2.15) after adjustment for nonpulmonary function covariates |
No correlation between MIP and survival | ||||
Nizet TAC et al., 2005 [58] | Chronic hypercapnic COPD | Prospective, single-center study | 47 | No significant association |
Frankenstein L et al., 2008 [54] | CHF | Prospective, single-arm study | 158 | No significant association |
Habedank D et al., 2013 [55] | CHF | Single-center study | 249 | No significant association |
Hui D et al., 2014 [56] | Advanced cancer | Prospective, single-center study | 222 | No significant association |
White AC et al., 2005 [59] | Hematopoietic stem cell transplantation | Prospective observational study | 56 | No significant association |
Jackson M et al., 1994 [57] | Patients with a thoracoplasty for tuberculosis | Single-center study | 32 | No significant association |