Body Mass and Weekly Training Distance Influence the Pain and Injuries Experienced by Runners Using Minimalist Shoes: A Randomized Controlled Trial

Background: Minimalist shoes have been popularized as a safe alternative to conventional running shoes. However, a paucity of research is available investigating the longer-term safety of minimalist shoes. Purpose: To compare running-related pain and injury between minimalist and conventional shoes in trained runners and to investigate interactions between shoe type, body mass, and weekly training distance. Study Design: Randomized clinical trial; Level of evidence, 2. Methods: Sixty-one trained, habitual rearfoot footfall runners (mean ± SD: body mass, 74.6 ± 9.3 kg; weekly training distance, 25 ± 14 km) were randomly allocated to either minimalist or conventional shoes. Runners gradually increased the time spent running in their allocated shoes over 26 weeks. Running-related pain intensity was measured weekly by use of 100-mm visual analog scales. Time to first running-related injury was also assessed. Results: Interactions were found between shoe type and weekly training distance for weekly running-related pain; greater pain was experienced with minimalist shoes ( P < .05), and clinically meaningful increases (>10 mm) were noted when the weekly training distance was more than 35 km/wk. Eleven of 30 runners sustained an injury in conventional shoes compared with 16 of 31 runners in minimalist shoes (hazard ratio, 1.64; 95% confidence interval, 0.63-4.27; P = .31). A shoe × body mass interaction was found for time to first running-related injury ( P = .01). For runners using minimalist shoes, relative to runners using conventional shoes, the risk of sustaining an injury became more likely with increasing body mass above 71.4 kg, and the risk was moderately increased (hazard ratio, 2.00; 95% confidence interval, 1.10-3.66; P = .02) for runners using minimalist shoes who had a body mass of 85.7 kg. Conclusions: Runners should limit weekly training distance in minimalist shoes to avoid running-related pain. Heavier runners are at greater risk of injury when running in minimalist shoes. Registration: Australian New Zealand Clinical Trials Registry (ACTRN12613000642785).

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Physical activity modifies the risk of atrial fibrillation in obese individuals: The HUNT3 study

European Journal of Preventive Cardiology ◽

10.1177/2047487318784365 ◽

2018 ◽

Vol 25 (15) ◽

pp. 1646-1652 ◽

Cited By ~ 14

Author(s):

Lars E Garnvik ◽

Vegard Malmo ◽

Imre Janszky ◽

Ulrik Wisløff ◽

Jan P Loennechen ◽

...

Keyword(s):

Physical Activity ◽

Atrial Fibrillation ◽

Body Mass Index ◽

Confidence Interval ◽

Body Mass ◽

High Body Mass Index ◽

Overweight And Obesity ◽

Hazard Ratio ◽

Increased Risk

Background Atrial fibrillation is the most common heart rhythm disorder, and high body mass index is a well-established risk factor for atrial fibrillation. The objective of this study was to examine the associations of physical activity and body mass index and risk of atrial fibrillation, and the modifying role of physical activity on the association between body mass index and atrial fibrillation. Design The design was a prospective cohort study. Methods This study followed 43,602 men and women from the HUNT3 study in 2006–2008 until first atrial fibrillation diagnosis or end of follow-up in 2015. Atrial fibrillation diagnoses were collected from hospital registers and validated by medical doctors. Cox proportional hazard regression analysis was performed to assess the association between physical activity, body mass index and atrial fibrillation. Results During a mean follow-up of 8.1 years (352,770 person-years), 1459 cases of atrial fibrillation were detected (4.1 events per 1000 person-years). Increasing levels of physical activity were associated with gradually lower risk of atrial fibrillation ( p trend 0.069). Overweight and obesity were associated with an 18% (hazard ratio 1.18, 95% confidence interval 1.03–1.35) and 59% (hazard ratio 1.59, 95% confidence interval 1.37–1.84) increased risk of atrial fibrillation, respectively. High levels of physical activity attenuated some of the higher atrial fibrillation risk in obese individuals (hazard ratio 1.53, 95% confidence interval 1.03–2.28 in active and 1.96, 95% confidence interval 1.44–2.67 in inactive) compared to normal weight active individuals. Conclusion Overweight and obesity were associated with increased risk of atrial fibrillation. Physical activity offsets some, but not all, atrial fibrillation risk associated with obesity.

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Lithium vs valproate in the maintenance treatment of bipolar I disorder: A post- hoc analysis of a randomized double-blind placebo-controlled trial

Australian & New Zealand Journal of Psychiatry ◽

10.1177/0004867419894067 ◽

2019 ◽

Vol 54 (3) ◽

pp. 298-307

Author(s):

Mehar G Kang ◽

Hong Qian ◽

Kamyar Keramatian ◽

Trisha Chakrabarty ◽

Gayatri Saraf ◽

...

Keyword(s):

Confidence Interval ◽

Atypical Antipsychotic ◽

Maintenance Treatment ◽

Atypical Antipsychotics ◽

Controlled Trial ◽

Hazard Ratio ◽

Double Blind ◽

Double Blind Placebo ◽

Post Hoc Analysis ◽

Post Hoc

Objective: Lithium and valproate are commonly used either in monotherapy or in combination with atypical antipsychotics in maintenance treatment of bipolar I disorder; however, their comparative efficacy is not well understood. This study aimed to compare the efficacy of valproate and lithium on mood stability either in monotherapy or in combination with atypical antipsychotics. Methods: We performed a post hoc analysis using data from a 52-week randomized double-blind, placebo-controlled trial, that recruited 159 patients with recently remitted mania during treatment with lithium or valproate and adjunctive atypical antipsychotic therapy. Patients were randomized to discontinue adjunctive atypical antipsychotic at 0, 24 or 52 weeks. Results: No significant differences in efficacy were observed between valproate and lithium (hazard ratio: 0.99; 95% confidence interval: [0.66, 1.48]) in time to any mood event. Valproate with 24 weeks of atypical antipsychotic was significantly superior to valproate monotherapy in preventing any mood relapse (hazard ratio: 0.46; 95% confidence interval: [0.22, 0.97]) while lithium with 24 weeks of atypical antipsychotic was superior to lithium monotherapy in preventing mania (hazard ratio: 0.27; 95% confidence interval: [0.09, 0.85]) but not depression. Conclusion: Overall, this study did not find significant differences in efficacy between the two mood-stabilizing agents when used as monotherapy or in combination with atypical antipsychotics. However, study design and small sample size might have precluded from detecting an effect if true difference in efficacy existed. Further head-to-head investigations with stratified designs are needed to evaluate maintenance therapies.

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Incidence and Radiographic Predictors of Valgus Tibiotalar Tilt After Hindfoot Fusion

Foot & Ankle International ◽

10.1177/1071100717690439 ◽

2017 ◽

Vol 38 (5) ◽

pp. 519-525 ◽

Cited By ~ 6

Author(s):

Sara Lyn Miniaci-Coxhead ◽

Benjamin Weisenthal ◽

John P. Ketz ◽

A. Samuel Flemister

Keyword(s):

Confidence Interval ◽

Valgus Deformity ◽

Hazard Ratio ◽

Radiographic Measurement ◽

Level Of Evidence ◽

Common Procedure ◽

First Metatarsal ◽

Metatarsal Angle ◽

Hindfoot Fusion ◽

Hindfoot Arthrodesis

Background: The development of valgus tibiotalar tilt following hindfoot arthrodesis is rarely discussed in the literature. The purpose of this study was to determine the incidence of valgus tibiotalar tilt and to evaluate if there were any radiographic predictors for the development of valgus tibiotalar tilt. Methods: Patients who underwent hindfoot fusion between January 1, 2004 and December 31, 2013 were identified. Charts were reviewed for demographic information and operative details. Preoperative and postoperative radiographs were reviewed for the development of tibiotalar tilt, and standardized measurements and angles were calculated. A total of 187 patients were included. There were 106 (56.7%) females and 81 (43.3%) males. The average age was 52 years (range, 11-82 years). The most common indication for surgery was adult-acquired flatfoot deformity (n = 92, 49.2%), followed by arthritis (n = 83, 44.4%). The most common procedure was triple arthrodesis (n = 101, 54%). Twenty-seven patients demonstrated tibiotalar tilt preoperatively. Results: A total of 51 patients (27.3%) developed valgus tibiotalar tilt postoperatively at an average of 3.6 months after surgery. We found that an increase in the preoperative Meary (lateral talar–first metatarsal) angle (hazard ratio, 1.039; 95% confidence interval, 1.002-1.077; P < .05) was associated with the development of tibiotalar tilt. An increase in the postoperative Meary angle (hazard ratio, 1.052; 95% confidence interval, 0.999-1.108; P = .0528) approached significance for the development of tibiotalar tilt. Conclusion: The development of valgus tibiotalar tilt following hindfoot fusion was a notable phenomenon, occurring in 27% of our patient population. The preoperative Meary angle was the only radiographic measurement that was significantly associated with the development of valgus tibiotalar tilt, although the postoperative Meary angle approached significance. These findings should encourage surgeons to be aware of patients with large deformities and of their propensity to develop a valgus deformity about the ankle. Level of Evidence: Level III, retrospective comparative series.

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Severe Acute Kidney Injury and Mortality in Extremely Low Gestational Age Neonates

Clinical Journal of the American Society of Nephrology ◽

10.2215/cjn.18841220 ◽

2021 ◽

Vol 16 (6) ◽

pp. 862-869

Author(s):

Sangeeta Hingorani ◽

Robert H. Schmicker ◽

Patrick D. Brophy ◽

Patrick J. Heagerty ◽

Sandra E. Juul ◽

...

Keyword(s):

Confidence Interval ◽

Gestational Age ◽

Regression Models ◽

Cox Regression ◽

Controlled Trial ◽

Hazard Ratio ◽

Time Dependent ◽

Recombinant Erythropoietin ◽

The Relationship ◽

Extremely Low Gestational Age

Background and objectivesAKI is associated with poor short- and long-term outcomes. Questions remain about the frequency and timing of AKI, and whether AKI is a cause of death in extremely low gestational age neonates.Design, setting, participants, & measurementsThe Recombinant Erythropoietin for Protection of Infant Kidney Disease Study examines the kidney outcomes of extremely low gestational age neonates enrolled in the Preterm Epo Neuroprotection study, a randomized, placebo-controlled trial of recombinant human erythropoietin. We included 900 of 941 patients enrolled in Preterm Epo Neuroprotection. Baseline characteristics were compared by primary exposure (severe AKI versus none/stage 1 AKI) using unadjusted logistic regression models. Cox regression models estimated the relationship between severe AKI and death after adjustment for potential confounders. Time-dependent AKI was modeled as a binary outcome and a categorical variable by stage of AKI. We fit Cox models using time-dependent AKI status lagged by <7 days before death. Landmark analyses examined the relationship of death with development of severe AKI.ResultsSevere AKI occurred in 168 of 900 (19%, 95% confidence interval, 17% to 20%) neonates, and stage 3 AKI occurred in 60 (7%, 95% confidence interval, 5% to 8%). Stage 3 AKI occurring 7 days before death (hazard ratio, 3.88; 95% confidence interval, 1.26 to 11.96), intraventricular hemorrhage (hazard ratio, 2.01; 95% confidence interval, 1.01 to 3.99) and sepsis (hazard ratio, 2.85; 95% confidence interval, 1.12 to 7.22) were all independently associated with death. Severe AKI occurring 7 days before death (hazard ratio, 2.21; 95% confidence interval, 0.92 to 5.26) was associated with death but not statistically significant. In a landmark analysis, after adjusting for potential confounders, late (after day 14 and before day 28) severe AKI was strongly associated with higher hazard of death (hazard ratio, 4.57; 95% confidence interval, 1.82 to 11.5).ConclusionsSevere AKI occurs frequently in extremely low gestational age neonates. Stage 3 AKI is associated with mortality, and this association is present 7 days before death.

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Ivermectin in combination with doxycycline for treating COVID-19 symptoms: a randomized trial

Journal of International Medical Research ◽

10.1177/03000605211013550 ◽

2021 ◽

Vol 49 (5) ◽

pp. 030006052110135

Author(s):

Reaz Mahmud ◽

Md. Mujibur Rahman ◽

Iftikher Alam ◽

Kazi Gias Uddin Ahmed ◽

A.K.M. Humayon Kabir ◽

...

Keyword(s):

Placebo Group ◽

Treatment Group ◽

Confidence Interval ◽

Recovery Time ◽

Controlled Trial ◽

Hazard Ratio ◽

Data Repository ◽

Rt Pcr ◽

Clinical Recovery ◽

Number Of Patients

Objective We evaluated whether ivermectin combined with doxycycline reduced the clinical recovery time in adults with COVID-19 infection. Methods This was a randomized, blinded, placebo-controlled trial in patients with mild-to-moderate COVID-19 symptoms randomly assigned to treatment (n = 200) and placebo (n = 200) groups. The primary outcome was duration from treatment to clinical recovery. Secondary outcomes were disease progression and persistent COVID-19 positivity by RT-PCR. Results Among 556 screened patients, 400 were enrolled and 363 completed follow-up. The mean patient age was 40 years, and 59% were men. The median recovery time was 7 (4–10, treatment group) and 9 (5–12, placebo group) days (hazard ratio, 0.73; 95% confidence interval, 0.60–0.90). The number of patients with a ≤7-day recovery was 61% (treatment group) and 44% (placebo groups) (hazard ratio, 0.06; 95% confidence interval, 0.04–0.09). The proportion of patients who remained RT-PCR positive on day 14 and whose disease did not progress was significantly lower in the treatment group than in the placebo group. Conclusions Patients with mild-to-moderate COVID-19 infection treated with ivermectin plus doxycycline recovered earlier, were less likely to progress to more serious disease, and were more likely to be COVID-19 negative by RT-PCR on day 14. Trial Registration ClinicalTrials.gov Identifier: NCT04523831. Data Repository ID Dryad. doi:10.5061/dryad.qjq2bvqf6

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Επίπεδα αδιπονεκτίνης στον ορό και τη βρογχοκυψελιδική έκπλυση (BAL) ασθενών με μη μικροκυτταρικό καρκίνο πνεύμονα (NSCLC)

10.12681/eadd/42314 ◽

2017 ◽

Author(s):

Παρασκευή Μπούρα

Keyword(s):

Body Mass Index ◽

Regression Analysis ◽

Confidence Interval ◽

Bronchoalveolar Lavage ◽

Body Mass ◽

Cox Regression ◽

Performance Status ◽

Hazard Ratio ◽

Cox Regression Analysis

Η αδιπονεκτίνη είναι μια από τις κυριότερες αδιποκίνες που παράγονται από τον λιπώδη ιστό. Προηγούμενες μελέτες έδειξαν τη δυνητική χρησιμότητα της αδιπονεκτίνης ορού ως διαγνωστικού ή/και προγνωστικού βιοδείκτη σε διάφορους συμπαγείς όγκους, αλλά τα σχετικά δεδομένα για τον καρκίνο του πνεύμονα, ειδικότερα, είναι ελλιπή. Επιπρόσθετα, η διαγνωστική ή και προγνωστική αξία των επιπέδων αδιπονεκτίνης σε άλλα βιολογικά υγρά -εκτός του περιφερικού αίματος- ασθενών με καρκίνο πνεύμονα ή και με οποιαδήποτε άλλη μορφή καρκίνου, δεν έχει, απ’ όσο γνωρίζουμε, μελετηθεί. Ο πρωταρχικός σκοπός της παρούσας μελέτης ήταν η περαιτέρω διερεύνηση της δυνητικής προγνωστικής αξίας των προθεραπευτικών επιπέδων αδιπονεκτίνης στον ορό και σε δείγματα βρογχοκυψελιδικής έκπλυσης (bronchoalveolar lavage, BAL) ασθενών με μη μικροκυτταρικό καρκίνο πνεύμονα (ΜΜΚΠ) προχωρημένου σταδίου. Στον παρόν ερευνητικό έργο μελετήθηκαν προοπτικά 29 νεοδιαγνωσθέντες ασθενείς με ΜΜΚΠ σταδίου IV. Τα προθεραπευτικά επίπεδα αδιπονεκτίνης ορού και BAL μετρήθηκαν με τη χρήση ανοσοενζυμικής μεθόδου (ELISA), και, ακολούθως, συσχετίσθηκαν με δημογραφικές, κλινικές και παθολογοανατομικές παραμέτρους. Αναλυτικότερα, οι παράμετροι που αξιολογήθηκαν συμπεριελάμβαναν το φύλο, την ηλικία, το Performance Status (PS), το δείκτη μάζας σώματος (Body Mass Index, BMI), την απώλεια βάρους > 10%, καθώς και τον ιστολογικό τύπο, βαθμό διαφοροποίησης (grade) και μέγεθος του πρωτοπαθούς όγκου. Η συσχέτιση των επιπέδων αδιπονεκτίνης και των λοιπών μεταβλητών με τη συνολική επιβίωση των ασθενών αξιολογήθηκε με μονοπαραγοντική και πολυπαραγοντική ανάλυση παλινδρόμησης του Cox (univariate and multivariate Cox regression analysis).Σύμφωνα με τα αποτελέσματα της μελέτης μας, η μέση ηλικία των ασθενών ήταν 65.6 έτη (SD= 10.1 έτη), ενώ η πλειοψηφία ήταν άνδρες (24/29 περιπτώσεις, 82.8%). Ο κυρίαρχος ιστολογικός τύπος ήταν το αδενοκαρκίνωμα (18/29 περιπτώσεις, 62.1%). Η λειτουργική κατάσταση (performance status, PS) των ασθενών ήταν 0 και 1-2 σε 17/29 περιπτώσεις (58.6%) και 12/29 περιπτώσεις (41.4%), αντιστοίχως. Απώλεια βάρους μεγαλύτερη του 10% παρατηρήθηκε σε 10/29 ασθενείς (34.5%). Οι διάμεσες τιμές επιπέδων αδιπονεκτίνης σε ορό και BAL ήταν 17710 ng/ml και 911.5 ng/ml, αντιστοίχως. Δεν παρατηρήθηκαν στατιστικώς σημαντικές συσχετίσεις μεταξύ των επιπέδων αδιπονεκτίνης (τόσο στον ορό όσο και στο BAL) και των κλινικών και παθολογοανατομικών παραμέτρων που αξιολογήθηκαν. Η μονοπαραγοντική ανάλυση παλινδρόμησης του Cox έδειξε ότι τα επίπεδα αδιπονεκτίνης δεν συσχετίζονταν σε στατιστικά σημαντικό βαθμό με την επιβίωση. Ο μόνος προγνωστικός παράγοντας που αναγνωρίστηκε, τόσο στη μονοπαραγοντική όσο και στην πολυπαραγοντική ανάλυση επιβίωσης, ήταν το PS [Hazard ratio (95% Confidence Interval): 2.75 (1.17-6.46), (p=0.02)]Συμπερασματικά, τα αποτελέσματα της προοπτικής μας μελέτης απέτυχαν να αναδείξουν στατιστικά σημαντικά συσχετίσεις των επιπέδων αδιπονεκτίνης (ορού και BAL) με τη συνολική επιβίωση καθώς και με τις δημογραφικές και κλινικοπαθολογοανατομικές παραμέτρους που αξιολογήθηκαν (συμπεριλαμβανομένου του BMI και της απώλειας βάρους), σε ασθενείς με ΜΜΚΠ σταδίου IV, σε συμφωνία με τις περισσότερες προηγούμενες κλινικές παρατηρήσεις.

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Comparison of the Number of Attempts in Creating Pneumoperitoneum for Laparoscopic Cholecystectomy Using Direct Trocar Versus Veress Needle Insertion

10.53350/pjmhs211571787 ◽

2021 ◽

Vol 15 (7) ◽

pp. 1787-1790

Author(s):

Kamran Hamid ◽

Shabbir Ahmad ◽

Faisal Shabbir ◽

Amer Latif ◽

Shahzad A. ◽

...

Keyword(s):

Body Mass Index ◽

Laparoscopic Cholecystectomy ◽

Body Mass ◽

Controlled Trial ◽

Needle Insertion ◽

Veress Needle ◽

Key Words Laparoscopic Cholecystectomy ◽

Safe Alternative ◽

Trocar Insertion ◽

Direct Trocar Insertion

Aim: To compare the number of attempts at creating pneumoperitoneum for laparoscopic cholecystectomy using direct trocar versus veress needle insertion techniques. Design: Randomized controlled trial Place and Duration of Study: Department of Surgery, Allama Iqbal Memorial Hospital Sialkot and Govt. Sardar Begum Teaching Hospital, Sialkot from 27th September 2017 to 26th September 2020. Methodology: Six hundred and eight patients of both male and female patients, having uncomplicated cholelithiasis were selected. All participants were randomized into two equal groups, Group A (direct trocarInsertion) and the Group B (veress needle insertion). All trocars and veress needle used were disposable, with a safety shield. All procedures were carried out by the single experienced surgeons and his team. Data was noted, regarding age, sex, body mass index (BMI) and the number of attempts to create the successful pneumoperitoneum. Results: The number of attempts to create successful pneumoperitoneum in DTI group was significantly feweras compared to VNI group (p=0.026) but we found no statisticallysignificant difference between age, gender, and body mass index. Conclusion: The direct trocar insertion is a safe alternative to veress needle insertion in laparoscopic cholecystectomy because it requires fewernumber of attempts for successful creation of pneumoperitoneum as compared to the veress needle. Key words: Laparoscopic cholecystectomy, Veress needle insertion, Direct trocar insertion, Pneumoperitoneum

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Role of Postoperative Patient-Reported Outcomes to Predict Ankle Arthroplasty and Arthrodesis Revision

Foot & Ankle International ◽

10.1177/1071100719869204 ◽

2019 ◽

Vol 41 (1) ◽

pp. 10-16 ◽

Cited By ~ 1

Author(s):

Sameer Desai ◽

Jason M. Sutherland ◽

Alastair Younger ◽

Murray Penner ◽

Andrea Veljkovic ◽

...

Keyword(s):

Confidence Interval ◽

Patient Reported Outcomes ◽

Cox Regression ◽

Ankle Arthrodesis ◽

Hazard Ratio ◽

Total Ankle Arthroplasty ◽

Level Of Evidence ◽

Ankle Arthroplasty ◽

Patient Reported

Background: Patient-reported outcomes are becoming common for measuring patient-centric outcomes in surgery. However, there is little known about the relationship between postoperatively collected patient-reported outcomes and objective clinical outcomes. The objective of this study was to measure whether postoperative Ankle Osteoarthritis Scale (AOS) values were associated with risk of revision among patients having ankle arthrodesis or total ankle arthroplasty for treatment of symptomatic end-stage ankle arthritis. Methods: This is a retrospective analysis of a longitudinal cohort of ankle arthrodesis and total ankle arthroplasty patients. A single center recruited patients between 2003 and 2013 and follow-up was at least 4 years. Patients completed the AOS preoperatively and annually following surgery. An extended Cox regression model incorporating time-varying AOS values was used to model risk of failure. A total of 336 patients and 348 ankles were included, representing 139 ankle arthrodesis procedures and 209 total ankle arthroplasties. Results: The median follow-up time for revisions was 8.2 years and 46 patients had a revision. Higher values of patients’ AOS scores in the postoperative period were associated with a higher likelihood of revision (hazard ratio, 1.04 per 1-point increase; 95% confidence interval, 1.03-1.05). Ankle arthrodesis was associated with a reduced risk of revision compared with ankle fusion (hazard ratio, 0.12; 95% confidence interval, 0.03-0.49). Conclusion: This study showed that persistent pain and poor function after fusion or replacement surgery, as measured by elevated values of the AOS, were associated with higher risk of further surgery. Level of Evidence: Level III, retrospective cohort study.

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An Injury Prevention Program for Professional Ballet: A Randomized Controlled Investigation

Orthopaedic Journal of Sports Medicine ◽

10.1177/2325967120937643 ◽

2020 ◽

Vol 8 (7) ◽

pp. 232596712093764

Author(s):

Angelina M. Vera ◽

Bene D. Barrera ◽

Leif E. Peterson ◽

Thomas R. Yetter ◽

David Dong ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Injury Prevention ◽

Controlled Trial ◽

Intervention Group ◽

Injury Rate ◽

Hazard Ratio ◽

Control Group ◽

Level Of Evidence ◽

Entire Study ◽

Randomized Controlled

Background: Few investigations have examined dance-specific injury prevention programs (IPPs), and no published randomized controlled trials are available that evaluate IPPs for dance. Hypothesis: The implementation of an IPP will significantly reduce the risk of injury in professional ballet dancers. Study Design: Randomized controlled trial; Level of evidence, 2. Methods: A randomized controlled trial was designed that entailed a superiority model for the intervention group. All professional dancers from a single ballet company were eligible to participate. Randomization and allocation were performed before the start of the season. The control group practiced and performed without change to preexisting standard operating practice. The IPP group was instructed to perform a 30-minute exercise program 3 times per week over the 52-week study period. Injuries were recorded. Standard continuous and categorical data comparisons and correlations were used. Cox proportional hazards regression models for recurrent failures were used wherein the hazard ratio indicates the relative likelihood of injury in the control versus intervention groups. Results: Of the 52 eligible dancers, 75% (n = 39) participated. Of these 39 dancers, 19 (9 males, 10 females; mean age, 26.6 ± 4.0 years) were randomized to the control group and 20 (11 males, 9 females; mean age, 25.1 ± 5.1 years) to the IPP group. No significant ( P > .05) difference was found in baseline demographics between groups. A total of 116 injuries were recorded for the entire study population (49 IPP; 67 control). Traumatic and chronic injuries accounted for 54% and 46% of injuries, respectively. The injury rate was 82% less (IPP hazard ratio, 0.18; z = –2.29; P = .022) in the IPP group after adjustment for confounding variables, and time between injuries was 45% longer (IPP hazard ratio, 0.55; z = –2.20; P = .028) than for controls. Conclusion: The present study is the first prospective randomized controlled investigation of an IPP for professional ballet. The results showed an 82% decrease in injury rate for the intervention group and an extended period from previous injury to subsequent injury. Registration: NCT04110002 ( ClinicalTrials.gov identifier ).

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Shoe Cushioning Influences the Running Injury Risk According to Body Mass: A Randomized Controlled Trial Involving 848 Recreational Runners

The American Journal of Sports Medicine ◽

10.1177/0363546519892578 ◽

2019 ◽

Vol 48 (2) ◽

pp. 473-480 ◽

Cited By ~ 3

Author(s):

Laurent Malisoux ◽

Nicolas Delattre ◽

Axel Urhausen ◽

Daniel Theisen

Keyword(s):

Randomized Controlled Trial ◽

Body Mass ◽

Injury Risk ◽

Controlled Trial ◽

Common Belief ◽

Level Of Evidence ◽

Randomized Controlled ◽

Running Activity ◽

Recreational Runners ◽

Stratified Analysis

Background: Shoe cushioning is expected to protect runners against repetitive loading of the musculoskeletal system and therefore running-related injuries. Also, it is a common belief that heavier runners should use footwear with increased shock absorption properties to prevent injuries. Purpose: The aim of this study was to determine if shoe cushioning influences the injury risk in recreational runners and whether the association depends on the runner’s body mass. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: Healthy runners (n = 848) randomly received 1 of 2 shoe prototypes that only differed in their cushioning properties. Global stiffness was 61.3 ± 2.7 and 94.9 ± 5.9 N/mm in the soft and hard versions, respectively. Participants were classified as light or heavy according to their body mass using the median as a cut-off (78.2 and 62.8 kg in male and female runners, respectively). They were followed over 6 months regarding running activity and injury (any physical complaint reducing/interrupting running activity for at least 7 days). Data were analyzed through time-to-event models with the subhazard rate ratio (SHR) and their 95% confidence interval (CI) as measures of association. A stratified analysis was conducted to investigate the effect of shoe cushioning on the injury risk in lighter and heavier runners. Results: The runners who had received the hard shoes had a higher injury risk (SHR, 1.52 [95% CI, 1.07-2.16]), while body mass was not associated with the injury risk (SHR, 1.00 [95% CI, 0.99-1.01]). However, after stratification according to body mass, results showed that lighter runners had a higher injury risk in hard shoes (SHR, 1.80 [95% CI, 1.09-2.98]) while heavier runners did not (SHR, 1.23 [95% CI, 0.75-2.03]). Conclusion: The injury risk was higher in participants running in the hard shoes compared with those using the soft shoes. However, the relative protective effect of greater shoe cushioning was found only in lighter runners. Registration: NCT03115437 (ClinicalTrials.gov identifier)

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