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Acknowledgements
diabetes
DIABETES
The authors of this study would like to express their sincere appreciation for all the respected participants and the Yasuj University of Medical Sciences research committee. Also, the personnel of the diabetes clinic in Yasuj are sincerely thanked for their support and cooperation.
PMC10577942
Author contributions
All authors contributed to the study’s conception and design. Material preparation, data collection, and analysis were performed by Soraya Bagheri, Seyed Majid Ahmadi, Sajjad Reisi, and Sajad Hassanzadeh. The first draft of the manuscript was written by Seyed Majid Ahmadi, Seyed Ahmadreza Ahmadi, Isaac Moradishibany, H...
PMC10577942
Funding
The current investigation has been financially aided by Yasuj University of Medical Sciences (ID: 990070). This study is written based on a professional doctoral dissertation (internal medicine specialization) and has been approved by Yasuj University of Medical Sciences.
PMC10577942
Data Availability
It is possible to access the data after coordination with the corresponding author by email.
PMC10577942
Declarations
PMC10577942
Competing interests
The authors declare no competing interests.
PMC10577942
Ethics approval and consent to participate
All procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1975, as revised in 2000. The participants in the present study indicated their informed consent for participation in the research...
PMC10577942
Consent for publication
“Not Applicable”.
PMC10577942
Abbreviations
Diabetic Neuropathy
DIABETIC NEUROPATHY
Visual analog scaleOne-way analysis of covarianceDiabetes MellitusDiabetic Peripheral NeuropathyDiabetic NeuropathyMichigan Diabetic Neuropathy Symptom ScoreSerotonin–Norepinephrine Reuptake Inhibitors
PMC10577942
References
PMC10577942
Background
ACUTE HYPOXEMIC RESPIRATORY FAILURE
The effects of awake prone position on the breathing pattern of hypoxemic patients need to be better understood. We conducted a crossover trial to assess the physiological effects of awake prone position in patients with acute hypoxemic respiratory failure.
PMC10433569
Methods
acute hypoxemic respiratory failure
ACUTE HYPOXEMIC RESPIRATORY FAILURE
Fifteen patients with acute hypoxemic respiratory failure and PaO
PMC10433569
Results
Compared to supine position, prone position increased PaO
PMC10433569
Supplementary Information
The online version contains supplementary material available at 10.1186/s13054-023-04600-9.
PMC10433569
Keywords
PMC10433569
Background
acute hypoxemic respiratory failure
ACUTE HYPOXEMIC RESPIRATORY FAILURE, RECRUITMENT, ACUTE RESPIRATORY DISTRESS SYNDROME
In intubated patients with moderate-to-severe acute respiratory distress syndrome, prone positioning reduces intrapulmonary shunt and generates lung recruitment, optimizes ventilation/perfusion matching, lowers alveolar dead space and reduces right ventricle afterload [In recent years, prone position has been proposed ...
PMC10433569
Methods
This sequential crossover study was conducted in the intensive care unit of a university hospital in Italy between October 2018 and June 2020. The study was funded by an unrestricted research grant by the European Society of Intensive Care Medicine (ESICM-2017 Bernhard Dräger Award). The study was approved by instituti...
PMC10433569
Patients
chest trauma, neutropenia
NEUTROPENIA, CHRONIC OBSTRUCTIVE PULMONARY DISEASE, SYNDROME, ACUTE EXACERBATION OF ASTHMA, ACUTE HYPOXEMIC RESPIRATORY FAILURE, CARDIOGENIC PULMONARY EDEMA
Adult patients admitted to the intensive care unit due to acute hypoxemic respiratory failure were assessed for the enrolment. Acute hypoxemic respiratory failure was defined as an acute onset syndrome characterized by new or worsening impairment in oxygenation. Patients were considered eligible for inclusion if the fo...
PMC10433569
Protocol
Patients received high-flow nasal oxygen for 1 h in the supine semirecumbent position. Gas flow was set at 60 L/min, the temperature of the humidification chamber (MR860 or ARIVO2, Fisher and Paykel healthcare) was set according to patient's comfort, FiOFor safety reasons, enteral feeding was interrupted 1 h before pro...
PMC10433569
Endpoints
LUNG
The primary objectives of this study were to assess the effects of prone position on arterial oxygenation (as defined by the PaOSecondary endpoints of the study were the effects of prone position on:Breathing pattern: respiratory rate, inspiratory effort (the negative deflection of Gas exchange: PaCORespiratory mechani...
PMC10433569
Sample size calculation
Given the physiological design of the study, we did not perform a formal sample size calculation. Consistently with previous investigations with similar design on the topic [
PMC10433569
Statistical analysis
EVENT
Categorical data are expressed as the event rate (%), while continuous data are expressed as the median [interquartile range]. Normality in the distribution of continuous variables was assessed with the Kolmogorov–Smirnov test.Normally distributed quantitative variables in the three study steps were compared using ANOV...
PMC10433569
Gas exchange and subjective symptoms
dyspnea
ADVERSE EVENTS
None of the fifteen enrolled patients experienced any serious adverse events. Thirteen out of 15 patients showed increased blood oxygenation after 2 h of prone positioning (mean difference 45 mmHg [95% CI 23–68], PaCOThere was no change in perceived dyspnea among the three study phases, but patients exhibited less tole...
PMC10433569
Effort to breath and respiratory mechanics
Respiratory rate decreased during prone positioning (mean difference − 2 breaths per minute [95% CI − 6 to − 1], Compared to supine position, prone position increased inspiratory effort (ΔProne position was associated with changes in respiratory system resistive properties, with an increased time constant compared to b...
PMC10433569
Tidal volume
Compared to supine position, prone position did not yield changes in tidal volume (all Tidal volume distribution (expressed in % of global tidal volume) in supine and prone position. Results are expressed as means (standard deviation). Prone position promoted tidal volume distribution towards dorsal, dependent lung reg...
PMC10433569
End-expiratory lung impedance
Prone position increased EELI compared to supine phases before and after the intervention (mean % increase 279% [95%CI: 133 to 330], The increase in EELI occurred throughout all lung regions, but was prominent in dorsal ROIs.The increase in EELI led to a reduction in the dynamic strain during prone position, compared t...
PMC10433569
Discussion
ventilator-induced lung injury, hypoxemic respiratory failure, hypoxemia, ARDS
ADVERSE EVENTS, RECRUITMENT, ADVERSE EFFECTS, ARDS, ACUTE RESPIRATORY DISTRESS SYNDROME, HYPOXEMIC RESPIRATORY FAILURE
The results of this sequential study on the physiological effects of awake prone positioning in patients with moderate-to-severe hypoxemic respiratory failure undergoing high-flow nasal oxygen can be summarized as follows:Awake prone positioning improves arterial oxygenation without serious periprocedural adverse event...
PMC10433569
Conclusions
hypoxemia
RECRUITMENT, ACUTE RESPIRATORY FAILURE
In patients undergoing high-flow nasal oxygen and exhibiting moderate-to-severe hypoxemia due to acute respiratory failure, prone position improves oxygenation by enhancing recruitment of dorsal lung regions, homogenizes ventilation distribution and reduces respiratory rate. Prone position does not affect
PMC10433569
Acknowledgements
None.
PMC10433569
Author contributions
DLG designed the study. All authors contributed to patients’ enrollment. LDC and LSM analyzed the data. DLG drafted the first version of the manuscript. AP, SMM and MA revised the manuscript. All the authors reviewed the final draft of the manuscript and agreed on submitting it to Critical Care.
PMC10433569
Funding
This study was supported by a grant by ESICM (2017 Draeger award) and by Ministero della Saluto (Ricerca corrente 2023).
PMC10433569
Availability of data and materials
The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.
PMC10433569
Declarations
PMC10433569
Ethics approval and consent to participate
The study was approved by local Ethics Committee, and informed consent was obtained by enrolled patients according to committee recommendation.
PMC10433569
Consent for publication
Not applicable.
PMC10433569
Competing interests
DLG has received speaking fees by Gilead, Intersurgical, MSD and GE, and reports having received travel accommodation by Fisher and Paykel. MA has received personal fees by Maquet, and a research grant by Toray. DLG and MA disclose a research grant by GE.
PMC10433569
References
PMC10433569
Background:
GIRD, shoulder pain
PATHOLOGY
Maladaptation can provoke important alterations in the arthrokinematics such as an internal rotation reduction in the dominant shoulder compared with the nondominant shoulder known as glenohumeral internal rotation deficit (GIRD). Though the number of studies investigating GIRD in athletic population, there are not stu...
PMC10519522
Methods:
GIRD, shoulder pain
An open single-arm trial with 35 patients was adopted for evaluating the efficacy of GIRD treatment in patients with shoulder pain. All patients with shoulder pain who attended the consultation, accepted, and agreed to participate in the study between October 2020 and March 2021 were included. A treatment sequence incl...
PMC10519522
Results:
painful shoulder
Treatment of the patients significantly increased the IR of the painful shoulder in all the patients (
PMC10519522
Conclusions:
painful shoulder and reduced the GIRD
The treatment administrated in this study significantly increased the internal rotation of the treated and painful shoulder and reduced the GIRD from the first consultation.
PMC10519522
Level of evidence:
Level 3.
PMC10519522
1. Introduction
Shoulder pain, GIRD, shoulder pain, pain
PATHOLOGY, RECURRENCE
Shoulder pain is a frequent disabling joint problem in the general population. The reported incidence ranges between 0.9% and 2.5%Shoulder pain is mainly related to the glenohumeral joint.Recovery from this ailment is slow and is associated with a high recurrence or persistence pain at 12-month.This study aimed to desc...
PMC10519522
2. Materials and Methods
PMC10519522
2.1. Study design
GIRD, NCT05108311, shoulder pain
An open single-arm trial (clinical trial registration number: NCT05108311) was adopted for evaluating the efficacy of reducing GIRD in patients with shoulder pain using an exercise routine initiated at the time of the first consultation. All patients underwent a medical examination.
PMC10519522
2.2. Ethics approval
subclavian muscle, Myofascial, scapulothoracic joints, GIRD, pectoralis muscle, sternocostoclavicular to acromioclavicular joints, Myofascial releases external rotators, adduction
MINOR
The study was conducted in accordance with the Declaration of Helsinki and approved by the Ethics Committee of the Clínica Universitaria de Navarra (Project 2020.095 of June 18, 2020). Informed consent was obtained from all subjects and/or their legal guardian(s) for publication of identifying information/images in an ...
PMC10519522
2.3. Sample
Shoulder pain, shoulder pain
All patients with shoulder pain who attended the consultation, accepted, and agreed to participate in the study between October 1, 2020 and March 31, 2021 were included. The shoulder pain in the patients was understood as when they manifested an unpleasant sensory and emotional experience directly associated with actua...
PMC10519522
2.4. Measurements
abduction
All participants underwent a physical examination by physiotherapist with one more than 20 years of experience (RJ-L), followed by anthropometric and sociodemographic data that is sex, age, height, weight, occupation, marital status, descent, previous surgeries, and sport habits (documented via questionnaire and by mea...
PMC10519522
2.5. Treatment
scapular adduction, decubitus, abduction
DECUBITUS
The treatment here is applied to the patients and is based on a manual therapy aimed at increasing the IR of a painful shoulder and reducing, at the same time, the GIRD. This kind of treatment has traditionally been used to improve the range of motion in situations of mobility deficits of the shoulder joint complex, su...
PMC10519522
2.6. The minimal clinically important difference calculation
The minimal clinically important difference (MCID) was estimated from a distribution-based calculation using Cohen
PMC10519522
2.7. Statistical analysis
Data distribution was evaluated using Kolmogorov–Smirnov statistics with Lilliefors correction. Descriptive statistics are cited as means ± SD in case of normal distribution and as median and interquartile range in case of non-normal distribution for each of the variables that were calculated. A Student
PMC10519522
3. Results
painful shoulder, shoulder pain
Treatment of the patients significantly increased the IR of the painful shoulder in all the patients ((A) Internal rotation (IR) in patients with shoulder pain before (IRGIRD before and after treatment and improvement percentage are represented in Figure
PMC10519522
4. Discussion
painful shoulder and reduced the GIRD, shoulder flexion, GIRD, cross-body
POSTERIOR CAPSULAR THICKENING, STRETCHES
In this study, we aim to describe the efficacy of the GIRD treatment in nonathlete population. Although the definition of GIRD an exact value is still controversial,GIRD treatment involves targeting posterior capsular thickening and the posterior rotator cuff muscular adaptations in the form of “sleeper stretches” (arm...
PMC10519522
Acknowledgments
We wish to acknowledge Dr John Jairo Aguilera-Correa for his writing assistance, and Dr Amr A. Abdelkader from the International Centre for Orthopaedics and Neurosciences (Doha, Qatar) for his help in reviewing the manuscripts for language-related aspects, and Mr. José Luis Lara-Cabrero from Clínica CEMTRO (Madrid, Spa...
PMC10519522
Abbreviations:
shoulder pain
external rotationglenohumeral internal rotation deficitinternal rotationminimal clinically important differencestandard deviationThe authors have no funding and conflicts of interest to disclose.The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasona...
PMC10519522
References
PMC10519522
Key Points
PMC10119738
Question
Does treadmill perturbation-based balance training (PBT) reduce daily-life fall rates among community-dwelling adults 65 years or older?
PMC10119738
Findings
In this randomized clinical trial involving 140 highly functioning older adults, those who received an 4-session PBT intervention (totaling 80 minutes) experienced a statistically nonsignificant 22% reduction in daily-life fall rates over a 12-month period.
PMC10119738
Meaning
Findings of this trial suggest the need for future studies to investigate possible effects of current treadmill PBT on daily-life falls.
PMC10119738
Importance
injuries
Falls are common and the leading cause of injuries among older adults, but falls may be attenuated by the promising and time-efficient intervention called perturbation-based balance training (PBT).
PMC10119738
Objective
To evaluate the effects of a 4-session treadmill PBT intervention compared with regular treadmill walking on daily-life fall rates among community-dwelling older adults.
PMC10119738
Design, Setting, and Participants
This 12-month, assessor-blinded randomized clinical trial was conducted from March 2021 through December 2022 in Aalborg University in Denmark. Participants were community-dwelling adults 65 years or older and were able to walk without a walking aid. Participants were randomized to either PBT (intervention group) or tr...
PMC10119738
Interventions
Participants who were randomized to the intervention group underwent four 20-minute sessions of PBT, including 40 slip, trip, or mixed slip and trip perturbations. Participants who were randomized to the control group performed four 20-minute sessions of treadmill walking at their preferred speed. The 3 initial trainin...
PMC10119738
Main Outcomes and Measures
fractures
Primary outcome was the daily-life fall rates that were collected from fall calendars for the 12 months after the third training session. Secondary outcomes were the proportion of participants with at least 1 fall and recurrent falls, time to first fall, fall-related fractures, fall-related injuries, fall-related healt...
PMC10119738
Results
A total of 140 highly functioning, community-dwelling older adults (mean [SD] age, 72 [5] years; 79 females [56%]), 57 (41%) of whom had a fall in the past 12 months, were included in this trial. Perturbation training had no significant effect on daily-life fall rate (incidence rate ratio [IRR]: 0.78; 95% CI, 0.48-1.27...
PMC10119738
Conclusions and Relevance
Results of this trial showed that participants who received an 80-minute PBT intervention experienced a statistically nonsignificant 22% reduction in daily-life fall rates. There was no significant effect on other daily-life fall-related metrics; however, a statistically significant decrease in falls was found in the l...
PMC10119738
Trial Registration
ClinicalTrials.gov Identifier:
PMC10119738
Introduction
injuries
Falling is the leading cause of injuries in older adults, and the associated costs of treatment and rehabilitation burden society substantially.The recently published world guidelines for fall prevention highlight PBT as a future research priority.
PMC10119738
Methods
PMC10119738
Study Design, Setting, and Participants
neurological disease, osteoporosis-related fractures, cognitive impairment, fracture, Parkinson or multiple sclerosis, osteoporosis
NEUROLOGICAL DISEASE, OSTEOPOROSIS
This assessor-blinded, parallel-group (1:1 ratio) RCT was conducted between March 2021 and December 2022 at a laboratory in Aalborg University in Denmark. The trial protocol was approved by the North Denmark Region Committee on Health Research Ethics and the Danish Data Protection Agency. All participants provided writ...
PMC10119738
Randomization and Interventions
After the pretraining assessments, participants were randomized in a 1:1 ratio to either the PBT (intervention) group or control group (
PMC10119738
Participant Flowchart
PBT indicates perturbation-based balance training.All participants in the PBT group were assigned to four 20-minute PBT sessions, and participants in the control group were assigned to 4 treadmill walking training sessions; the initial 2 training sessions were performed on the same day immediately after the pretraining...
PMC10119738
Training Schedule
sudden small deceleration
POSITIVE
The figure illustrates the arrangement of the training sessions (A). During slip perturbations (B), the participant walked at their preferred walking speed when a sudden acceleration reversed the direction of the belt movement before the belt returned to the preferred walking speed. During trip perturbations (C), the p...
PMC10119738
Perturbation-Based Balance Training (Intervention)
anxiety
Each of the 4 PBT sessions lasted approximately 20 minutes and consisted of 40 perturbations (20 to each leg) delivered on a uniformly moving treadmill with no lateral rails (Split 70/157/ASK; Woodway). A safety harness prevented participants from falling to the ground if they could not regain balance after a perturbat...
PMC10119738
Treadmill Walking Training (Control)
In each of the 4 treadmill walking training sessions, the control participants performed 20 minutes of treadmill walking at their preferred walking speed. The duration of these walks matched the PBT group's time on the treadmill.
PMC10119738
Outcome Assessment
fracture, fractures, injury or unpleasantness
ADVERSE EVENTS, EVENT
This RCT’s primary outcome was the daily-life fall rates that were collected from fall calendars for the 12 months after the third training session. A fall was defined as “an unexpected event in which the participant comes to rest on the ground, floor, or lower level.”Secondary outcomes included the proportion of parti...
PMC10119738
Statistical Analysis
REGRESSION, SENSITIVITY
An a priori sample size calculation was performed using a Poisson regression model in G*Power, version 3.1.9.4 (University of Kiel). To detect a significant (2-sided α = .05) difference between groups of 50% from a base fall rate of 0.85 with 80% power and an expected 20% dropout, a total of 140 participants, with 70 i...
PMC10119738
Results
PMC10119738
Enrollment and Adherence
Of the 199 individuals screened for eligibility, 140 were included (mean [SD] age, 72 [5] years; 79 females [56%] and 61 males [44%]) and randomized to either the PBT or control group (
PMC10119738
Baseline Characteristics of Participants
Frailty
Abbreviation: PBT, perturbation-based balance training.Tilburg Frailty Indicator: score range of 0 to 15, with a lower score indicating less frailty.Vulnerable Elders-13 Survey: score range of 0 to 10, with a lower score indicating less vulnerable.Short Falls Efficacy Scale: score range of 7 to 28, with a lower score i...
PMC10119738
Daily-Life and Laboratory Falls
For the primary outcome, 62 falls in the PBT group (rate of falls per person-year of follow-up: 0.90; 95% CI, 0.58-1.21) and 78 in the control group (rate of falls per person-year of follow-up: 1.14; 95% CI, 0.76-1.52) were reported, resulting in a nonsignificant 22% relative between-group difference in fall rates (inc...
PMC10119738
Comparison of the Number of Falls in the Intervention and Control Groups
PBT indicates perturbation-based balance training.
PMC10119738
Daily-Life Fall Results From Intention-to-Treat Analysis After 12 Months
EVENTS
Abbreviations: HR, hazard ratio; IRR, incidence rate ratio; NA, not applicable; PBT, perturbation-based balance training; RR, risk ratio.Primary outcome. The rate is the falls per person-year of follow-up.Not enough events to conduct analysis.The laboratory fall rates were similar at baseline but were significantly low...
PMC10119738
Sensitivity Analyses
REGRESSION
The Poisson regression with bootstrapping yielded results that were comparable to those of the negative binomial regression for all count outcomes (eAppendix 3 in
PMC10119738
Safety
knee injury, injuries
ADVERSE EVENTS
No serious adverse events were reported in the present RCT. Nevertheless, 2 injuries occurred during PBT: a knee injury and a muscle strain in the thigh. The participant with the knee injury had 1 appointment with the general practitioner, but none of the injuries required any further health care treatment. An overview...
PMC10119738
Discussion
In this trial of a 4-session treadmill PBT intervention, there was not a statistically significant decrease in daily-life fall rates among community-dwelling older adults compared with those in the control group. There was, however, a significant reduction in laboratory fall rates associated with PBT.The significant de...
PMC10119738
Limitations
This trial has several limitations. First, participants were unblinded to group randomization due to the nature of training interventions. Given that the initial fall reporting was a participant-reported outcome, the lack of blinding may have contributed to fewer falls reported in the PBT group. However, daily-life fal...
PMC10119738
Conclusions
In this RCT, participants who received an 80-minute PBT intervention experienced a statistically nonsignificant 22% reduction in daily-life fall rates. There was no significant effect on other daily-life fall-related metrics; however, a statistically significant decrease in falls was found in the laboratory setting. Fu...
PMC10119738
Aims/hypothesis
NOCTURNAL HYPOGLYCAEMIA
It is generally recommended to reduce basal insulin doses after exercise to reduce the risk of post-exercise nocturnal hypoglycaemia. Based on its long
PMC9988601
Methods
hypoglycaemia, diabetes
TYPE 1 DIABETES, HYPOGLYCAEMIA, DIABETES
The ADREM study (Adjustment of insulin Degludec to Reduce post-Exercise (nocturnal) hypoglycaeMia in people with diabetes) was a randomised controlled, crossover study in which we compared 40% dose reduction (D40), or postponement and 20% dose reduction (D20-P), with no dose adjustment (CON) in adults with type 1 diabe...
PMC9988601
Results
We recruited 18 participants (six women, age 38 ± 13 years, HbA
PMC9988601
Conclusions/interpretation
EVENTS, TYPE 1 DIABETES, NOCTURNAL HYPOGLYCAEMIA
Post-exercise adjustment of degludec does not mitigate the risk of subsequent nocturnal hypoglycaemia in people with type 1 diabetes. Although reducing degludec reduced next-day time below range, this did not translate into fewer hypoglycaemic events, while postponing degludec should be avoided because of increased tim...
PMC9988601
Trial registration
EudraCT number 2019-004222-22
PMC9988601
Funding
The study was funded by an unrestricted grant from Novo Nordisk, Denmark.
PMC9988601
Graphical abstract
PMC9988601
Supplementary Information
The online version of this article (10.1007/s00125-023-05893-9) contains peer-reviewed but unedited supplementary material.
PMC9988601
Keywords
PMC9988601
Introduction
TYPE 1 DIABETES MELLITUS
Regular physical exercise is recommended for people with type 1 diabetes mellitus given its beneficial effects on general well-being, cardiometabolic health and insulin requirements [Insulin degludec is a second-generation long-acting insulin analogue with a much longer
PMC9988601
Methods
PMC9988601