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Respiratory Medicine 2024Salbutamol is a cornerstone for relieving acute asthma symptoms, typically administered through a pressurized metered-dose inhaler (pMDI). Dry powder inhalers (DPIs)... (Randomized Controlled Trial)
Randomized Controlled Trial Comparative Study
BACKGROUND
Salbutamol is a cornerstone for relieving acute asthma symptoms, typically administered through a pressurized metered-dose inhaler (pMDI). Dry powder inhalers (DPIs) offer an alternative, but concerns exist whether DPIs provide an effective relief during an obstructive event.
OBJECTIVE
We aimed to show non-inferiority of Salbutamol Easyhaler DPI compared to pMDI with spacer in treating methacholine-induced bronchoconstriction. Applicability of Budesonide-formoterol Easyhaler DPI as a reliever was also assessed.
METHODS
This was a randomized, parallel-group trial in subjects sent to methacholine challenge (MC) test for asthma diagnostics. Participants with at least 20 % decrease in forced expiratory volume in 1 s (FEV) were randomized to receive Salbutamol Easyhaler (2 × 200 μg), Ventoline Evohaler with spacer (4 × 100 μg) or Budesonide-formoterol Easyhaler (2 × 160/4.5 μg) as a reliever. The treatment was repeated if FEV did not recover to at least -10 % of baseline.
RESULTS
180 participants (69 % females, mean age 46 yrs [range 18-80], FEV%pred 89.5 [62-142] %) completed the trial. Salbutamol Easyhaler was non-inferior to pMDI with spacer in acute relief of bronchoconstriction showing a -0.083 (95 % LCL -0.146) L FEV difference after the first dose and -0.032 (-0.071) L after the last dose. The differences in FEV between Budesonide-formoterol Easyhaler and Salbutamol pMDI with spacer were -0.163 (-0.225) L after the first and -0.092 (-0.131) L after the last dose.
CONCLUSION
The study confirms non-inferiority of Salbutamol Easyhaler to Ventoline Evohaler with spacer in relieving acute bronchoconstriction, making Easyhaler a sustainable and safe reliever for MC test and supports its use during asthma attacks.
Topics: Humans; Methacholine Chloride; Female; Bronchoconstriction; Male; Adult; Asthma; Middle Aged; Albuterol; Dry Powder Inhalers; Forced Expiratory Volume; Bronchodilator Agents; Young Adult; Administration, Inhalation; Metered Dose Inhalers; Adolescent; Bronchial Provocation Tests; Treatment Outcome; Aged; Inhalation Spacers; Budesonide, Formoterol Fumarate Drug Combination
PubMed: 38851404
DOI: 10.1016/j.rmed.2024.107693 -
Contemporary Clinical Trials... Jun 2024Enteral nutrition (EN) is preferred when oral feeding is not possible. The use of the Nasogastric Tube (NGT) ensures rapid and low-risk nutrient administration. However,...
BACKGROUND
Enteral nutrition (EN) is preferred when oral feeding is not possible. The use of the Nasogastric Tube (NGT) ensures rapid and low-risk nutrient administration. However, confirming the placement through chest radiography, besides delaying the initiation of nutritional therapy, exposes patients to radiation. The pH test of gastric aspirate provides a quicker check for NGT placement, but its reliability is compromised by challenges related to aspirating gastric secretions.
STUDY OBJECTIVE
The main objective of this study is to assess the high-performance placement of NGTs for nutritional purposes, optimizing the evaluation of correct insertion through pH testing using an electronic pH meter. Additionally, the study aims to evaluate patient tolerance to the intervention.
MATERIALS AND METHODS
This single-center RCT will include 150 EN candidate patients divided into three groups. Each group will use distinct NGTs, evaluating placement through pH testing and chest radiography for safety. Tolerance, complications related to NGT placement, and costs will be assessed, with data collected anonymously through a secure electronic database.
ETHICAL CONSIDERATIONS
authorization no. 3624, Territorial Ethical Committee Lombardy 5, October 20, 2023.
IMPLICATIONS AND PERSPECTIVES
This protocol introduces innovative technologies, such as advanced NGTs and an electronic pH meter, aiming to optimize enteral nutrition management. This RCT focuses on replacing X-rays as the primary method for verifying NGT placement, thereby reducing costs, time, and patient exposure to radiation. Data analysis may provide insights into managing patients on pH-altering medication. Implementing innovative technologies has the potential to reduce errors and improve economic efficiency and process sustainability.
PubMed: 38845620
DOI: 10.1016/j.conctc.2024.101312 -
Journal of Sports Science & Medicine Jun 2024The aim of this study was two-fold: (i) to compare physical fitness adaptations following small-sided games (SSG) and running-based high-intensity interval training... (Randomized Controlled Trial)
Randomized Controlled Trial
Sex Influences the Extent of Physical Performance Adaptations in Response to Small-Sided Games and Running-Based High-Intensity Interval Training: A Parallel Study Design Involving Men and Women Soccer Players.
The aim of this study was two-fold: (i) to compare physical fitness adaptations following small-sided games (SSG) and running-based high-intensity interval training (HIIT), considering sex interactions; and (ii) to describe intra-individual variations of adaptations in both men and women developmental/trained soccer players over an 8-week randomized parallel study design involving 25 women and 27 men. Pre and post-intervention assessments included countermovement jump (CMJ), 10-meter linear sprint test, change-of-direction (COD) deficit, and final velocity at 30-15 Intermittent Fitness Test (VIFT). Significant interactions between time, groups and sex were found in 10-m sprint (F = 6.042; = 0.018; η = 0.112). No significant interactions between time, groups and sex were found in CMJ (F F = 0.609; = 0.439; η = 0.013), COD deficit (F F = 2.718; p = 0.106; η = 0.054) and VIFT (F F = 1.141; = 0.291; η = 0.023). Significant interactions were found between time and sex in CMJ (F F = 29.342; < 0.001; η= 0.379), 10-m sprint (F F = 4.359; = 0.042; η = 0.083), COD deficit (F F = 5.066; = 0.029; η= 0.095) and VIFT (F F = 11.248; = 0.002; η = 0.190). In conclusion, this study suggests similar effects of HIIT in both sexes. However, for women, SSG may entail less efficacy and more inter-individual variability compared to men. Therefore, HIIT could potentially be a better solution for women, whereas both training approaches were equally effective in men.
Topics: Humans; Soccer; High-Intensity Interval Training; Female; Male; Adaptation, Physiological; Sex Factors; Athletic Performance; Young Adult; Running; Physical Fitness; Exercise Test; Adult
PubMed: 38841647
DOI: 10.52082/jssm.2024.265 -
Journal of Sports Science & Medicine Jun 2024Small-sided games (SSGs) are frequently utilized in training settings to elicit specific stimuli that can promote physical fitness adaptations over time. However,... (Randomized Controlled Trial)
Randomized Controlled Trial
Can The Pitch Dimension Influence the Physical Fitness Adaptations Induced by Small-Sided Training Programs Added to Regular In-Field Training? A Randomized Controlled Study in Youth Soccer Players.
Small-sided games (SSGs) are frequently utilized in training settings to elicit specific stimuli that can promote physical fitness adaptations over time. However, various task constraints, such as pitch dimensions, can significantly influence both the acute external and internal load responses. Thus, understanding the impact of different pitch dimensions on physical fitness adaptations is crucial. This study sought to compare the physical adaptations induced by an SSG-based program utilizing more elongated pitches (SSGlw2; length-to-width ratio: 2.0) versus less elongated pitches (SSGwl1; length-to-width ratio: 1.0) on the Yo-Yo intermittent recovery test level 1 (YYIRT), and 30-meter sprint. This study employed a randomized controlled design. Forty-eight male soccer players (16.4 ± 0.6 years) participated. These players were randomly allocated to two experimental groups (N = 16, SSGlw1; N = 16, SSGlw2) and underwent two weekly additional training sessions over an 8-week period, while a group of 16 players continued with their regular in-field sessions as a control group. Evaluations were conducted before and after the intervention period. Significant interactions time u group were observed in regards YYIRT (F = 15.857; p < 0.001; = 0.413) and 30-m sprint test (p < 0.001). Between-group differences on YYIRT were found in post-intervention (p < 0.001), on which SSGlw2 (p < 0.001) and SSGlw1 (p < 0.001) were significantly greater in comparison to control group. Additionally, between-group differences on 30-m sprint were found in post-intervention (p < 0.001), on which SSGlw2 was significantly better than SSGlw1 (p < 0.001) and control group (p < 0.001). Coaches are advised to prioritize the use of more elongated pitch sizes to promote adaptations in sprint performance, while still acknowledging that aerobic capacity improvements remain significant compared to other pitch shapes.
Topics: Humans; Soccer; Male; Adolescent; Adaptation, Physiological; Physical Fitness; Physical Conditioning, Human; Athletic Performance; Running; Exercise Test
PubMed: 38841646
DOI: 10.52082/jssm.2024.487 -
Journal of Sports Science & Medicine Jun 2024Microdosing can facilitate better accommodation to the training stimulus while aligning with the scheduling needs of teams. In this study, the effectiveness of... (Randomized Controlled Trial)
Randomized Controlled Trial
Microdosing can facilitate better accommodation to the training stimulus while aligning with the scheduling needs of teams. In this study, the effectiveness of microdosing exposure was investigated by comparing the effects of microdosing plyometric jump training (microPJT) with those of regular plyometric jump training (regPJT) and a control group not exposed to plyometric training. The comparison focused on the effects on jumping performance, reactive strength index (RSI), and acceleration over a 10-meter distance. Fifty-two male youth soccer players (16.3 ± 0.6 years old) from under-17 teams participated in a randomized controlled study, with interventions lasting 8 weeks. Assessments were conducted twice, before and after the intervention, measuring squat jump (SJ), countermovement jump (CMJ), RSI during drop jumps, and acceleration in a 10-meter sprint test. The regPJT group completed 34 bilateral jumps and 48 unilateral jumps per week over two weekly sessions, totaling 82 jumps. Conversely, the microPJT group performed 17 bilateral jumps and 24 unilateral jumps weekly over 4 sessions week, totaling 41 jumps. Significant interactions between groups and time were observed concerning SJ (p < 0.001; = 0.282), CMJ (p < 0.001; = 0.368), RSI (p < 0.001; = 0.400) and 10-m sprint time (p < 0.001; = 0.317). Between-group analysis indicated that both the microPJT (p < 0.001) and regPJT (p < 0.001) groups exhibited significant better results compared to the control group in post-intervention evaluation of SJ, CMJ, RSI and 10-m sprint time, while no significant differences were found between experimental groups (p > 0.050). In conclusion, this study has revealed that both microPJT and regPJT are equally effective in enhancing jumping performance and acceleration time in soccer players. This suggests that a smaller training volume, distributed more frequently across the week, can effectively induce improvements in soccer players.
Topics: Humans; Soccer; Plyometric Exercise; Adolescent; Male; Athletic Performance; Acceleration; Muscle Strength
PubMed: 38841635
DOI: 10.52082/jssm.2024.342 -
International Journal of Chronic... 2024The use of inhaled bronchodilators is the mainstay of treatment for patients with chronic obstructive pulmonary disease (COPD). Although the soft mist inhaler (SMI) was... (Observational Study)
Observational Study
PURPOSE
The use of inhaled bronchodilators is the mainstay of treatment for patients with chronic obstructive pulmonary disease (COPD). Although the soft mist inhaler (SMI) was developed to overcome the disadvantages of pressurized metered dose and drug powder inhalers, misuse during handling has been frequently observed in many studies. However, few studies have focused on SMI misuse among patients with COPD. Thus, we aimed to assess and identify the risk factors associated with SMI misuse among patients with COPD.
PATIENT AND METHODS
In this prospective, observational, cross-sectional study, we enrolled patients with COPD who were undergoing SMI treatment between January 2018 and March 2020. An advanced nurse practitioner assessed the participants' handling of the device by using a check list.
RESULTS
Among 159 participants, 136 (85.5%) reported inhaler misuse. Duration of COPD and COPD assessment test (CAT) scores were positively associated with inhaler misuse; adherence and education level were negatively associated with inhaler misuse. In the multivariable analysis, a low educational level (less than high school), high CAT score (≥ 10), and short duration of COPD (≤ 2 years) were identified as risk factors for SMI misuse.
CONCLUSION
SMI misuse remains common among patients with COPD. Therefore, clinicians should pay close attention to their patients using SMIs, especially in the early period after the diagnosis of COPD.
Topics: Humans; Pulmonary Disease, Chronic Obstructive; Male; Female; Cross-Sectional Studies; Risk Factors; Aged; Prospective Studies; Middle Aged; Bronchodilator Agents; Administration, Inhalation; Nebulizers and Vaporizers; Medication Adherence; Equipment Design; Risk Assessment; Educational Status; Lung
PubMed: 38835808
DOI: 10.2147/COPD.S458200 -
Aging Cell Jun 2024With aging skeletal muscle fibers undergo repeating cycles of denervation and reinnervation. In approximately the 8th decade of life reinnervation no longer keeps pace,...
With aging skeletal muscle fibers undergo repeating cycles of denervation and reinnervation. In approximately the 8th decade of life reinnervation no longer keeps pace, resulting in the accumulation of persistently denervated muscle fibers that in turn cause an acceleration of muscle dysfunction. The significance of denervation in important clinical outcomes with aging is poorly studied. The Study of Muscle, Mobility, and Aging (SOMMA) is a large cohort study with the primary objective to assess how aging muscle biology impacts clinically important traits. Using transcriptomics data from vastus lateralis muscle biopsies in 575 participants we have selected 49 denervation-responsive genes to provide insights to the burden of denervation in SOMMA, to test the hypothesis that greater expression of denervation-responsive genes negatively associates with SOMMA participant traits that included time to walk 400 meters, fitness (VO), maximal mitochondrial respiration, muscle mass and volume, and leg muscle strength and power. Consistent with our hypothesis, increased transcript levels of: a calciumdependent intercellular adhesion glycoprotein (CDH15), acetylcholine receptor subunits (CHRNA1, CHRND, CHRNE), a glycoprotein promoting reinnervation (NCAM1), a transcription factor regulating aspects of muscle organization (RUNX1), and a sodium channel (SCN5A) were each negatively associated with at least 3 of these traits. VO and maximal respiration had the strongest negative associations with 15 and 19 denervation-responsive genes, respectively. In conclusion, the abundance of denervationresponsive gene transcripts is a significant determinant of muscle and mobility outcomes in aging humans, supporting the imperative to identify new treatment strategies to restore innervation in advanced age.
Topics: Humans; Aging; Male; Muscle, Skeletal; Aged; Female; Middle Aged; Cohort Studies; Adult
PubMed: 38831622
DOI: 10.1111/acel.14115 -
PloS One 2024This study examined functional trajectories of subjects during the transition phase between ambulatory and non-ambulatory Duchenne muscular dystrophy (DMD) to inform...
This study examined functional trajectories of subjects during the transition phase between ambulatory and non-ambulatory Duchenne muscular dystrophy (DMD) to inform clinical trial designs for new therapeutics. Ambulatory, pulmonary, and upper limb function leading up to loss of ambulation (LoA) and non-ambulatory measures following LoA were quantified; time ordering of pulmonary and upper limb milestones relative to LoA were determined; and the 10-second time threshold for 10-meter walk/run (10MWR) as a marker of approaching LOA was explored. Included in this analysis were 51 subjects aged between 7 and 18 years who experienced LoA during follow-up in the PRO-DMD-01 natural history study. Mean age at LoA was 12.7 (7.1-18.6) years. Mean annual rates of decline in forced vital capacity (FVC) <80%-predicted and performance of upper limb (PUL) 1.2 total score were smaller before than after LoA, but not significantly (FVC %-predicted: 5.6% vs. 10.1%, p = 0.21; PUL 1.2 total score: 2.3 vs. 3.8 units, p = 0.20). More than half of patients experienced clinically significant deficits in FVC %-predicted and PUL 1.2 before experiencing LoA. Among subjects with baseline 10MWR >10 s, those with <1 year to LoA had similar mean ages but significantly worse mean ambulatory function at baseline compared to those with ≥1 year to LoA. Enriching DMD clinical trials for patients with declining pulmonary or upper limb function is achievable without restricting enrollment to non-ambulatory patients. The sequencing of LoA and initial deficits in pulmonary and upper limb function varied across patients and highlights the potential for composite outcomes or multi-outcome trial designs to assess disease-modifying therapies more comprehensively.
Topics: Humans; Muscular Dystrophy, Duchenne; Child; Adolescent; Male; Walking; Clinical Trials as Topic; Vital Capacity; Upper Extremity; Disease Progression
PubMed: 38829874
DOI: 10.1371/journal.pone.0304099 -
PloS One 2024The productivity and well-being of honey bee colonies are greatly influenced by the nutrients present in the hives. A study was conducted to evaluate different...
The productivity and well-being of honey bee colonies are greatly influenced by the nutrients present in the hives. A study was conducted to evaluate different supplemental feeds on honey bee productive performance during dearth periods. Thirty colonies were grouped into five (four treatment groups and one control group) and each group contained three sub-groups (2 weak, 2 strong, and 2 very strong). Control groups were not given any supplementation. Treatment diets were T1 (50% sugar syrup + 14% roasted barley powder (beso) + 36% roasted spiced pea powder (Shiro)), T2 (50% powder sugar + 14% white sorghum powder + 36% bakery yeast, T3 (50% powder sugar + 14% white sorghum powder + 36% skimmed milk powder), T4 (50% sugar syrup with infusion of stinging nettle and 1% kerefa + 50% white sorghum powder). Feed was given on the entrance sides. The performance of experimental colonies was measured every 21 days in two phases during the dry season (from 3_2_2021 to 27_4_2021) and the rainy season (from 28-7_2021 to 1_10_2021). Feed intake, space (cm2) of pollen, nectar, and honey in the comb were measured using a frame-sized transparent grid meter. The study revealed significant differences (p<0.0001) in all measured parameters among the various treatments. The diet provided by T4 showed the highest levels of crude protein (18.15%) and carbohydrates (92.15%), whereas the diet presented by T3 had the lowest crude protein content (6.66%) and the diet offered by T1 had the lowest carbohydrate content (61.91%). In general, colonies that received T4 showcased superior performance compared to others. They exhibited a feed intake of 98.3%, a nectar area of 54.3 cm2, a pollen area of 68.7 cm2, a honey area of 311.2 cm2, and a honey yield of 7 kg. Consequently, their net profit amounted to 51.54 USD. On the other hand, the colonies that received T1 had the lowest performance indicators. They demonstrated a feed intake of only 54.7%, a nectar area of 37.6 cm2, a pollen area of 48.8 cm2, a honey area of 254.3 cm2, a honey yield of 2.8 kg, and a net profit of 18.81 USD. The significance of this study was to enable the beekeepers in realizing the effects of feed supplements on the productivity and profitability of honeybee colonies.
Topics: Animals; Bees; Ethiopia; Dietary Supplements; Animal Feed; Honey; Pollen; Seasons
PubMed: 38809892
DOI: 10.1371/journal.pone.0303579 -
Scientific Reports May 2024Carotenoids play a role in preventing and impeding the progression of atherosclerotic cardiovascular diseases (ASCVDs) through their anti-oxidative effects. This study...
Association between atherosclerotic cardiovascular disease score and skin carotenoid levels estimated via refraction spectroscopy in the Japanese population: a cross-sectional study.
Carotenoids play a role in preventing and impeding the progression of atherosclerotic cardiovascular diseases (ASCVDs) through their anti-oxidative effects. This study evaluated associations between ASCVD risk and skin carotenoid (SC) levels, reflecting dietary carotenoid intake. Participants' ASCVD risk was assessed using the Hisayama ASCVD risk prediction model, and SC levels were measured through a reflection spectroscope (Veggie Meter). The associations between high ASCVD risk and SC levels were analyzed using logistic regression analysis and a restricted cubic spline (RCS) model. A total of 1130 men and women (mean age: 56 years) from participants who underwent a health examination in Seirei Center for Health Promotion and Prevention Medicine in 2019 and 2022 were analyzed. Of these, 4.6% had moderate or high ASCVD risk. Mean SC values were 236, 315, 376, 447, and 606 in quintile Q1 to Q5, respectively. The adjusted odds ratios (95% confidence intervals) of SC quintile for moderate- or high-risk ASCVD was 0.24 (0.12-0.51) in Q5 (495 ≤), 0.42 (0.23-0.77) in Q4, 0.50 (0.29-0.88) in Q3, and 0.68 (0.41-1.12) in Q2 compared to Q1 (< 281). High SC values continuously showed non-linear inverse association with moderate- or high-risk for ASCVD in Japanese adults. Non-invasive SC measurements may be a good indicator for recommending carotenoids to prevent cardiovascular disease.
Topics: Humans; Female; Male; Carotenoids; Middle Aged; Cross-Sectional Studies; Japan; Skin; Atherosclerosis; Aged; Adult; Cardiovascular Diseases; Risk Factors; Spectrum Analysis; East Asian People
PubMed: 38806551
DOI: 10.1038/s41598-024-62772-y