Crossover study
Dotaz
Zobrazit nápovědu
OBJECTIVES: This study quantified blood bicarbonate (HCO3-) kinetics and gastrointestinal upset to determine the gender-related ergogenic potential of sodium bicarbonate (0.15-, 0.25- and 0.35 gSB·kgFat-free mass (FFM)-1) in high intensity functional training. DESIGN: Double-blind randomized placebo-controlled crossover. METHODS: Thirty female and male athletes performed two bouts of the Wingate Anaerobic Test (WAnTPRE-HIFT and WAnTPOST-HIFT) interspaced with two 3-min bouts of Wall Balls and Burpees 120 min after ingestion of three sodium bicarbonate doses. Blood HCO3- was determined pre-ingestion, after supplementation and before/post exercise. Gastrointestinal upset was evaluated 120 min post-ingestion. Control (CTRL) measurements were performed. RESULTS: There were significant gender × treatment interactions for: changes in blood HCO3- at 60 min post-ingestion (p = 0.014; η2p = 0.104; at 0.15 gSB·kgFFM-1 males experienced higher increase than females); peak power (p = 0.015; η2p = 0.103) and average power (p = 0.005; η2p = 0.124) during WAnTPOST-HIFT, and changes in peak power between the Wingate Anaerobic Test bouts (p = 0.049; η2p = 0.081). Sodium bicarbonate compared to PLA had no significant impact on Wall Balls and Burpees performance. The dose of 0.35 gSB·kgFFM-1 resulted in higher less severe gastrointestinal symptoms compared to CTRL and 0.15 gSB·kgFFM-1 (p = 0.001; W = 0.178); and higher total gastrointestinal upset compared to CTRL, PLA and 0.15 gSB·kgFFM-1 (p < 0.001; W = 0.323). CONCLUSIONS: There were dose- and gender-related differences in extracellular buffering capacity and ergogenic potential of sodium bicarbonate. The study suggested a detrimental impact of gastrointestinal upset on performance.
- MeSH
- dospělí MeSH
- dvojitá slepá metoda MeSH
- hydrogenuhličitan sodný * aplikace a dávkování farmakologie krev MeSH
- klinické křížové studie * MeSH
- látky zvyšující výkon aplikace a dávkování farmakologie MeSH
- lidé MeSH
- mladý dospělý MeSH
- sexuální faktory MeSH
- zátěžový test MeSH
- Check Tag
- dospělí MeSH
- lidé MeSH
- mladý dospělý MeSH
- mužské pohlaví MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- randomizované kontrolované studie MeSH
High specification mattresses periodically redistribute pressure using alternating air cells, offloading tissues. This study aimed to evaluate the effects of alternating air pressure gradients on sacral tissue physiology. This randomised cross-over study recruited 15 healthy participants to test the three mattress settings (fast cycle, normal cycle, and slow cycle). Participants were asked to adopt supine, lateral, and high sitting (head of bed at 40°) postures, whilst transcutaneous tissue gas tensions and interface pressures at the sacrum were continuously monitored. Comparison between mattress settings and postures showed no statistical difference (p > 0.05) between peak pressure index values at the sacrum for each air inflation cycle speed setting. By contrast, a significantly higher sacral (p < 0.05) contact area was observed for high sitting. During high sitting, ischemic responses during both fast and normal air inflation cycle speed settings were recorded. During the slow air inflation cycle speed, most participants (60%-100%) showed high levels of perfusion. The present study identified a main effect of posture on interface pressure and perfusion over the sacrum. The alternating mattress speed influenced local tissue perfusion, with the greatest changes in tissue oxygenation occurring in a high-speed setting.
- MeSH
- dekubity * prevence a kontrola MeSH
- design vybavení MeSH
- dospělí MeSH
- klinické křížové studie MeSH
- lidé MeSH
- lůžka * MeSH
- mladý dospělý MeSH
- postura těla * fyziologie MeSH
- tlak vzduchu * MeSH
- zdraví dobrovolníci pro lékařské studie MeSH
- Check Tag
- dospělí MeSH
- lidé MeSH
- mladý dospělý MeSH
- mužské pohlaví MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- randomizované kontrolované studie MeSH
Twenty-eight endurance-trained males aged 31.1 ± 10.2 years (body mass [BM] 81.9 ± 9.0 kg) completed this randomized double-blind placebo (PLA)-controlled crossover study investigating the effect of 12-week Colostrum Bovinum (COL) supplementation (25gCOL·day-1) on aerobic fitness and capacity, time to exhaustion, BM and body composition (BC), and blood lactate concentration. There were four main-before/after supplementation study visits (COLPRE and COLPOST; PLAPRE, and PLAPOST). During study visits, BM and BC evaluation, incremental rowing test (IRT) to exhaustion, and evaluation of resting (REST) and post-exercise (POST-IRT) blood lactate concentration were performed. COL, but not PLA supplementation, significantly increased (p < 0.05) time to ventilatory threshold (TVT). Moreover, the implemented treatments had large (mL·min-1) and moderate (mL·min-1·kg-1) effects on oxygen uptake at VT (VO2VT), as well as moderate effect on power output at VT (PVT; W·kg-1) with the highest values observed at COLPOST visit. Neither significant influence of COL supplementation on time to exhaustion (TEXH) in IRT, BM, and BC on blood lactate was observed. Importantly, there were significantly (p < 0.05) higher increases in VO2VT (mL·min-1 and mL·min-1·kg-1) after COL compared to PLA supplementation. In summary, COL supplementation resulted in a favorable increase in TVT, and tended to improve some of the evaluated threshold indicators, namely VO2VT and PVT in endurance-trained male athletes during IRT. Therefore, COL supplementation may be considered as a support to improve aerobic fitness and capacity in endurance-trained males; however, supplementation strategy must be personalized and properly incorporated into the individual training. TRIAL REGISTRATION: The study protocol was registered at ClinicalTrials.gov (NCT06390670).
- MeSH
- dospělí MeSH
- dvojitá slepá metoda MeSH
- fyzická vytrvalost * MeSH
- klinické křížové studie MeSH
- kolostrum * MeSH
- kyselina mléčná krev MeSH
- lidé MeSH
- mladý dospělý MeSH
- potravní doplňky * MeSH
- složení těla * MeSH
- spotřeba kyslíku MeSH
- vytrvalostní trénink * MeSH
- Check Tag
- dospělí MeSH
- lidé MeSH
- mladý dospělý MeSH
- mužské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- randomizované kontrolované studie MeSH
BACKGROUND: In the ARIEL4 trial of rucaparib versus standard-of-care chemotherapy in patients with relapsed BRCA-mutated ovarian carcinoma, the primary endpoint was met, showing improved investigator-assessed progression-free survival with rucaparib. Here, we present the final overall survival analysis of the trial and other post-progression outcomes. METHODS: This open-label, randomised, controlled phase 3 trial was done at 64 hospitals and cancer centres in 12 countries, including Brazil, Canada, Czech Republic, Hungary, Israel, Italy, Poland, Russia, Spain, Ukraine, the UK, and the USA. Eligible patients were women aged 18 or older with BRCA1 or BRCA2-mutated ovarian carcinoma and had received at least two previous chemotherapy regimens. Patients had to have evaluable disease as per Response Evaluation Criteria in Solid Tumors (RECIST; version 1.1) criteria and an Eastern Cooperative Oncology Group performance status of 0 or 1. Patients were randomly assigned (2:1) using an interactive response technology and block randomisation (block size of six) and stratified by progression-free interval after the most recent platinum-containing therapy to receive oral rucaparib (600 mg twice daily administered in 28-day cycles) or chemotherapy on the basis of platinum-sensitivity status. In the chemotherapy group, patients with platinum-resistant disease (progression-free interval ≥1 to <6 months) or partially platinum-sensitive disease (progression-free interval ≥6 to <12 months) received weekly paclitaxel (starting dose 60-80 mg/m2 on days 1, 8, and 15). Patients with fully platinum-sensitive disease (progression-free interval ≥12 months) received the investigator's choice of platinum-based chemotherapy (single-agent cisplatin or carboplatin, or platinum-doublet chemotherapy), in 21-day or 28-day cycles. The primary endpoint (previously reported) was investigator-assessed progression-free survival, assessed in the efficacy population (all randomly assigned patients with deleterious BRCA1 or BRCA2 mutations without reversion mutations) and in the intention-to-treat population (all randomly assigned patients). Overall survival was a prespecified secondary endpoint and was analysed in the intention-to-treat population. Safety was assessed in all patients who received at least one dose of assigned study treatment. The cutoff date was April 10, 2022. This study is registered with ClinicalTrials.gov, NCT02855944; enrolment is complete and the study is closed. FINDINGS: Between March 1, 2017, and Sept 24, 2020, 349 eligible patients were randomly assigned to receive rucaparib (n=233) or chemotherapy (n=116). 332 (95%) of 349 patients were white and 17 (5%) patients were other or of unknown race. In the chemotherapy group, 80 (69%) of 116 patients crossed over to receive rucaparib. Median follow-up was 41·2 months (IQR 37·8-44·6). At data cutoff for this final analysis (April 10, 2022), 244 (70%) of 349 patients had died: 167 (72%) of 233 in the rucaparib group and 77 (66%) of 116 in the rucaparib group. Median overall survival was 19·4 months (95% CI 15·2-23·6) in the rucaparib group versus 25·4 months (21·4-27·6) in the chemotherapy group (hazard ratio 1·3 [95% CI 1·0-1·7], p=0·047). No new safety signals were observed, including during crossover to rucaparib. The most common grade 3-4 adverse events across treatment groups included anaemia or decreased haemoglobin (reported in 59 [25%] of 232 patients in the rucaparib group and seven [6%] of 113 in the chemotherapy group), and neutropenia or decreased neutrophil count (in 26 [11%] of 232 in the rucaparib group and 16 [14%] of 113 patients in the chemotherapy group). Serious adverse events were reported in 66 (28%) of 232 patients in the rucaparib group and 14 (12%) of 113 patients in the chemotherapy group. Ten treatment-related deaths were reported in the rucaparib group, two of which were linked to judged to be related to rucaparib (cardiac disorder and myelodysplastic syndrome), and one death related to treatment was reported in the chemotherapy group, with no specific cause linked to the treatment. INTERPRETATION: These data highlight the need for a better understanding of the most appropriate treatment for patients who have progressed on a poly(adenosine diphosphate-ribose) polymerase (PARP) inhibitor, and the optimal sequencing of chemotherapy and PARP inhibitors in advanced ovarian cancer. FUNDING: Clovis Oncology.
- MeSH
- doba přežití bez progrese choroby MeSH
- dospělí MeSH
- indoly * terapeutické užití aplikace a dávkování škodlivé účinky MeSH
- lidé středního věku MeSH
- lidé MeSH
- lokální recidiva nádoru * farmakoterapie genetika patologie MeSH
- mutace * MeSH
- nádory vaječníků * farmakoterapie genetika patologie mortalita MeSH
- paclitaxel aplikace a dávkování škodlivé účinky MeSH
- PARP inhibitory terapeutické užití škodlivé účinky aplikace a dávkování MeSH
- protein BRCA1 * genetika MeSH
- protein BRCA2 * genetika MeSH
- protokoly protinádorové kombinované chemoterapie * terapeutické užití MeSH
- senioři MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky, fáze III MeSH
- multicentrická studie MeSH
- randomizované kontrolované studie MeSH
- srovnávací studie MeSH
BACKGROUND: Evidence suggests that brain-computer interface (BCI)-based rehabilitation strategies show promise in overcoming the limited recovery potential in the chronic phase of stroke. However, the specific mechanisms driving motor function improvements are not fully understood. OBJECTIVE: We aimed at elucidating the potential functional brain connectivity changes induced by BCI training in participants with chronic stroke. METHODS: A longitudinal crossover design was employed with two groups of participants over the span of 4 weeks to allow for within-subject (n = 21) and cross-group comparisons. Group 1 (n = 11) underwent a 6-day motor imagery-based BCI training during the second week, whereas Group 2 (n = 10) received the same training during the third week. Before and after each week, both groups underwent resting state functional MRI scans (4 for Group 1 and 5 for Group 2) to establish a baseline and monitor the effects of BCI training. RESULTS: Following BCI training, an increased functional connectivity was observed between the medial prefrontal cortex of the default mode network (DMN) and motor-related areas, including the premotor cortex, superior parietal cortex, SMA, and precuneus. Moreover, these changes were correlated with the increased motor function as confirmed with upper-extremity Fugl-Meyer assessment scores, measured before and after the training. CONCLUSIONS: Our findings suggest that BCI training can enhance brain connectivity, underlying the observed improvements in motor function. They provide a basis for developing novel rehabilitation approaches using non-invasive brain stimulation for targeting functionally relevant brain regions, thereby augmenting BCI-induced neuroplasticity and enhancing motor recovery.
- MeSH
- cévní mozková příhoda * patofyziologie diagnostické zobrazování MeSH
- chronická nemoc MeSH
- default mode network * patofyziologie diagnostické zobrazování MeSH
- dospělí MeSH
- klinické křížové studie MeSH
- lidé středního věku MeSH
- lidé MeSH
- longitudinální studie MeSH
- magnetická rezonanční tomografie MeSH
- mozek * patofyziologie diagnostické zobrazování MeSH
- nervová síť * patofyziologie diagnostické zobrazování MeSH
- rehabilitace po cévní mozkové příhodě * metody MeSH
- rozhraní mozek-počítač * MeSH
- senioři MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
BACKGROUND: The study aimed to assess the acute effects of overcoming isometric split squats on subsequent single-leg drop jump (DJ) performance and the contralateral effect in volleyball players, considering training status differences. METHODS: Ten male elite (ELI) and ten amateur (AMA) volleyball players took part in two experimental sessions in which they performed conditioning activity (CA) consisted of 3 sets of overcoming isometric 3-second split squats, differing in the limb used: dominant (DL) or non-dominant (ND-L). Single-leg DJ was performed before and at the 4th and 8th minute post-CA for both limbs. The best post-CA attempt in terms of jump height (JH) was analyzed. RESULTS: Results revealed a significant increase in jump height (JH) in the non-dominant limb (ND-L) from 13.7 ± 2.6 cm to 15.5 ± 2.7 cm after CA performed by the ND-L (p = 0.001; Hedge's g = 0.65). Similarly, the reactive strength index (RSI) of the ND-L improved from 0.40 ± 0.06 to 0.45 ± 0.08 (p = 0.008; g = 0.58). Additionally, contact time in the ND-L increased significantly from 342 ± 36 ms to 375 ± 42 ms after CA performed by the dominant limb (p = 0.001; g = 0.66). In the elite (ELI) group, JH significantly increased from 16.4 ± 2.4 cm to 18.3 ± 3.3 cm (p < 0.001; g = 0.79), while RSI in the dominant limb (DL) improved from 0.47 ± 0.06 to 0.53 ± 0.07 (p = 0.011; g = 0.68). CONCLUSIONS: Results suggest that the examined CA effectively induces the post-activation performance enhancement in DJ among elite volleyball players, with a predominantly local impact on the limb executing the CA. TRIAL REGISTRATION: NCT06459050 (Retrospectively registered).
- Publikační typ
- časopisecké články MeSH
Initially, molecular hydrogen was considered a physiologically inert and non-functional gas. However, experimental and clinical studies have shown that molecular hydrogen has anti-inflammatory, anti-apoptotic, and strong selective antioxidant effects. This study aimed to evaluate the effects of 60 minutes of molecular hydrogen inhalation on respiratory gas analysis parameters using a randomized, double-blind, placebo-controlled, crossover design. The study was conducted at Faculty of Physical Culture, Palacký University Olomouc from September 2022 to March 2023. Twenty, physically active female participants aged 22.1 ± 1.6 years who inhaled either molecular hydrogen or ambient air through a nasal cannula (300 mL/min) for 60 minutes while resting were included in this study. Metabolic response was measured using indirect calorimetry. Breath-by-breath data were averaged over four 15-minute intervals. Compared with placebo (ambient air), molecular hydrogen inhalation significantly decreased respiratory exchange ratio and ventilation across all intervals. Furthermore, the change in respiratory exchange ratio was negatively correlated with body fat percentage from 30 minutes onwards. In conclusion, 60 minutes of resting molecular hydrogen inhalation significantly increased resting fat oxidation, as evidenced by decreased respiratory exchange ratio, particularly in individuals with higher body fat percentages.
- MeSH
- aplikace inhalační MeSH
- dospělí MeSH
- dvojitá slepá metoda MeSH
- klinické křížové studie MeSH
- lidé MeSH
- mladý dospělý MeSH
- odpočinek * MeSH
- placebo MeSH
- vodík * aplikace a dávkování farmakologie MeSH
- zdraví dobrovolníci pro lékařské studie MeSH
- Check Tag
- dospělí MeSH
- lidé MeSH
- mladý dospělý MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- randomizované kontrolované studie MeSH
INTRODUCTION: Nerve grafting with the sural nerve is a standard treatment method for radial nerve injury that requires another incision at the lateral ankle distal from the injured upper limb. The aim of this study was to investigate the common trunk (CTCB) of the inferior lateral brachial cutaneous nerve (ILBCN) and posterior antebrachial cutaneous nerve (PACN) as a possible donor inside the lateral intermuscular septum. MATERIALS AND METHODS: The arms and legs of 8 formalin-embalmed cadaver specimens were studied. The radial nerve, common trunk of the ILBCN and PACN, and the sural nerve were identified and measured in length and diameter. For histological examination, nerve samples from 6 fresh cadavers were harvested and processed for further axonal counting. RESULTS: The average length of the CTCB was 114.92 ± 18.9 mm. To match the diameter of the radial nerve at its proximal third, 3 cables of CTCB graft were necessary, which corresponds to a defect length of 3.8 cm. At the level of the distal third, the number of grafts was reduced to 2 with a corresponding defect length of 5.7 cm. The radial nerve contained 15162 ± 318 axons, and the CTCB comprised 3959 ± 176 axons. To match the axon count of the recipient nerve, 4 grafts of CTCB were necessary, which corresponded to a defect length of 2.8 cm. CONCLUSION: CTCB is a consistent and easily dissected cutaneous nerve branch of the radial nerve that can be used for bridging small gaps after neuroma-in-continuity in radial nerve palsy.
- MeSH
- lidé středního věku MeSH
- lidé MeSH
- mrtvola MeSH
- nervový transfer * metody MeSH
- nervus radialis * chirurgie anatomie a histologie zranění MeSH
- nervus suralis * transplantace anatomie a histologie MeSH
- senioři MeSH
- zákroky plastické chirurgie * metody MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
BACKGROUND: Results from the Distal vs Conventional Radial Access (DISCO RADIAL) trial confirmed distal radial access (DRA) as a valid alternative to conventional transradial access, with equally low rates of radial artery occlusion (RAO), yet higher crossovers but shorter hemostasis. OBJECTIVES: The purpose of the study was to investigate whether patient anthropometric measures influence the effect of randomized access on key secondary outcomes. METHODS: DISCO RADIAL was an international, multicenter, randomized controlled trial in which patients with indications for percutaneous coronary procedure using a 6-F Slender sheath were randomized to DRA (n = 650) or transradial access (n = 657) implementing best practices to reduce RAO. The primary endpoint of the trial was incidence of forearm RAO, which was extremely uncommon. Secondary endpoints, including sheath insertion time, radial artery spasm, crossover (failure to obtain access through assigned access site), hemostasis time, and access site complications, were the focus of the current analysis. Regression models (linear for continuous and logistic for binary outcomes) were used to determine whether anthropometric measures (weight, height, body mass index, and body surface area) influenced the effect of randomized access on outcomes. RESULTS: Across tertiles of weight, height, body mass index, and body surface area, both before and after adjustment for sex and age, the main effect of vascular access on radial artery spasm, crossover, hemostasis time, and access site complications remained, with no significant interaction effect. CONCLUSIONS: The results of this exploratory analysis are consistent with the main findings of the trial and support the use of DRA in all patients, regardless of anthropometric measures.
- Publikační typ
- časopisecké články MeSH
Huntington's disease (HD) is a debilitating neurodegenerative disorder characterized by severe motor deficits, cognitive decline and psychiatric disturbances. An early and significant morphological hallmark of HD is the activation of astrocytes triggered by mutant huntingtin, leading to the release of inflammatory mediators. Fingolimod (FTY), an FDA-approved sphingosine-1-phosphate (S1P) receptor agonist is used to treat multiple sclerosis (MS), a neuroinflammatory disease, and has shown therapeutic promise in other neurological conditions. Our study aimed to investigate the therapeutic potential of FTY for treating HD by utilizing a well-characterized mouse model of HD (zQ175dn) and wild-type littermates. The study design included a crossover, long-term oral treatment with 1 mg/kg to 2 mg/kg FTY from the age of 15-46 weeks (n = 128). Different motor behavior and physiological parameters were assessed throughout the study. The findings revealed that FTY rescued disease-related body weight loss in a sex-dependent manner, indicating its potential to regulate metabolic disturbances and to counteract neurodegenerative processes in HD. FTY intervention also rescued testicular atrophy, restored testis tissue structure in male mice suggesting a broader impact on peripheral tissues affected by huntingtin pathology. Histological analyses of the brain revealed delayed accumulation of activated astrocytes contributing to the preservation of the neural microenvironment by reducing neuroinflammation. The extent of FTY-related disease improvement was sex-dependent. Motor functions and body weight improved mostly in female mice with sustained estrogen levels, whereas males had to compensate for the ongoing, disease-related testis atrophy and the loss of androgen production. Our study underscores the beneficial therapeutic effects of FTY on HD involving endogenous steroid hormones and their important anabolic effects. It positions FTY as a promising candidate for therapeutic interventions targeting various aspects of HD pathology. Further studies are needed to fully evaluate its therapeutic potential in patients.
- MeSH
- fingolimod hydrochlorid * terapeutické užití farmakologie MeSH
- Huntingtonova nemoc * farmakoterapie metabolismus MeSH
- modely nemocí na zvířatech MeSH
- modulátory receptorů sfingosin-1-fosfátu * farmakologie terapeutické užití MeSH
- myši inbrední C57BL MeSH
- myši MeSH
- pohybová aktivita účinky léků MeSH
- receptory sfingosin-1-fosfátu agonisté metabolismus MeSH
- testis účinky léků patologie metabolismus MeSH
- zvířata MeSH
- Check Tag
- mužské pohlaví MeSH
- myši MeSH
- ženské pohlaví MeSH
- zvířata MeSH
- Publikační typ
- časopisecké články MeSH