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BMC Musculoskeletal Disorders Jul 2022A small, wearable thermo device that uses Peltier elements for programmed heat and cold stimulation has been developed recently and is expected to be applied in... (Clinical Trial)
Clinical Trial
BACKGROUND
A small, wearable thermo device that uses Peltier elements for programmed heat and cold stimulation has been developed recently and is expected to be applied in conventional contrast bath therapy. This study was aimed to examine improvements in trapezius muscle hardness and subjective symptoms resulting from alternating heat and cold stimulation, with different rates of cooling.
METHODS
This cross-over study included four conditions. Twenty healthy young male individuals (age, 22.3 ± 4.5 years) participated in this study. These four interventions targeted the unilateral trapezius muscle of the dominant arm after a 15-min typing task. Specifically, heat and cold stimulations were applied at different ratios (the heating/cooling rate of 3:1, 3:2, and 3:3) or not applied. Each intervention was separated by at least one week. Skin temperature at the stimulation area was recorded using a data logger. Outcome measures included muscle hardness (measured using a portable tester) and subjective symptoms (muscle stiffness and fatigue). Each item was assessed at three time points: baseline, after typing, and after the intervention.
RESULTS
Two-way analysis of variance with repeated measures found an interaction effect for muscle hardness between four conditions (3:1, 3:2, 3:3, and no) and three time points (p < 0.05). Only in the 3:1 condition were the post-intervention values lower than those after typing (p < 0.01). There was also an interaction effect for subjective muscle stiffness (p < 0.05); the values after the intervention in the 3:1 condition were lower than those after intervention in the no stimulation condition (p < 0.01). There was no significant relationship between changes in muscle hardness and changes in subjective symptoms in the 3:1 condition.
CONCLUSIONS
Our results demonstrate that alternating heat and cold stimulations with a different cooling rate could affect the degree of improvement in muscle hardness and subjective symptoms. In particular, the 3:1 condition has the possibility to improved muscle hardness within the condition and subjective muscle stiffness between conditions.
TRIAL REGISTRATION
UMIN000040620. Registered 1 June 2020, https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046359.
Topics: Adolescent; Adult; Cross-Over Studies; Hot Temperature; Humans; Joint Diseases; Male; Shoulder; Superficial Back Muscles; Wearable Electronic Devices; Young Adult
PubMed: 35831832
DOI: 10.1186/s12891-022-05623-z -
International Journal of Environmental... Jun 2022South Asian women living in the UK are particularly at high risk of obesity-related complications, such as type 2 diabetes and cardiovascular disease. Exposure to large... (Randomized Controlled Trial)
Randomized Controlled Trial
South Asian women living in the UK are particularly at high risk of obesity-related complications, such as type 2 diabetes and cardiovascular disease. Exposure to large portion sizes is a risk factor for obesity. Specifically designed tableware helps individuals to manage weight by controlling food portion sizes. Thirty-one ( = 31) overweight or obese South Asian adult women participated in a randomised cross-over trial aimed to assess the efficacy, acceptance, and weight change of two guided/calibrated commercially available portion control tools (Utensil set and Crockery Set) used in free-living conditions. Data on acceptance, perceived changes in portion size, frequency, and meal type was collected using paper questionnaires and 3-day diet diaries. Scores describing acceptance, ease of use, and perceived effectiveness were derived from five-point Likert scales from which binary indicators (high/low) were analysed for significance using multivariate variance analysis for repeated measurements. A reduction in BMI was observed at each point of measurement ( = 0.007). For overall tool use, the crockery set scored higher in all areas of acceptance, ease of use, and perceived efficacy for all comparisons. Self-selected portion sizes increased for salads and decreased for cooking oil and breakfast cereals with both tools. Further research to scale up and evaluate similar weight management interventions for this group is warranted.
Topics: Adult; Body Mass Index; Cross-Over Studies; Diabetes Mellitus, Type 2; Female; Humans; Obesity; Overweight; Portion Size; Weight Loss
PubMed: 35805371
DOI: 10.3390/ijerph19137714 -
BMJ Open Feb 2024Traditional potassium (K) binders for treating hyperkalaemia are unpalatable and poorly tolerated. Newer K binders are reportedly better tolerated; however, no published... (Randomized Controlled Trial)
Randomized Controlled Trial
Randomised, blinded, cross-over evaluation of the palatability of and preference for different potassium binders in participants with chronic hyperkalaemia in the USA, Canada and Europe: the APPETIZE study.
OBJECTIVES
Traditional potassium (K) binders for treating hyperkalaemia are unpalatable and poorly tolerated. Newer K binders are reportedly better tolerated; however, no published data describe their palatability, a determinant of long-term adherence. This study evaluated the palatability of and preference for three K binders: sodium and calcium polystyrene sulfonate (S/CPS), sodium zirconium cyclosilicate (SZC) and calcium patiromer sorbitex (patiromer).
DESIGN
Phase 4, randomised, participant-blinded, cross-over study. Participants were randomised to one of six taste sequences and, using a 'sip and spit' approach, tasted each K binder before completing a survey.
SETTING
17 centres across the USA, Canada and European Union.
PARTICIPANTS
144 participants with chronic kidney disease, hyperkalaemia and no recent use of K binders.
MAIN OUTCOME MEASURES
For the primary (USA) and key secondary (Canada and European Union) endpoints, participants rated palatability attributes (taste, texture, smell and mouthfeel) and willingness to take each K binder on a scale of 0-10 (rational evaluation). Feelings about each attribute, and the idea of taking the product once daily, were evaluated using a non-verbal, visual measure of emotional response. Finally, participants ranked the K binders according to palatability.
RESULTS
In each region, SZC and patiromer outperformed S/CPS on overall palatability (a composite of taste, texture, smell and mouthfeel), based on rational evaluation and emotional response. Taking the product once daily was more appealing for SZC and patiromer, creating greater receptivity than the idea of taking S/CPS. The emotional response to mouthfeel had the strongest influence on feelings about taking each product. In each region, a numerically greater proportion of participants ranked SZC as the most preferred K binder versus patiromer or S/CPS.
CONCLUSIONS
Preference for more palatable K binders such as SZC and patiromer may provide an opportunity to improve adherence to long-term treatment of hyperkalaemia.
TRIAL REGISTRATION NUMBER
NCT04566653.
Topics: Humans; Canada; Cross-Over Studies; Hyperkalemia; Potassium; Renal Insufficiency, Chronic; Silicates; Single-Blind Method
PubMed: 38387989
DOI: 10.1136/bmjopen-2023-074954 -
Gut Jan 2024Animal studies suggest that prebiotic, plant-derived nutrients could improve homoeostatic and hedonic brain functions through improvements in microbiome-gut-brain... (Randomized Controlled Trial)
Randomized Controlled Trial
OBJECTIVE
Animal studies suggest that prebiotic, plant-derived nutrients could improve homoeostatic and hedonic brain functions through improvements in microbiome-gut-brain communication. However, little is known if these results are applicable to humans. Therefore, we tested the effects of high-dosed prebiotic fibre on reward-related food decision-making in a randomised controlled within-subject cross-over study and assayed potential microbial and metabolic markers.
DESIGN
59 overweight young adults (19 females, 18-42 years, body mass index 25-30 kg/m) underwent functional task MRI before and after 14 days of supplementary intake of 30 g/day of inulin (prebiotics) and equicaloric placebo, respectively. Short chain fatty acids (SCFA), gastrointestinal hormones, glucose/lipid and inflammatory markers were assayed in fasting blood. Gut microbiota and SCFA were measured in stool.
RESULTS
Compared with placebo, participants showed decreased brain activation towards high-caloric wanted food stimuli in the ventral tegmental area and right orbitofrontal cortex after prebiotics (preregistered, family wise error-corrected p <0.05). While fasting blood levels remained largely unchanged, 16S-rRNA sequencing showed significant shifts in the microbiome towards increased occurrence of, among others, SCFA-producing , and changes in >60 predicted functional signalling pathways after prebiotic intake. Changes in brain activation correlated with changes in microbial abundance and associated activity previously linked with SCFA production, such as ABC transporter metabolism.
CONCLUSIONS
In this proof-of-concept study, a prebiotic intervention attenuated reward-related brain activation during food decision-making, paralleled by shifts in gut microbiota.
TRIAL REGISTRATION NUMBER
NCT03829189.
Topics: Animals; Female; Young Adult; Humans; Prebiotics; Overweight; Cross-Over Studies; Diet; Inulin; Fatty Acids, Volatile; Feces
PubMed: 37793780
DOI: 10.1136/gutjnl-2023-330365 -
Osteoarthritis and Cartilage Jan 2000Alternative medicine is used extensively by patients with chronic pain due to e.g., osteoarthritis. Only few of these drugs have be tested in a controlled setting and... (Clinical Trial)
Clinical Trial Randomized Controlled Trial
OBJECTIVE
Alternative medicine is used extensively by patients with chronic pain due to e.g., osteoarthritis. Only few of these drugs have be tested in a controlled setting and the present study was undertaken to examine the effect of ginger extract, one of the most popular herbal medications.
DESIGN
Ginger extract was compared to placebo and Ibuprofen in patients with osteoarthritis of the hip or knee in a controlled, double blind, double dummy, cross-over study with a wash-out period of one week followed by three treatment periods in a randomized sequence, each of three weeks duration. Acetaminophen was used as rescue medication throughout the study. The study was conducted in accordance with Good Clinical Practice (European Guideline for GCP).
RESULTS
A ranking of efficacy of the three treatment periods: Ibuprofen>ginger extract>placebo was found for visual analogue scale of pain (Friedman test: 24.65, P< 0.00001) and the Lequesne-index (Friedman test: 20.76, P< 0.00005). In the cross-over study, no significant difference between placebo and ginger extract could be demonstrated (Siegel-Castellan test), while explorative tests of differences in the first treatment period showed a better effect of both Ibuprofen and ginger extract than placebo (Chi-square, P< 0.05). There were no serious adverse events reported during the periods with active medications.
CONCLUSION
In the present study a statistically significant effect of ginger extract could only be demonstrated by explorative statistical methods in the first period of treatment before cross-over, while a significant difference was not observed in the study as a whole.
Topics: Adult; Aged; Aged, 80 and over; Anti-Inflammatory Agents, Non-Steroidal; Cross-Over Studies; Double-Blind Method; Female; Zingiber officinale; Humans; Ibuprofen; Male; Middle Aged; Osteoarthritis; Patient Compliance; Phytotherapy; Plant Extracts; Plants, Medicinal; Treatment Outcome
PubMed: 10607493
DOI: 10.1053/joca.1999.0264 -
BMC Emergency Medicine Mar 2023Accurate identification of the cricothyroid membrane is crucial for successful cricothyrotomy; however, a manoeuvre that helps identify it both accurately and quickly... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
Accurate identification of the cricothyroid membrane is crucial for successful cricothyrotomy; however, a manoeuvre that helps identify it both accurately and quickly remains unclear. The effectiveness of the so-called 'bottom-up manoeuvre' has never been investigated. This study aimed to examine whether the bottom-up manoeuvre is as rapid and accurate as the conventional 'top-down manoeuvre' at identifying the cricothyroid membrane.
METHODS
This study was a prospective randomised cross-over trial conducted at an academic medical centre between 2018 and 2019. Fifth-year medical students participated. The students were trained in the use of either the top-down manoeuvre or the bottom-up manoeuvre first. Each student subsequently performed the technique once on a volunteer. The students were then taught and practiced the other manoeuvre as well. The accuracy of cricothyroid membrane identification and the time taken by successful participants only were measured and compared between the manoeuvres using equivalence tests with two one-sided tests.
RESULTS
A total of 102 medical students participated in this study and there was no missing data. The accuracy of identification and time required for success were similar between the top-down manoeuvre and the bottom-up manoeuvre (65.7% vs. 70.6%, taking 13.8 s [interquartile range (IQR): 9.4-17.5] vs. 15.5 s [IQR: 11.5-19.9], respectively). The success rate was statistically equivalent (rate difference, 4.9%; 90% confidence interval [CI], -5.8 to 15.6; equivalence margin, -20.0 to 20.0). The time required for success was also statistically equivalent (median difference, 1.7 s; 90% CI, -0.2 to 3.3; equivalence margin, -4.0 to 4.0).
CONCLUSION
Among students first trained in both manoeuvres for identifying the cricothyroid membrane, the speed and accuracy of identification were similar between those using the bottom-up manoeuvre and those using the top-down manoeuvre.
Topics: Humans; Cross-Over Studies; Cricoid Cartilage; Prospective Studies; Thyroid Cartilage
PubMed: 36927402
DOI: 10.1186/s12873-023-00796-9 -
Endocrinology, Diabetes & Metabolism Jul 2021This study examined the effect of experimentally-induced hypoglycaemia on measures of myocardial blood flow and myocardial injury in adults with, and without, type 1... (Randomized Controlled Trial)
Randomized Controlled Trial
Effect of hypoglycaemia on measures of myocardial blood flow and myocardial injury in adults with and without type 1 diabetes: A prospective, randomised, open-label, blinded endpoint, cross-over study.
AIMS
This study examined the effect of experimentally-induced hypoglycaemia on measures of myocardial blood flow and myocardial injury in adults with, and without, type 1 diabetes.
METHODS
In a prospective, randomised, open-label, blinded, endpoint cross-over study, 17 young adults with type 1 diabetes with no cardiovascular risk factors, and 10 healthy non-diabetic volunteers, underwent hyperinsulinaemic-euglycaemic (blood glucose 4.5-5.5 mmol/L) and hypoglycaemic (2.2-2.5 mmol/L) clamps. Myocardial blood flow was assessed using transthoracic echocardiography Doppler coronary flow reserve (CFR) and myocardial injury using plasma high-sensitivity cardiac troponin I (hs-cTnI) concentration.
RESULTS
During hypoglycaemia, coronary flow reserve trended non-significantly lower in those with type 1 diabetes than in the non-diabetic participants (3.54 ± 0.47 vs. 3.89 ± 0.89). A generalised linear mixed-model analysis examined diabetes status and euglycaemia or hypoglycaemia as factors affecting CFR. No statistically significant difference in CFR was observed for diabetes status ( = .23) or between euglycaemia and hypoglycaemia ( = .31). No changes in hs-cTnI occurred during hypoglycaemia or in the recovery period ( = .86).
CONCLUSIONS
A small change in CFR was not statistically significant in this study, implying hypoglycaemia may require more than coronary vasomotor dysfunction to cause harm. Further larger studies are required to investigate this putative problem.
Topics: Blood Glucose; Cross-Over Studies; Diabetes Mellitus, Type 1; Humans; Hypoglycemia; Prospective Studies; Young Adult
PubMed: 34277982
DOI: 10.1002/edm2.258 -
Addiction (Abingdon, England) Mar 2023Smoking fewer cigarettes per day may increase the chances of stopping smoking. Capping the number of cigarettes per pack is a promising policy option, but the causal... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND AND AIMS
Smoking fewer cigarettes per day may increase the chances of stopping smoking. Capping the number of cigarettes per pack is a promising policy option, but the causal impact of such a change is unknown. This study aimed to test the hypothesis that lowering cigarette pack sizes from 25 to 20 reduces the number of cigarettes smoked.
DESIGN
This randomized controlled cross-over trial had two 14-day intervention periods with an intervening 7-day period of usual behaviour. Participants purchased their own cigarettes. They were instructed to smoke their usual brand from either one of two sizes of pack in each of two 14-day intervention periods: (a) 25 cigarettes and (b) 20 cigarettes. Participants were randomized to the order in which they smoked from the two pack sizes (a-b; b-a).
SETTING
Canada.
PARTICIPANTS
Participants were adult smokers who smoked from pack sizes of 25, recruited between July 2020 and June 2021. Of 252 randomized, 240 (95%) completed the study and 236 (94%) provided sufficient data for the primary analysis.
MEASUREMENTS
Cigarettes smoked per participant per day.
FINDINGS
Participants smoked fewer cigarettes per day from packs of 20 cigarettes [n = 234, mean = 15.7 standard deviation (SD) = 7.1] than from packs of 25 (n = 235, mean = 16.9, SD = 7.1). After adjusting for pre-specified covariates (baseline consumption and heaviness of smoking), modelling estimated that participants smoked 1.3 fewer cigarettes per day [95% confidence interval (CI) = -1.7 to -0.9], equivalent to 7.6% fewer (95% CI = -10.1 to -5.2%) from packs of 20 cigarettes.
CONCLUSIONS
Smoking from packs of 20 compared with 25 cigarettes reduced the number of cigarettes smoked per day.
Topics: Adult; Humans; Cross-Over Studies; Tobacco Products; Nicotiana; Smokers; Canada
PubMed: 36326156
DOI: 10.1111/add.16062 -
Kidney360 Aug 2023HDF and MCO have shown greater clearance of middle-size uremic solutes in comparison with HF dialyzers; MCO has never been studied in HDF. MCO in HDF does not increase...
KEY POINTS
HDF and MCO have shown greater clearance of middle-size uremic solutes in comparison with HF dialyzers; MCO has never been studied in HDF. MCO in HDF does not increase the clearance of B2M and results in a higher loss of albumin.
BACKGROUND
Middle molecule removal and albumin loss have been studied in medium cutoff (MCO) membranes on hemodialysis (HD). It is unknown whether hemodiafiltration (HDF) with MCO membranes provides additional benefit. We aimed to compare the removal of small solutes and 2-microglobulin (B2M), albumin, and total proteins between MCO and high-flux (HFX) membranes with both HD and HDF, respectively.
METHODS
The cross-over study comprised 4 weeks, one each with postdilutional HDF using HFX (HFX-HDF), MCO (MCO-HDF), HD with HFX (HFX-HD), and MCO (MCO-HD). MCO and HFX differ with respect to several characteristics, including membrane composition, pore size distribution, and surface area (HFX, 2.5 m; MCO, 1.7 m). There were two study treatments per week, one after the long interdialytic interval and another midweek. Reduction ratios of vitamin B12, B2M, phosphate, uric acid, and urea corrected for hemoconcentration were computed. Dialysis albumin and total protein loss during the treatment were quantified from dialysate samples.
RESULTS
Twelve anuric patients were studied (six female patients; 44±19 years; dialysis vintage 35.2±28 months). The blood flow was 369±23 ml/min, dialysate flow was 495±61 ml/min, and ultrafiltration volume was 2.8±0.74 L. No significant differences were found regarding the removal of B2M, vitamin B12, and water-soluble solutes between dialytic modalities and dialyzers. Albumin and total protein loss were significantly higher in MCO groups than HFX groups when compared with the same modality. HDF groups had significantly higher albumin and total protein loss than HD groups when compared with the same dialyzer. MCO-HDF showed the highest protein loss among all groups.
CONCLUSIONS
MCO-HD is not superior to HFX-HD and HFX-HDF for both middle molecule and water-soluble solute removal. Protein loss was more pronounced with MCO when compared with HFX on both HD and HDF modalities. MCO-HDF has no additional benefits regarding better removal of B2M but resulted in greater protein loss than MCO-HD.
Topics: Cross-Over Studies; Hemodiafiltration; Renal Dialysis; Humans; Albumins
PubMed: 37651666
DOI: 10.34067/KID.0000000000000185 -
Scientific Reports Sep 2022Extended cut-off filtration by medium cut-off membranes (MCO) has been shown to be safe in maintenance hemodialysis (HD). The notion of using them for the control of... (Randomized Controlled Trial)
Randomized Controlled Trial
Extended cut-off filtration by medium cut-off membranes (MCO) has been shown to be safe in maintenance hemodialysis (HD). The notion of using them for the control of chronic low-grade inflammation and positively influencing cellular immune aberrations seems tempting. We conducted an open label, multicenter, randomized, 90 day 2-phase cross over clinical trial (MCO- vs. high flux-HD). 46 patients underwent randomization of which 34 completed the study. Dialysate- or pre- and post-dialysis serum inflammatory mediators were assayed for each study visit. Ex vivo T cell activation was assessed from cryopreserved leucocytes by flow cytometry. Linear mixed models were used to compare treatment modalities, with difference in pre-dialysis serum MCP-1 levels after 3 months as the predefined primary endpoint. Filtration/dialysate concentrations of most mediators, including MCP-1 (mean ± SD: 10.5 ± 5.9 vs. 5.1 ± 3.8 pg/ml, P < 0.001) were significantly increased during MCO- versus high flux-HD. However, except for the largest mediator studied, i.e., YKL-40, this did not confer any advantages for single session elimination kinetics (post-HD mean ± SD: 360 ± 334 vs. 564 ± 422 pg/ml, P < 0.001). No sustained reduction of any of the studied mediators was found neither. Still, the long-term reduction of CD69+ (P = 0.01) and PD1+ (P = 0.02) activated CD4+ T cells was striking. Thus, MCO-HD does not induce reduction of a broad range of inflammatory mediators studied here. Long-term reduction over a 3-month period was not possible. Increased single session filtration, as evidenced by increased dialysate concentrations of inflammatory mediators during MCO-HD, might eventually be compensated for by compartment redistribution or increased production during dialysis session. Nevertheless, lasting effects on the T-cell phenotype were seen, which deserves further investigation.
Topics: Cephalosporins; Chitinase-3-Like Protein 1; Cross-Over Studies; Dialysis Solutions; Hemodiafiltration; Humans; Inflammation; Inflammation Mediators; Membranes, Artificial; Phenotype; Prospective Studies; Renal Dialysis
PubMed: 36180564
DOI: 10.1038/s41598-022-20818-z