Design and participants Danish school children aged 8–10 years were cluster randomised to a small-sided ball game group (SSG) (n=96, four schools, five. We investigated the exercise intensity and fitness effects of frequent school- based low-volume high-intensity training for 10 months in 8–year-old children. J Sports Med Phys Fitness. Oct doi: /S [Epub ahead of print]. Fitness effects of one year soccer training of and.
Patients who met 4 criteria were diagnosed of RLS. After an individualized explanation of the administration system, rotigotine transdermal patches were maintained for 24 h, with rotation of the application sites.
In case of requiring dose reduction, this was done progressively to avoid a rebound effect on symptomatology.. At the beginning of the study, main demographic data were collected age, gender, ethiology of renal failure, vintage and associated comorbidities diabetes mellitus, arterial hypertension, peripheral vascular disease, ischemic heart disease, Charlson comorbidity index, smoking, alcohol habit, caffeine derivatives.
Also, the following variables were analyzed.. It consists of 10 questions with 5 possible answers. Each answer is scored from 0 to 4. The simplest way to analyze the result is the sum of the total score.
From 15 points up, it is considered severe symptomatology. The higher the score, the greater the severity. The QS assesses using a qualitative scale 1: Quality of life was assessed using an approved health questionnaire adapted to RLS: The simplest way to analyze the results is the sum of the total score. Overall, the higher the score, the poorer quality of life for a RLS patient.
It consists of 2 sections; the first evaluates the nighttime sleep. It consists of 6 questions, 5 more specific and valued from 0 not to 3 much and a sixth question that is dedicated to global assessment with 7 possibilities from 0 very bad to 7 very good. In the second section daytime sleepiness is assessed. It consists of 6 specific questions valued from 0 never to 3 frequently. Compliance with the treatment was evaluated by reviewing the transdermal patch at the beginning of the HD session.
Those patients who presented absence of the transdermal patch in 3 regular revisions were classified as noncompliant.. Adverse effects analyzed by anamnesis during the usual sessions of HD were: The statistical analysis was performed using the SPSS program version By Kolmogorov—Smirnov test the data did not present a normal distribution. The quantitative variables were expressed by means and standard deviation. The qualitative variables, by percentage.
The quantitative data were compared using the Wilcoxon test for nonparametric related variables and the qualitative data using the McNemar test. A total of 66 patients prevalent in the HD program were analyzed. Five were excluded 3 had dementia, one did not accept to participate and another patient had a psychiatric disorder. Of the remaining 61 patients, 14 were diagnosed with RLS, with a prevalence of During the study period there were 5 dropouts one due to cardiorespiratory arrest, 3 due to revocation of informed consent and one due to malignant hematological disease , none of dropouts was the related to the present study.
Of the 9 remaining patients, The average Charlson index was The main comorbidities were: The main etiology of chronic kidney disease was diabetes mellitus The rest of the etiologies are shown in Fig. Among the potential triggers, No significant differences were observed in the main biochemical parameters and HD adequacy in both phases of the study Table 1.
Similarly, no changes were made in the patient's usual medication related to RLS during the study No patient was taking levodopa, clonidine, gabapentin, l -carnitine or antiemetics. Biochemical parameters and adequacy of hemodialysis.. No significant differences were found between the groups studied.. The values of the main variables analyzed in the different phases of the study are shown in Table 2. Regarding the severity of the symptoms, No relevant changes were observed in the GRLS scale Results expressed as mean standard deviation , initial vs.
John Hopkins restless leg syndrome quality of life; QS: During phase 2 of the study, we observed a significant improvement in GRLS No allergic reactions were observed in the application area. None of the patients in our study presented augmentation effect.. Overall, after the introduction of rotigotine phase 2 , we observed a significant improvement in terms of quality of life related to SPI JH-QoL Table 3 shows the difference of means of the main variables in the different phases of the study.
There was a significant improvement in terms of severity of symptoms 1. Analysis of differences between study groups.. Analysis of the mean changes of the main variables between the study groups. Results expressed as mean standard deviation.. Analysis using the nonparametric statistical test U of Mann—Whitney.. In these patients, the use of rotigotine improved the clinical symptoms, quality of life and sleep habits; it is a safe drug, with minimal adverse effects and complete therapeutic compliance..
The prevalence of RLS in our HD unit, it is practically the same as previously described in the literature 4, Patients with RLS have a decreased in life quality with depression and anxiety as well as a abnormalities in sleep habits producing daytime sleepiness and fatigue. The presence of all these symptoms affected quality of life and sleep habits.. Currently, therapy with non-ergotamine dopamine agonists has become the first-line of therapy for moderate-severe involvement of RLS.
The most commonly used medications are pramipexole, ropinirole and, more recently, rotigotine. Main randomized clinical trials with pharmacological intervention in patients with restless legs syndrome in renal replacement therapy.. Within this group of drugs, the use of rotigotine has been extended in the every day practice due to the efficacy, good tolerance, few adverse effects, low prevalence of paradoxical potentiation of symptoms or augmentation effect and no need for dose adjustment in CKD patients.
In addition transdermal application facilitates therapeutic adherence, by decreasing the number of tablets the majority of patients on multiple medications, facilitating therapeutic compliance. The draw back is the high cost, superior to the rest of the non-ergotamine agonists. In our study, rotigotine was a safe and effective drug, with minimal adverse effects and complete therapeutic compliance, there were no dropouts and achieved a significant improvement in clinical symptoms, quality of life related to RLS and sleep habits..
To date, uremic RLS has been underestimated as evidenced by the fact that none of the patients diagnosed received specific treatment for RLS. Among other reasons, this was probably due to: All these aspects have lead to the use of various medications without clear guidelines, based on the clinical experiences themselves or on a few published works..
There is a significant prevalence of RLS, a pathology that causes significant symptomatology associated to deterioration of the quality of life, without lack of specific abnormalities in blood count or biochemical parameters. Based on the results obtained in this study we should consider establishing different strategies to assess the presence of RLS in our patients..
Those cases with reasonable doubts will be discussed with the Neurology Service for a more exhaustive assessment. In the same way, the severity of the symptoms and the quality of life and sleep habits will be assessed by means of the tests described above and, in addition the patient will receive dietetic advice and the appropriate medical treatment according to the individual clinical characteristics..
Within the multiple limitations of our study, we must mention the small number of patients included which forced the use of nonparametric statistical tests, as well as the short time of follow-up.
The sample size was conditioned by our limited population in HD, while the week period was established to avoid possible confounding effect derived from the usual changes in medications after the quarterly analytical determinations in our HD unit.
Therefore, we cannot rule out the possibility that a longer period of followup could entail some change in relation to the effectiveness, safety and tolerance of rotigotine. Studies with a larger number of patients and longer duration would be necessary to confirm the benefits of rotigotine observed in our patients in HD.. In conclusion, we can state that there is considerable prevalence RLS, with an intense symptomatology and a deteriorated quality of life and sleep habits.
The use of rotigotine improved clinical symptoms, quality of life and sleep habits in HD patients with RLS. It proved to be a safe drug, with minimal adverse effects and complete therapeutic compliance.
However, future studies would be necessary to confirm the benefit of rotigotine in the HD population with RLS.. The authors declare that they have no conflicts of interest.. Please cite this article as: Home Articles in press Archive. Previous article Next article. January - February Pages Effects of rotigotine on clinical symptoms, quality of life and sleep hygiene adequacy in hemodialysis-associated restless legs syndrome. This item has received.
Under a Creative Commons license. Show more Show less. Background Restless legs syndrome RLS is a neurological disorder characterized by bothersome symptoms associated with impaired quality of life and sleep hygiene. Rotigotine is a novel therapeutic alternative, although few studies have been published in patients on hemodialysis HD with RLS treated with rotigotine.
Material and methods A single-center, week prospective study. Nevertheless, future studies should be performed to confirm the benefits of rotigotine in RLS patients on hemodialysis. Introduction Restless legs syndrome RLS is an entity characterized by an uncontrollable impulse to move limbs, especially lower limbs, accompanied by discomfort or unpleasant sensations in these extremities such as itching, tingling, pain, stretching, etc. Methods During the months from January to April , a prospective, week, single-center study was performed in patients with RLS included in regular HD in our center.
The study was approved by the Hospital Ethics and Clinical Research Committee and it was carried out in accordance with the Helsinki Declaration. In case of requiring dose reduction, this was done progressively to avoid a rebound effect on symptomatology. Also, the following variables were analyzed. Degree of severity of restless legs syndrome symptoms and questionnaire on specific symptoms The degree of severity of the symptoms was determined by the severity scale GRLS established by the IRLSSG19 and the symptomatology in both lower limbs by means of a questionnaire of specific symptoms QS.
Quality of life and sleep habits Quality of life was assessed using an approved health questionnaire adapted to RLS: Tests for normality were included in the model, and all data were found to be normally distributed. Differences between the time restricted feeding and control groups at baseline were analyzed by an independent samples t -test continues variables or the McNemar test categorical variables.
Data were included for 46 participants, and means were estimated using an intention-to-treat analysis using last observation carried forward. Repeated measures two-factor ANOVA with groups time restricted feeding and control as the between-subject factor and time week 1 and 12 as the within-subject factor was used to compare changes in dependent variables between the groups over time.
As portrayed in Fig. No subjects reported dropping out of the time restricted feeding group due to issues with the diet. Subjects in the time restricted feeding group were compliant with the prescribed eating window Weekly adherence to the 8-hour feeding window by the time restricted feeding group. Each bar indicates the mean number of days per week that the time restricted feeding subjects were compliant with the 8-hour feeding window.
On average, the time restricted feeding group was compliant with the prescribed eating window Self-reported dietary intake, eating duration, and physical activity at baseline and week 12 1. Data for all variables were collected over a 7-d period at baseline prior to the commencement of the study and week 12 in the TRF and control groups.
Data were included for 46 participants; means were estimated using an intention-to-treat analysis using last observation carried forward. No difference between groups for any parameter Independent samples t -test. Self-reported intake of macronutrients, dietary cholesterol and fiber did not differ between groups at baseline or post-treatment.
Body weight remained stable during the 2-week baseline period Fig. Body weight decreased in the time restricted group —2. There were no statistically significant differences i. Weight loss by the time restricted feeding group versus controls 1. Body weight remained stable during the 2-week baseline period week B1 and week B2.
Body composition and metabolic disease risk factors after 12 weeks 1. Homeostatic model assessment Insulin resistance; RMR: This study is the first trial to examine the impact of time restricted feeding on body weight and metabolic disease risk factors in an obese population. We show here that 12 weeks of 8-h time restricted feeding i. We also demonstrate that this fasting regimen produces significant reductions in systolic blood pressure relative to controls. Adherence to the time restricted feeding window was assessed daily via self-report.
However, no one in the time restricted feeding group reported dropping out due to issues with the diet. These preliminary findings suggest that time restricted feeding may be somewhat well tolerated over short periods in obese subjects. This may be due, in part, to the shorter trial duration 3 months implemented here, when compared to the h time restricted feeding study 4 months [ 11 ].
In comparison to other forms of intermittent fasting [ 4—10 ], time restricted feeding appears to produce less weight loss. We speculate that this difference in weight loss is due to greater overall caloric restriction achieved with other forms of intermittent fasting, versus time restricted feeding.
The greater degree of energy restriction achieved with alternate day fasting is most likely the result of the vigilant calorie counting on fast days. Since time restricted feeding does not require subjects to monitor calorie intake at all, this may explain why the average caloric deficit achieved with time restricted feeding is lower. One potential confound in the current study is the lack of an objective measure to assess eating duration. As time restricted feeding is a recent concept, methods to objectively record eating time have yet to be optimized.
Self-reporting of eating duration, as used in the current study, may not be optimal. Objective methods of recording eating events show a mean eating duration that is different from what is widely believed [ 11 ]. Our study also permitted the consumption of low energy drinks including coffee, tea, and diet soda. These drinks contain caffeine, which is known to perturb circadian rhythm [ 17 ].
Since time restricted feeding is based on the principle of circadian rhythm regulation of metabolism, low-energy caffeinated drinks may not count significantly towards energy consumption, but can have significant impact on circadian regulation. Future trials in this area can be improved by using objective measures to better assess daily eating durations. Moreover, how the placement of the feeding window influences weight loss and adherence will also be important to examine.
We chose to prescribe a feeding window of We assumed that this window would produce maximal adherence, as it would cause minimal disruption to the typical eating schedule i. However, recent trials [ 18, 19 ] have found that consuming larger meals earlier in the day produce better weight loss than similar sized meals consumed later in the evening. Whether weight loss and adherence can be improved by shifting the eating window earlier in the day warrants investigation.
Metabolic disease risk indicators remained relatively unaffected by the time restricted feeding regimen. Systolic blood pressure was the only parameter that improved over the course of the study, relative to controls.
Reductions in insulin, insulin resistance, triglycerides, and homocysteine were also observed over time, but these effects were not statistically different from the control group. In the study by Moro et al.
It is likely that the degree of weight loss produced by 8-h time restricted feeding was not large enough to improve these outcome measures. It should also be noted that the obese subjects in the present study were metabolically healthy at baseline, i. Previous work indicates that intermittent fasting regimens [ 4, 8, 10 ] and other lifestyle regimens [ 21, 22 ] have little effect on cardiometabolic disease risk factors in healthy obese subjects. It will be of interest to examine whether time restricted feeding can improve these risk factors in other groups of obese patients, such as those with compromised insulin sensitivity or dyslipidemia [ 23, 24 ].
This study has several limitations. First, the study was not a randomized controlled trial. We compared the effects of time restricted feeding to a matched historical control group from a previous weight loss trial conducted by our group.
The trial [ 10 ] from which the controls were selected was conducted between — As such, the lapse of up to five years between trials could have influenced what the control subjects knew about weight control, and what foods were available in the marketplace due to seasonality. These issues should be considered when interpreting the present findings. In order to truly determine the effect of time restricted feeding on body weight and other metabolic disease variables, future trials should implement a randomized design where controls are enrolled concurrently.
Second, the study was quite short 12 weeks. Longer-term trials will be needed to determine the degree of weight loss that can be achieved with time restricted feeding. Third, adherence and dietary intake were assessed by self-report, thus our estimates of eating duration and caloric deficit may be inaccurate [ 25, 26 ]. Implementing mobile apps to assess adherence in real-time [ 11 ] will help determine how well subjects can adhere to the prescribed eating window.
Fourth, subjects completed a 7-d food record during the baseline period, which may have influenced their eating behaviors [ 27 ]. Recent findings suggest that subjects are more likely to report foods that are considered healthy and socially desirable, and omit foods that are considered unhealthy, when completing study-related food records [ 27 ].
Fifth, our study involved only metabolically healthy obese subjects, so our findings cannot be generalized to other populationgroups.
In summary, these findings suggest that 8-h time restricted feeding produces mild caloric restriction and weight loss in obese adults, without intentional calorie counting. This diet may also offer some clinical benefit by reducing systolic blood pressure.
These preliminary data offer promise for the use of time restricted feeding as a weight loss technique in obese adults, but longer-term, larger-scale randomized controlled trials will be required before solid conclusions can be reached. The other authors have no conflicts of interest to report. KG designed the research, conducted the clinical trial, analyzed the data, performed the statistical analysis, and wrote the manuscript; KKH, NH, JS, CMK, and JFT assisted with the conduction of the clinical trial; SP assisted with data interpretation and wrote the manuscript; KAV designed the research, analyzed the data, and wrote the manuscript.
Molecular mechanisms and clinical applications. Longo VD , Panda S. Chaix A , et al. Time-restricted feeding is a preventative and therapeutic intervention against diverse nutritional challenges. Bhutani S , et al. Alternate day fasting and endurance exercise combine to reduce body weight and favorably alter plasma lipids in obese humans. Catenacci VA , et al.
A randomized pilot study comparing zero-calorie alternate-day fasting to daily caloric restriction in adults with obesity. Harvie MN , et al. The effects of intermittent or continuous energy restriction on weight loss and metabolic disease risk markers: A randomized trial in young overweight women.
Int J Obes Lond. Heilbronn LK , et al. Alternate-day fasting in nonobese subjects: Effects on body weight, body composition, and energy metabolism. Am J Clin Nutr. Hoddy KK , et al. Meal timing during alternate day fasting: Impact on body weight and cardiovascular disease risk in obese adults. Alternate day fasting ADF with a high-fat diet produces similar weight loss and cardio-protection as ADF with a low-fat diet. Trepanowski JF , et al. A Randomized Clinical Trial.
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Here we report our investigations on the binding interactions of a NDI diammonium dichloride salt (NDI·Cl2) with cucurbit[n]uril (CB[n], n = 8, 10) and the. Although aware of the negative effect of smoke on their own health, only 20% of BMC International Health and Human Rights Prenatal Music Exposure Induces Long-Term Neural Effects PLoS ONE 8(10): e ww-2.info