scholarly journals The target matters – general vs. individualized exercise prescription for fertile-aged women with metabolic risk: a randomized controlled trial

2020 ◽  
Author(s):  
Maritta K Poyhonen-Alho ◽  
Vesa Hyrylä ◽  
Mika P. Tarvainen ◽  
Heikki O. Tikkanen ◽  
Saila Koivusalo ◽  
...  

Abstract Background Little is known about the associations of different depths of individualization of the exercise intervention on cardiorespiratory fitness (CRF), metabolic outcomes and cardiac autonomic regulation in at-risk subjects. This randomized trial compared the effect of general physical activity (PA) guideline -targeted and highly individualized exercise intervention on maximal oxygen uptake, heart rate variability, body composition, and glucose and lipid profiles in fertile-aged women with increased risk for gestational diabetes. Methods Forty-five women with previous gestational diabetes or BMI>30kg/m 2 were randomized into general advice without intervention (Group 1), individualized intervention planned according to PA questionnaires and general guidelines for exercise training (Group 2) and highly individualized intervention based on results from the pre-intervention cardiopulmonary exercise test (CPET) groups (Group 3). All subjects performed pre-intervention CPET on a cycle ergometer with step incremental protocol until volitional fatigue, followed by a 3-month intervention period and post-intervention CPET. Examinations included HRV assessment during CPET and body composition (bioimpedance), blood glucose and lipid profiles. Results Total dropout was 53.8% at various points of the study leaving 8 subjects in Group 1, 12 subjects in Group 2 and 10 subjects in Group 3. CRF improved only in Group 3 (+1.9 ml/kg/min, 95% CI 0.3 to 3.5). This was associated with an increase in high-density lipoprotein (0.18 mmol/L, 95% CI 0.04 to 0.32) and increased HRV. In Group 2, we found a decrease in body mass index (-0.7 kg/m 2, 95% CI -1.3 to -0.1), fasting insulin (-4.14 mU/L, 95% CI -6.58 to -1.70), insulin resistance (-1.21, 95% CI -1.88 to -0.54), and low-density lipoprotein (-0.44 mmol/L, 95% CI -0.79 to -0.09). The dropouts in Group 1 had significantly less weight, smaller waist circumference, less visceral fat, and higher maximal oxygen uptake compared to the continuers in Group 1. Conclusions To improve CRF and cardiac autonomic function the exercise intervention should be highly individualized. PA intervention focused to achieve general exercise guidelines is not enough to improve CRF over 3-month period but combined with weight loss has beneficial effects on the metabolic profile. In randomized controlled trials, dropout may be biased. Trial Registration clinicaltrials.gov (NCT01675271)

Author(s):  
Atit Kumar ◽  
Prashant Kumar Mishra ◽  
Saurabh Shukla

Background: Direct laryngoscopy and endotracheal intubation frequently induce cardiovascular stress response characterised by hypertension and tachycardia due to reflex sympathetic stimulation. Considering the clinical significance of these changes stress attenuation is needed to blunt these responses. β- blockers are used to reduce the unwanted hemodynamic responses. Esmolol is ultra-short acting cardio selective β blocker. Labetalol is useful in not only attenuating the response to laryngoscopy and intubation but also in preventing perioperative cardiovascular events. Present study compared the efficacy of esmolol and labetalol for attenuation of sympathomimetic response to laryngoscopy and intubation.Methods: It was a prospective, randomized, controlled study carried out in 75 adult patients with ASA 1 and ASA 2 posted for elective surgeries. Patients were allocated randomly into Group-1 (esmolol) and Group-2 (labetalol) and Group-3 (placebo) of 25 patients each. Inj. esmolol (1mg/kg) or Inj. labetalol (0.4 mg/kg) or placebo (0.9NS) dissolved up to 5 ml in distilled water was injected intravenously 5 minutes prior to intubation. All patients premeditated with Inj. glycopyrrolate (4µg/kg). Patient were then induced with Inj. propofol (2mg/kg), Inj. scoline (2mg/kg) given followed by laryngoscopy and intubation. Haemodynamic readings were noted at T0 (baseline before injecting the drug), T1 (1 minute after injecting the drug), T2 (after intubation), T3 (2 minutes after intubation), T4 (4 minutes after intubation), T5 (6 minutes after intubation), T6 (8 minutes after injection), T7 (10 minutes after injection).Results: Gr-1, Gr-2 and Gr-3, when compared with each other for systolic BP, diastolic BP, mean BP, and HR, showed a statistically significant difference at different intervals.Conclusions: Both the drugs are found to be effective in attenuation of hemodynamic reflex without any side effects. Further studies are recommended to substantiate the findings in present study.


2018 ◽  
Vol 4 (2) ◽  
pp. 35-39
Author(s):  
Md Khairuzzaman ◽  
MA Mannan ◽  
Abdul Matin ◽  
Mst Monjuman Ara Sarker ◽  
Nihar Ranjan Sarker ◽  
...  

Background: Chlorhexidine cleansing of the cord can reduce neonatal mortality among newborns.Objective: The aim of study was to determine the effect of cord cleansing with chlorhexidine in reduction of umbilical infection among newborns in hospital settings.Methodology: This randomized controlled trial was carried out between April 2013 to July 2014 and 510 newborns were randomly assigned within a tertiary level hospital in Bangladesh to receive 1 of 3 cord care regimens single cord cleansing with 4% chlorhexidine(Group-1), multiple cord cleansing with 4% chlorhexidine (Group-2)  and clean and dry cord care (Group-3 : control).Results: The risk of umbilical cord infection (omphalitis) was significantly reduced in both the single (Relative risk [RR] 0.15 [95% CI] 0.008-0.93) and multiple chlorhexidine cleansing group (RR 0.37 [95% CI] 0.04- 0.99) compared to the dry cord care group.  The risk of omphalitis was not significantly different between multiple and single chlorhexidine cleansing group (RR 3.14 [0.13-76.54]). Conclusion: Chlorhexidine significantly reduce the risk of umbilical infection in both single and multiple cord cleansing neonates.Bangladesh Journal of Infectious Diseases 2017;4(2):35-39


2021 ◽  
Vol 103-B (10) ◽  
pp. 1595-1603
Author(s):  
Paul Magill ◽  
Janet C. Hill ◽  
Leeann Bryce ◽  
Una Martin ◽  
Al Dorman ◽  
...  

Aims In total knee arthroplasty (TKA), blood loss continues internally after surgery is complete. Typically, the total loss over 48 postoperative hours can be around 1,300 ml, with most occurring within the first 24 hours. We hypothesize that the full potential of tranexamic acid (TXA) to decrease TKA blood loss has not yet been harnessed because it is rarely used beyond the intraoperative period, and is usually withheld from ‘high-risk’ patients with a history of thromboembolic, cardiovascular, or cerebrovascular disease, a patient group who would benefit greatly from a reduced blood loss. Methods TRAC-24 was a prospective, phase IV, single-centre, open label, parallel group, randomized controlled trial on patients undergoing TKA, including those labelled as high-risk. The primary outcome was indirect calculated blood loss (IBL) at 48 hours. Group 1 received 1 g intravenous (IV) TXA at the time of surgery and an additional 24-hour postoperative oral regime of four 1 g doses, while Group 2 only received the intraoperative dose and Group 3 did not receive any TXA. Results Between July 2016 and July 2018, 552 patients were randomized to either Group 1 (n = 241), Group 2 (n = 243), or Group 3 (n = 68), and 551 were included in the final analysis. The blood loss did differ significantly between the two intervention groups (733.5 ml (SD 384.0) for Group 1 and 859.2 ml (SD 363.6 ml) for Group 2; mean difference -125.8 ml (95% confidence interval -194.0 to -57.5; p < 0.001). No differences in mortality or thromboembolic events were observed in any group. Conclusion These data support the hypothesis that in TKA, a TXA regime consisting of IV 1 g perioperatively and four oral 1 g doses over 24 hours postoperatively significantly reduces blood loss beyond that achieved with a single IV 1 g perioperative dose alone. TXA appears safe in patients with history of thromboembolic, cardiovascular, and cerebrovascular disease. Cite this article: Bone Joint J 2021;103-B(10):1595–1603.


2016 ◽  
Vol 32 (7) ◽  
pp. 488-495 ◽  
Author(s):  
Illymack CF de Araújo ◽  
Elenice Defune ◽  
Luciana PF Abbade ◽  
Hélio A Miot ◽  
Matheus Bertanha ◽  
...  

Objectives Compare the efficacy and safety of fibrin gel to 8% papain gel for wound dressing of venous ulcers. Method Patients with chronic venous ulcers were randomly assigned to one in three groups: Group 1—fibrin gel; Group 2—8% papain gel; Group 3—carbopol gel (control). Patients were seen every 15 days during 2 months, verifying reduction of the ulcer area, local infection, exudation, and epithelization. All serious or nonserious adverse events were recorded. Results Fifty-five patients (total of 63 ulcers) were randomly distributed in three groups (G1 = 21; G2 = 19; G3 = 23). No patient was excluded or discontinued treatment throughout the study. The areas of the ulcers were similarly reduced in all groups (14.3%, 21.1%, and 30.4% in groups 1, 2, and 3, respectively), and all had significant reduction in exudation and contamination. Conclusion The data demonstrate that neither fibrin gel nor papain gel were able to improve the process of ulcer-healing, as compared to control.


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
T.V Fofanova ◽  
M.D Smirnova ◽  
F.T Ageev

Abstract Background Long-term adherence to lipid-lowering treatment is a challenge. Purpose To develop a technical tool, an auto-call program, aimed to increase patient adherence to lipid-lowering therapy, and patient outcome in ambulatory care. Methods 919 ambulatory patients were studied, divided to three groups: with low or moderate risk of developing atherosclerosis complications (Group 1); with high or very high risk of atherosclerosis complications, but without coronary artery disease (CAD) symptoms (Group 2); patients with symptomatic CAD (Group 3). At baseline, patients were invited to participate in the auto-call program (call-reminder to take the medication); the duration of study was 1 year. 663 patients (71.3%) consented to auto-calls received, 256 patients (28.7%) declined auto-calls. These two groups were comparable according to age, gender, the presence of comorbidities, the level of baseline adherence to lipid-lowering therapy, and the level of anxiety and depression. Treatment adherence was evaluated using Morisky-Green Medication Adherence Scale. Results Group 1. After 1 year, the auto-call group showed a significantly higher degree of decrease in low-density lipoprotein cholesterol, LDL-C (p=0.001) and triglyceride, TG (p=0.002), and increase in high-density lipoprotein cholesterol, HDL-C (p=0.03) compared to the auto-call rejection group. Group 2. After 1 year, the auto-call group showed a significantly higher degree of decrease in total cholesterol, TC (p&lt;0.02) and LDL-C (p&lt;0.01), and increase in HDL-C (p=0.2) compared to the auto-call rejection group. Moreover, in the auto-call group, the baseline TC level was higher (6.4±1.5 mmol/l vs 6.0±1.4 mmol/l, p=0.03). Group 3. After 1 year, the auto-call group showed a significantly higher degree of decrease in TC (p&lt;0.005) and TG (p&lt;0.05). The degree of decline in LDL-C was higher in the auto-call group (−25.9 (−27.3; −17.0) vs −20.1 (−21.3; −0.2), however, non-significant. After 1 year, treatment adherence increased in the total cohort from 1.91 score (1.80; 2.02) to 2.6 score (2.52; 2.80), p&lt;0.000001. However, in Group 3, a significant increase in scores from 2.0 (1.9; 2.2) to 3.0 (2.6; 3.1) was observed only in the auto-call group (p&lt;0.00001). In Group 1 and Group 2, the increase in adherence did not depend on the presence or absence of auto-calls. It should be noted that adherence to therapy in patients of Group 3 was significantly higher at baseline (2.0 (1.9; 2.2) than in Group 1 (1.7 (1.6; 1.9), p&lt;0.005) and Group 2 (1.9 (1.7; 2.1), p&lt;0.05), respectively. Conclusions Utilizing a high-tech auto-call reminder tool in patients with hyperlipidemia and CAD was associated with increased adherence to lipid-lowering therapy, which, in turn, resulted in significant decrease in LDL-C compared to patients who declined to participate in the auto-call program. Funding Acknowledgement Type of funding source: None


2020 ◽  
Author(s):  
Xiaotian Sun ◽  
Yang Xu ◽  
Xueting Zhang ◽  
Cuiyun Ma ◽  
Aitong Li ◽  
...  

Abstract Background: Esophagogastroduodenoscopy is very useful in diagnosing and treating upper gastrointestinal mucosal disorders, but too much foam and water in stomach decrease its diagnostic efficiency. Simethicone administration can help remove excessive foam. Aims: To determine the optimal simethicone administration strategies in a comparative randomized controlled clinical trial.Methods: Adult outpatients with indications for esophagogastroduodenoscopy were enrolled and randomly divided into Group 1 (simethicone solution intake 20-30 min before procedure, n=110), Group 2 (simethicone solution intake 31-60 min before procedure, n=92) and Group 3 (simethicone solution intake >60 min before procedure). Primary and secondary outcome were procedure time and the patients' satisfaction after the examination. All symptoms like abdominal pain, distension were recorded.Results: No statistically significant differences were found on the patients’ demographic and clinical features, and mean examination time (all P values >0.05). The distribution of patients with different endoscopic and pathological diagnosis was comparable among three groups, respectively (P=0.607; P=0.289). However, the proportion of patients with Gastric Cleanness Grade A was most in Group 2 (n=73, 79.3%), and patient proportion with Gastric Cleanness Grade C was most found in Group 1 (n=72, 65.5%), which was greatly different (P<0.001). There was no statistically significant difference on the satisfaction scores [immediately 6 (3-8) vs. 6 (1-10) vs. 6 (1-9), P=0.533; 2h after 10 (8-10) vs. 10 (10-10) vs. 10 (8-10), P=0.463].Conclusion: Simethicone solution intake 31-60 min before esophagogastroduodenoscopy can help obtain best gastric cleanness, which is recommended in clinical practice (registered at ClinicalTrials.gov, NCT03776916).


Author(s):  
Chen Sarbagili Shabat ◽  
Franco Scaldaferri ◽  
Eran Zittan ◽  
Ayal Hirsch ◽  
Maria Chiara Mentella ◽  
...  

Abstract Background We evaluated whether integration of novel diets for donors and patients in addition to fecal transplantation (FT) could increase FT remission rate in refractory ulcerative colitis (UC). Methods This was a blinded randomized controlled trial in adults with active UC, defined by a simple clinical colitis activity index (SCCAI) of ≥5 and ≤ 11 and endoscopic Mayo score 2-3, refractory to medication. Group 1 received free diet and single donor standard FT by colonoscopy on day 1and rectal enemas on days 2 and 14 without dietary conditioning of the donor. Group 2: FT as above but with dietary pre-conditioning of the donor for 14 days and a UC Exclusion Diet (UCED) for the patients. Group 3 received the UCED alone. The primary endpoint was week 8 clinical steroid free remission, defined as SCCAI &lt;3. Results Sixty two of 96 planned patients were enrolled. Remission week 8 Group 1 was 2/17 (11.8%), Group 2 4/19 (21.1%), Group 3 6/15 (40%) (NS). Endoscopic remission was Group 1 2/17 (12%), Group 2 3/19 (16%), Group 3 4/15 (27%) (Group 1 vs.3 p=0.38). Mucosal healing (Mayo 0) was achieved only in Group 3 (3/15, 20%) vs. 0/36 FT patients (p=0.022). Exacerbation of disease occurred in 3/17 (17.6%) Group 1, 4/19 (21.1%) Group 2, and 1/15 (6.7%) Group 3 (Group 2 vs.3, p=0.35). Conclusions UCED alone appeared to achieve higher clinical remission and mucosal healing than single donor FT with or without diet. The study was stopped for futility by a safety monitoring board.


2020 ◽  
Vol 103 (12) ◽  
pp. 1255-1261

Objective: To compare the effect of cord clamping time on the incidence of neonatal anemia, clinical outcomes, and maternal and neonatal complications in term vaginal delivered newborns. Materials and Methods: A randomized controlled study was undertaken. Two hundred forty healthy full term vaginal delivered newborns were randomly allocated to either 30-seconds, 1-minute, or 2-minutes groups (group 1, 2, and 3) of umbilical cord clamping. During the interval between delivery and cord clamping, the attendant held the neonate supine at the level of the introitus. Neonatal venous hematocrit (Hct) was measured at 48 to 72 hours after birth. Results: Two hundred thirty newborns completed the present study. Neonatal anemia (Hct less than 45%) was detected in six of 77 cases (7.8%) in group 1, five of 76 cases (6.6%) in group 2, and three of 77 case (3.9%) in group 3, and there were no significant differences among the groups. Mean venous hematocrit values at 48 to 72 hours of life ± standard deviations were 53.1±6.4% in group 1, 53.0±5.5% in group 2, and 53.0±5.7% in group 3. The incidence of polycythemia (hematocrit more than 65%) and neonatal jaundice were similar among all the groups. There were no significant differences in the estimated postpartum blood loss and other neonatal outcomes. Conclusion: Neonatal hematocrit was not significantly different following delayed cord clamping (DCC) at 30-seconds, 1-minute, and 2-minutes, but the incidence of neonatal anemia decreased with the longer timing of DCC. The estimated blood loss and other complications were not different between the groups. Therefore, a minimum of a one minute DCC should be considered for neonatal anemic prevention when compared with the 30-seconds DCC. Keywords: Delayed cord clamping, Timing, Hematocrit, Neonatal anemia


2008 ◽  
Vol 2 ◽  
pp. BBI.S445 ◽  
Author(s):  
Mohamed A.K. Abdelhalim ◽  
N.J. Siiddiqi ◽  
A.S. Alhomida ◽  
Mohammed S. Al-Ayed

Hypercholesterolemia and hypertriglyceridemia are considered as important risk factors during the atherosclerotic process. The aim of the present investigation was to study the total cholesterol (TC), low-density lipoprotein cholesterol (LDLC), high density lipoprotein (HDL), triglyceride (TG), platelet levels and hydroxyproline fractions during the pathogenesis of atherosclerosis. For this purpose, twenty five 12-weeks, New Zealand white male rabbits, were purchased, individually caged, and divided into either control group or cholesterol-fed group. The control group (n = 10) was fed 100 g/day of normal diet, ORC-4 (Oriental Yeast Co. Ltd., Tokyo, Japan) for a period of 15 weeks. The cholesterol-fed group (n = 15) was fed a high cholesterol and saturated fat diet of ORC-4 containing 1% cholesterol plus 1% olive oil (100 g/day) for periods of 5 (group 1), 10 (group 2) and 15 (group 3) weeks. Blood sample from each animal was taken at the end of the experimental period for the biochemical analysis. The results of the present study showed that TC, LDLC, TG, HDLC and platelets were significantly (P < 0.01) increased in cholesterol-fed rabbits as compared with control rabbits. The serum hydroxyproline (Hyp) in rabbits belonging to group 1 showed no significant alteration when compared to control group. Group 2 rabbits showed a significant increase of 103% (P < 0.01) and 100% (P < 0.001) in free and protein—bound hydroxyproline fractions respectively when compared to control rabbits. However, there was no significant change in peptide—bound and total serum hydroxyproline levels as compared to the control group (P > 0.05). There was no significant (P > 0.05) decrease of free serum hydroxyproline in group 3 rabbits when compared to control rabbits. On the other hand, group 3 rabbits showed a significant increase in peptide-bound and protein- bound Hyp by 517% (P < 0.05) and 100% (P < 0.01) respectively when compared to control rabbits. However, total serum Hyp in group 3 rabbits showed no significant (P > 0.05) change when compared to control rabbits. These results suggest that feeding rabbits high cholesterol and saturated fat diet for feeding periods of 5, 10 and 15 weeks induced significant change in TC, LDLC, HDL, TG, platelet levels and various Hyp fractions in serum without any significant change in the total Hyp content.


2020 ◽  
Vol 45 (5) ◽  
pp. 601-611
Author(s):  
Mehmet Fatih Alpdemir ◽  
Medine Alpdemir

AbstractObjectivesThe aim of this study was to compare low-density lipoprotein cholesterol (LDL-C) estimations using various formulas with directly measured LDL-C (d-LDL-C) in the Turkish population.Material and methodsA total of 1,478 participants who were aged between 18 and 80 were classified into five groups according to serum triglyseride (TG) concentration as follows: <100, 100–199, 200–299, 300–399, and 400–1000 mg/dL. Glucose (Glu), LDL-C, total cholesterol (TC), HDL-C, TG, and HbA1C were measured with Cobas 6000 c501. d-LDL-C concentrations were measured by a homogenous direct assay using reagents. We investigated the accuracy 10 equations that are Friedewald, De Cordova, Ahmadi, Anandaraja, Teerakanchana, Chen, Hattori, Vujovic, Puavillai, and Hatta for estimating LDL-C in this study.ResultsIn group 1, Anandaraja formula correlated best with d-LDL-C (r=0.367), but this correlation is weakly. In group 2; Teerakanchana formula (r=0.931), in group 3; Friedewald and Teerakanchana formulas (r=0.935, r=0.961), in group 4; Teerakanchana formula (r=0.950) and in group 5, Anandaraja formula (r=0.792) correlated best with d-LDL-C.ConclusionsIn this study, although there was a strong correlation between d-LDL-C measurement and estimated LDL-C formulas, there was a negative bias between results of these formulas and the d- LDL-C.


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