Effect of Treatment of Mild Gestational Diabetes on Long-Term Maternal Outcomes.
American journal of perinatology. 2020;(5):475-482
OBJECTIVE The main purpose of this article is to evaluate whether identification and treatment of women with mild gestational diabetes mellitus (GDM) during pregnancy affects subsequent maternal body mass index (BMI), anthropometry, metabolic syndrome, and risk of diabetes. STUDY DESIGN This is a follow-up study of women who participated in a randomized controlled treatment trial for mild GDM. Women were enrolled between 5 and 10 years after their index pregnancy. Participants underwent blood pressure, height, weight, and anthropometric measurements by trained nursing personnel using a standardized approach. A nurse-assisted questionnaire regarding screening and treatment of diabetes or hypercholesterolemia, diet, and physical activity was completed. Laboratory evaluation included fasting serum glucose, fasting insulin, oral glucose tolerance test, and a lipid panel. Subsequent diabetes, metabolic syndrome, obesity, and adiposity in those diagnosed with mild GDM and randomized to nutritional counseling and medical therapy (treated) were compared with those who underwent routine pregnancy management (untreated). Multivariable analyses were performed adjusting for race/ethnicity and years between randomization and follow-up visit. RESULTS Four-hundred fifty-seven women with mild GDM during the index pregnancy were included in this analysis (243 treated; 214 untreated) and evaluated at a median 7 years after their index pregnancy. Baseline and follow-up characteristics were similar between treatment groups. Frequency of diabetes (9.2 vs. 8.5%, p =0.80), metabolic syndrome (32.2 vs. 34.3%, p =0.63), as well as adjusted mean values of homeostasis model assessment for insulin resistance (2.5 vs. 2.3, p =0.11) and BMI (29.4 vs. 29.1 kg/m2, p =0.67) were also not different. CONCLUSION Identification and treatment of women with mild GDM during pregnancy had no discernible impact on subsequent diabetes, metabolic syndrome, or obesity 7 years after delivery.
Feasibility and Preliminary Outcomes of a Physical Therapist-Administered Physical Activity Intervention After Total Knee Replacement.
Arthritis care & research. 2020;(5):661-668
OBJECTIVE To explore the feasibility, fidelity, safety, and preliminary outcomes of a physical therapist-administered physical activity (PA) intervention after total knee replacement (TKR). METHODS People who had undergone a unilateral TKR and were receiving outpatient physical therapy (PT) were randomized to a control or intervention group. Both groups received standard PT for TKR. The intervention included being provided with a Fitbit Zip, step goals, and 1 phone call a month for 6 months after discharge from PT. Feasibility was measured by rates of recruitment and retention, safety was measured by the frequency of adverse events, and fidelity was measured by adherence to the weekly steps/day goal created by the physical therapist and participant monitoring of steps/day. An Actigraph GT3X measured PA, which was quantified as steps/day and minutes/week of engaging in moderate-to-vigorous PA. Our preliminary outcome was the difference in PA 6 months after discharge from PT between the control and intervention groups. RESULTS Of the 43 individuals who were enrolled, 53.4% were women, the mean ± SD age was 67.0 ± 7.0 years, and the mean ± SD body mass index was 31.5 ± 5.9 kg/m2 . For both the control and intervention groups, the recruitment and retention rates were 64% and 83.7%, respectively, and adherence to the intervention ranged from 45% to 60%. No study-related adverse events occurred. The patients in the intervention group accumulated a mean 1,798 more steps/day (95% confidence interval [95% CI] 240, 3,355) and spent 73.4 more minutes/week (95% CI -14.1, 160.9) engaging in moderate-to-vigorous PA at 6 months than those in the control group. CONCLUSION A physical therapist-administered PA intervention is feasible and safe, demonstrates treatment fidelity, and may increase PA after TKR. Future research is needed to establish the effectiveness of the intervention.
Acute and chronic effects of muscle power training on blood pressure in elderly patients with type 2 diabetes mellitus.
Clinical and experimental hypertension (New York, N.Y. : 1993). 2020;(2):153-159
The aim of the present study was to evaluate the effects of 12 weeks of muscle power training (MPT) on casual blood pressure (BP) (before and after each training session) and resting BP (pre- and post-training program) in type 2 diabetes mellitus (T2DM) elderly.Methods: Twelve T2DM elderly individuals (68.75 ± 7.83 years), non-insulin-dependents participated in the present study and performed the MPT program twice a week. Casual BP was measured before and after training sessions, and resting BP was measured 48 h before the first and 48 h after the last training session.Results: Significant decrease in casual systolic (SBP) (-7.08 ± 4.12 mm Hg [effect size [ES]: -1.42 to -0.11]; p < 0.01) and diastolic (DBP) BP (-3.14 ± 1.24 mm Hg [ES: -1.24 to -0.18]; p > 0.01) was found after training sessions, without significant effect (p > 0.05) of the week along time or casual BP × week interaction. No significant change in resting SBP (-5.08 ± 8.93 mm Hg [ES: -0.41]; p = 0.07) and DBP (0.47 ± 6.06 mm Hg [ES: +0.11]; p = 0.79) was found.Conclusion: MPT was able to reduce casual BP after training sessions. However, there was no significant reduction in resting BP after MPT. Nevertheless, although not statistically significant, there were important clinical reductions in resting SBP in T2DM elderly patients.
One-Year Comparison of a Community-Based Exercise Program Versus a Day Hospital-Based Exercise Program on Quality of Life and Mental Health in Severely Burned Children.
Archives of physical medicine and rehabilitation. 2020;(1S):S26-S35
OBJECTIVE To compare the effects of long-term psychosocial functioning and mental health of a "day hospital"-based exercise program (DAYEX) versus a community-based exercise program (COMBEX). DESIGN A prospective design that consisted of 2 groups (DAYEX and COMBEX). SETTING A children's hospital specialized in burn care. PARTICIPANTS Patients (N=18; DAYEX [n=9], COMBEX [n=9]) were assessed at intensive care unit discharge and up to 1 year postburn. INTERVENTIONS The Child Health Questionnaires (CHQ-Child Form [CHQ-CF87] and CHQ-Parent Form [CHQ-PF28]) were used to assess changes in quality of life from discharge to 1 year postburn. MAIN OUTCOME MEASURES CHQ-PF28 and CHQ-CF87. RESULTS Demographic characteristics and total body surface area burned were similar in both groups. Length of hospital stay was significant in the COMBEX group. CHQ-CF87 and CHQ-PF28 documented significant improvements in both groups between discharge and 1 year. Significance was evident in Physical Functioning, Bodily Pain, Self-Esteem, Change in Health, and Family Activities. CHQ-CF87 showed improvement in Family Cohesion in COMBEX more than DAYEX. CHQ-PF28 showed improvement in Role/Social Limitations-Emotional, Bodily Pain, and Family Activities in COMBEX more than DAYEX. CONCLUSIONS The proposed COMBEX program is feasible and beneficial physically, psychosocially, and mentally. The results show some improvements in the COMBEX group in optimizing function and health in severely burned children. The COMBEX group performed at least as well as the DAYEX group. Larger-scale studies are needed to validate current findings.
Effects on Volume Load and Ratings of Perceived Exertion in Individuals' Advanced Weight Training After Transcranial Direct Current Stimulation.
Journal of strength and conditioning research. 2020;(1):89-96
Lattari, E, Rosa Filho, BJ, Fonseca Junior, SJ, Murillo-Rodriguez, E, Rocha, N, Machado, S, and Maranhão Neto, GA. Effects on volume load and ratings of perceived exertion in individuals' advanced weight training after transcranial direct current stimulation. J Strength Cond Res 34(1): 89-96, 2020-The aim of this study was investigate the effects of transcranial direct current stimulation (tDCS) on volume load and ratings of perceived exertion. Fifteen young healthy individuals, aged between 20 and 30 years in advanced strength training were recruited. Test and retest of the 10 maximum repetitions (10RM) were performed to determine the reliability of load used. Subjects performed 3 experimental conditions in a randomized, double-blinded crossover design: anodic stimulation (a-tDCS), cathodic stimulation (c-tDCS), and sham (2 mA for 20 minutes targeting the dorsolateral prefrontal cortex left). Immediately after the experimental conditions, subjects completed 1 set of maximum repetitions with 10RM load (volume load) and answered to OMNI-RES (poststimulation) (level of significance p ≤ 0.05). The volume load showed main effect for condition (F(2, 28) = 164.801; p < 0.001). In poststimulation, a-tDCS was greater than c-tDCS (p ≤ 0.001) and sham (p ≤ 0.001). For ratings of perceived exertion (OMNI-RES), the results showed main effect for condition (F(2, 28) = 9.768; p ≤ 0.05). In poststimulation, c-tDCS was greater than a-tDCS (p ≤ 0.05) and sham (p ≤ 0.05). We conclude that the use of a-tDCS may promote increase in volume load for the LP45 exercise. Moreover, higher volume loads are necessary to maximize muscle strength and anabolism.
Effects of Community-Based Exercise in Adults With Severe Burns: A Randomized Controlled Trial.
Archives of physical medicine and rehabilitation. 2020;(1S):S36-S41
OBJECTIVE To investigate the efficacy of community-based exercise programs in the rehabilitation of adult patients with burns compared with standard of care (SOC). DESIGN Randomized controlled trial, with 2:1 randomization. SETTING Assessments were performed in a hospital setting. The intervention was performed in a community setting. PARTICIPANTS Adult patients (N=45) with ≥30% total body surface area burns were randomized to participate in a community-based exercise program (n=31) or SOC (n=14). Patient sampling was consecutive and referred. INTERVENTIONS The community-based exercise program consisted of 12 weeks of exercise with a community-based trainer after hospital discharge. The SOC group did not receive exercise training. MAIN OUTCOME MEASURES Change in lean body mass index, peak torque, and peak oxygen consumption from discharge to 12 weeks postdischarge, presented as mean ± SE. RESULTS The community-based exercise program group showed a significant increase in peak oxygen consumption compared with SOC (community-based exercise program: Δ=7.723±1.522mL/kg/min, P=.0006; SOC: Δ=2.200±1.150mL/kg/min, P=.0765; community-based exercise program vs SOC, P=.0236). The community-based exercise program group exhibited a significant within group increase in lean body mass index (Δ=1.107±0.431kg/m2, P=.0003; SOC: Δ=1.323±0.873kg/m2, P=.2808). Both groups showed significant within-group increases in peak torque (community-based exercise program: Δ=35.645±7.566Nm, P=.0003; SOC: Δ=34.717±11.029Nm, P=.0082). No significant differences were noted between the 2 groups for lean body mass index or peak torque. CONCLUSIONS Patients who participate in a community-based exercise program show significant improvements in cardiopulmonary fitness compared with SOC, supporting the use of a community-based exercise program as an alternative therapy to SOC in adults with severe burns.
Compression Therapy to Prevent Recurrent Cellulitis of the Leg.
The New England journal of medicine. 2020;(7):630-639
BACKGROUND Chronic edema of the leg is a risk factor for cellulitis. Daily use of compression garments on the leg has been recommended to prevent the recurrence of cellulitis, but there is limited evidence from trials regarding its effectiveness. METHODS In this single-center, randomized, nonblinded trial, we assigned participants with chronic edema of the leg and recurrent cellulitis, in a 1:1 ratio, to receive leg compression therapy plus education on cellulitis prevention (compression group) or education alone (control group). Follow-up occurred every 6 months for up to 3 years or until 45 episodes of cellulitis had occurred in the trial. The primary outcome was the recurrence of cellulitis. Participants in the control group who had an episode of cellulitis crossed over to the compression group. Secondary outcomes included cellulitis-related hospital admission and quality-of-life assessments. RESULTS A total of 183 patients were screened, and 84 were enrolled; 41 participants were assigned to the compression group, and 43 to the control group. At the time of a planned interim analysis, when 23 episodes of cellulitis had occurred, 6 participants (15%) in the compression group and 17 (40%) in the control group had had an episode of cellulitis (hazard ratio, 0.23; 95% confidence interval [CI], 0.09 to 0.59; P = 0.002; relative risk [post hoc analysis], 0.37; 95% CI, 0.16 to 0.84; P = 0.02), and the trial was stopped for efficacy. A total of 3 participants (7%) in the compression group and 6 (14%) in the control group were hospitalized for cellulitis (hazard ratio, 0.38; 95% CI, 0.09 to 1.59). Most quality-of-life outcomes did not differ between the two groups. No adverse events occurred during the trial. CONCLUSIONS In this small, single-center, nonblinded trial involving patients with chronic edema of the leg and cellulitis, compression therapy resulted in a lower incidence of recurrence of cellulitis than conservative treatment. (Funded by Calvary Public Hospital Bruce; Australian and New Zealand Clinical Trials Registry number, ACTRN12617000412336.).
Hemorheological Alterations in Patients with Heart Failure with Reduced Ejection Fraction Treated by Resveratrol.
Cardiovascular therapeutics. 2020;:7262474
Objectives: Several beneficial effects of resveratrol have already been published. This study evaluated the effect of resveratrol on the hemorheological parameters in patients with heart failure with reduced ejection fraction. Methods: In our double-blind, placebo-controlled human clinical trial, we enrolled 60 outpatients with heart failure. Patients were randomized into two groups: receiving either 100 mg resveratrol capsule daily or placebo for 3 months. Hematocrit was determined by microhematocrit centrifuge. Plasma and whole blood viscosity was evaluated by capillary viscometer. Erythrocyte aggregation was measured by both LORCA and Myrenne aggregometers. LORCA ektacytometer was used for measuring erythrocyte deformability. Exercise capacity was assessed by a 6-minute walk test. Results: Resveratrol treatment did not have any significant effect on hematocrit and viscosity. The erythrocyte deformability also remained unchanged. However, significant improvement of red blood cell aggregation was observed in the resveratrol group compared to baseline after 3 months. Furthermore, positive correlation was found between the exercise capacity and the hemorheological properties (Hct, WBV, and RBC aggregation and deformability) as well. Conclusion: These findings indicate that resveratrol can significantly reduce red blood cell aggregation, which may positively influence microcirculation, which may contribute to the improvement of tissue perfusion and oxygen supply in heart failure.
Efficacy and safety of once-daily nitisinone for patients with alkaptonuria (SONIA 2): an international, multicentre, open-label, randomised controlled trial.
The lancet. Diabetes & endocrinology. 2020;(9):762-772
BACKGROUND Alkaptonuria is a rare, genetic, multisystem disease characterised by the accumulation of homogentisic acid (HGA). No HGA-lowering therapy has been approved to date. The aim of SONIA 2 was to investigate the efficacy and safety of once-daily nitisinone for reducing HGA excretion in patients with alkaptonuria and to evaluate whether nitisinone has a clinical benefit. METHODS SONIA 2 was a 4-year, open-label, evaluator-blind, randomised, no treatment controlled, parallel-group study done at three sites in the UK, France, and Slovakia. Patients aged 25 years or older with confirmed alkaptonuria and any clinical disease manifestations were randomly assigned (1:1) to receive either oral nitisinone 10 mg daily or no treatment. Patients could not be masked to treatment due to colour changes in the urine, but the study was evaluator-blinded as far as possible. The primary endpoint was daily urinary HGA excretion (u-HGA24) after 12 months. Clinical evaluation Alkaptonuria Severity Score Index (cAKUSSI) score was assessed at 12, 24, 36, and 48 months. Efficacy variables were analysed in all randomly assigned patients with a valid u-HGA24 measurement at baseline. Safety variables were analysed in all randomly assigned patients. The study was registered at ClinicalTrials.gov (NCT01916382). FINDINGS Between May 7, 2014, and Feb 16, 2015, 139 patients were screened, of whom 138 were included in the study, with 69 patients randomly assigned to each group. 55 patients in the nitisinone group and 53 in the control group completed the study. u-HGA24 at 12 months was significantly decreased by 99·7% in the nitisinone group compared with the control group (adjusted geometric mean ratio of nitisinone/control 0·003 [95% CI 0·003 to 0·004], p<0·0001). At 48 months, the increase in cAKUSSI score from baseline was significantly lower in the nitisinone group compared with the control group (adjusted mean difference -8·6 points [-16·0 to -1·2], p=0·023). 400 adverse events occurred in 59 (86%) patients in the nitisinone group and 284 events occurred in 57 (83%) patients in the control group. No treatment-related deaths occurred. INTERPRETATION Nitisinone 10 mg daily was well tolerated and effective in reducing urinary excretion of HGA. Nitisinone decreased ochronosis and improved clinical signs, indicating a slower disease progression. FUNDING European Commission Seventh Framework Programme.
A Five-Ingredient Nutritional Supplement and Home-Based Resistance Exercise Improve Lean Mass and Strength in Free-Living Elderly.
Old age is associated with lower physical activity levels, suboptimal protein intake, and desensitization to anabolic stimuli, predisposing for age-related muscle loss (sarcopenia). Although resistance exercise (RE) and protein supplementation partially protect against sarcopenia under controlled conditions, the efficacy of home-based, unsupervised RE (HBRE) and multi-ingredient supplementation (MIS) is largely unknown. In this randomized, placebo-controlled and double-blind trial, we examined the effects of HBRE/MIS on muscle mass, strength, and function in free-living, older men. Thirty-two sedentary men underwent twelve weeks of home-based resistance band training (3 d/week), in combination with daily intake of a novel five-nutrient supplement ('Muscle5'; M5, n = 16, 77.4 ± 2.8 y) containing whey, micellar casein, creatine, vitamin D, and omega-3 fatty acids, or an isocaloric/isonitrogenous placebo (PLA; n = 16, 74.4 ± 1.3 y), containing collagen and sunflower oil. Appendicular and total lean mass (ASM; +3%, TLM; +2%), lean mass to fat ratios (ASM/% body fat; +6%, TLM/% body fat; +5%), maximal strength (grip; +8%, leg press; +17%), and function (5-Times Sit-to-Stand time; -9%) were significantly improved in the M5 group following HBRE/MIS therapy (pre vs. post tests; p < 0.05). Fast-twitch muscle fiber cross-sectional areas of the quadriceps muscle were also significantly increased in the M5 group post intervention (Type IIa; +30.9%, Type IIx, +28.5%, p < 0.05). Sub-group analysis indicated even greater gains in total lean mass in sarcopenic individuals following HBRE/MIS therapy (TLM; +1.65 kg/+3.4%, p < 0.05). We conclude that the Muscle5 supplement is a safe, well-tolerated, and effective complement to low-intensity, home-based resistance exercise and improves lean mass, strength, and overall muscle quality in old age.