scholarly journals Fall and Balance Outcomes After an Intervention to Promote Leg Strength, Balance, and Walking in People With Diabetic Peripheral Neuropathy: “Feet First” Randomized Controlled Trial

2010 ◽  
Vol 90 (11) ◽  
pp. 1568-1579 ◽  
Author(s):  
Robin L. Kruse ◽  
Joseph W. LeMaster ◽  
Richard W. Madsen
Keyword(s):  
Diabetes Mellitus ◽  
Randomized Controlled Trial ◽  
Lower Extremity ◽  
Controlled Trial ◽  
Weight Bearing ◽  
Intervention Group ◽  
Control Group ◽  
Foot Care ◽  
Randomized Controlled ◽  
Lower Extremity Strength

Background Weight-bearing exercise has been discouraged for people with diabetes mellitus and peripheral neuropathy (DM+PN). However, people with diabetes mellitus and insensate feet have an increased risk of falling. Lower-extremity exercise and balance training reduce fall risk in some older adults. It is unknown whether those with neuropathy experience similar benefits. Objective As part of a study of the effects of weight-bearing exercise on foot ulceration in people with DM+PN, the effects of a lower-extremity exercise and walking intervention on balance, lower-extremity strength (force-generating capacity), and fall incidence were determined. Design The study was an observer-masked, 12-month randomized controlled trial. Setting Part 1 of the intervention took place in physical therapy offices, and part 2 took place in the community. Patients The participants were 79 people who were mostly sedentary, who had DM+PN, and who were randomly assigned to either a control group (n=38) or an intervention group (n=41). Intervention Part 1 included leg strengthening and balance exercises and a graduated, self-monitored walking program; part 2 included motivational telephone calls. Both groups received regular foot care, foot care education, and 8 sessions with a physical therapist. Measurements The measurements collected were strength, balance, and participant-reported falls for the year after enrollment. Results There were no statistically significant differences between the groups for falls during follow-up. At 12 months, there was a small increase in the amount of time that participants in the intervention group could stand on 1 leg with their eyes closed. No other strength or balance measurements differed between the groups. Limitations The study was designed to detect differences in physical activity, not falls. The intensity of the intervention was insufficient to improve strength and balance in this population. Conclusions The training program had a minimal effect on participants' balance and lower-extremity strength. Increasing weight-bearing activity did not alter the rate of falling for participants in the intervention group relative to that for participants in the control group. People who are sedentary and who have DM+PN appear to be able to increase activity without increasing their rate of falling.

scholarly journals Effect of Weight-Bearing Activity on Foot Ulcer Incidence in People With Diabetic Peripheral Neuropathy: Feet First Randomized Controlled Trial

2008 ◽  
Vol 88 (11) ◽  
pp. 1385-1398 ◽  
Author(s):  
Joseph W LeMaster ◽  
Michael J Mueller ◽  
Gayle E Reiber ◽  
David R Mehr ◽  
Richard W Madsen ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Peripheral Neuropathy ◽  
Diabetic Peripheral Neuropathy ◽  
Controlled Trial ◽  
Weight Bearing ◽  
Intervention Group ◽  
Foot Ulcer ◽  
Control Group ◽  
Foot Care ◽  
Randomized Controlled

BackgroundWeight-bearing exercise has been contraindicated among people with diabetic peripheral neuropathy (DM+PN). However, recent cohort studies have suggested that daily weight-bearing activity is associated with lower risk for foot ulceration.ObjectiveThe objective of this study was to determine the effect of a lower-extremity exercise and walking intervention program on weight-bearing activity and foot ulcer incidence in people with DM+PN.DesignThis was an observer-blinded, 12-month randomized controlled trial.SettingThe settings were physical therapy offices in part 1 of the intervention and the community in part 2 of the intervention.ParticipantsThe participants were 79 individuals with DM+PN who were randomly assigned either to a control group (n=38) or an intervention group (n=41) group.InterventionIntervention components included leg strengthening and balance exercises; a graduated, self-monitored walking program (part 1); and motivational telephone calls every 2 weeks (part 2). Both groups received diabetic foot care education, regular foot care, and 8 sessions with a physical therapist.MeasurementsTotal and exercise bout–related daily steps at baseline and at 3, 6, and 12 months were measured by accelerometers. Foot lesions/ulcers were photographed and classified by an independent panel of dermatologists. Use of adequate footwear was monitored.ResultsAt 6 months, bout-related daily steps increased 14% from baseline in the intervention group and decreased 6% from baseline in the control group. Although the groups did not differ statistically in the change in total daily steps, at 12 months steps had decreased by 13% in the control group. Foot ulcer rates did not differ significantly between groups.ConclusionPromoting weight-bearing activity did not lead to significant increases in foot ulcers. Weight-bearing activity can be considered following adequate assessment and counseling of patients with DM+PN.

scholarly journals EVALUASI INTERVENSI MEDIA BOOKLET TERHADAP TINGKAT PENGETAHUAN DAN KEPATUHAN PASIEN DIABETES MELITUS TIPE 2 DI PUSKESMAS BANJARBARU SELATAN

2019 ◽  
Vol 6 (1) ◽  
Author(s):  
Valentina Meta Srikartika ◽  
M. Rasyid Akbar ◽  
Herningtyas Nautika Lingga
Keyword(s):  
Diabetes Mellitus ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
P Value ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Level Of Knowledge ◽  
Diabetes Melitus

ABSTRAKKeberhasilan pengobatan diabetes melitus tidak hanya dipengaruhi oleh kualitas pelayanan kesehatan, keterampilan petugasnya, sikap, dan pola hidup pasien, tetapi dipengaruhi juga oleh kepatuhan pasien terhadap pengobatannya. Tingkat kepatuhan minum obat pasien diabetes mellitus di Indonesia mayoritas masih berada dibawah 50%. Tujuan dari penelitian ini adalah mengukur pengaruh edukasi melalui media booklet terhadap pengetahuan dan kepatuhan pasien diabetes melitus tipe 2. Jenis penelitian yang digunakan adalah Randomized Controlled Trial (RCT). Populasi yang didapat dari penelitian ini sebanyak 40 orang dengan kelompok kontrol 20 orang dan kelompok intervensi 20 orang. Kelompok kontrol merupakan kelompok yang tidak mendapatkan booklet, sedangkan kelompok intervensi adalah kelompok yang mendapatkan booklet sebagi media edukasi. Pengetahuan dan kepatuhan responden diukur melalui kuesioner yang diberikan sebelum (pretest) dan 2 minggu kemudian (posttest). Rata-rata skor pengetahuan dan kepatuhan pre-test dibandingkan dengan skor post-test dengan menggunakan uji Wilcoxon. Berdasarkan hasil analisis, terjadi perbedaan tingkat pengetahuan dan kepatuhan yang signifikan (p value < 0,001) antara sebelum dan sesudah pemberian booklet pada kelompok intervensi dan tidak ada perbedaan yang signifikan pada tingkat pengetahuan (p value = 0,83) dan kepatuhan (p value = 0,317) pada kelompok kontrol. Oleh karena itu, dapat disimpulkan bahwa media booklet dapat meningkatkan tingkat pengetahuan dan kepatuhan pada pasien diabetes melitus.Kata-kata kunci: Diabetes melitus, pengetahuan, kepatuhan, bookletABSTRACTThe success of a treatment of diabetes mellitus is not only influenced by the quality of health services, the skills of its officers, attitudes, and lifestyle of patients, but it is also influenced by patient adherence to treatment. The level of medication compliance among diabetes patients in Indonesia were still below 50%. The purpose of this study was to measure the effect of education through booklet media on the knowledge and compliance of patients with type 2 diabetes mellitus. The type of research used was Randomized Controlled Trial (RCT). The population obtained from this study were 40 people with a control group of 20 people and an intervention group of 20 people. The control group was the group that did not get the booklet, while the intervention group was the group that received the booklet as an educational medium. Knowledge and compliance of respondents was measured through questionnaires given before (pretest) and 2 weeks later (posttest). The average score of knowledge and adherence between pretest and posttest will be compared using Wilcoxon analysis. Based on the results of data analysis with the Wilcoxon test, there was a significant difference in the level of knowledge and compliance (p value < 0.001) between before and after booklet administration in the intervention group and no significant difference in knowledge level (p value = 0.83) and compliance (p value = 0.317) in the control group. It can be concluded that the booklet media can increase the level of knowledge and compliance in diabetes mellitus patients.Keywords: Diabetes mellitus, knowledge, compliance, booklet

scholarly journals Neuromuscular Training Warm-up Prevents Acute Noncontact Lower Extremity Injuries in Children’s Soccer: A Cluster Randomized Controlled Trial

2021 ◽  
Vol 9 (4) ◽  
pp. 232596712110057
Author(s):  
Matias Hilska ◽  
Mari Leppänen ◽  
Tommi Vasankari ◽  
Sari Aaltonen ◽  
Pekka Kannus ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Lower Extremity ◽  
Outcome Measure ◽  
Controlled Trial ◽  
Intervention Group ◽  
Neuromuscular Training ◽  
Control Group ◽  
Injury Incidence ◽  
Warm Up ◽  
Randomized Controlled

Background: Prevention of sports injuries is essential in youth, as injuries are associated with less future physical activity and thus greater all-cause morbidity. Purpose: To investigate whether a neuromuscular training warm-up operated by team coaches is effective in preventing acute lower extremity (LE) injuries in competitive U11-U14 soccer players. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: Twenty top-level U11 to U14 soccer clubs in Finland were randomized into intervention and control groups and assessed for 20 weeks. Participants included 1403 players (280 female, 1123 male; age range, 9-14 years): 673 players (44 teams) in the intervention group and 730 players (48 teams) in the control group. The intervention group team coaches were introduced to a neuromuscular training warm-up to replace the standard warm-up 2 to 3 times per week. The control teams were asked to perform their standard warm-up. Injury data collection was done via weekly text messages. The primary outcome measure was a soccer-related acute LE injury, and the secondary outcome measure was an acute noncontact LE injury. Results: A total of 656 acute LE injuries occurred: 310 in the intervention group and 346 in the control group. The overall acute LE injury incidence was 4.4 per 1000 hours of exposure in the intervention group and 5.5 per 1000 hours of exposure in the control group, with no significant difference between groups (incidence rate ratio [IRR], 0.82 [95% CI, 0.64-1.04]). There were 302 acute noncontact LE injuries: 129 in the intervention group (incidence, 1.8 per 1000 hours) and 173 in the control group (2.7 per 1000 hours). A significant reduction in acute noncontact LE injuries of 32% (IRR, 0.68 [95% CI, 0.51-0.93]) was observed in the intervention group compared with the control group. Furthermore, significant reductions in injury incidence in favor of the intervention group were seen in the subanalyses of acute noncontact LE injuries, leading to ≤7 days of time loss and fewer ankle and joint/ligament injuries. Conclusion: A neuromuscular training warm-up operated by team coaches was found to be effective in preventing acute noncontact LE injuries in children’s soccer, but this was not seen in all acute LE injuries. Clinical Relevance: We encourage children’s soccer coaches and health care professionals to implement neuromuscular training warm-up in youth sports. Registration: ISRCTN14046021 (ISRCTN registry).

scholarly journals Effectiveness of a Non-pharmacological Intervention to Control Diabetes Mellitus in a Primary Care Setting in Kerala: A Cluster-Randomized Controlled Trial

2021 ◽  
Vol 9 ◽  
Author(s):  
Arya Rahul ◽  
Sujatha Chintha ◽  
Thekkumkara Surendran Anish ◽  
Kannamkottapilly Chandrasekharan Prajitha ◽  
Pillaveetil Sathyadas Indu
Keyword(s):  
Diabetes Mellitus ◽  
Primary Care ◽  
Randomized Controlled Trial ◽  
Glycemic Control ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Randomized Controlled ◽  
Baseline Values ◽  
Cluster Randomized

Background: Despite being the first Indian state with a dedicated Non-Communicable Disease (NCD) program, glycemic control among a large proportion of patients is low in Kerala. This study tries to find evidence for a standardized non-pharmacological strategy delivered through Junior Public Health Nurses (JPHNs) in achieving and maintaining glycemic control among diabetic patients registered with NCD clinics of primary health care settings.Design: A cluster randomized controlled trial was conducted among adult patients with Diabetes Mellitus attending NCD clinics of primary care settings of South Kerala, India. JPHNs of the intervention group received additional module-based training while standard management continued in the control group. Sequence generation was done by random permuted blocks method and a cluster of 12 patients was selected from each of the 11 settings by computer-generated random numbers. Patients were followed up for 6 months with monthly monitoring of Fasting Blood Sugar (FBS), Post-Prandial Blood Sugar (PPBS), blood pressure, Body Mass Index (BMI), and health-related behaviors. Knowledge and skills/practice of JPHNs were also evaluated. Analysis of Covariance was done to study the final outcome adjusting for the baseline values and a model for glycemic control was predicted using multilevel modeling.Results: We analyzed 72 participants in the intervention group and 60 participants in the control group according to the intention-to-treat principle. The intervention was associated with a significant reduction in FBS (p &lt; 0.001) and PPBS (p &lt; 0.001) adjusting for the baseline values. The achievement of glycemic control was 1.5 (95% CI: 1.05–2.3) times better with intervention and they showed a better trend of maintenance of glycemic control (FBS, p = 0.003 and PPBS, p = 0.039). Adjusting for clustering and the baseline values, the intervention showed a significant effect on FBS (B = −3.1, SE = 0.57; p &lt; 0.001) and PPBS (B = −0.81, SE = 0.3; p &lt; 0.001) with time. Drug adherence score (p &lt; 0.001), hours of physical activity (p &lt; 0.001), BMI (p = 0.002), fruit intake (p = 0.004), and green leafy vegetable intake (p = 0.01) were the major predictors of FBS control. The practice/skills score of the JPHNs significantly improved with intervention (p &lt; 0.001) adjusting for baseline values.Conclusion: A well-designed health worker intervention package incorporated into the existing health system can translate into attitude change and skill development in the health workers which can reflect in the improvement of glycemic control among the patients.Trial registration: [URL: http://www.ctri.nic.in], identifier [CTRI/2017/11/010622].

scholarly journals Effect of the Pregnant+ Smartphone App on the Dietary Behavior of Women With Gestational Diabetes Mellitus: Secondary Analysis of a Randomized Controlled Trial (Preprint)

2020 ◽  
Author(s):  
Lisa Garnweidner-Holme ◽  
Lena Henriksen ◽  
Liv Elin Torheim ◽  
Mirjam Lukasse
Keyword(s):  
Diabetes Mellitus ◽  
Randomized Controlled Trial ◽  
Usual Care ◽  
Controlled Trial ◽  
Intervention Group ◽  
Dietary Behavior ◽  
Smartphone App ◽  
Control Group ◽  
Food Frequency ◽  
Randomized Controlled

BACKGROUND The prevalence of gestational diabetes mellitus (GDM) is increasing worldwide. A healthy diet and stable blood glucose levels during pregnancy can prevent adverse health outcomes for the mother and the newborn child. Mobile health may be a useful supplement to prenatal care, providing women with targeted dietary information concerning GDM. OBJECTIVE We analyzed secondary data from a two-arm, multicentered, nonblinded randomized controlled trial to determine if a smartphone app with targeted dietary information and blood glucose monitoring had an effect on the dietary behavior of women with GDM. METHODS Women with a 2-hour oral glucose tolerance test level of ≥9 mmol/L were individually randomized to either the intervention group receiving the Pregnant+ app and usual care or the control group receiving usual care only. Eligible women were enrolled from 5 diabetes outpatient clinics in the Oslo region, Norway, between October 2015 and April 2017. The Pregnant+ app promoted 10 GDM-specific dietary recommendations. A healthy dietary score for Pregnant+ (HDS-P+) was constructed from a 41-item food frequency questionnaire and used to assess the intervention effect on the dietary behavior completed at trial entry and at around gestation week 36. Dietary changes from baseline to week 36 were examined by a paired sample two-tailed <i>t</i> test. Between-group dietary differences after the intervention were estimated with analysis of covariance, with adjustment for baseline diet. RESULTS A total of 238 women participated: 115 were allocated to the intervention group and 123 to the control group. Of the 238 women, 193 (81.1%) completed the food frequency questionnaire both at baseline and around gestational week 36. All the participants showed improvements in their HDS-P+ from baseline. However, the Pregnant+ app did not have a significant effect on their HDS-P+. The control group reported a higher weekly frequency of choosing fish meals (<i>P</i>=.05). No other significant differences were found between the intervention and control groups. There were no significant demographic baseline differences between the groups, except that more women in the intervention group had a non-Norwegian language as their first language (61 vs 46; <i>P</i>=.02). CONCLUSIONS Our findings do not support the supplementation of face-to-face follow-up of women with GDM with a smartphone app in the presence of high-standard usual care, as the Pregnant+ app did not have a beneficial effect on pregnant women’s diet. CLINICALTRIAL ClinicalTrials.gov NCT02588729; https://clinicaltrials.gov/ct2/show/NCT02588729

scholarly journals Effect of the Pregnant+ Smartphone App on the Dietary Behavior of Women With Gestational Diabetes Mellitus: Secondary Analysis of a Randomized Controlled Trial

10.2196/18614 ◽  
2020 ◽  
Vol 8 (11) ◽  
pp. e18614
Author(s):  
Lisa Garnweidner-Holme ◽  
Lena Henriksen ◽  
Liv Elin Torheim ◽  
Mirjam Lukasse
Keyword(s):  
Diabetes Mellitus ◽  
Randomized Controlled Trial ◽  
Usual Care ◽  
Controlled Trial ◽  
Intervention Group ◽  
Dietary Behavior ◽  
Smartphone App ◽  
Control Group ◽  
Food Frequency ◽  
Randomized Controlled

Background The prevalence of gestational diabetes mellitus (GDM) is increasing worldwide. A healthy diet and stable blood glucose levels during pregnancy can prevent adverse health outcomes for the mother and the newborn child. Mobile health may be a useful supplement to prenatal care, providing women with targeted dietary information concerning GDM. Objective We analyzed secondary data from a two-arm, multicentered, nonblinded randomized controlled trial to determine if a smartphone app with targeted dietary information and blood glucose monitoring had an effect on the dietary behavior of women with GDM. Methods Women with a 2-hour oral glucose tolerance test level of ≥9 mmol/L were individually randomized to either the intervention group receiving the Pregnant+ app and usual care or the control group receiving usual care only. Eligible women were enrolled from 5 diabetes outpatient clinics in the Oslo region, Norway, between October 2015 and April 2017. The Pregnant+ app promoted 10 GDM-specific dietary recommendations. A healthy dietary score for Pregnant+ (HDS-P+) was constructed from a 41-item food frequency questionnaire and used to assess the intervention effect on the dietary behavior completed at trial entry and at around gestation week 36. Dietary changes from baseline to week 36 were examined by a paired sample two-tailed t test. Between-group dietary differences after the intervention were estimated with analysis of covariance, with adjustment for baseline diet. Results A total of 238 women participated: 115 were allocated to the intervention group and 123 to the control group. Of the 238 women, 193 (81.1%) completed the food frequency questionnaire both at baseline and around gestational week 36. All the participants showed improvements in their HDS-P+ from baseline. However, the Pregnant+ app did not have a significant effect on their HDS-P+. The control group reported a higher weekly frequency of choosing fish meals (P=.05). No other significant differences were found between the intervention and control groups. There were no significant demographic baseline differences between the groups, except that more women in the intervention group had a non-Norwegian language as their first language (61 vs 46; P=.02). Conclusions Our findings do not support the supplementation of face-to-face follow-up of women with GDM with a smartphone app in the presence of high-standard usual care, as the Pregnant+ app did not have a beneficial effect on pregnant women’s diet. Trial Registration ClinicalTrials.gov NCT02588729; https://clinicaltrials.gov/ct2/show/NCT02588729

scholarly journals The Effect of Financial Incentives on Quality Measures in the Treatment of Diabetes Mellitus: a Randomized Controlled Trial

2021 ◽  
Author(s):  
Rahel Meier ◽  
Corinne Chmiel ◽  
Fabio Valeri ◽  
Leander Muheim ◽  
Oliver Senn ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Blood Pressure ◽  
Randomized Controlled Trial ◽  
Financial Incentives ◽  
Controlled Trial ◽  
Intervention Group ◽  
Quality Measures ◽  
Control Group ◽  
Randomized Controlled ◽  
Patients With Diabetes

Abstract Background Financial incentives are often used to improve quality of care in chronic care patients. However, the evidence concerning the effect of financial incentives is still inconclusive. Objective To test the effect of financial incentives on quality measures (QMs) in the treatment of patients with diabetes mellitus in primary care. We incentivized a clinical QM and a process QM to test the effect of financial incentives on different types of QMs and to investigate the spill-over effect on non-incentivized QMs. Design/Participants Parallel cluster randomized controlled trial based on electronic medical records database involving Swiss general practitioners (GPs). Practices were randomly allocated. Intervention All participants received a bimonthly feedback report. The intervention group additionally received potential financial incentives on GP level depending on their performance. Main Measures Between-group differences in proportions of patients fulfilling incentivized QM (process QM of annual HbA1c measurement and clinical QM of blood pressure level below 140/95 mmHg) after 12 months. Key Results Seventy-one GPs (median age 52 years, 72% male) from 43 different practices and subsequently 3838 patients with diabetes mellitus (median age 70 years, 57% male) were included. Proportions of patients with annual HbA1c measurements remained unchanged (intervention group decreased from 79.0 to 78.3%, control group from 81.5 to 81.0%, OR 1.09, 95% CI 0.90–1.32, p = 0.39). Proportions of patients with blood pressure below 140/95 improved from 49.9 to 52.5% in the intervention group and decreased from 51.2 to 49.0% in the control group (OR 1.16, 95% CI 0.99–1.36, p = 0.06). Proportions of non-incentivized process QMs increased significantly in the intervention group. Conclusion GP level financial incentives did not result in more frequent HbA1c measurements or in improved blood pressure control. Interestingly, we could confirm a spill-over effect on non-incentivized process QMs. Yet, the mechanism of spill-over effects of financial incentives is largely unclear. Trial Registration ISRCTN13305645

Effectiveness of a web-based medication adherence tool with patient centered communication: Results of a clustered randomized controlled trial (Preprint)

2019 ◽  
Author(s):  
Jan van Lieshout ◽  
Joyca Lacroix ◽  
Aart van Halteren ◽  
Martina Teichert
Keyword(s):  
Randomized Controlled Trial ◽  
Medication Adherence ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Community Pharmacies ◽  
Web Based ◽  
Randomized Controlled ◽  
Tailored Interventions ◽  
Increased Risk

BACKGROUND Growing numbers of people use medication for chronic conditions; non-adherence is common, leading to poor disease control. A newly developed web-based tool to identify an increased risk for non-adherence with related potential individual barriers might facilitate tailored interventions and improve adherence. OBJECTIVE To assess the effectiveness of the newly developed tool to improve medication adherence. METHODS A cluster randomized controlled trial assessed the effectiveness of this adherence tool in patients initiating cardiovascular or oral blood glucose lowering medication. Participants were included in community pharmacies. They completed an online questionnaire comprising an assessments of their risk for medication non-adherence and subsequently of barriers to adherence. In pharmacies belonging to the intervention group, individual barriers displayed in a graphical profile on a tablet were discussed by pharmacists and patients at high non-adherence risk in face to face meetings and shared with their general practitioners and practice nurses. Tailored interventions were initiated by the healthcare providers. Barriers of control patients were not presented or discussed and these patients received usual care. The primary outcome was the difference in medication adherence at 8 months follow-up between patients with an increased non-adherence risk from intervention and control group, calculated from dispensing data. RESULTS Data from 492 participants in 15 community pharmacies were available for analyses (intervention 253, 7 pharmacies; control 239, 8 pharmacies). The intervention had no effect on medication adherence (-0.01; 95%CI -0.59 – 0.57; P= .96), neither in the post hoc per protocol analysis (0.19; 95%CI -0.50 – 0.89; P=.58). CONCLUSIONS This study showed no effectiveness of a risk stratification and tailored intervention addressing personal barriers for medication adherence. Various potential explanations for lack of effect were identified. These explanations relate for instance to high medication adherence in the control group, study power and fidelity. Process evaluation should elicit possible improvements and inform the redesign of intervention and implementation. CLINICALTRIAL The Netherlands National Trial Register: NTR5186. Date: May 18, 2015 (http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5186)

scholarly journals Effect of leg wrapping technique on prevention of spinal induced hypotension and fetal acidosis during cesarean section: Randomized controlled trial

2019 ◽  
Vol 10 (2) ◽  
pp. 70
Author(s):  
Samah Nasser Abd El-Aziz El-Shora ◽  
Amina Mohamed Rashad El-Nemer
Keyword(s):  
Randomized Controlled Trial ◽  
Cesarean Section ◽  
Controlled Trial ◽  
Intervention Group ◽  
Cost Effective ◽  
Control Group ◽  
Induced Hypotension ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Wrapping Technique

Background and aim: Hypotension during cesarean section (CS) under spinal anesthesia has been a subject of scientific study for more than 50 years and the search for the most effective strategy to achieve hemodynamic stability remains challenging. Aim: The study was carried out to apply leg wrapping technique for the prevention of spinal-induced hypotension (SIH) during CS.Methods: Randomized Controlled Trial design was utilized at cesarean delivery operating room Mansoura General Hospital in El-Mansoura City during the period from May 2018 to November 2018. A purposive sample of 88 pregnant women, assigned randomly to an intervention group (n = 44) in which their legs wrapped with elastic crepe bandage and control group (n = 44) in which no wrapping was done. Data collected for maternal, neonatal hemodynamic and signs of hypotension, the feasibility of application and cost analysis.Results: There was a statistically significant difference in the incidence of SIH and Ephedrine use among both groups (18.20% in leg wrapping group whereas 75% in control group). In addition, neonatal acidosis and NICU admission were less among leg wrapping group (11.40%, 9.10% respectively). Economically, leg wrapping technique was cost effective compared to the cost of the hospital regimen for treating SIH and admission to (NICU).Conclusion and recommendations: Leg wrapping technique was cost effective and an efficient method for decreasing SIH, neonatal acidosis and Ephedrine administration. It is recommended to apply leg wrapping technique in maternal hospitals' protocol of care for decreasing SIH during CS.

Investigating the Impact of Cognitive Training for Individuals With Bothersome Tinnitus: A Randomized Controlled Trial

2021 ◽  
pp. 019459982199474
Author(s):  
Maggie Xing ◽  
Dorina Kallogjeri ◽  
Jay F. Piccirillo
Keyword(s):  
Randomized Controlled Trial ◽  
Cognitive Training ◽  
Mixed Model ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Functional Index ◽  
Open Label ◽  
Randomized Controlled ◽  
The Impact

Objective To evaluate the effectiveness of cognitive training in improving tinnitus bother and to identify predictors of patient response. Study Design Prospective open-label randomized controlled trial. Setting Online. Methods Participants were adults with subjective idiopathic nonpulsatile tinnitus causing significant tinnitus-related distress. The intervention group trained by using auditory-intensive exercises for 20 minutes per day, 5 days per week, for 8 weeks. The active control group trained on the same schedule with non–auditory intensive games. Surveys were completed at baseline, 8 weeks, and 12 weeks. Results A total of 64 participants completed the study. The median age was 63 years (range, 25-69) in the intervention group and 61 years (34-68) in the control group. Mixed model analysis revealed that within-subject change in Tinnitus Functional Index in the intervention group was not different than the control group, with marginal mean differences (95% CI): 0.24 (–11.20 to 10.7) and 2.17 (–8.50 to 12.83) at 8 weeks and 2.33 (–8.6 to 13.3) and 3.36 (–7.91 to 14.6) at 12 weeks, respectively. When the 2 study groups were compared, the control group had higher Tinnitus Functional Index scores than the intervention group by 10.5 points at baseline (95% CI, –0.92 to 29.89), 8.1 at 8 weeks (95% CI, –3.27 to 19.42), and 9.4 at 12 weeks (95% CI, –2.45 to 21.34). Conclusion Auditory-intensive cognitive training was not associated with changes in self-reported tinnitus bother. Given the potential for neuroplasticity to affect tinnitus, we believe that future studies on cognitive training for tinnitus remain relevant.

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