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   Table of Contents - Current issue
July-September 2019
Volume 4 | Issue 3
Page Nos. 65-87

Online since Thursday, October 3, 2019

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A study protocol on effectiveness of theory-based intervention on self-care and glycated hemoglobin among type 2 diabetes patients in National Center for Diabetes in Yemen p. 65
Abeer Yahya Ahmed Al-Washali, Abdul Rahman Hejar, Kadri Shahar Hayati, Ismail Suriani, Yahya A Elezzy
Background and objectives: Diabetes is a complex, chronic illness that needs unceasing medical care with multifactorial risk-reduction strategies. Adequate glycemic control is recommended to reduce diabetes complication. Adequate self-care is important to improve glycemic control. Despite the importance of glycemic control, the majority of diabetic patients in Yemen have poor glycemic control. Poor glycemic control is a sign of poor self-care behaviors. Inadequate self-care increases patient’s morbidity and mortality, costs of medication and laboratory tests and cost in time and effort of care providers. The purpose of this study was to develop, implement, and evaluate the effect of Information-Motivation-Behavioral Skills (IMB) model-based Diabetes Self-Management on diabetes self-care behaviors (diet, physical activity, and foot care) and glycated hemoglobin among patients with type 2 diabetes in the National Center for Diabetes in Yemen. Subjects and methods: This is a parallel-randomized controlled trial, which will be conducted at the National Center of Diabetes in Yemen. Eligible participants who give consent will be randomized to an intervention group and a control group (usual care) after baseline assessment. The intervention group will receive the intervention, which is a 3-hour session, based on the information motivation behavioral skills model to improve the self-care behaviors (diet, physical activity, and foot care) and glycated hemoglobin. A post-intervention assessment will be done at 6 months after the intervention. Patient recruitment began in February, 2018. Analysis of primary outcome measure will be completed in July 2019, and the study will be finished in September 2019. Study protocol: 1.0. The protocol was approved by the Ethics Committee for Research Involving Human Subjects from Universiti Putra Malaysia on February 7, 2017 (reference No. FPSK (FR16) 015) and Al Thawra Hospital Ethics Committee (reference No. 2/2018). Outcome measures: The primary outcomes of this study are the changes in diabetes self-care behaviors (diet, physical activity, foot care) and glycated hemoglobin. The secondary outcomes are the changes in information motivation and behavioral skills of diet, physical activity, and foot care. Discussion: This theory-based randomized controlled trial aims to improve the glycemic control of patients with type 2 diabetes through improving the adherence to diabetes self-care behaviors. Trial registration: This trial was registered in the Australian New Zealand Clinical Trials Registry (ANZCTR) (registration number: ACTRN12617001037392) on July 17, 2017. http://www.anzctr.org.au/ACTRN12617001037392.aspx
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Effects of electroanalgesia on knee osteoarthritis: study protocol for a randomized, triple-blind, placebo-controlled trial p. 70
Camila Cadena Almeida, Klaus Porto Azevedo, Tatiana Andrade Cacho, Júlia B. L. Garcia Leal, Geovanna Nascimento Montanini, Danielly Nery T. Silva, Patrícia Azevedo Garcia, João Luiz Quagliotti Durigan
Background and objectives: Osteoarthritis of the knee is considered the major cause of pain and dysfunction of the motor apparatus and mainly affects female individuals over 60 years. Electrotherapy presents a reasonable level of evidence for pain control and inconsistent results. Thus, this study aims to verify the efficacy of electroanalgesia, using different currents, for knee osteoarthritis. Subjects and methods: This is a randomized, triple-blind, placebo-controlled clinical trial. Individuals will be randomly divided into four groups, and subjected to four different types of currents: transcutaneous electric nerve stimulation in Group 1, bipolar interferential current in Group 2, Aussie in Group 3, and placebo in Group 4, presenting different modulations and 20 minutes of intervention each. Patients have been recruited since August 2017. The primary outcome measures will be analyzed in June 2020 and the study will finish in August 2020. Protocol version: 1.0. This study was approved by the Ethics Committee of University of Brasilia on July 18, 2017 (CAEE: 62256516.2.0000.0030). Outcome measures: Primary and secondary outcomes will be analyzed at baseline, 1, 3 and 6 months after the start of the study. The primary outcome is pain assessed by numerical verbal scale, pain-pressure threshold, and brief pain inventory. The secondary outcomes are function and quality of life (including Western Ontario and McMaster Universities Osteoarthritis Index, The Medical Outcomes Study 36-item Short-Form Health Survey, Timed Get-Up-and-Go test, 30-second Sit-to-Stand test, Stair-ascend test, 6-minute walk test, 40-meter fast-walk test). Discussion: We hope to provide evidence for finding suitable electroanalgesia on knee osteoarthritis. Trial registration: Registered in the Brazilian Clinical Trials Registry (ReBEC) (RBR-875zsw) on November 24, 2017.
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Comparison of efficacy of continuous and intermittent walking exercise on blood pressure and renal function in elderly hypertensive subjects: study protocol for a randomized controlled trial p. 76
Piyapong Prasertsri, Orachorn Boonla, Jatuporn Phoemsapthawee, Kanoknuch Naravoratham, Petcharat Trongtosak
Background and objectives: Hypertension (HTN) affects millions of people worldwide. HTN plays a major etiologic role in the development of cerebrovascular disease, ischemic heart disease, cardiac and renal failure. Although the treatment of HTN has been shown to prevent cardiovascular disease and to extend life, HTN remains inadequately managed everywhere. Exercise therapy has been shown to enhance efficacy of medication treatment. Even regular physical activity of lower intensity and duration has been shown to be associated with about a 20% decrease in mortality. Nevertheless, elderly individuals are limited in the duration of exercise due to their decline in physical fitness. Therefore, we aim to evaluate and compare the efficacy of continuous and intermittent exercise on blood pressure, renal function, as well as blood pressure-related variables including cardiac autonomic function, cardiovascular risks, and oxidative stress in elderly individuals with HTN. Subjects and methods: This is a prospective, randomized controlled trial. A total of 50 elderly subjects with HTN will be recruited from Mueang District, Chonburi Province, Thailand. The subjects will be randomized into two groups and undergo walking exercise training. The continuous walking exercise group (n = 25) will perform walking exercise continuously for 30 minutes/day, 3 days/week for 12 weeks. The intermittent walking exercise group (n = 25) will perform walking exercise intermittently for 10 minutes/session, 3 consecutive sessions/day with 1-minute interval between sessions, 3 days/week for 12 weeks. The primary outcome measures will be systolic and diastolic blood pressure levels and renal function (serum creatinine and uric acid concentrations, estimated glomerular filtration rate, and estimate creatinine clearance) before and 12 weeks after intervention. The secondary outcome measures will be cardiac autonomic function, cardiovascular risks (blood glucose, serum lipid profile, atherosclerogenic index), and oxidative stress (plasma malondialdehyde and blood glutathione and glutathione disulfide) before and 12 weeks after intervention. The recruitment of subjects began on May 2, 2018. Outcome measures will be analyzed on October 29, 2018. This trial will be completed on October 27, 2018. Protocol version: 1.0. This trial has been approved by the Human Ethics Committee of the Burapha University on January 15, 2018 (approval No. 218/2560). Discussion: The intermittent walking exercise can be applied as an effectively therapeutic treatment of HTN in elderly individuals. Trial registration: This trial has been registered in the Thai Clinical Trials Registry (TCTR) (identification No. TCTR20180226003) on February 23, 2018.
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Changes in insulin resistance and inflammatory factors in cataract patients with glaucoma after phacoemulsification and trabeculectomy: a self-controlled trial p. 81
Jian-Feng Zhao, Yu Geng, Qian-Bo Chen, Jing-Hui Yang, Yan Li
Background and objective: Cataract with glaucoma can adversely affect visual acuity and corneal endothelial cells. Studies have shown that after phacoemulsification combined with trabeculectomy in patients with cataract and glaucoma, blood lipid ratio and insulin sensitivity are associated with intraocular pressure, visual acuity and corneal endothelial cells, which may be used for the evaluation of efficacy. Interleukins are the main mediators of the inflammatory response and are involved in the pathogenesis of cataract. In this trial, we will examine the postoperative changes in interleukin-10, interleukin-2 and interleukin-1β levels in patients with cataract with glaucoma, and analyze the correlation between insulin sensitivity and corneal endothelial cell density to assess whether inflammatory factors can be used to evaluate efficacy. Participants and methods: This prospective, single-center, open-label, self-controlled clinical trial will include 160 patients with cataract combined with glaucoma, 35–65 years of age, from the Department of Ophthalmology, First Affiliated Hospital of Kunming Medical University, China. All patients will receive phacoemulsification and trabeculectomy, and will be followed up at 5 days, and at 1 and 3 months. Patient recruitment will begin on December 30, 2019 and end on December 30, 2020. Analysis of the results will be performed from May 1, 2021 to May 30, 2021. This study is scheduled to end on June 30, 2021. This study was approved by the Medical Ethics Committee, First Affiliated Hospital of Kunming Medical University, China, on December 15, 2013 (approval No. 20131215085), and will be performed in accordance with the principles of the Declaration of Helsinki, adopted by the World Medical Association. Study protocol version is 1.0. Written informed consent to participate will be obtained from each participant. Results: The primary outcome measure will be serum interleukin-2 level, as an index of the inflammatory response, 3 months after surgery. Secondary outcome measures will include serum interleukin-2 level before and 5 days and 1 month after surgery, serum levels of interleukin-1β, interleukin-10, C-reactive protein and tumor necrosis factor-α, best corrected visual acuity, endothelial cell density, mean cell area, coefficient of variation, insulin sensitivity index and intraocular pressure before and 5 days and 1 and 3 months after surgery, and incidence of adverse reactions at 5 days and 1 and 3 months after surgery. From January 2014 to June 2017, our team undertook and completed a small-sample study of 80 cataract patients (95 eyes) with glaucoma. The best corrected visual acuity was significantly improved, endothelial cell density and intraocular pressure were significantly reduced, interleukin-1β, interleukin-2, interleukin-10, C-reactive protein and tumor necrosis factor-α levels were significantly decreased (P < 0.05), and mean cell area, coefficient of variation and insulin sensitivity index were significantly increased (P < 0.05) after phacoemulsification and trabeculectomy. None of the patients had adverse reactions during the treatment. Conclusion: The trial will confirm whether phacoemulsification combined with trabeculectomy has a good therapeutic effect in patients with cataract combined with glaucoma, and clarify whether the effect is associated with the regulation of insulin sensitivity index, corneal endothelial cells and inflammatory factors. Trial registration: This study was registered with the Chinese Clinical Trial Registry on September 10, 2019 (registration number: ChiCTR1900025837).
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