Clinical trials in degenerative diseases最新文献

{"title":"Efficacy and safety of freeze-dried form of Tragia involucrata L. decoction in treating diabetes: a randomized controlled clinical trial","authors":"M. Pallie, P. Perera, C. Goonasekara, N. Kumarasinghe, M. Arawwawala","doi":"10.4103/2542-3975.300614","DOIUrl":"https://doi.org/10.4103/2542-3975.300614","url":null,"abstract":"Background and objectives: Tragia involucrata L. (Family: Euphorbiaceae, S. Wel Kahambiliya) is a highly used medicinal plant in both systems of Sri Lankan traditional medicine and Ayurveda medicine. This plant is used for the treatment of diseases such as diabetes, wounds, dysuria, and epilepsy. The aim of this study was to evaluate the efficacy and safety of the freeze-dried form of Tragia involucrata L. decoction in the treatment of diabetes. Subjects and methods: This randomized, two-arm, open-label, controlled clinical trial was conducted in type 2 diabetes patients at National Ayurveda Teaching Hospital in Colombo, Sri Lanka during the year 2016–2017. Thirty-six type 2 diabetes patients aged 18–70 years were included in each group. Patients received treatment with 120 mL of Tragia involucrata L. decoction and 500 mg of metformin, twice a day, for 14 days used as the test drug and positive control drug groups. Fasting blood glucose level was measured on days 0, 8, and 15. Lipid profile and liver and kidney functions were measured on days 0 and 15. This study was approved by the Ethics Review Committee, Institute of Indigenous Medicine (ERCIIM), University of Colombo, Rajagiriya, Sri Lanka (approval No. ERC 16/61) on October 27, 2016. Results: Fasting blood glucose levels in the test group were significantly decreased on days 8 and 15 compared to day 0 (P < 0.05). There was no significant change in the lipid profile values before and after treatment (P > 0.05). Also the decoction did not cause changes in the function of the liver and kidneys. Further no other adverse reactions were recorded in the patients. Conclusion: Tragia involucrata L. can reduce fasting blood glucose level and has antidiabetic effects in diabetes.","PeriodicalId":92014,"journal":{"name":"Clinical trials in degenerative diseases","volume":"33 1","pages":"31 - 36"},"PeriodicalIF":0.0,"publicationDate":"2020-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"80109153","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Efficacy and safety of Qufushengji powder in patients with diabetic foot ulcers: study protocol for a parallel randomized controlled trial","authors":"Guo-Dong Qi, W. Qi, H. Wen, K. Shen","doi":"10.4103/2542-3975.300615","DOIUrl":"https://doi.org/10.4103/2542-3975.300615","url":null,"abstract":"Background and objective: Qufushengji powder is a classical external medicine in Chongqing Orthopaedic Hospital of Traditional Chinese Medicine for surgical ulcer. This trial is designed to demonstrate the safety and efficacy of Qufushengji powder for treatment of diabetic foot ulcers. Participants and methods: This is a parallel randomized controlled trial, which will be conducted at Chongqing Orthopaedic Hospital of Traditional Chinese Medicine, China. The included patients with moderate to severe diabetic foot ulcers will be randomly divided into control group and intervention group. Patients in the control and intervention groups will be sterilely bandaged with Kangfuxin solution and applied gauze strips of Qufushengji powder based on conventional therapy. In the study execution time of each stage, patient recruitment began in June 2020. The analysis of primary outcome measure will be completed in July 2021, and the study will be finished in May 2022. The protocol was approved by the Ethics Committee for Research Involving Human Subjects from Chongqing Orthopedics Hospital of Traditional Chinese Medicine on May 24, 2019 (approval No. 2019-17). Outcome measures: Ulcer healing rate after 12 weeks of treatment is primary outcome measure. Secondary outcome measures include relief of local foot symptoms, functional recovery and adverse events. Discussion: Results of this trial will provide preliminary evidence for the use of Qufushengji powder in the clinical treatment of diabetic foot ulcers. Trial registration: This trial was registered in the Chinese Clinical Trial Registry on April 25, 2020 (registration number: ChiCTR2000032315).","PeriodicalId":92014,"journal":{"name":"Clinical trials in degenerative diseases","volume":"44 1","pages":"37 - 41"},"PeriodicalIF":0.0,"publicationDate":"2020-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"76450334","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Outcomes in obese patients undergoing direct anterior hip replacement: a nonrandomized study","authors":"Sophia Stasi, D. Tzefronis, G. Papathanasiou, Michail Sarantis, G. Macheras","doi":"10.4103/2542-3975.288781","DOIUrl":"https://doi.org/10.4103/2542-3975.288781","url":null,"abstract":"Background and objective: In recent years, there has been growing interest in the minimally invasive surgical techniques used for the performance of total hip arthroplasty (THA). Among these, direct anterior approach–minimally invasive surgery (DAA-MIS) has generated scientific interest because of its soft-tissue–preserving nature. Data from studies involving obese patients in relation to minimally invasive techniques such as DAA-MIS are controversial, while further comparative studies are needed between nonobese and obese patients. The aim of this study was to compare pain levels, functionality and quality of life between obese and nonobese hip osteoarthritic patients who underwent THA via DAA-MIS. Subjects and methods: This nonrandomized study included 60 patients aged > 50 years. Patients were divided into two equal groups according to their body mass index (< 30 kg/m2 vs. ≥ 30 kg/m2). Measurements were recorded prior to surgery and postoperatively (6th and 12th weeks). Pain was measured using the Face Pain Scale–Revised. Functionality was measured with the Timed Up & Go test and the modified Harris Hip Score-Greek version. Quality of life was evaluated using the 12-item International Hip Outcome Tool–Greek version. The protocol of this study was approved by both the Ethics Committee and Scientific Research Council of the “KAT” General Hospital of Attica, Athens, Greece (ref: ΔΣ234/12-03-2019) on March 12, 2019. Results: Six weeks after DAA-MIS, both obese and nonobese patients had significantly less pain (Face Pain Scale-Revised), higher functionality (Timed Up & Go test and modified Harris Hip Score-Greek version) and better quality of life (12-item International Hip Outcome Tool–Greek version), compared to preoperative measurements (P < 0.001). The improvement in all overall outcomes continued, with a further statistically significant difference in the 12th week’s measurements (P < 0.001). There were no statistically significant differences between groups at the 6th and 12th postoperative weeks (P > 0.05). Conclusion: Both obese and nonobese patients benefited from the DAA-MIS procedure. The obesity should not be considered as a contraindication to DAA-MIS in patients undergoing THA. Trial registration: This study analyzes part of data collected for an ongoing larger trial [World Health Organization’s International Clinical Trials Registry Platform (ISRCTN15066737)].","PeriodicalId":92014,"journal":{"name":"Clinical trials in degenerative diseases","volume":"328 1","pages":"25 - 30"},"PeriodicalIF":0.0,"publicationDate":"2020-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"85418706","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Efficacy of Pilates exercises and supplementation with Camellia sinensis extract in body composition of female patients diagnosed with metabolic syndrome: a randomized, double-blind, placebo-controlled clinical trial","authors":"Silvana Junges, Aline Veigas, Maria Gabriela Valle Gottlieb","doi":"10.4103/2542-3975.274077","DOIUrl":"https://doi.org/10.4103/2542-3975.274077","url":null,"abstract":"Background and objective: Evidence suggests that the intake of functional foods, such as Camellia sinensis extract (CSE), and Pilates exercises could play a key role in reducing the risk for metabolic syndrome. This study aimed to explore the efficacy of Pilates exercises and supplementation with CSE in body composition of female patients diagnosed with metabolic syndrome. Subjects and methods: A placebo-controlled, double-blind, randomized clinical trial was conducted with postmenopausal participants meeting the diagnostic criteria for metabolic syndrome. A total of 50 participants were randomized into four groups: Pilates + CSE (n = 14); Pilates + Placebo (n = 11); CSE (n = 11), and Placebo (n = 14). Intervention groups (CSE and Pilates + CSE) were given a capsule containing 500 mg of CSE every day for 24 weeks. The placebo group received one capsule containing placebo for 24 weeks. The 60-minute Pilates exercises were performed twice a week for 24 weeks. Body composition at baseline and after intevention was assessed. This study protocol was approved by the Institutional Ethics Committee of Pontifical Catholic University. Results: The mean lean mass and percentage lean mass of the Pilates + CSE and Pilates + Placebo groups were significantly higher than those of the CSE and Placebo groups (P < 0.05). There was a reduction in percentage fat mass and fat mass in the Pilates + CSE and Pilates + Placebo groups compared with the Placebo group (P < 0.05). Conclusion: Pilates exercises with or without supplementation with CSE can improve the body composition in postmenopausal women with metabolic syndrome. Trial registration: N° registro ReBEC:RBR-2sgtn2.","PeriodicalId":92014,"journal":{"name":"Clinical trials in degenerative diseases","volume":"8 1","pages":"1 - 4"},"PeriodicalIF":0.0,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"84537518","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Hotspots and prospects of stem cell therapy for type 2 diabetes: bibliometric and visual analysis based on publications, clinical registries, drug approval information, and patent information in China and the United States","authors":"","doi":"10.4103/2542-3975.281716","DOIUrl":"https://doi.org/10.4103/2542-3975.281716","url":null,"abstract":"Background and objective: Healthy diet, exercise, drugs, and insulin-based interventions can help control the progression of type 2 diabetes. However, these methods are insufficient for advanced disease progression. Previous studies found that the transplantation of stem cells to repair or replace damaged tissues and cells is a promising treatment for type 2 diabetes. This article aimed to summarize and visualize the current status and frontiers of research into stem cell therapies for type 2 diabetes, both in China and globally. Methods: WanFang (China) and Web of Science (United States) entries were retrieved for studies on stem cell therapies for type 2 diabetes. Visualization techniques were used to analyze publication year, country, institutional affiliation, author, journal, funding source, and keywords, as well as to compare the distribution of different types of stem cells for the treatment of type 2 diabetes. We also retrieved relevant clinical trial, drug, and patent information available from the Chinese Clinical Trial Registry, ClinicalTrials.gov, China National Medical Products Administration, US Food and Drug Administration, China National Intellectual Property Administration, and US Patent and Trademark Office. Results and conclusion: We found that: (1) stem cell therapy for type 2 diabetes was first reported in 1998. Thereafter, the number of relevant studies has risen at a slow rate, but increased rapidly since 2012. In China, stem cell therapy for type 2 diabetes was first reported in 2000, two years later than the first publication globally. (2) Bone marrow mesenchymal stem cells and pancreatic stem cells are the main types of stem cells used in China for treatment of type 2 diabetes. (3) In China, studies regarding stem cell therapy for type 2 diabetes were mainly associated with Shanghai Jiao Tong University, Peking Union Medical College, Chinese Academy of Medical Sciences, and Affiliated Hospital of Qingdao University School of Medicine. In the United States, relevant articles were mainly from the University of California and Harvard University. (4) In China, stem cell therapy for type 2 diabetes was mainly reported in two core journals, Chinese Journal of Tissue Engineering Research and Chinese Journal of Diabetes Mellitus, whereas, PLoS One, Diabetes, Diabetologia, and Stem Cell Research Therapy were the major relevant journals worldwide. (5) Globally, institutions providing major sources of funding for stem cell therapy for type 2 diabetes included the US National Institutes of Health, US Department of Health and Human Services, and National Natural Science Foundation of China. (6) There were four relevant clinical registries in the China Clinical Trial Registry and 17 on ClinicalTrials.gov. (7) No approval of stem cells as a treatment for type 2 diabetes has been issued in China or other countries. However, numerous relevant patents have been filed. Here, we report development trends, research hotspots, and the distribu","PeriodicalId":92014,"journal":{"name":"Clinical trials in degenerative diseases","volume":"23 1","pages":"5 - 17"},"PeriodicalIF":0.0,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81218569","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Information for Authors - Clinical Trials in Degenerative Diseases (CTDD)","authors":"","doi":"10.4103/2542-3975.281717","DOIUrl":"https://doi.org/10.4103/2542-3975.281717","url":null,"abstract":"","PeriodicalId":92014,"journal":{"name":"Clinical trials in degenerative diseases","volume":"23 1","pages":"18 - 23"},"PeriodicalIF":0.0,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"73278222","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Remote ischemic conditioning of the brain in dementia patients: protocol for a crossover non-pharmaceutical intervention study","authors":"C. Voucharas","doi":"10.4103/2542-3975.274076","DOIUrl":"https://doi.org/10.4103/2542-3975.274076","url":null,"abstract":"Background and objectives: Brain ischemia is one of the mechanisms causing dementia; this refers to vascular dementia, however its involvement in other forms of dementia cannot be excluded. We will study the potential neuroprotection of ischemia/reperfusion of a peripheral organ or tissue against cerebral I/R injury in people with mild cognitive impairment (percondition) and early and middle stage dementia (postcondition). Subjects and methods: This crossover study will be held with individuals suffering from peripheral arteriopathy that can cause intermittent claudication after structured exercise, thus inducing extensive transient leg’s ischemia. The level of cerebral function will be checked at baseline and after the intervention with cognitive tests, electroencephalography, magnetic resonance imaging, blood tests, immunological examinations, Event Related Potentials and level of proteins of cerebrospinal fluid (only at baseline). We will examine the possible slowing of progression or the improvement of the disease (dementia), we will suggest or exclude possible biomarkers that are transmitted to the process as well as the intracellular mode of action in the target organs, with a study comprising independent samples and comparison groups. Patient recruitment will begin in January 2020, the analysis of primary outcome measures will be completed in August 2021, and the study will finish in December 2021. The study was approved by the Ethical Committee of the “Greek Association of Alzheimer’s Disease and Related Disorders” (Alzheimer Hellas) (Pr Nr 250 / 2019 AI) on November 8, 2019. Outcome measures: Participants’ cognitive function will be assessed by cognitive scales (primary outcome measure), electroencephalography, magnetic resonance imaging, blood tests and immunological examinations, and cognitive induced potentials (secondary outcome measure) at the beginning and at the end of the study. Discussion: This is the first time in the literature that protection of the human brain from dementia of different stages by remote conditioning is investigated. Also innovating is the method that the remote organ ischemia is achieved. The above mentioned strategy of cerebral protection from the initiation or the development of dementia is safe and costless. Trial registration: ClinicalTrials.gov NCT04168021 registered on November 18, 2019.","PeriodicalId":92014,"journal":{"name":"Clinical trials in degenerative diseases","volume":"68 1 1","pages":"89 - 93"},"PeriodicalIF":0.0,"publicationDate":"2019-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"88479061","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Psoriatic arthritis: combinational therapy of biologics and methotrexate – What do we know?","authors":"S. Dauth, M. Köhm, F. Behrens","doi":"10.4103/2542-3975.274078","DOIUrl":"https://doi.org/10.4103/2542-3975.274078","url":null,"abstract":"Psoriatic arthritis (PsA) is a systemic inflammatory disease characterized by musculoskeletal involvement mostly associated with skin psoriasis. PsA is associated with significant morbidity and disability, and thus constitutes a major socioeconomic burden. For therapeutic strategies, early diagnosis and sufficient treatment lead to the best outcome with prevention of structural damage and loss of function. The combination of biologics (e.g., tumor necrosis factor inhibitors) and methotrexate (MTX) shows a significantly stronger clinical effect in the treatment of rheumatoid arthritis compared to biologic monotherapy as demonstrated by randomized controlled clinical trials. However, the influence of concomitant MTX on biologic therapy for PsA has not yet been fully clarified due to the lack of data from controlled studies that directly compare both treatment strategies, biologic monotherapy and combination of biologic and MTX. Moreover, data from subgroup analyses, register studies and from non-interventional clinical trials show discrepant results. The Germany-wide MUST study is a placebo-controlled, multicenter, randomized study to investigate the influence of MTX on the efficacy, safety and adherence to biologic therapy with ustekinumab in patients with active PsA. The aim of the study is to evaluate whether MTX naive patients would achieve a greater disease improvement with the combination of MTX and biological therapy than with a biologic monotherapy and whether MTX patients who, in addition to MTX, start a biologic therapy would become worse if MTX is discontinued. Data from randomized and controlled clinical trials are important to better understand the role of MTX as a concomitant medication in patients with PsA. The MUST study offers the ideal opportunity to investigate this question in a controlled study and to find out whether the addition of MTX to ustekinumab therapy is beneficial for patients. The results of this and other studies could improve PsA treatment by potentially omitting additional, possibly ineffective, medication that might increase the risk of adverse reactions. This article gives an overview of the current knowledge and published data regarding the effect of MTX as additional therapy to biological treatments in PsA patients. Additionally, the article introduces current efforts to evaluate the role of MTX for PsA treatment, including the MUST study.","PeriodicalId":92014,"journal":{"name":"Clinical trials in degenerative diseases","volume":"46 1","pages":"94 - 100"},"PeriodicalIF":0.0,"publicationDate":"2019-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"88197817","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Management of type 2 diabetes mellitus in the elderly population with cardiovascular diseases","authors":"R. Kant, Nathan Gilreath, V. Verma","doi":"10.4103/2542-3975.274079","DOIUrl":"https://doi.org/10.4103/2542-3975.274079","url":null,"abstract":"Addressing the glycemic control of the elderly patients with type 2 diabetes mellitus (T2DM) requires creating an individualized plan for each patient due to the heterogeneity among this population. The personalized plan should address topics such as comorbidities, polypharmacy, and cost of medications. One of the major comorbidities that necessitate consideration is cardiovascular disease (CVD), which makes it essential for clinicians to stay updated with literature on cardiovascular safety of diabetes medications. Metformin, along with dietary changes and adequate exercise, should be the first line treatment for patients with T2DM. Glucagon-like peptide-1 receptor agonists and sodium-glucose cotransporter-2 inhibitors should be considered for add-on therapy for elderly patients with CVD whom do not reach their hemoglobin A1c goal on metformin alone. All drugs in these two categories have been shown to be safe in patients with CVD and most of them have shown to reduce adverse cardiovascular events. Sulfonylureas should be used cautiously in elderly due to their high risk of hypoglycemia. Thiazolidinediones, saxagliptin and alogliptin should be avoided in patients with heart failure. With the high rate of major adverse cardiovascular events in elderly population, it is imperative to consider cardiovascular safety and efficacy of non-insulin diabetes medications in formulating management plan for elderly patients with concurrent T2DM and CVD.","PeriodicalId":92014,"journal":{"name":"Clinical trials in degenerative diseases","volume":"336 1","pages":"101 - 103"},"PeriodicalIF":0.0,"publicationDate":"2019-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"77777154","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"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","authors":"Piyapong Prasertsri, Orachorn Boonla, Jatuporn Phoemsapthawee, Kanoknuch Naravoratham, Petcharat Trongtosak","doi":"10.4103/2542-3975.267997","DOIUrl":"https://doi.org/10.4103/2542-3975.267997","url":null,"abstract":"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.","PeriodicalId":92014,"journal":{"name":"Clinical trials in degenerative diseases","volume":"139 1","pages":"76 - 80"},"PeriodicalIF":0.0,"publicationDate":"2019-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"86266722","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}