Sonu Maurya , Itagi Ravi Kumar , Amit Singh , Sriloy Mohanty , Raghuram Nagaratna
{"title":"评估瑜伽作为1型糖尿病辅助治疗的效果:随机对照试验的研究方案","authors":"Sonu Maurya , Itagi Ravi Kumar , Amit Singh , Sriloy Mohanty , Raghuram Nagaratna","doi":"10.1016/j.aimed.2023.02.006","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><p><span>Individuals with type 1 diabetes mellitus (T1DM) confront serious lifestyle alterations that include an absolute daily requirement for exogenous insulin, monitoring their glucose control, and paying attention to dietary intake. Yoga is an ancient mind-body practice increasingly recognized to have health benefits in various clinical and non-clinical conditions. The current trial was intended to evaluate the efficacy of yoga therapy on </span>glycemic variability and physical activity among patients with T1DM.</p></div><div><h3>Methods</h3><p>This is a single-centre, parallel-group prospective, randomized, open-blind end-point trial to evaluate the effectiveness of yoga therapy as an adjunct to T1DM care. 88 Patients aged between 12 and 17 years will be recruited from a charitable hospital for patients with T1DM and randomly allocated either to the intervention or control arm with an allocation ratio of 1:1. The control group will continue the standard care provided by the treating physicians, and the yoga group will be administered an additional Yoga module for three months. The monitoring of glycemic fluctuation will be assessed by the continuous glucose monitor, HbA1c<span>, C-peptide, Insulin dose, lipid profile, and using psychological questionnaires such as Peds QL 3.0 Type-1 Diabetes Module, Peds QL 4.0 Generic Core Sale, Hypoglycemic fear survey, Kutcher Adolescent depression scale, Type 1 Diabetes stress scale, Physical Activity Questionnaire for Adolescents, will be done at baseline and three months.</span></p></div><div><h3>Discussion</h3><p>The study is intended to address the physical and other risk factors among patients with T1DM. The study is prospectively registered on the India Clinical Trial Registry.</p></div>","PeriodicalId":7343,"journal":{"name":"Advances in integrative medicine","volume":null,"pages":null},"PeriodicalIF":1.7000,"publicationDate":"2023-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Evaluating the effect of yoga as an adjunct therapy in type 1 diabetes care: Study protocol for randomised control trial\",\"authors\":\"Sonu Maurya , Itagi Ravi Kumar , Amit Singh , Sriloy Mohanty , Raghuram Nagaratna\",\"doi\":\"10.1016/j.aimed.2023.02.006\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Background</h3><p><span>Individuals with type 1 diabetes mellitus (T1DM) confront serious lifestyle alterations that include an absolute daily requirement for exogenous insulin, monitoring their glucose control, and paying attention to dietary intake. Yoga is an ancient mind-body practice increasingly recognized to have health benefits in various clinical and non-clinical conditions. The current trial was intended to evaluate the efficacy of yoga therapy on </span>glycemic variability and physical activity among patients with T1DM.</p></div><div><h3>Methods</h3><p>This is a single-centre, parallel-group prospective, randomized, open-blind end-point trial to evaluate the effectiveness of yoga therapy as an adjunct to T1DM care. 88 Patients aged between 12 and 17 years will be recruited from a charitable hospital for patients with T1DM and randomly allocated either to the intervention or control arm with an allocation ratio of 1:1. The control group will continue the standard care provided by the treating physicians, and the yoga group will be administered an additional Yoga module for three months. The monitoring of glycemic fluctuation will be assessed by the continuous glucose monitor, HbA1c<span>, C-peptide, Insulin dose, lipid profile, and using psychological questionnaires such as Peds QL 3.0 Type-1 Diabetes Module, Peds QL 4.0 Generic Core Sale, Hypoglycemic fear survey, Kutcher Adolescent depression scale, Type 1 Diabetes stress scale, Physical Activity Questionnaire for Adolescents, will be done at baseline and three months.</span></p></div><div><h3>Discussion</h3><p>The study is intended to address the physical and other risk factors among patients with T1DM. The study is prospectively registered on the India Clinical Trial Registry.</p></div>\",\"PeriodicalId\":7343,\"journal\":{\"name\":\"Advances in integrative medicine\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":1.7000,\"publicationDate\":\"2023-03-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Advances in integrative medicine\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S2212958823000034\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"Medicine\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Advances in integrative medicine","FirstCategoryId":"1085","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S2212958823000034","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"Medicine","Score":null,"Total":0}
Evaluating the effect of yoga as an adjunct therapy in type 1 diabetes care: Study protocol for randomised control trial
Background
Individuals with type 1 diabetes mellitus (T1DM) confront serious lifestyle alterations that include an absolute daily requirement for exogenous insulin, monitoring their glucose control, and paying attention to dietary intake. Yoga is an ancient mind-body practice increasingly recognized to have health benefits in various clinical and non-clinical conditions. The current trial was intended to evaluate the efficacy of yoga therapy on glycemic variability and physical activity among patients with T1DM.
Methods
This is a single-centre, parallel-group prospective, randomized, open-blind end-point trial to evaluate the effectiveness of yoga therapy as an adjunct to T1DM care. 88 Patients aged between 12 and 17 years will be recruited from a charitable hospital for patients with T1DM and randomly allocated either to the intervention or control arm with an allocation ratio of 1:1. The control group will continue the standard care provided by the treating physicians, and the yoga group will be administered an additional Yoga module for three months. The monitoring of glycemic fluctuation will be assessed by the continuous glucose monitor, HbA1c, C-peptide, Insulin dose, lipid profile, and using psychological questionnaires such as Peds QL 3.0 Type-1 Diabetes Module, Peds QL 4.0 Generic Core Sale, Hypoglycemic fear survey, Kutcher Adolescent depression scale, Type 1 Diabetes stress scale, Physical Activity Questionnaire for Adolescents, will be done at baseline and three months.
Discussion
The study is intended to address the physical and other risk factors among patients with T1DM. The study is prospectively registered on the India Clinical Trial Registry.
期刊介绍：
Advances in Integrative Medicine (AIMED) is an international peer-reviewed, evidence-based research and review journal that is multi-disciplinary within the fields of Integrative and Complementary Medicine. The journal focuses on rigorous quantitative and qualitative research including systematic reviews, clinical trials and surveys, whilst also welcoming medical hypotheses and clinically-relevant articles and case studies disclosing practical learning tools for the consulting practitioner. By promoting research and practice excellence in the field, and cross collaboration between relevant practitioner groups and associations, the journal aims to advance the practice of IM, identify areas for future research, and improve patient health outcomes. International networking is encouraged through clinical innovation, the establishment of best practice and by providing opportunities for cooperation between organisations and communities.
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