Evaluating the effect of yoga as an adjunct therapy in type 1 diabetes care: Study protocol for randomised control trial

IF 1.7 Q2 Medicine
Sonu Maurya , Itagi Ravi Kumar , Amit Singh , Sriloy Mohanty , Raghuram Nagaratna
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引用次数: 0

Abstract

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.

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
背景1型糖尿病(T1DM)患者面临严重的生活方式改变,包括每天绝对需要外源性胰岛素、监测血糖控制和注意饮食摄入。瑜伽是一种古老的身心练习,越来越被认为在各种临床和非临床条件下对健康有益。本试验旨在评估瑜伽治疗对T1DM患者血糖变异性和体力活动的疗效。方法本试验是一项单中心、平行组、前瞻性、随机、开放盲终点试验,旨在评估瑜伽疗法作为T1DM辅助治疗的有效性。88名年龄在12至17岁之间的T1DM患者将从慈善医院招募,并以1:1的分配比例随机分配到干预组或对照组。对照组将继续接受治疗医生提供的标准护理,瑜伽组将接受为期三个月的额外瑜伽模块。血糖波动的监测将通过连续血糖监测仪、HbA1c、C肽、胰岛素剂量、脂质概况进行评估,并使用心理问卷,如Peds QL 3.0 1型糖尿病模块、Peds QL 4.0通用核心销售、低血糖恐惧调查、Kutcher青少年抑郁量表、1型糖尿病压力量表、青少年体育活动问卷,将在基线和三个月内完成。讨论本研究旨在解决T1DM患者的身体和其他危险因素。该研究在印度临床试验注册中心进行了前瞻性注册。
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来源期刊
Advances in integrative medicine
Advances in integrative medicine INTEGRATIVE & COMPLEMENTARY MEDICINE-
CiteScore
3.20
自引率
11.80%
发文量
0
审稿时长
15 weeks
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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