Bhasin Gitika, Dafale Rucha S, Annapoorna K, Kamath Shobha U, Matlani Divya, Rana Raju, Prabhu Mukhyaprana M, Pandey Akhilesh K, Shetty Sahana, Shetty Lavya, Vasanthalaxmi K, Manjula S D
Division of Yoga, Centre for Integrative Medicine and Research (CIMR), Manipal, Manipal Academy of Higher Education (MAHE), Manipal, Karnataka, 576104, India.
Department of Physiology, Kasturba Medical College (KMC), Manipal, Manipal Academy of Higher Education (MAHE), Manipal, Karnataka, 576104, India.
Contemp Clin Trials Commun. 2025 May 17;45:101493. doi: 10.1016/j.conctc.2025.101493. eCollection 2025 Jun.
Impaired Fasting Glucose (IFG) with elevated glycated hemoglobin (HbA1c) is a key precursor to type 2 diabetes mellitus (T2DM). Although asymptomatic, IFG significantly raises the risk of developing T2DM and cardiovascular complications, emphasizing the need for early intervention. The Therapeutic Yoga Module (TYM) was designed to offer a feasible and effective remedy for improving glycemic control.
The TYM was designed by combining different yoga practices including asanas, pranayama, relaxation, and dhyana. After validating the module, a feasibility study was carried out on 12 individuals. Subsequently, the preliminary impact was assessed on 29 individuals (intervention group = 14 and control group = 15) with IFG. The study evaluated practicality, participant acceptance, and changes in Fasting Blood Glucose (FBG) and HbA1c levels over 12 weeks.
The TYM achieved a content validity index (CVI) of 0.75, with 15 out of 20 practices deemed effective by the expert panel. The Intra-Class Correlation (ICC) coefficient of 0.864 indicated strong reliability. Feasibility testing revealed high participant acceptance, with an average attendance rate of 84.9 %. The intervention group showed significant improvements in FBG (from 108.79 mg/dL to 91.00 mg/dL, P < 0.001) and HbA1c (from 6.00 % to 5.73 %, P < 0.001), compared to the control group, which had more modest improvements. The analysis of covariance (ANCOVA) analysis confirmed that these improvements were primarily attributable to TYM.
Preliminary findings suggest that TYM may be a promising complementary intervention for individuals with IFG or at risk of T2DM.
Clinical Trials Registry - India (CTRI); Registration number: CTRI/2022/04/042307; Registration Date: April 29, 2022.
空腹血糖受损(IFG)且糖化血红蛋白(HbA1c)升高是2型糖尿病(T2DM)的关键先兆。尽管IFG没有症状,但它会显著增加患T2DM和心血管并发症的风险,这凸显了早期干预的必要性。治疗性瑜伽模块(TYM)旨在提供一种可行且有效的改善血糖控制的方法。
TYM通过结合不同的瑜伽练习来设计,包括体式、呼吸控制法、放松和冥想。在验证该模块后,对12名个体进行了可行性研究。随后,对29名患有IFG的个体(干预组 = 14名,对照组 = 15名)进行了初步影响评估。该研究评估了实用性、参与者的接受度以及12周内空腹血糖(FBG)和HbA1c水平的变化。
TYM的内容效度指数(CVI)为0.75,专家小组认为20种练习中的15种有效。组内相关系数(ICC)为0.864,表明可靠性很强。可行性测试显示参与者接受度很高,平均出勤率为84.9%。与改善程度较小的对照组相比,干预组的FBG(从108.79毫克/分升降至91.00毫克/分升,P < 0.001)和HbA1c(从6.00%降至5.73%,P < 0.001)有显著改善。协方差分析(ANCOVA)证实这些改善主要归因于TYM。
初步研究结果表明,TYM可能是对IFG个体或有T2DM风险个体有前景的辅助干预措施。
印度临床试验注册中心(CTRI);注册号:CTRI/2022/04/042307;注册日期:2022年4月29日。