Gitika Bhasin , Rucha S. Dafale , Annapoorna K. , Shobha U. Kamath , Divya Matlani , Raju Rana , Mukhyaprana M. Prabhu , Akhilesh K. Pandey , Sahana Shetty , Lavya Shetty , Vasanthalaxmi K. , Manjula S.D.
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引用次数: 0
Abstract
Background
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.
Methods
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.
Results
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.
Conclusion
Preliminary findings suggest that TYM may be a promising complementary intervention for individuals with IFG or at risk of T2DM.
Trial registration
Clinical Trials Registry - India (CTRI); Registration number: CTRI/2022/04/042307; Registration Date: April 29, 2022.
期刊介绍:
Contemporary Clinical Trials Communications is an international peer reviewed open access journal that publishes articles pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from a wide range of disciplines including medicine, life science, pharmaceutical science, biostatistics, epidemiology, computer science, management science, behavioral science, and bioethics. Contemporary Clinical Trials Communications is unique in that it is outside the confines of disease specifications, and it strives to increase the transparency of medical research and reduce publication bias by publishing scientifically valid original research findings irrespective of their perceived importance, significance or impact. Both randomized and non-randomized trials are within the scope of the Journal. Some common topics include trial design rationale and methods, operational methodologies and challenges, and positive and negative trial results. In addition to original research, the Journal also welcomes other types of communications including, but are not limited to, methodology reviews, perspectives and discussions. Through timely dissemination of advances in clinical trials, the goal of Contemporary Clinical Trials Communications is to serve as a platform to enhance the communication and collaboration within the global clinical trials community that ultimately advances this field of research for the benefit of patients.