EFFICACY OF THREE-MONTH YOGA INTERVENTION ON THE MANAGEMENT OF TYPE 1 DIABETES - A RANDOMIZED CONTROLLED TRIAL

Abstract

BACKGROUND The chronic autoimmune disease known as type 1 diabetes mellitus (T1DM) is brought on by the death of the pancreatic β cells that produce insulin, which results in insulin insufficiency and hyperglycemia. Although it can occur at any age, children and adolescents are most likely to experience it. T1DM, which has increased over the past 25 years, affects about 10% of all diabetics globally. In 2021, 8.4 million persons worldwide were forecast to have type 1 diabetes mellitus (T1DM); by 2040, that number is expected to rise to 13.5–17.4 million. The 10th edition of the International Diabetes Federation (IDF) reports that the number of children and adolescents worldwide who have type 1 diabetes is on the rise. The rising prevalence of Type 1 diabetes will also lead to other comorbidities (Zaharia et al., 2022), which are associated with a socioeconomic burden in developing nations (Andersen et al., 2024), thereby increasing the demand for complementary therapies, such as yoga, which can help manage T1DM and related comorbidities. Also, this rising burden of diabetes globally as well as in India, fuelled by lifestyle factors and stress, increases the demand for therapies like yoga, which aids in the reduction of psychological burden (Nagarathna et al, 2020). T1DM patients who follow strict glycaemic control plans are more likely to experience severe hypoglycaemic episodes, which are typified by the requirement for outside help to restore glucose levels. (Gubitosi et al., 2017). In certain situations, hyperglycemia can cause tissue and organ damage over time. More severe types of diabetic ketoacidosis and hyperosmolar can also result in stupor and coma. (Alyahyawi et al, 2021). According to interesting research, yoga therapy also improves pro-inflammatory markers such as Interleukin-6 (IL-6) (Raveendran et al, 2018), C Reactive Protein (CRP) (Kinser et al, 2012), highly sensitive CRP (hs-CRP) (Saud et al, 2022), and the incretin effect through glucagon-like peptide-1 (GLP-1). These findings support the mechanism of action of yoga therapy in the prevention and management of type 2 diabetes. Clinical problems like heart disease have been reported to improve with yoga.Quintão et al, 2015 & Cui et al, 2017) hypertension (Galantino et al, 2008) Type 2 diabetes mellitus (T2DM) (Cui et al, 2017) endocrine disorders (Innes et al, 2016) depression (Jw V et al, 2002) musculoskeletal disorders (Quintão et al, 2015) etc. Studies show the therapeutic benefits of yoga for children as well (Cox et al, 1987). Numerous studies assessed the yoga benefits for the T2DM population (Abdul-Rasoul et al, 2013 & Al-Abdulrazzaq et al, 2022) but due to limited research on adolescents with T1DM, we proposed this study. According to recent research, yoga practice has a positive impact on glycated hemoglobin and the quality of life for teenagers with type 1 diabetes. There is not randomized control research available yet, though. We looked at how yoga interventions affected the quality of life and glycated hemoglobin levels in teenagers with type 1 diabetes. AIM AND OBJECTIVE OF THE STUDY Aim of the study: To evaluate the impact of a three-month yoga intervention on glycated hemoglobin (HbA1c) and quality of life in teenagers with type 1 diabetes by conducting a randomized controlled trial Objective of the study: By evaluating the effects of yoga on participants with type 1 diabetes's HbA1c, average blood glucose, quality of life, depression, and fear of hypoglycemia in the yoga intervention group and control group, the study sought to assess the benefits of yoga for these individuals. METHOD Study Design: Two steps were taken to conduct the study. Step 1. Development of a yoga module The YM was designed after a comprehensive literature review of ancient literature and modern science, targeting glycemic control and pancreas activation at functional and 41 yogic practices for type 1 diabetes. The recommended practices were then validated by 20 experts from various fields of yoga science, therapy, and research for further review and endorsement. Out of 41 practices, 32 practices were finalized using Lawshe’s formula with a CVR cut-off at 0.4, suitable for the module of teaching. Further, a feasibility test was conducted in a hospital set up by an expert, offline, for six days a week for three months. The study confirmed the feasibility of the yoga module tested through offline about regularity and ease of practice, the efficacy of the Module, and construct satisfaction, and reported no adverse events during feasibility testing. Step 2: Randomized Controlled Trial (RCT) Participants: Conducted a single-blinded, two-arm, parallel-group randomized controlled trial. We recruited the participants through Ramakrishna Mission Sevashram Charitable Hospital. The screening and recruitment process, as well as the selection, were initiated in December 2021 for a one-month intervention that was scheduled to begin in January 2022 and end in March 2022. The trial was conducted on 92 patients [mean age, 13.35 SD 2.41 years] with clinical type 1 diabetes randomized to either an adjunct yoga intervention or usual care. Intervention: To acquaint them with the module, the yoga intervention group got YM offline in the hospital for three months under the guidance of a skilled yoga therapist. During the trial time, the control group was observed and instructed not to begin a yoga practice routine. Every subject was evaluated twice, namely before and after the trial. Measure: Data were collected for the primary biochemical test of type 1 diabetes [ glycated hemoglobin and Average blood glucose] along with secondary measures of daily insulin requirements, PedsQL-3.0, PedsQL-4.0, Kutcher Adolescent Depression Scale, and Fear of Hypoglycemia questionnaire. Statistical analysis: The investigation was conducted using the Statistical Package for Social Sciences (SPSS) version 23.0. The Shapiro-Wilk test was used to determine whether continuous variables were normal. To illustrate baseline attributes, we employed descriptive statistics with a mean (standard deviation) or number (percentages). Additionally, within-group and between-group comparisons were conducted using parametric or non-parametric tests, depending on the data distribution. A paired sample t-test and Wilcoxon’s signed-rank test were used to find within-group differences for average and non-normal data, respectively. Independent sample t-test and Mann-Whitney’s test will determine the group differences. Results: Comparing the yoga intervention group to the control group after the intervention, the results show a significant improvement in both major and secondary variables, with statistical significance at P <.001. Conclusion: Among teenagers with type 1 diabetes, the three-month adjuvant yoga intervention was linked to better glycaemic control and quality of life. Keywords: Type 1 diabetes; Yoga; Glycated hemoglobin; hypoglycemia