|Year : 2022 | Volume
| Issue : 1 | Page : 51-57
Effect of one year of yoga therapy on glycemic control among patients with Type 2 diabetes mellitus: A randomized controlled trial
Rajesh Kulkarni1, Padmaja Walvekar2
1 Associate Professor, Department of Community Medicine, KAHER's J. N. Medical College, Belagavi, Karnataka, India
2 Professor, Department of Community Medicine, KAHER's J. N. Medical College, Belagavi, Karnataka, India
|Date of Submission||13-Feb-2022|
|Date of Decision||27-May-2022|
|Date of Acceptance||07-Jun-2022|
|Date of Web Publication||30-Jul-2022|
Dr. Rajesh Kulkarni
Department of Community Medicine, Jawaharlal Nehru Medical College, KLE University of Higher Education and Research (KAHER), Nehru Nagar, Belagavi - 590 010, Karnataka
Source of Support: None, Conflict of Interest: None
Context: India is well-endowed in using yoga therapy for the management of type 2 diabetes mellitus (T2DM) which is a safe, effective, and easy-to-learn alternative treatment that can be practiced by elderly and persons with disabilities.
Aim: Effect of 1 year of yoga therapy on glycemic control among patients having T2DM: A randomized controlled trial (RCT).
Settings and Design: RCT conducted at and Urban Health Centre (UHC) for 1 year.
Materials and Methods: One hundred and twenty diagnosed and registered for T2DM from UHC enrolled as participants who were divided into exercise and yoga interventional group by computer-generated, randomized number sequence method. The yogic practice was advised to 60 study participants and the reaming 60 participants were advised to do exercises for 1 year. The glycemic outcome was evaluated by Random Blood Sugar (RBS) and HbA1c which were examined at baseline, 6 months, and at the end of 1 year.
Statistical Analysis Used: Paired and unpaired (independent) t-test. Generalized estimating equations models were performed on the glycemic control variables to assess the differences between the two intervention groups.
Results: The post hoc analysis of 120 T2DM patient's data inferred that yoga and exercise have shown statistically significant (P < 0.05) effect on reducing HbA1C. However, no statistically significant difference (P > 0.05) was observed when the yoga group was compared with the exercise group on glycemic control (reducing HbA1c).
Conclusions: Yoga is as effective as exercise, hence people with morbidities or who are unable to go for exercise can practice yoga at home which will help them for proper control of HbA1c and RBS.
Keywords: Diabetes mellitus, Exercise, HbA1c, Yoga
|How to cite this article:|
Kulkarni R, Walvekar P. Effect of one year of yoga therapy on glycemic control among patients with Type 2 diabetes mellitus: A randomized controlled trial. Indian J Phys Ther Res 2022;4:51-7
|How to cite this URL:|
Kulkarni R, Walvekar P. Effect of one year of yoga therapy on glycemic control among patients with Type 2 diabetes mellitus: A randomized controlled trial. Indian J Phys Ther Res [serial online] 2022 [cited 2022 Aug 19];4:51-7. Available from: https://www.ijptr.org/text.asp?2022/4/1/51/353015
| Introduction|| |
Type 2 diabetes mellitus (T2DM) is a complex metabolic disorder that is distinguished by defects in insulin secretion and insulin action, leading to hyperglycemia. It is considered to be the leading cause of morbidity and mortality worldwide, related with severe cardiovascular manifestations, cerebrovascular ailment, or chronic kidney disease. The prevalence of T2DM was estimated to be 366 million in 2011, which is likely to raise 51%, attaining a prevalence of 552 million in 2030. The estimated prevalence of T2DM in India was 60 million in 2011 and may likely increase to 63%, achieving 98 million by 2030., The significant increase in the prevalence poses an alert to the Indian healthcare system to make necessary actions for the management of diabetes.
India is well-endowed in using yoga therapy for the management of T2DM. More worrisome is the rising prevalence in children and young adults. Yoga is a mind/body practice that incorporated three main components namely physical postures, meditation, and breathing exercises., The regular practice of yoga is associated with a shift of the autonomic equilibrium toward parasympathetic dominance. The parasympathetic balance is associated with conserving and restoring energies which helps inhibit the heart and alimentary activity, enabling secretion.
Diabetes is estimated to be the seventh prominent cause of death by 2030. The global prevalence of T2DM was assessed to be 6.4%. In Asia, approximately 15% of the population – or 1 in 7 adults – have been stated to have either high fasting blood glucose or impaired glucose tolerance. Among these, 5%–12% of these individuals develop type 2 diabetes every year. As of now, India is the country with the second-highest number of type 2 diabetic patients, and the figure is likely to increase two-fold by 2030. In India, the increased prevalence of T2DM is due to factors such as genetic predisposition and environmental factors contributing to increased abdominal obesity and insulin resistance.,
Yoga is an effective alternative treatment requiring no equipment, professionals and have sound evidence to possess long-term benefits. The role of exercise in diabetic is known and according to ADA guidelines, adults with diabetes should be counseled to accomplish at least 150 min/week of modest-intensity aerobic physical activity (50%–70% of maximum heart rate), spread over at least 3 days/week with no more than 2 successive days without exercise.
Along with medication, there are a number of treatments modalities are available to manage and treat diabetes such as life style modification, diet, yoga, and exercise. Although studies have been conducted in India to elucidate the impact of yoga on diabetes, most studies involve a limited number of patients with limited follow-up and more importantly involving only blood sugar estimations to evaluate the results. Since the literature is unclear regarding the most beneficial forms of yoga and exercise on glycemic outcome among subjects with T2DM, the present study randomized to compare the effect of yoga versus exercise treatment on glycemic outcome in subjects with T2DM.
| Subjects and Methods|| |
A randomized controlled trial (RCT) was performed at Urban Health Centre, Ashok Nagar, Belagavi. Study participants were recruited from the Diabetic Register maintained at Urban Health Centre, Ashok Nagar, Belagavi. The study was organized from July 2018 to December 2019. Institutional ethics committee had approved the study (ref no. KLEU/EC/17-18/D-102; Dated June 5, 2017) and participants provided informed consent before enrolment in the study.
The patients who will be eligible as per the inclusion criteria will be enrolled at the time of data collection from the OPD of Urban Health Centre, Ashok Nagar, which is Urban Field practice area of the Department of Community Medicine, Jawaharlal Nehru Medical College, KLE University, Belagavi. The sample size was calculated using below-mentioned formula
Where, Z1-α = at 95%, Confidence Interval = 1.96, Z1-β = at 80%, Power of the test = 0.84, Mean and SD for exercise and yoga intervention groups were taken: 0.59 and 3.34,, X1-X2 = Expected impact size, n = (0.84 + 1.96)2 (0.592 + 3.342)/(9.0 – 7.29)2 = 57. Accounting drop-out cases as 10%, then the calculated sample size was = 63 in each group. Participants were randomly divided into exercise and yoga interventional group by computer-generated, randomized number sequence method. T2DM patients of both genders in the age group of 28–60 years, with HbA1c concentrations of 6.5% or more, on medication with oral hypoglycemic agents (OHA) with at least 1-year duration and those who were permanent residents of urban field practice area of Ashok Nagar were included in the study as study participants. T2DM patients with known vascular complication of diabetes, such as coronary artery disease, stroke, nephropathy, retinopathy, and poly neuropathy were excluded from the study as this can interfere with the physical activities of the patients. Participants who had impairment of speech, hearing, vision, or cognition and patients on insulin and pregnant women were also excluded from the study. The details of the recruitment and workflow are depicted in CONSORT flow diagram [Figure 1].
|Figure 1: CONSORT flow diagram of participants' allocation, intervention, dropouts, follow-up, and analysis|
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During the first visit, socio-demographic details, medication, medical history, any associated health problem, and duration of diabetes were obtained by interviewing the participants. All study subjects were given health education regarding diet by a qualified nutritionist before the beginning of the study and also told about the importance of treatment adherence.
Yoga intervention group
The number of study participants in yoga intervention group is 65. The Yoga intervention comprised of hatha yoga classes with asanas (physical poses), relaxation, pranayama (breathing exercises), and meditation. The yoga instructor explained six yoga asanas to the study subjects.
Yoga teacher taught 60 min session which consisted of Surya namaskara – 20 min which included 12 steps, deep relaxation including muscle relaxation technique for 10 min, and 20 min yoga postures or asnas. The asanas consisted of Pavanamuktasana in the supine position, Bhujangasana and Shalabhasana in the prone position, Ardha Matsyendrasana in the sitting position which was followed by 10 min of pranayama. The time and occurrence of classes were roughly 50–60 min, 3 days in a week for 2 months. In the remaining days of the week, study participants were instructed to practice yoga at their home and to maintain a daily log book for seeing the adherence. For the first 2 months, intensive yoga teaching sessions were conducted by the yoga teacher. For the next 4 months, the patient was instructed to continue yoga under the observation of a recognized family member. The research staff nurse coordinated and did the follow-up of study participants to monitor compliance and provide individualized feedback.
Every month when the patient comes to the urban health center to collect his anti-diabetic drugs, random blood sugar levels (RBS) were checked, cross verification of participant family member checklist was done, and health education and counseling on nutritional aspects was given on the importance of adherence to proper diet and treatment. After 6 months and at the end of 1 year baseline investigations were repeated.
Exercise intervention group
The number of study participants in exercise group is 65. Exercise intervention refers to any unsupervised exercise training and subjects were counseled to enhance the physical activity that involves expenditure of energy such as a walking, jogging, and cycling for 45 min every day preferably in the morning hours with proper footwears. One person in the family was identified and was given a checklist to monitor whether the participant is regularly doing exercise. A research medico-social worker uses to coordinate and had done the follow-up of study participants.
For the estimation of biochemical parameters like rasting blood sugar (RBS, Rxl-Max 500) HbA1c (Bio-Rad D-10) about 5 ml of blood was drawn and analyzed by phlebotomist of Sisco Research Laboratories of Belagavi at Urban Health Centre. Anthropometric measurements like height and weight were obtained by trained researcher. The BMI was obtained using the formula (weight in kg/height (meter)2.
The data analysis was done to understand the descriptive and inferential statistics in terms of the central tendency of glycemic values and variations in yoga and exercise groups. The statistical significance from the baseline to 6 months and baseline to 12 months was measured by paired t-test, and variation in the yoga and exercise groups was calculated by an unpaired (independent) t-test. Statistical programming package SPSS version 25.0 was used for calculations. As the data violated the normality and homogeneity of variance, generalized estimating equations (GEE) models were performed instead of mixed-model ANOVA. GEE models were performed on the glycemic control variables to assess the differences between the two intervention groups.
| Results|| |
The demographic details of the patients are provided in [Table 1]. [Table 1] compares the background characteristics of study participants between the exercise group and yoga group. No significant association was identified between the intervention group and any of the given socio-demographic variables (P > 0.05) suggesting a good randomization.
|Table 1: Comparison of background characteristics between exercise group and yoga group|
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Female participants were slightly more than the male participants in the exercise (57.3%) and yoga intervention (42.7%). In our study, most of the study participants had 5–9 years of duration as diabetics (45.5% in the exercise intervention and 54.5% in the yoga intervention). The majority of study participants belonged to class III socioeconomic status according to Modified B. G. Prasad classification [Table 1].
Comparing glycemic control between exercise group and yoga group at different points of time
The mean change in the HbA1c levels at 6 and 12 months from the baseline for the yoga and exercise intervention groups are provided in [Table 2].
|Table 2: Mean change in glycated hemoglobin at 6 months and 12 months from the baseline (n=120)|
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GEE model analysis showed no significant effect of Intervention × Time on HbA1c (P = 0.318). However, there was a significant decrease of HbA1c in both the groups after 6 months and 12 months compared to baseline. Similarly, there were no significant effects of Intervention × Time on RBS (P = 0.431). However, there was a significant decrease (P = 0.431) of RBS in both the groups after 6 months and 12 months compared to baseline [Table 3].
|Table 3: Comparison of glycemic control between exercise group and yoga group at different point of time|
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Multiple linear regression for determining predictors of change in HbA1c and RBS
On comparing the effect of demographic variables with the change in HbA1c levels, it was identified that none of the variables were found significant predictors of change in HbA1c [Table 4].
|Table 4: Multiple linear regression for determining predictors of change in glycated hemoglobin|
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Age was found to be significant predictor of change in RBS (P = 0.032). With each year increase in age, there was 0.783 times increase in RBS level keeping other variables constant [Table 5].
|Table 5: Multiple linear regression for determining predictors of change in random blood sugar|
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Correlation between number of days respective intervention practiced and change in HbA1c and RBS
The correlation of number of days respective intervention practiced with each dependent variable was found to be low and insignificant (P > 0.05). The correlation of number of days respective intervention practiced with each dependent variable is visualized in [Figure 2] and [Figure 3].
|Figure 2: Scatter plot showing correlation between number of days respective intervention practiced and change in HbA1c|
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|Figure 3: Scatter plot showing correlation between number of days respective intervention practiced and change in RBS|
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| Discussion|| |
The present study was one of the very few studies which is community-based conducted at urban field practice area for 1 year of time with an adequate sample size among T2DM patients with three times reading baseline, 6 months and at the end 1 year. In our study, we found that both yoga and exercise are equally effective in glycemic control. Results obtained after statistical analysis in this study and its comparison with already published research, we can say that yoga as well as exercise both helps in reducing random blood glucose levels as well as Hb1Ac level in patients with T2DM.
Jayawardena et al. performed a meta-analysis involving eight studies with 842 participants to find the influence of yoga on glycemic control in subjects with T2DM. It was identified in the pooled analysis that a substantial reduction in the levels of fasting blood glucose (15.16 mg/dl), post prandial blood glucose (28.66 mg/dl), and glycated hemoglobin (0.39%) were seen in the yoga group compared to the exercise group. Ramamoorthi et al. in a meta-analysis involving 12 RCTs and 2 non-RCTs identified that yoga improved fasting blood glucose levels in the prediabetic state.
The beneficial effect of yoga in type II diabetes has been ascribed to improved insulin sensitivity at target tissues decreasing insulin resistance and accordingly increasing peripheral glucose utilization. It has also been hypothesized that yoga can revitalize or restore beta cells of the pancreas. Apart from reducing the dosage of oral hypoglycemic drugs or insulin, yoga can delay the development of the disease process.
In our study, there was a significant decrease of RBS and HbA1c in both yoga and exercise groups. Recent studies showed a significant decline in the levels of FBS and PPBS in type 2 diabetic patients on OHA undertaking yoga training when compared to subjects who are only on OHA., Similarly, a significant reduction in FBS and PPBS after yoga training has been proved in T2DM patients on OHA in a study. Keerthi et al. analyzed the consequence of yoga on quality of life (QoL) and Indian diabetes risk score in normotensive, diabetic, prediabetic individuals and it was identified that a significant improvement in QoL was seen and yoga diminished the risk of diabetes among Indian prediabetic people and diabetic individuals.
A decrease in HbA1c levels in the yoga group agrees with the earlier studies done by Malhotra et al. and Selvin et al. reported that a 1% reduction in HbA1c levels is related with a 37% decrease in microvascular complications and a 14% decrease in myocardial infarctions., Thus, in this study the observed 1.17% decrease in HbA1c levels might be projected to yield a 40% decline in risk of microvascular complications and a16% decrease in cardiovascular disease risk. In a meta-analysis conducted by Thind et al. involving 23 studies with 2473 participants, yoga improved glycemic outcomes and reduced the risks of complications of type 2 diabetes mellitus. Similar to our study, Gordon et al. observed that conventional physical training improved glycemic outcome in type 2 diabetic individuals. The present study has few limitations. Since this study is for 1 year and most of the yoga practice and exercise was unsupervised and adherence was mainly based on study participants reporting. Large multicenter trials with improved methodology are needed for further research.
| Conclusion|| |
Yoga is as effective as exercise, hence people with morbidities or who are unable to go for exercise can practice yoga at home which will help them for proper control of HbA1c and blood sugar levels. It appears extremely promising for primary and secondary prevention of diabetes mellitus.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2], [Figure 3]
[Table 1], [Table 2], [Table 3], [Table 4], [Table 5]