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 Table of Contents  
ORIGINAL ARTICLE
Year : 2021  |  Volume : 12  |  Issue : 4  |  Page : 517-523

Impact of yoga intervention on physical and mental health of adults with type 2 diabetes: Study design and methodology


1 Department of Clinical Trials, Madras Diabetes Research Foundation, Chennai, Tamil Nadu, India
2 School of Public Health, SRMIST, Chennai, Tamil Nadu, India
3 Krishnamacharya Yoga Mandiram, Chennai, Tamil Nadu, India

Date of Submission01-Jul-2021
Date of Decision16-Jul-2021
Date of Acceptance28-Jul-2021
Date of Web Publication12-Jan-2022

Correspondence Address:
Dr. Subramani Poongothai
Department of Clinical Trials, Madras Diabetes Research Foundation, ICMR Centre for Advanced Research on Diabetes, No. 4 Conran Smith Road, Gopalapuram, Chennai, Tamil Nadu.
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/jod.jod_88_21

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  Abstract 

Objective: The aim of this study was to discuss the components of yoga intervention and experimental design used to assess its effectiveness in diabetes care centers in Chennai. Materials and Methods: An interventional, randomized prospective study design was adopted. The study was conducted over a 6-month period. Based on inclusion and exclusion criteria, participants were selected from Dr Mohan’s Diabetes Specialities Centre. Informed consent was obtained, and participants were randomly assigned to either the intervention or the control group in a 1:1 ratio. Participants in the intervention group underwent yoga training every 2 weeks for up to 3 months. Each yoga session lasted 35 min and included a variety of asanas and pranayama techniques. Participants were also given an audio recording (CD) of the yoga instructions, and they were encouraged to practice yoga at home and advised to keep track of their progress in a dairy provided. Diabetes care was provided to the control group on a routine basis. In addition to biochemical parameters, mental health parameters were also assessed. Independent t-test was performed using SPSS 24.0. Results: A total of 152 participants were screened and randomized with 76 in the intervention arm and 76 in the control arm. There were no challenges in participants recruitment and retention. Data were collected during enrollment, 13 and 26 weeks. At baseline, the intervention arm’s mean HbA1c (%) was 8.4 ± 1.1%, whereas in the control arm, it was 8.3 ± 1.1% (P = 0.290), and fasting blood glucose levels were 142± 27 mg/dL in the intervention arm and 141 ± 29 mg/dL in the control arm (P = 0.811). There was no significant difference between groups in terms of lipid profile or mental health parameters at baseline. Conclusion: There is a major lacuna for controlled trials with methodological rigor in yoga intervention; this study may contribute to fill this requirement by systematically elucidating the role of yoga in the management of diabetes and to prevent complications. This study will provide a cost-effective care for people with diabetes. TRIAL REGISTRATION: CTRI/2018/04/013169

Keywords: Mental health, physical health, type 2 diabetes, yoga intervention


How to cite this article:
Poongothai S, Vidyulatha A, Nisha T, Lalasa M, Bhavani Sundari B, Karkuzhali K, Thanujah M, Latha S. Impact of yoga intervention on physical and mental health of adults with type 2 diabetes: Study design and methodology. J Diabetol 2021;12:517-23

How to cite this URL:
Poongothai S, Vidyulatha A, Nisha T, Lalasa M, Bhavani Sundari B, Karkuzhali K, Thanujah M, Latha S. Impact of yoga intervention on physical and mental health of adults with type 2 diabetes: Study design and methodology. J Diabetol [serial online] 2021 [cited 2022 Jan 27];12:517-23. Available from: https://www.journalofdiabetology.org/text.asp?2021/12/4/517/335602




  Introduction Top


Type 2 diabetes mellitus (T2DM) has emerged as a serious public health problem. According to the International Diabetes Federation, the global diabetes population will rise to around 642 million by 2040, with the majority of the increase occurring in low- and middle-income countries such as India.[1] The problem is exacerbated by the fact that diabetes onset in India occurred a decade earlier than in the rest of the world and the prevalence of undiagnosed diabetes is also quite high.[2],[3] Diabetes treatment is expensive across the world, and even more so in our nation because it is an out-of-pocket expense for the majority of people.[4]

Uncontrolled diabetes affects all major organs, such as the heart, kidneys, eyes, skin, digestive, and neurological systems. Uncontrolled diabetes is also known to have a deleterious effect on a person’s mental health, either directly or indirectly, triggering changes in mood, anxiety, depression, and a deterioration in some cognitive processes. A substantial number of research in the field of diabetes has examined the effects of the illness on cognitive performance. T2DM and poor glucose management were shown to be associated with decreased cognitive function, suggesting that the severity of T2DM is likely to contribute to accelerate cognitive aging.[5] According to the researchers, it is clinically and conceptually essential to look at sequential changes in various domains across time. Diabetes, according to Shuba and Karan’s[6] research findings, diabetes is associated with lower levels of cognitive function.

There are few researches that indicate bi-directional connections between mental health and cardiometabolic disease (e.g., diabetes).[7],[8] Depression, for example, is a risk factor for the development of T2DM.[9],[10] It has a negative impact on diabetic self-care[9],[11] and impairs glycemic control[12] and quality of life,[13],[14] and the cost of treatment is considerable. Furthermore, diabetes is linked to an increased risk of developing depression.[15]

The intricacy of the involvement of mind–body functioning problems impacting pervasively the quality of life warrants a need to identify cost-effective prevention and management strategies for T2DM. Strategies that can enhance one’s positive psychological state while also addressing physiological and psychological functioning factors are required. Any lifestyle strategy that aids in the reduction of physical inactivity, poor sleep, depression, stress, and dysfunctional habits, all of which are frequent in T2DM, is critical for its management. Over the last three decades, research on yoga has solidified the evidence that yoga supports a “mind–body” oriented practice that promotes a “relaxation response,” which relieves stress and promotes positive coping skillset. Yoga, as a multi-component practice that includes asanas (postures), pranayama (breath control), dhyana (focus and contemplation), and other lifestyle disciplines, is a holistic approach and intervention strategy in addressing various psychophysiological problems.

Yoga practices provide an opportunity for self-regulation and control by promoting flexibility, strength, stamina, balance, energy, and also mental serenity along with emotional regulation. Researchers have documented that yoga practices improve mood, subjective well-being, anxiety, positive health-related behaviors, physical functional status, performance, and quality of life in both clinical and general populations.

Many controlled trials on yoga for diabetes indicate that yoga may promote improvement in certain clinical parameters such as glycemic index, lipid levels, weight, and so on. Some studies have reported psychological well-being and better quality of life in same target groups.

Stress is the physiological effort imposed on the body when adapting, coping, or adjusting.[16] It can be beneficial and necessary in keeping a person attentive and task-oriented. Intense or persistent stress, in contrast, can be overwhelming and detrimental to the body.[17] Stressful life experiences are significantly associated with poor mental and physical health.[18] Chronic stress has been associated with health problems such as depression, anxiety, obesity, heart disease, and high blood pressure.

Yoga has been found to reduce anxiety, stress, salivary cortisol levels, and depression.[19],[20] Yoga has a positive influence on cognitive brain functions and may thus be used in conjunction with conventional medical therapy to improve cognitive brain functions in T2DM patients.[21]

Yoga is an ancient mind–body practice that has been actively promoted in India for the management of T2DM, hypertension, and other chronic diseases.[22],[23],[24],[25] Yoga’s effectiveness as an intervention varies greatly. Many people think of yoga as a physical intervention that includes bodily postures (asanas), breathing methods (pranayama), meditation, attitude and behavioral change, and mental discipline. The benefits of yoga as a physical activity option in T2DM include (a) a holistic concept in which physical activities are linked to a larger lifestyle package that includes diet, relaxation, and stress management; (b) modest cardiovascular demands in comparison to other types of exercise, making it an appropriate alternative for clinical groups requiring a moderate degree of physical activity; (c) minimal impact, therefore meeting a requirement for obese persons who have difficulties in mobility.

Yoga has lately gained popularity in a number of nations across the world. Nearly half of the adults in several developed countries such as Australia, Scotland, UK, Taiwan, Singapore, and the USA[26],[27],[28],[29],[30] use complementary therapies for treatment.

Yoga may be a viable approach for boosting trait mindfulness levels in a healthy population. Mindfulness entails being aware of what is happening on inside and outside of us at all times. Another essential aspect of mindfulness is being aware of our thoughts and feelings as they occur in moment to moment. Mindfulness is defined as being “aware of” or “conscious of” something in a non-judgmental way. Yoga practice improves one’s “present orientation.” There is, however, a dearth of yoga research on T2DM that focusses on the effects on mindfulness.

There has been positive evidence stating that yoga practices are beneficial in improving specific clinical parameters which are important for T2DM management. Research on yoga and T2DM has focussed only on glycemic control and cardiovascular risks in the past. No studies have been done on the association among depressive symptoms, cognitive function, and quality of life. Short-term studies, non-randomized, non-specific form of intervention, small sample size, non-injury-prone practice which caters to specific needs that can enhance the adherence are issues often highlighted in systematic reviews on impact of yoga. The current study focusses on the effect of holistic intervention, i.e., yoga on the psychological issues along with cognitive functions and impact on biochemical parameters, in people with T2DM. There is a major lacuna for controlled trials with methodological rigor in yoga intervention. Here, we describe the components of the yoga intervention and the experimental design used to test its effectiveness in diabetes care centers in Chennai, as well as the results of recruitment.


  Materials and Methods Top


Study design, patient identification, and recruitment

This study was an interventional, randomized prospective trial and was performed for a period of 6 months at Madras Diabetes Research Foundation, Chennai and was approved by Institutional Ethics Committee. CTRI/2018/04/013169 is the trial registration number.

The study was carried out in accordance with good clinical practice criteria established by the International Conference on Harmonization guidelines and outlined in Schedule Y (Amended 2005), Declaration of Helsinki as reviewed and amended from time to time.

Participants with T2DM were selected from Dr. Mohan’s Diabetes Specialities Centre in Chennai. Participants in the research ranged in age from 18 to 65 years, with documented T2DM and had HbA1c levels ranging from ≥ 7.0% to ≤ 10.5%, were recruited. Participants having type 1 diabetes mellitus, serum creatine concentration >132.6 mmol/L or liver function impairment, abnormal biochemistry or hematology or urine tests, participants with significant alcohol, drug, or medication abuse, currently under psychiatrist’s care using antipsychotic or mood stabilizer medications or having diagnosed with dementia or bipolar disorder or schizophrenia were excluded from the study. Pregnant or lactating women as well as those who had a recorded cardiovascular disease incidence during the previous 12 months were also excluded.

The study’s specifics were clearly explained to the participants in their preferred language (English or Tamil), and written consent was acquired. Participants who consented to take part in the trial were randomly allocated to either the intervention or control group. Before any study-related procedures were done, the investigator obtained consent from each patient. The information was handled in absolute confidentiality and in compliance with local data protection regulations.

Sample size and randomization

To measure the outcome variables such as change in HBA1c levels, sample size was calculated using the formula n = 2 (/ES)2. A sample of 76 participants in each group was required to give more than 90% power with α=0.05 to detect a 0.5% treatment difference in HbA1c in the intervention arm and assuming a standard deviation of 0.5–2%. Hence, the total sample size for the study with 10% dropout rate is 152.

The participants were randomized in blocks of five to one of the two groups to prevent bias. Consenting individuals were randomly assigned either to the intervention or standard group by the computer-generated random numbers. The research participants were assigned in a one-to-one ratio, and enrollment was handled by the principal investigator.

Intervention

Yoga intervention

At the diabetic center, a single yoga instructor from Krishnamacharya Yoga Mandiram conducted and supervised 35-min yoga sessions. The instructor received training in small group intervention teaching approach; hence, only five individuals were trained in a single session over the course of a day, and there were numerous sessions. The instruction was delivered to participants in the intervention group once every 2 weeks for 3 months. The yoga practice will begin with 2–3 min of warmup followed by 20 min of asanas (Tadasana, Parshwa uttanasana, Trikonasana, Apanasana, Jatara parivritti, Dwipadapeetam, Chakravakasana vinyasa) and will end with 8 min of Shavasana and 6 min of Pranayama technique. All of these asanas were performed dynamically, with movement and breathing synchronized. The asanas were adapted to meet the requirements and abilities of the participants in order to improve learning while keeping safety in mind. The yoga intervention aids in glucose management by lowering stress and boosting metabolism.

Participants in the intervention group were encouraged to attend yoga sessions every 2 weeks for a 12-week period. After 12 weeks of intervention, there was a 3-month follow-up period (12 weeks). During the follow-up period, participants were encouraged and instructed to continue their yoga practice at home, as well as to log their yoga practice in the provided yoga booklet throughout the follow-up period. During these 3 months, follow-up was carried very intensively by means of regular phone calls and at times home visits were performed to ensure compliance. Participants were encouraged to continue their yoga practice at home and were evaluated after the intervention sessions ended. To the participants in the control group, standard care of treatment was given: medication, diet, and exercise.

Data collection

Data were collected from participants during screening, enrollment (baseline), end of the 13 and 26 weeks, as shown in [Table 1]. There were follow-up visits for every 2 weeks to ensure compliance. During the scheduled follow-up assessment, participants completed the survey questionnaire and laboratory blood tests requested with the help of a care coordinator. Assessment was conducted by research staff blinded to randomization condition.
Table 1: Schedule of evaluations

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Outcome measures

The primary outcome measures are glycated hemoglobin (HbA1c) and fasting blood glucose levels. HbA1c was determined by liquid chromatography using the variant machine (Bio-Rad, Hercules, CA, USA), and fasting blood glucose was determined using the hexokinase technique on AU 680 Analyzer (Beckman Coulter, USA) using kits supplied by Roche Diagnostics (Mannheim, Germany). In addition, blood was drawn to assess the lipid profile and serum electrolytes. The Hitachi-912 Auto analyzer was used to measure serum cholesterol, serum triglycerides, and high-density lipoprotein (HDL) cholesterol, and the Friedewald method was used to compute low-density lipoprotein (LDL) cholesterol.[31]

Blood pressure was measured in sitting position using the electronic OMRON equipment. Two blood pressure readings were obtained 5 min apart, and the mean of the two was recorded. Anthropometric measures including height and weight were acquired using standard techniques. The formula weight (kg)/height squared was used to determine body mass index (m2).[32]

Changes in depression, cognitive impairment, perceived stress, mindfulness behavior, and quality of life were examined as secondary outcomes connected to mental health evaluation. Depression was measured using PHQ-9, a self-reported questionnaire of nine items. Each of the nine items was scored from 0 (not at all) to 3 (nearly every day) and participants exceeding score 5 were diagnosed as depressed.[33] Cognitive impairment was measured using Montreal Cognitive Assessment (MoCA).[34] The MoCA evaluates attention, concentration, executive processes, recall memory, language, visual constructional abilities, conceptual thinking, and awareness. Perceived Stress Scale (PSS), a 10-item questionnaire, was used to evaluate perceived stress. It includes questions on feelings and thoughts during the last month on a 5-point argument scale and points were given with boldfaced brackets: [0], [1], [2], [3], or [4].[35] PSS 10 questions 4, 5, 7, and 8 were positively stated, and scores were computed by reverse coding [0=4], [1=3], [2=2], etc. for the four positive items. The overall assessment score was obtained by summing up all of the scores across all 10 items. The Audit of Diabetes-Dependent-Quality of Life (ADDQoL) questionnaire was used to measure quality of life, which highlights positive and negative sentiments about life.[36]

The Mindful Attention Awareness Scale (MAAS), a 15-item scale, was used to assess a core characteristic of mindfulness: a receptive state of mind in which attention, informed by a sensitive awareness of what is currently occurring in the present, simply observes what is taking place.[37]


  Results Top


Recruitment was completed over a 19-month period, from June 2018 to January 2020, using a well-coordinated recruitment plan. As shown in [Figure 1], a total of 152 participants were screened and randomly assigned to one of the two group with 76 participants in the intervention arm and 76 in the controlled arm. The average age of participants was 53 ± 7.5 years with 47% (72) being males and 99.3% (151) being married and 35% having more than a high school degree.
Figure 1: Allocation of participants to intervention and control arms

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As shown in [Table 2], the mean BMI in the intervention arm was 27.4 ± 3.9 kg/m2 and in the control arm was 26.7 ± 3.3 kg/m2 with no significant difference (P = 0.272). The mean HbA1c (%) in the intervention arm was 8.5 ± 1.1% and in the control arm was 8.3 ± 1.1% and showed no significant difference between the two arms (P = 0.29). Fasting blood glucose levels also showed no significant difference and in the intervention arm it was 142 ± 27.4 mg/dL and in the control arm it was 141± 28.7 mg/dL and showed no significant difference (P = 0.81).
Table 2: Baseline characteristics of the study population

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The intervention group’s mean systolic and diastolic blood pressures were 123 ± 11 and 78 ± 7 mmHg, respectively, whereas in the control group, blood pressures were 123 ± 10 and 77 ± 7 mmHg, with no significant difference between groups at baseline.

As shown in [Table 3], the average MoCA (Cognition) scores in the intervention and control groups were 25.8 ± 2.1 and 25.4 ± 2.4, respectively, with no significant difference (P = 0.31). The patient Health Questionnaire revealed no statistically significant difference (P = 0.137) across arms, with 6.9 ± 4.8 mean in the intervention arm and 5.9 ± 3.7 mean in the control arm, indicating that participants in both the arms were moderately depressed. The mean perceived stress score in the intervention arm was 12.7 ± 6 and that in the control arm was 14.3 ± 5.6 and showed no significant difference (P = 0.079). The average of the MASS scale (mindfulness) was 78.5 ± 9.6 in the intervention arm and 79.2 ± 9.3 in the control arm, with no significant difference (P = 0. 653). Quality of life similarly showed no significant difference (P = 0.294) across arms, with a mean of -1.3 ± 1.5 in the intervention arm and -1.5 ± 1.4 in the control arm, showing that diabetes has a moderate impact on quality of life in both arms.
Table 3: Baseline Mental Health Assessment score for the study population

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  Discussion Top


The incidence of T2DM rises with increase in age, physical inactivity, and sedentary lifestyle. Stress and psychological factors also play a significant role in the development of T2DM.

Lifestyle management is considered as a significant strategy to the care of T2DM. Yoga is an ancient practice that has the ability to improve a number of T2DM-related indicators. Yoga promotes blood circulation, oxygen uptake, physical fitness, relaxation, and overall well-being. Yoga has also been shown to enhance metabolic processes, neuroendocrine state, and inflammatory responses by decreasing sympathetic activity and the cytokine axis. Yoga also selectively activates certain brain structures and neurochemicals that enhance optimism, alertness, motivated behavior, post-traumatic stress disorder symptoms, anxiety symptoms, memory, and associated metabolic and inflammatory responses.[38]

Yoga has also been shown to improve stamina, weight reduction, general functional efficiency, self-esteem, and to develop healthy attitudes and habits that aid in self-care. Though there have been studies that look at the impact of yoga intervention on depressive symptoms, stress, cognitive impairment, mindfulness, and quality of life on their own, there has been no study in India that looks at the comprehensive assessment of mental health and the impact of yoga on T2DM.

Yoga is a widely available low-cost approach in the community offered via yoga centers. In this hospital-based study, yoga is offered as an add-on support to the participants along with medical care to study the feasibility, acceptance, and delivery of the intervention. The only challenge encountered during recruiting was to make participants understand yoga as a mind–body technique, which can also be a part of medical management. Participants cooperated for evaluation; challenges such as retention, intervention management, and non-compliance did not impact on their normal care. The expected outcomes of this project are a reduction in blood sugars, lipid profile, blood pressure, and improvements in quality of life, cognition, and mood with a reduction in depressive scores and stress scores. The benefits of yoga practice on T2DM and lifestyle disorders will be studied further. If this integrated approach was found effective, it will be a cost-effective and acceptable method to help manage T2DM and will be beneficial for the community to become healthier. Such cost-effective collaborative care such as yoga intervention in primary care centers may be the future what this country needs.


  Conclusion Top


Given the growing prevalence of T2DM and lifestyle-related diseases in the Indian population, it is critical to investigate psychosocial variables such as depression, stress, and cognitive impairment, as they play an essential role in the management of these disorders. Maintaining excellent glycemic control at this stage necessitates behavioral changes in addition to standard treatment. There is a major lacuna for controlled trials with methodological rigor in yoga intervention; this study may contribute to fill this requirement by systematically elucidating the potentials of yoga interventions in the management of T2DM and its consequences, as well as to better understand the impact of yoga on depressive symptoms, stress, cognitive impairment, mindfulness, and quality of life. If proven, this holistic approach will serve as a cost-effective care for people with T2DM.

Acknowledgements

The authors would like to acknowledge and thank Ms. Lakshmi, data entry operator at Madras Diabetes Research Foundation for the secretarial support of the study and Ms. Jeba Rani and team for the software development.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
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