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\title{Development and Validation of a Yoga Module for Adolescents with Type 1 Diabetes}
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             \author[1]{Sonu  Maurya}

             \author[2]{Dr. Itagi Ravi  Kumar}

             \author[3]{Dr. Amit  Singh}

             \author[4]{Dr. R.  Nagaratna}

             \affil[1]{  SVYASA University, Bangalore}

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\date{\small \em Received: 13 December 2019 Accepted: 2 January 2020 Published: 15 January 2020}

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\begin{abstract}
        


Background: Most adolescent patients with type 1 diabetes (T1D) do not meet treatment goals, which increases their risk for diabetes-related complications; therefore, finding ways to improve adherence to therapy is crucial. Yoga is known to more people as physical posture and a way to glycemic variability management strategy. The previous study has reported the beneficial role of yoga in improving glycemic variability and autoimmune disorder. However, a validated yoga module for T1D, is unavailable. DevelopmentandValidationofaYogaModuleforAdolescentswithType1DiabetesStrictly as per the compliance and regulations of: 2020Objective: This study developed and validated a Junior yoga module (JYM) for adolescents with T1D.

\end{abstract}


\keywords{autoimmune disorder, type 1 diabetes, yoga and diabetes, yoga, adolescents.}

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\let\tabcellsep& 	 	 		 
\section[{Introduction}]{Introduction}\par
ost adolescent patients with type 1 diabetes (T1D) do not meet treatment goals, which increases their risk for diabetes-related complications; therefore, finding ways to improve adherence to therapy is crucial \hyperref[b45]{(Patel et al., 2018)}. Type 1 diabetes (T1D) develops in genetically predisposed people as a result of the destruction of the pancreatic beta cells caused by an autoimmune insulitis \hyperref[b10]{(Briscoe et al., 2007;}\hyperref[b64]{Sharma, 2017)}. Increased thirst, frequent urination, bed-wetting in children and adolescents who previously didn't wet the bed during the night, extreme hunger, unintended weight loss, irritability and other mood changes, fatigue, and weakness, blurred vision are some major symptoms \hyperref[b23]{(Fowler, 2008;}\hyperref[b30]{Kalra et al., 2013)}.\par
Adolescents experience significant physiological and psychosocial changes during this developmental stage, including increased insulin resistance related to pubertal hormones, significant weight gain, higher insulin needs, and independence from parents. Unfortunately, this newfound autonomy often results in problems with T1D. It may further exacerbate poor glycemic control. Besides, adolescents with chronic hyperglycemic conditions may be more likely to engage in high-risk behaviors, such as drug and alcohol use, cigarette smoking, etc. \hyperref[b15]{(Comeaux, 2010;}\hyperref[b45]{Patel et al., 2018;}\hyperref[b75]{Weitzman et al., 2015)}.\par
Yoga is a mind-body intervention and comprises physical practice (äsana), breathing technique (präëäyäma), and meditation, and relaxation techniques. Yoga is a popular complementary and alternative medicine modality worldwide \hyperref[b22]{(Falkenberg et al., 2018)}.\par
Many studies have reported several health benefits of yoga for a clinical condition such as asthma, diabetes, pulmonary tuberculosis, epilepsy, fibromyalgia, and arthritis \hyperref[b16]{(Cramer, 2015;}\hyperref[b24]{Gowtham, 2018;}\hyperref[b28]{Hongasandra, 2017}  \hyperref[b22]{(Falkenberg et al., 2018)}, improvements in physical fitness, immune activity \hyperref[b32]{(Kosuri \& Sridhar, 2009)}, improved beta-cell function \hyperref[b54]{(Raj, 2016)}, and reduced stress as physiological mechanisms for beneficial effects of yoga on the immune system in adolescents \hyperref[b61]{(Sahay, 2007;}\hyperref[b39]{Mohan et al., 2005;}\hyperref[b70]{Szablewski, 2014)}. 
\section[{II.}]{II.} 
\section[{Quality of Life and Type 1 Diabetes}]{Quality of Life and Type 1 Diabetes}\par
Children with type 1 diabetes mellitus (T1DM) have to deal with a complex and demanding daily treatment regime, which can harm the quality of life (QoL) of these patients \hyperref[b55]{(Rasoul et al., 2013)}. Although children and adolescents with T1DM have to live with a demanding treatment regime, overall results revealed that their generic QoL is not impaired compared to healthy peers \hyperref[b20]{(Duru et al., 2015)}. Young adults with Type 1 diabetes mellitus are a high-risk group with suboptimal glycemic outcomes when compared with older adults with Type 1 diabetes \hyperref[b1]{(Ambler et al., 2006)}. Management is challenging because of psychosocial issues; for example, body image perceptions \hyperref[b43]{(Neumark et al., 2002)}, the increased incidence of psychiatric illness \hyperref[b8]{(Bernstein et al., 2013)}, eating disordered \hyperref[b53]{(Quick et al., 2012)}, and impaired quality of life \hyperref[b31]{(Kibbey et al., 2013;}\hyperref[b29]{Ingerski et al., 2010)}. Some studies suggest that low glycemic variability may be associated with lower quality of life, negative moods, blood glucose fluctuations \hyperref[b47]{(Penckofer et al., 2012)}. A meta-analysis of 27 studies demonstrated that depression is majorly associated with hyperglycemia for type 1 diabetes  {\ref (Lustman et al., 2000)}. Moods such as anxiety and anger often accompany depression with type 1 diabetes \hyperref[b48]{(Peyrot \& Rubin, 1997)}; anxiety is associated with poor glycemic control \hyperref[b3]{(Anderson et al., 2002)}. Anger is also linked to depression \hyperref[b44]{(Pasquini et al., 2004)}. It is associated with glucose fluctuation and poorer self-management of hyperglycemia for persons with type 1 diabetes.\par
For persons with type 1 diabetes, high glucose values suggest to impact mood negatively, positive mood rating decreased, whereas negative mood ratings increased, tension and anger is reported to be higher in type 1 diabetes individuals in the hyperglycemic range compared with those in the hypoglycemic range with continuous glucose monitoring (CGM) \hyperref[b26]{(Hermanns et al., 2007)}. However, glycated hemoglobin (HbA1c) has been the standard for assessing glycemic control, glycemic variability \hyperref[b27]{(Hirsch, 2005)}. 
\section[{III.}]{III.} 
\section[{Yoga and Immune System}]{Yoga and Immune System}\par
Yoga is an ancient mind-body practice that is increasingly recognized to have health benefits in a variety of clinical and non-clinical conditions \hyperref[b22]{(Falkenberg et al., 2018)}. Among various types of yoga, emphasizing both physical and mental training, and typically consists of yoga poses, breathing, and meditation \hyperref[b40]{(Nagendra, 2003)}. It is stated that yoga not only increased physical endurance but also reduced pro-inflammatory markers such as interferon ? (INF-?), interleukin-6 (IL-6), interleukin-2 (IL-2), and stress level \hyperref[b51]{(Pullen et al., 2008)}. Based on these results, yoga practice is required to achieve consistent effects, especially on circulating inflammatory markers \hyperref[b22]{(Falkenberg et al., 2018)}, improvements in physical fitness, immune activity \hyperref[b32]{(Kosuri \& Sridhar, 2009)}, improved beta-cell function \hyperref[b54]{(Raj, 2016)}, and reduced stress as a physiological mechanism for beneficial effects of yoga on the immune system \hyperref[b61]{(Sahay, 2007;}\hyperref[b39]{Mohan et al., 2005;}\hyperref[b70]{Szablewski, 2014)}. The practice of yoga reduced inflammation and smaller autonomic, endocrine, and inflammatory response to the stressors and novices. The yoga practice demonstrated more rapid declines (recovery) in stress hormone and proinflammatory cytokines production and better glycemic control in T1D \hyperref[b68]{(Sreedevi, 2017)}. Yoga is a cost-effective option in the treatment and prevention of autoimmune disorder, with data from several studies suggesting that yoga and other mindbody therapies can reduce stress-related hyperglycemia and have a positive effect on glycemic control, balancing harmonizing the body, mind, and emotions. Increasing evidence suggests that yoga practice tackles the pro-inflammatory mechanisms of T1D and helps in controlling autoimmune disorders  {\ref (Amita et}   
\section[{a) Materials and methods}]{a) Materials and methods}\par
The content validity of JYM for adolescents with T1D is assessed by a panel of 20 experienced yoga experts. The JYM for children and adolescents with T1D is developed in the form of tailor-made yoga practices that are supported by classical texts and research evidence.\par
All the 41 practices in the JYM, is discussed and rated as i.\par
Not essential, ii.\par
Useful but not essential, iii. Essential.\par
Lawshe's formula is adopted to arrive at the content validity ratio (CVR) after obtaining the ratings. 
\section[{Figure}]{Figure}\par
The steps followed to execute the above-mentioned methods are as follows:\par
Step 1: Compilation of literature on Type 1 diabetes Step 1: Compilation of literature on yoga and diabetes a. In this phase, we reviewed traditional and contemporary yoga texts. b. Research paper on the use of yoga in diabetes, immune and metabolic disorders, including modern scientific reviews of T1D, were identified using different search engines such as Pub Med and Google Scholar. Indexing terms such as yoga immune disorder, metabolic disorder, and yoga, and diabetes. All experimental studies that used yoga as the therapy for diabetes are included.\par
Step 2: Shorting the literature on yoga and diabetes A summary of the literature is tabulated for a quick overview. Then, studies done on different practices and published in journals as a scientific background is extracted. 
\section[{Step 3: Preparing yoga module based on previous literature on yoga and diabetes}]{Step 3: Preparing yoga module based on previous literature on yoga and diabetes}\par
Based on classical texts and research evidence a detailed protocol with tailor-made practices is developed. 
\section[{Step 4: Validation of JYM by expert}]{Step 4: Validation of JYM by expert}\par
Yoga experts with clinical experience are provided with this complete module (who had either a doctorate or Doctor of medicine degree in yoga, with a minimum of 5 years experience or a Master's degree in yoga/ yoga therapist, with a minimum of 7 years experience). These experts were requested to participate in evaluating the content validity for the proposed instrument on a 3-point scale rated as follows: (i) not essential (has no role in improving any symptoms or the quality of life of patients with T1D), (ii) useful but not essential (useful in improving general wellbeing, but the benefits are not specific to T1D symptoms), and (iii) essential (very effective for T1D).\par
An expert panel, including 20 experts with the above qualifications, involved for determining the content validity. Experts in yoga therapy with clinical experience ( ?5 years) were also considered yoga experts. Among the 20 experts, more than ten has previously applied yoga therapy in patients with diabetes and were already using most of the practice included in this module.\par
The CVR for the total scale was computed based on expert validation. According to Lawshe's formula, if more than half of the panelists indicate that an item is essential, then that item has the minimum content validity. The CVR for our scale was ?0.49, which was considered satisfactory for a panel of 20 experts. 
\section[{b) Statistical Analysis}]{b) Statistical Analysis}\par
The cut-off value of 0.49 is calculated by applying Lowshe's formula for CVR (Lawshe, 1975). The mean CVR across the item indicated the overall test content validity.\par
Where, Ne = total number of panelists indicating "essential" for each practice. N = total number of panelist IV. 
\section[{Result}]{Result}\par
The data analysis showed that out of 41 JYM practices, 27 indicated significant content validity in (Table \hyperref[tab_2]{1}). 14 practice (Table \hyperref[tab_3]{2}) had a CVR score of below 0.49, indicating low content validity.     
\section[{Pärçva Ürdhva Hastäsanä}]{Pärçva Ürdhva Hastäsanä} 
\section[{Täòäsanä Pratyägama}]{Täòäsanä Pratyägama}\par
Mountain pose twist 5 each side 1 c. 
\section[{Bhünaman Pratyägama}]{Bhünaman Pratyägama}\par
Greeting the earth pose with twist 5 each side 1 d. 
\section[{Naukäsaï cälana}]{Naukäsaï cälana}\par
Rowing the boat flow 5 1 4. Specific breathing practice for Type 1 Diabetes mellitus a.  
\section[{Vyäghra Çväsana}]{Vyäghra Çväsana} 
\section[{M aëòükäsana}]{M aëòükäsana}\par
Frog pose 1 1 c. 
\section[{Garbhäsana}]{Garbhäsana}\par
Embryo pose 1 1 d. 
\section[{Üñöräsana}]{Üñöräsana}\par
Camel pose 1 1 e. 
\section[{Bäläsana}]{Bäläsana}\par
Child pose 1 1 f. 
\section[{Pavanamuktäsana}]{Pavanamuktäsana}\par
Wind relieving pose 1 1 10. 30 second relaxation after each Äsana (as per the condition) 11. Specific Supine Äsana for Type 1 Diabetes mellitus a. 
\section[{Setubandhäsana}]{Setubandhäsana}\par
Bridge pose 1 1 b.  
\section[{M atsyäsana}]{M atsyäsana} 
\section[{Bhujaì gäsana}]{Bhujaì gäsana}\par
Cobra pose 1 1 b. 
\section[{Tiryaka Bhujaì gäsana}]{Tiryaka Bhujaì gäsana}\par
Swaying cobra pose 1 1\par
1. Specific relaxation after Äsana for Type 1 Diabetes a. 
\section[{Çaväsana}]{Çaväsana}\par
Dep relaxation technique 1 5 2. Specific Pranayama for Type 1 Diabetes mellitus a.  
\section[{Anuloma-Viloma}]{Anuloma-Viloma} 
\section[{Discussion}]{Discussion}\par
In the present study, we developed a JYM for adolescents with T1D by choosing specific yoga practices from the traditional literature and scientific studies on yoga to target certain symptoms of adolescents with T1D. Validated JYM by the yoga experts taking their suggestions is finalized. Similarly, an effort was made to retain only those practices which were rated by all experts as useful. The yoga practices are included, as suggested by the experts. All the experts opined that these practices should be easy for children and adolescents with T1D. Relaxation practice is also included between the session as per the advice of the experts. So, The matching of yoga practices with symptoms of adolescents finalized after reviewing traditional literature \hyperref[b62]{(Saraswati, 2004;} {\ref Mukibodha, 2000)}. The present study was closely associated with previous studies on the validation of JYM  {\ref (Ahilan,}   \hyperref[b72]{Vaishali et al., 2012;}\hyperref[b11]{Campaigne, 1985)}.\par
In the present, there is no previous study that focused on the validation of a yoga module for T1D. This study is done in two phases: a) We are designing the yoga module for T1D, b) expert validation of the module for T1D.\par
In the first phase, the JYM was designed based on literature reviews of traditional text reference and recent research publications. We did not find any direct source for yogic practice capable of improving T1D symptoms. However, the latest Hatha Yogic text has increasingly emphasized on improving health through different yogic practices. Besides, recent findings on T1D reported by several schools of yoga have helped in the formulation of a yoga module for T1D. The CVR calculation for all 41 practices is completed in our yoga module. Of these, 27 practices (CVR?0.42) were included in the validated yoga module (Table \hyperref[tab_2]{1}). The remaining fourteen poses (Table \hyperref[tab_3]{2}) (CVR <0.49), namely Butterfly, Tadasana, (0.1), Dorsal stretch (0.2), Rabit breathing, Janusirasana, Ardhapadapaschimittanasana, Kurmasana, Bharadwajasana, Salabhasana (0.3), Veerasana, Vyaghrasana, Makarasana, Halasana, Kapalbhati (0.4) were used as a complementary for important posture to stimulate the pancreases and synchronization along with body and mind. These practices were slightly challenging for T1D therapy. Apart from these fourteen practices, the 27 poses included for T1D treatment; thus, the final CVR satisfied the minimum value, as per Lowshe's CVR.\par
Similar to any other exercise protocol, an ideal yoga module consists of frequencies, intensities, duration, and progression. Determining the appropriate mode depends upon the patient's preference and safety issues associated with the T1D or other conditions. Keeping in view the safety and patient's ability the duration and frequency of the pose customized for practice (Table \hyperref[tab_4]{3}).\par
Çithilikaraëa Vyäyäma (Loosening Practice) include in this module helped in loosening the joint and strengthen the muscles, which consequently helped in improving the function of abdominal organs \hyperref[b18]{(Dhirendra, 1973)}.\par
Süryanamaskära (Sun Salutation), A series of dynamic yoga posture in a specific sequence, stimulate insulin production through brain signaling, exerting beneficial effects on the glycemic outcome \hyperref[b54]{(Raj, 2016)}.\par
Yogäsana (Yoga Posture) rejuvenates of pancreatic cells through the alternating abdominal contraction and relaxations involved in yoga practice. Improves blood supply to muscles, enhances insulin receptors expression in the muscles, with forwards bending pose, © 2020 Global Journals manage and pressurizing the pancreas, stimulating insulin secretion \hyperref[b0]{(Ahilan, 2015;}\hyperref[b21]{Eda, 2014)}.\par
Çuddhikriyä (Cleansing Processes), Agnisära Kriyä (stimulating the digestive fire) involves pulling the abdomen in and snapping it backward and forward while holding one's breath. Helps in the producing of insulin and controlling glucose levels in the blood; the effect of this action massage the internal organs and increases blood flow to the area \hyperref[b33]{(Kudigra, 2018;}\hyperref[b57]{Raveendran et al., 2018)}.\par
Präëäyäma (regulated breath), Anulomvilom (alternate nostril breathing), improves components of healthrelated fitness, cardio respiratory endurance, flexibility, and body fat percentages.\par
Bhrämaré (humming bee breath), a soothing and calming effect on the mind, improves mental and physical health \hyperref[b4]{(Author, 2019;}\hyperref[b68]{Sreedevi, 2017)}. Dhyäna (Meditation): This leads to beneficial psychological effects, such as a faster reaction to stimuli and less prone to various forms of stress, anxiety reduction, and blood pressure control. Meditation on the Manipur Chakra (solar plexus), visualization of the pancreas during meditation, gives positive effects on sugar levels \hyperref[b5]{(Balaji et al., 2012;}\hyperref[b21]{Eda, 2014;}\hyperref[b54]{Raj, 2016)}. 
\section[{VI.}]{VI.} 
\section[{Conclusion}]{Conclusion}\par
A comprehensive and traditional texts based yoga module was developed and validated by 20 experts who agree to most of the practices. Whoever, future studies must determine the feasibility and efficacy of T1D. 
\section[{Sources of funding None Conflict of interest None}]{Sources of funding None Conflict of interest None}\begin{figure}[htbp]
\noindent\textbf{2}\includegraphics[]{image-2.png}
\caption{\label{fig_0}Step 2 :}\end{figure}
     \begin{figure}[htbp]
\noindent\textbf{1} \par 
\begin{longtable}{P{0.03960573476702509\textwidth}P{0.31227598566308246\textwidth}P{0.05940860215053763\textwidth}P{0.050268817204301076\textwidth}P{0.321415770609319\textwidth}P{0.06702508960573476\textwidth}}
\tabcellsep \tabcellsep \tabcellsep \tabcellsep \tabcellsep D D D D )\\
\tabcellsep \tabcellsep \tabcellsep \tabcellsep \tabcellsep (\\
SL. no.\tabcellsep Practice Name\tabcellsep CVR\tabcellsep SL. no.\tabcellsep Practice Name\tabcellsep CVR\\
1\tabcellsep Vyäghra Çväsana\tabcellsep 0.9\tabcellsep 15\tabcellsep Pavanamuktäsana\tabcellsep 1\\
2\tabcellsep Pärçva Ürdhva Hastäsanä\tabcellsep 0.5\tabcellsep 16\tabcellsep Bhujaìgäsana\tabcellsep 0.9\\
3\tabcellsep TäåäsanaPratyägama\tabcellsep 1\tabcellsep 17\tabcellsep Tiryaka Bhujaìgäsana\tabcellsep 0.6\\
4\tabcellsep bhunamanPratyägama\tabcellsep 0.7\tabcellsep 18\tabcellsep Dhanuräsana\tabcellsep 1\\
5\tabcellsep Naukäsaïcälana\tabcellsep 0.9\tabcellsep 19\tabcellsep Setubandhäsana\tabcellsep 0.6\\
6\tabcellsep Süryanamaskära\tabcellsep 1\tabcellsep 20\tabcellsep Matsyäsana\tabcellsep 0.5\\
7\tabcellsep Trikoëäsana\tabcellsep 0.7\tabcellsep 21\tabcellsep Naukäsana\tabcellsep 0.7\\
8\tabcellsep Tiryaka Trikoëäsana\tabcellsep 0.8\tabcellsep 22\tabcellsep Uttänapädäsana\tabcellsep 0.6\\
9\tabcellsep Pärçvakoëäsan\tabcellsep 0.5\tabcellsep 23\tabcellsep Çaväsana\tabcellsep 1\\
10\tabcellsep Vakräsana\tabcellsep 1\tabcellsep 24\tabcellsep Anuloma-Viloma\tabcellsep 1\\
11\tabcellsep Maëòükäsana\tabcellsep 0.9\tabcellsep 25\tabcellsep Bhrämaré\tabcellsep 0.8\\
12\tabcellsep Garbhäsana\tabcellsep 0.7\tabcellsep 26\tabcellsep Guided Meditation on the Visualization of Pancreas\tabcellsep 0.7\\
13\tabcellsep Üñöräsana\tabcellsep 0.7\tabcellsep 27\tabcellsep Agnisärakriyä\tabcellsep 0.7\\
14\tabcellsep Bäläsana\tabcellsep 0.5\tabcellsep \tabcellsep \tabcellsep \end{longtable} \par
 
\caption{\label{tab_2}Table 1 :}\end{figure}
 \begin{figure}[htbp]
\noindent\textbf{2} \par 
\begin{longtable}{P{0.07671480144404333\textwidth}P{0.6351985559566786\textwidth}P{0.13808664259927797\textwidth}}
Sl. No\tabcellsep Practice\tabcellsep CVR\\
1\tabcellsep Sasäìgäsana Çväsana(Rabit breathing)\tabcellsep 0.3\\
2\tabcellsep Citrapataìga(Butterfly)\tabcellsep 0.1\\
3\tabcellsep Dorsal stretch\tabcellsep 0.2\\
4\tabcellsep Täåäsana\tabcellsep 0.1\\
5\tabcellsep Véräsana\tabcellsep 0.4\\
6\tabcellsep Jänusiräsana\tabcellsep 0.3\\
7\tabcellsep Vyäghräsana\tabcellsep 0.4\\
8\tabcellsep Ardhapädäpaçcimottänäsana\tabcellsep 0.3\\
9\tabcellsep Kürmäsana\tabcellsep 0.3\\
10\tabcellsep Bhardväjäsäna\tabcellsep 0.3\\
11\tabcellsep Makaräsana\tabcellsep 0.4\\
12\tabcellsep Çalabhäsana\tabcellsep 0.3\\
13\tabcellsep Haläsana\tabcellsep 0.4\\
14\tabcellsep Kapälabhäti\tabcellsep 0.4\end{longtable} \par
 
\caption{\label{tab_3}Table 2 :}\end{figure}
 \begin{figure}[htbp]
\noindent\textbf{3} \par 
\begin{longtable}{P{0.85\textwidth}}
Year 2020\\
50\end{longtable} \par
  {\small\itshape [Note: F © 2020 Global Journals Special Yoga Module for Type 1 Diabetes Mellitus]} 
\caption{\label{tab_4}Table 3 :}\end{figure}
 \begin{figure}[htbp]
\noindent\textbf{} \par 
\begin{longtable}{}
\end{longtable} \par
  {\small\itshape [Note: a.]} 
\caption{\label{tab_5}Specific loosening practice for Type 1 Diabetes mellitus}\end{figure}
 			\footnote{© 2020 Global Journals Development and Validation of a Yoga Module for Adolescents with Type 1 Diabetes} 		 		\backmatter   			 
\subsection[{Acknowledgments}]{Acknowledgments}\par
The authors acknowledge all the experts for offering their comments and inputs to develop this module. 			  			  				\begin{bibitemlist}{1}
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\end{bibitemlist}
 			 		 	 
\end{document}
