19(2): S2: 423-427, 2024 www.thebioscan.

com

A PROTOCOL FOR TESTING THE EFFICACY OF YOGA INTERVENTION IN

MANAGING CHRONIC KIDNEY DISEASE OF UNKNOWN ETIOLOGY IN
THE UDDANAM REGION
V Sasi Kala Boppadapu1 Dr. Ramesh M N2, Dr. Sri Krishna Chandaka3, Dr. Arun Thulasi4
1. Research Scholar, S-VYASA University, Bangalore, Karnataka, 560105. [email protected]
2. Professor, S-VYASA University, Bangalore, Karnataka, 560105. [email protected]
3.Associate Professor, Academy of Yoga Consciousness, Visakhapatnam, Andhra Pradesh, 531163.
[email protected]
4. Research Scholar, S-VYASA University, Bangalore, Karnataka, 560105. [email protected]

DOI: https://doi.org/10.63001/tbs.2024.v19.i02.S2.pp423-427

KEYWORDS ABSTRACT
CKDu,
Chronic Kidney Disease
Chronic Kidney Disease of Unknown Etiology (CKDu), a distinct form of CKD lacking traditional risk factors, has severely
of Unknown Etiology,
affected the Uddanam region of India, with a staggering 40-60% prevalence. Despite multiple investigations, the underlying
Uddanam region,
causes remain elusive, highlighting the urgent need for complementary therapeutic approaches. Yoga, an ancient Indian
yoga,
practice with proven efficacy in various chronic illnesses, offers promising potential for CKDu management. This study aims
validation,
to validate a yoga program for CKDu, assess its feasibility, and evaluate the efficacy of a three-month yoga intervention in
feasibility,
alleviating symptoms and complications through comprehensive biochemical, physiological, and psychological assessments.
efficacy testing.
Primary outcomes include biochemical markers, physiological parameters (e.g., blood pressure, body composition), and
Received on:
psychological assessments (quality of life, anxiety, stress). The validated and feasible yoga module is anticipated to
01-08-2024 demonstrate significant improvements in biochemical, physiological, and psychological outcomes in the intervention group
compared to the control group. Positive results support the integration of yoga as an adjunctive therapy for CKDu management.
Accepted on:

18-11-2024

INTRODUCTION causes remain elusive, drinking water sourced from bore wells,
hand pumps, and dug wells has been suspected as a potential
Chronic Kidney Disease of Unknown Etiology (CKDu), identified by contributor to the high CKDu prevalence (Reddy, D.V. Gunasekar,
the World Health Organization in the early 2000s, is a distinct form A, 2013). Despite multiple expert committees studying the
of CKD that lacks the traditional risk factors associated with CKD, situation from 2003 to 2013, proposing factors such as nitrate and
such as diabetes, hypertension, cardiovascular disease, and silica contamination, dehydration, tobacco chewing, seafood
obesity. A unique characteristic of CKDu is its geographical consumption, pesticide exposure, and analgesic use, no concrete
restriction to specific regions, including Mesoamerican conclusions have been drawn, highlighting the need for further
nephropathy in Central American countries, Balkan endemic studies to determine the exact causes of CKDu in the Uddanam
nephropathy in the Balkan states, aristolochic acid nephropathy region (Reddy, D.V., Gunasekar, A, 2013).
in regions using herbal medicines (e.g., Belgium, China), Sri CKDu shares similarities with CKD (Chronic Kidney Disease), which
Lankan nephropathy, and Uddanam endemic nephropathy in India. represents a critical global health challenge due to its substantial
The highest prevalence of CKDu has been reported in Uddanam, impact on morbidity and mortality rates. However, awareness
India, with unpublished cross-sectional estimates suggesting a among patients and healthcare providers remains remarkably
prevalence between 40% and 60% (Praveen Gadde, et al., 2017), inadequate (Tatapudi et al., 2019). CKDu and CKD initially lack
significantly higher than the highest CKD prevalence reported in symptoms. However, as kidney function deteriorates due to a
Nicaragua, Central America, where 10-20% of the adult population complex interaction of several aggravating factors, symptoms
have been affected (Torres et al., 2010; Ramírez-Rubio et al., related to impaired regulation of water and electrolyte balance,
2016). waste clearance, and red blood cell production become apparent.
The Uddanam region, comprising over 100 villages in north-coastal If unrecognized or untreated, kidney failure may manifest with
Andhra Pradesh, has been severely affected by CKDu. As of 2015, symptoms such as lethargy, weakness, shortness of breath,
it was estimated that more than 4,500 people had died from generalized swelling (oedema), loss of appetite, fatigue,
CKDu, and around 34,000 people were diagnosed with kidney congestive heart failure, metabolic acidosis, hyperkalemia, fatal
diseases in the preceding 10 years in this region (Abraham et al., arrhythmias including ventricular tachycardia, uremia leading to
2016). Kaviti is one of the worst-affected areas, and the high brain encephalopathy, pericarditis, or hypocalcemia (Narasimha
incidence of CKDu has led to social stigma, with neighboring Rao, Y., Prasada Rao M, 2018).
villagers hesitating to visit affected areas while the underlying

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The ancient Indian practice of yoga, encompassing meditation, establish yoga as a safe, beneficial, and cost-effective adjunct
relaxation, breath control, and physical postures (asanas), has treatment for slowing disease progression, reducing complications
gained recognition as a therapeutic intervention for various related to decreased estimated glomerular filtration rate (eGFR),
chronic illnesses. Regular yoga practice promotes harmony and mitigating cardiovascular risks, and improving QoL and survival in
functional balance among organ systems, leading to improved CKDu patients. Our proposed yoga-based lifestyle protocol aims
health and well-being. Notably, yoga has demonstrated efficacy to evaluate its effectiveness in managing CKDu, its symptoms, and
in enhancing the quality of life (QoL) for patients with chronic complications, with the belief that positive outcomes could
conditions such as lupus nephritis with CKD, cancer, Parkinson's motivate self-motivated exploration of alternative therapies.
disease, chronic lower back pain, and depression. The Aim and Objectives:
mechanisms underlying yoga's benefits involve decreasing The study aims to develop, perform content validation, and assess
oxidative stress and inflammation while boosting antioxidant the feasibility of a Yoga Module for patients with Chronic Kidney
defense mechanisms, resilience, mood, and metabolic regulation Disease of Unknown Etiology (CKDu).
(Büssing, A., et.al., 2012). Despite yoga's proven efficacy in CKD 1. To develop a comprehensive Yoga Module specifically designed
management, there is a dearth of research evaluating its potential for patients diagnosed with CKDu.
in CKDu. Given the nature of CKDu's spread and the need for 2. To validate the content of the Yoga Module, ensuring the
health promotion at individual and community levels, it is crucial inclusion of key components essential for designing and reporting
to explore complementary therapies alongside conventional interventions for CKDu.
treatment approaches. Yoga offers promising avenues for 3. To assess the feasibility of implementing the Yoga Module in a
alleviating symptoms and comorbidities of CKDu, owing to its clinical setting for CKDu patients.
established benefits in reducing oxidative stress, and Study Design:
inflammation, improving insulin sensitivity, controlling The validation, feasibility, efficacy testing of the Yoga module for
cardiovascular risk factors, and enhancing QoL (Levey, A.S., et CKDu will be conducted in three phases (Fig. 1).
al., 2012). Larger-scale and rigorous research is warranted to
Fig. 1.

• Validation of the Yoga Module

PHSAE 1

• Feasibility of Yoga Module

PHASE 2

• Efficacy testing of the Yoga

PHASE 3 Module

Phase 1: Validation of the Yoga Module the feasibility assessment results, necessary modifications to the
The initial list of yoga practices will be compiled using yoga module's design, delivery, or implementation strategies
a combination of traditional texts and published would be made for the third phase of the study.
scientific studies about kidney diseases. This would be Phase 3: Efficacy testing of the Yoga Module
taken to experts (Yoga) and asked to rate each practice Participants: A total of 100 participants would be randomly
on a scale of 0–3 (0 – Not essential, 1 – Essential, 2 – allocated equally to the intervention group and the control group
Useful but not essential, 3 –Not Necessary). Based on based on convenience sampling. Patients diagnosed with CKDu (or
the data obtained, (Lawshe's 1975) content validity CKD) will be identified from medical records at the District
ratio (CVR) will be calculated. Items that score above Medical Health Office (DMHO), Srikakulam, Uddanam region.
the calculated CVR score would be retained in the list Eligible participants will be recruited after attending an
and the module would be finalised. informational session conducted by the primary investigator,
Phase 2: Feasibility of the Yoga Module where informed consent will be obtained. Recruitment will
The feasibility of implementing the proposed yoga module will be continue until the target sample size is reached. Enrolled
evaluated in a sample of approximately 20-30 randomly recruited participants will then be randomly allocated to either the yoga
CKDu patients from the Uddanam region who meet the eligibility intervention group or the control group using computer-generated
criteria. The yoga intervention will be conducted over 4 weeks, random numbers to ensure unbiased group assignment. The
with sessions scheduled 5 days per week. A self-structured selection criteria for the study would be as follows:
questionnaire comprising both open-ended and closed-ended
questions will be administered to the participants. The Inclusion criteria:
questionnaire will explore various aspects such as acceptability, A. Individuals diagnosed with CKDu between
adherence, logistical consideration, participant satisfaction, Stage 1 to Stage 4.
adverse effects and qualitative feedback suggestions. Based on B. Participants of both genders aged 20 years to 70 years.

424
C. Willingness to participate in a 12-week Yoga program. Chronic Kidney Disease (CKD), such as diabetes and hypertension
Exclusion criteria: (Nistala, R., & Savin, V. 2017). Exploring this condition through
A. Individuals diagnosed with genetic kidney diseases, complementary therapies like yoga provides a distinct viewpoint
renal carcinoma, polycystic kidney disease or acute kidney that resonates with earlier research highlighting the advantages
pathologies of yoga in managing chronic diseases (McCall, et.al., 2013) Yoga
B. Pregnancy has shown effectiveness in lowering oxidative stress,
C. Those who had undergone renal replacement inflammation, and cardiovascular risks, all of which are important
therapy for managing chronic kidney disease (CKD). The protocol's strategy
D. Those identified with severe cognitive for creating a yoga module designed for CKDu responds to the
impairment pressing demand for supplementary therapies that work alongside
E. Individuals who are immobilized or have severe conventional treatment, ultimately improving patients' quality of
mobility restrictions life (QoL).
F. Individuals diagnosed with metabolic, The study employs a well-organized approach that includes
neurological or psychological problems content validation, feasibility testing, and efficacy evaluation,
G. Alcoholic or addiction to any other recreational ensuring that the intervention is carefully designed to meet the
drug(s) unique needs and preferences of CKDu patients. Comparable
H. Recent surgery phased approaches have shown effectiveness in interventions for
Intervention: numerous chronic conditions, where it is crucial to validate and
The intervention group will receive the structured yoga program assess feasibility as essential preliminary steps to ensure
(as developed in phase 2). The program will be conducted under appropriate design and implementation. The integration of
the supervision of a certified yoga trainer. Participants will attend diverse outcome measures, such as physiological, biochemical,
one-hour sessions, five days per week, for 12 weeks. and psychological assessments, is consistent with the
Control Group: biopsychosocial model of health, facilitating a comprehensive
The control group will receive standard care and education evaluation of the intervention's impact on the physical and mental
regarding CKDu management. Participants will be instructed to well-being of CKDu patients.
maintain their usual lifestyle and dietary habits during the study A possible constraint of the study lies in the challenge of
period. maintaining participant involvement, given the dedication
Outcome Measures: required for consistent yoga practice. Studies on yoga
A comprehensive assessment will be conducted at baseline and interventions for chronic disease management have noted
post-intervention (12 weeks) for both groups. The primary variations in adherence rates, particularly among those who are
outcomes will include the following: not well-acquainted with the practice. The feasibility phase will
Biochemical parameters: assess acceptability, adherence, and logistical factors, allowing
This would comprise of Complete Blood Count, Renal Function for crucial adjustments to the module's design or delivery before
Test, Liver Function Test, Thyroid Profile and Lipid Profile tests. efficacy testing takes place. The study's limitation lies in its
Physiological measures: concentration on a particular region, potentially restricting the
This includes Hand Grip Strength (for overall body strength & applicability of the findings to other populations that exhibit
functioning) and Bio Scan (a non-invasive tool used to assess varying CKDu risk factors.
various physiological parameters such as body composition, If successful, this study could help incorporate yoga as a cost-
hydration levels, and metabolic rate) effective complementary therapy for CKDu. The yoga module
Psychological assessment: provides CKDu patients with a proactive self-care approach that
These will include the 36-Item Short Form Survey Instrument (SF- improves their quality of life and may help slow the progression
36) Cronbach's α coefficient of the SF-36 questionnaire was 0.791, of the disease, while having few negative effects. This initiative
(Zhang, Y., et.al., 2012.), a patient-reported survey used to promotes resilience and self-management within an underserved
measure health-related quality of life across eight domains community. Future research could explore broadening the
internal consistency Cronbach’s alpha > 0.90(Linde, L., et.al., module's use in more CKDu-affected areas or investigating the
2008.)., Fatigue Assessment Scale (FAS) questionnaire designed to precise mechanisms through which the intervention reduces
measure the severity of fatigue in individuals the test — retest oxidative stress and improves metabolic health. This study
reliability was .89. (De Vries, J., et.al., 2004), Perseverative presents a valuable chance for comprehensive management in
Thinking Questionnaire (PTQ) tool to assess repetitive negative CKDu, tackling existing knowledge gaps and promoting
thinking patterns internal consistency alpha of 0.93 (Dereix-et.al., advancements in integrative methods for kidney health. Upon
2019.) such as worry and rumination, and Hamilton Rating Scale completion of the findings will be disseminated in journal and this
for Anxiety (HAM-A) for measuring the severity of anxiety dissemination strategy seeks to involve the scientific community
symptoms. Additionally, a self-administered Vedic Personality in the development, validation, and feasibility of integrative CKDu
Inventory (VPI) which assesses Sattva (gentle and controlled), treatment. Based on the literature review we assumed that this
Rajas (violent and uncontrolled) and Tamas (dull and study presents comprehensive results and novel methodologies
uncontrolled) would be used along with the Vata Pitta Kapha aimed at advancing future research, clinical practices, and policy-
Questionnaire to determine the individual's dominant body making to improve care and quality of life for CKDu patients
constitution (dosha) and related health attributes. globally.
Statistical Analysis: CONCLUSION
Appropriate statistical analyses will be performed to evaluate the
This study protocol provides a method for creating, validating,
efficacy of the yoga module intervention. Within-group and
and evaluating a yoga module specifically designed for patients
between-group comparisons will be conducted for the primary and
with Chronic Kidney Disease of Unknown Etiology. This protocol
secondary outcomes. Intention-to-treat analysis will be employed
focuses on the critical requirement for supportive, non-invasive
to handle missing data and assess the robustness of the findings.
strategies aimed at enhancing standard care and the quality of
DISCUSSION life for patients in Uddanam, India, where CKDu is widespread.
This study protocol outlines a structured method for developing, Validating content, testing feasibility, and assessing efficacy offer
validating, and assessing a yoga module designed for individuals a structured method for developing and implementing
with Chronic Kidney Disease of Unknown Etiology (CKDu), with a interventions that could be relevant to similar populations around
focus on areas with high prevalence, such as Uddanam, India. the globe. This study has the potential to validate yoga as a
Chronic Kidney Disease of Unknown Etiology (CKDu) (Gunasekara, supportive therapy for CKDu if it proves successful. The findings
T. S. C., De Silva, P. M. C., Herath, C., Siribaddana, S., will be shared and showcased to promote holistic
Siribaddana, N., Jayasumana, C., ... & Jayasundara, N. 2020) therapeutic approaches for CKDu and associated chronic kidney
remains unique challenges due to its unclear causes and the diseases.
absence of conventional risk factors typically associated with Safety Monitoring:

425
Participants' safety will be closely monitored throughout the • Dereix-Calonge, I., Ruiz, F.J., Suárez-Falcón, J.C. and
study. Any adverse events or side effects reported during or after Flórez, C.L., 2019. Adapting the Perseverative Thinking
the yoga sessions will be carefully documented and addressed. Questionnaire for measuring repetitive negative
Ethical Consideration: thinking in clinical psychology trainees. Training and
The study protocol will undergo a comprehensive review and Education in Professional Psychology, 13(2), p.145.
receive approval from the institutional review board and ethics • Gadde P, Sanikommu S, Manumanthu R, Akkaloori A.
committee RES/IEC-SVYASA/218/2021 to guarantee adherence to Uddanam nephropathy in India: a challenge for
ethical standards. This trial is registered under the Clinical Trials epidemiologists. Bull World Health Organ. 2017 Dec
Registry - India (CTRI), ensuring compliance with ethical standards 1;95(12):848-849. doi: 10.2471/BLT.17.196758. Epub
and transparency in research practices CTRI/2022/02/040564. We 2017 Oct 3. PMID: 29200526; PMCID: PMC5710086.
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study, including its purpose, objectives, methods, and • Gunasekara, T.S.C., De Silva, P.M.C., Herath, C.,
procedures. It will clearly state that participants have the Siribaddana, S., Siribaddana, N., Jayasumana, C.,
freedom to withdraw from the study at any time without any Jayasinghe, S., Cardenas-Gonzalez, M. and
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Declaration of Competing Interest: disease: an update. Kidney international
The authors declare that they have no known financial interests supplements, 3(4), pp.368-371.
or personal relationships that could have influenced the work
• Laws, R.L., Brooks, D.R., Amador, J.J., Weiner, D.E.,
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Kaufman, J.S., Ramírez-Rubio, O., Riefkohl, A.,
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Scammell, M.K., López-Pilarte, D., Sánchez, J.M. and
If the yoga intervention significantly improves biochemical,
Parikh, C.R., 2016. Biomarkers of kidney injury among
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• Lawshe, C. H. (1975). A Quantitative Approach to
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https://caepnet.org/~/media/Files/caep/knowledge-
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