Study protocol on effectiveness of yoga practice on composite biomarker age predictors (yBioAge) in an elderly Indian cohort- two-armed open label randomized controlled trial.

INTRODUCTION: The recent development of robust indices to quantify biological aging, along with the dynamic epidemiological transitions of population aging generate the unmet need to examine the extent up to which potential interventions can delay, halt or temporarily modulate aging trajectories. METHODS AND ANALYSIS: The study is a two-armed, open label randomised controlled trial. We aim to recruit 166 subjects, aged 60-75 years from the residential communities and old age clubs in Bangalore city, India, who will undergo randomisation into intervention or control arms (1:1). Intervention will include yoga sessions tailored for the older adults, 1 h per day for 5 days a week, spread for 12 months. Data would be collected at the baseline, 26th week and 52nd week. The primary outcome of the study is estimation in biological age with yoga practice. The secondary outcomes will include cardinal mechanistic indicators of aging- telomere length, interleukin-6 (IL-6), tumor necrosis factor receptor II (TNF-RII), high sensitivity c-reactive protein (hsCRP)], insulin signaling [insulin and IGF1], renal function [cystatin], senescence [growth differentiating factor 15 (GDF-15)] and cardiovascular function [N-terminal B-type natriuretic peptides (NT-proBNP)]. Analyses will be by intention-to-treat model. ETHICS & DISSEMINATION: The study is approved by the Institutional Ethics Committee of Swami Vivekananda Yoga Anusandhana Samsthana University, Bangalore (ID:RES/IEC-SVYASA/242/2022). Written informed consent will be obtained from each participant prior to inclusion. TRIAL REGISTRATION NUMBER: CTRI/2022/07/044442.

Adjunct tele-yoga on clinical status at 14 days in hospitalized patients with mild and moderate COVID-19: A randomized control trial.

Background: The initial insights from the studies on COVID-19 had been disappointing, indicating the necessity of an aggravated search for alternative strategies. In this regard, the adjunct potential of yoga has been proposed for enhancing the effectiveness of the standard of care with respect to COVID-19 management. We tested whether a telemodel of yoga intervention could aid in better clinical management for hospitalized patients with mild-to-moderate COVID-19 when complemented with the standard of care. Methods: This was a randomized controlled trial conducted at the Narayana Hrudyalaya, Bengaluru, India, on hospitalized patients with mild-to-moderate COVID-19 infection enrolled between 31 May and 22 July 2021. The patients (n = 225) were randomized in a 1:1 ratio [adjunct tele-yoga (n = 113) or standard of care]. The adjunct yoga group received intervention in tele-mode within 4-h post-randomization until 14 days along with the standard of care. The primary outcome was the clinical status on day 14 post-randomization, assessed with a seven-category ordinal scale. The secondary outcome set included scores on the COVID Outcomes Scale on day 7, follow-up for clinical status and all-cause mortality on day 28, post-randomization, duration of days at the hospital, 5th-day changes post-randomization for viral load expressed as cyclic threshold (Ct), and inflammatory markers and perceived stress scores on day 14. Results: As compared with the standard of care alone, the proportional odds of having a higher score on the 7-point ordinal scale on day 14 were ~1.8 for the adjunct tele-yoga group (OR = 1.83, 95% CI, 1.11-3.03). On day 5, there were significant reductions in CRP (P = 0.001) and LDH levels (P = 0.029) in the adjunct yoga group compared to the standard of care alone. CRP reduction was also observed as a potential mediator for the yoga-induced improvement of clinical outcomes. The Kaplan-Meier estimate of all-cause mortality on day 28 was the adjusted hazard ratio (HR) of 0.26 (95% CI, 0.05-1.30). Conclusion: The observed 1.8-fold improvement in the clinical status on day 14 of patients of COVID-19 with adjunct use of tele-yoga contests its use as a complementary treatment in hospital settings.

Study protocol for yoga-based lifestyle intervention for healthy ageing phenotype in the older adults (yHAP): a two-armed, waitlist randomised controlled trial with multiple primary outcomes.

INTRODUCTION: The conceptualisation of healthy ageing phenotype (HAP) and the availability of a tentative panel for HAP biomarkers raise the need to test the efficacy of potential interventions to promote health in older adults. This study protocol reports the methodology for a 24-week programme to explore the holistic influence of the yoga-based intervention on the (bio)markers of HAP. METHODS AND ANALYSIS: The study is a two-armed, randomised waitlist controlled trial with blinded outcome assessors and multiple primary outcomes. We aim to recruit 250 subjects, aged 60-80 years from the residential communities and old age clubs in Bangalore city, India, who will undergo randomisation into intervention or control arms (1:1). The intervention will include a yoga-based programme tailored for the older adults, 1 hour per day for 6 days a week, spread for 24 weeks. Data would be collected at the baseline and post-intervention, the 24th week. The multiple primary outcomes of the study are the (bio)markers of HAP: glycated haemoglobin, low-density lipoprotein cholesterol (LDL-C), systolic blood pressure, and forced expiratory volume in 1 s for physiological and metabolic health; Digit Symbol Substitution Test, Trail Making Tests A and B for cognition; hand grip strength and gait speed for physical capability; loneliness for social well-being and WHO Quality of Life Instrument-Short Form for quality of life. The secondary outcomes include inflammatory markers, tumour necrosis factor-alpha receptor II, C reactive protein, interleukin 6 and serum Klotho levels. Analyses will be by intention-to-treat and the holistic impact of yoga on HAP will be assessed using global statistical test. ETHICS AND DISSEMINATION: The study is approved by the Institutional Ethics Committee of Swami Vivekananda Yoga Anusandhana Samsthana University, Bangalore (ID: RES/IEC-SVYASA/143/2019). Written informed consent will be obtained from each participant prior to inclusion. Results will be available through research articles and conferences. TRIAL REGISTRATION NUMBER: CTRI/2021/02/031373.

Effect of hot arm and foot bath on heart rate variability and blood pressure in healthy volunteers.

Background Though hot arm and foot bath (HAFB) is widely used, a precise physiological response is not reported. Hence, the present study was conducted to evaluate the effect of HAFB on heart rate variability (HRV) and blood pressure (BP) in healthy volunteers. Materials and Methods Sixteen healthy male volunteers' aged 23.81 ± 5.27 (mean ± standard deviation) years were recruited. All the subjects underwent only one session of HAFB (104-degree Fahrenheit) for the duration of 20 min. Assessments such as Electrocardiography and BP were taken before and after the intervention. Results Results of this study showed a significant reduction in systolic-BP (SBP), diastolic-BP (DBP), mean arterial pressure (MAP), the mean of the intervals between adjacent QRS complexes or the instantaneous heart rate (RR interval), the number of interval differences of successive NN intervals greater than 50 ms (NN50), the proportion derived by dividing NN50 by the total number of NN intervals (pNN50), and high frequency (HF) band of HRV along with a significant increase in heart rate (HR), low-frequency (LF) band of HRV and LF/HF ratio compared to its baseline. Conclusions Results of this study suggest that 20 min of HAFB produce a significant increase in HR and a significant reduction in SBP, DBP, and MAP while producing parasympathetic withdrawal.

Effects of yogic breath regulation: A narrative review of scientific evidence.

Pranayama or breath regulation is considered as an essential component of Yoga, which is said to influence the physiological systems. We present a comprehensive overview of scientific literature in the field of yogic breathing. We searched PubMed, PubMed Central and IndMed for citations for keywords "Pranayama" and "Yogic Breathing". The search yielded a total of 1400 references. Experimental papers, case studies and case series in English, revealing the effects of yogic breathing were included in the review. The preponderance of literature points to beneficial effects of yogic breathing techniques in both physiological and clinical setups. Advantageous effects of yogic breathing on the neurocognitive, psychophysiological, respiratory, biochemical and metabolic functions in healthy individuals were elicited. They were also found useful in management of various clinical conditions. Overall, yogic breathing could be considered safe, when practiced under guidance of a trained teacher. Considering the positive effects of yogic breathing, further large scale studies with rigorous designs to understand the mechanisms involved with yogic breathing are warranted.

Comparative study on effect of neutral spinal bath and neutral spinal spray on blood pressure, heart rate and heart rate variability in healthy volunteers.

Background Hydrotherapeutic applications to the head and spine have shown to improve cardiovascular and autonomic functions. There is lack of study reporting the effect of either neutral spinal bath (NSB) or neutral spinal spray (NSS). Hence, the present study was conducted to evaluate and compare the effects of both NSB and NSS in healthy volunteers. Methods Thirty healthy subjects were recruited and randomized into either neutral spinal bath group (NSBG) or neutral spinal spray group (NSSG). A single session of NSB, NSS was given for 15 min to the NSBG and NSSG, respectively. Assessments were taken before and after the interventions. Results Results of this study showed a significant reduction in low-frequency (LF) to high-frequency (HF) (LF/HF) ratio of heart rate variability (HRV) spectrum in NSBG compared with NSSG (p=0.026). Within-group analysis of both NSBG and NSSG showed a significant increase in the mean of the intervals between adjacent QRS complexes or the instantaneous heart rate (HR) (RRI) (p=0.002; p=0.009, respectively), along with a significant reduction in HR (p=0.002; p=0.004, respectively). But, a significant reduction in systolic blood pressure (SBP) (p=0.037) and pulse pressure (PP) (p=0.017) was observed in NSSG, while a significant reduction in diastolic blood pressure (DBP) (p=0.008), mean arterial blood pressure (MAP) (p=0.008) and LF/HF ratio (p=0.041) was observed in NSBG. Conclusion Results of the study suggest that 15 min of both NSB and NSS might be effective in reducing HR and improving HRV. However, NSS is particularly effective in reducing SBP and PP, while NSB is particularly effective in reducing DBP and MAP along with improving sympathovagal balance in healthy volunteers.

Add-on Yoga Therapy for Social Cognition in Schizophrenia: A Pilot Study.

BACKGROUND: Yoga as a mind-body therapy is useful in lifestyle-related disorders including neuropsychiatric disorders. In schizophrenia patients, yoga has been shown to significantly improve negative symptoms, functioning, and plasma oxytocin level. AIM: The aim of the study was to study the effect of add-on yoga therapy on social cognition in schizophrenia patients. MATERIALS AND METHODS: In a single pre-post, study design, 15 schizophrenia patients stabilized on antipsychotic medication for 6 weeks were assessed for social cognition (theory of mind, facial emotion recognition, and social perception [SP]) and clinical symptoms (negative and positive symptoms and social disability) before and after twenty sessions of add-on yoga therapy. RESULTS: There was a significant improvement in the social cognition composite score after 20 sessions of yoga (t[13] = -5.37, P ≤ 0.001). Clinical symptoms also reduced significantly after twenty sessions of yoga. CONCLUSION: Results are promising to integrate yoga in clinical practice, if proven in well-controlled clinical trials.

Additional Practice of Yoga Breathing With Intermittent Breath Holding Enhances Psychological Functions in Yoga Practitioners: A Randomized Controlled Trial.

BACKGROUND AND OBJECTIVE: The practice of yoga is associated with enhanced psychological wellbeing. The current study assessed the correlation between the duration of yoga practice with state mindfulness, mind-wandering and state anxiety. Also, we examined if an additional 20 min of yoga breathing with intermittent breath holding (experimental group) for 8 weeks would affect these psychological variables more than regular yoga practice (control group) alone. METHODS: One hundred sixteen subjects were randomly assigned to experimental (n = 60) and control (n = 56) groups. State mindfulness attention awareness scale (SMAAS), Mind-Wandering Questionnaire (MWQ) and State anxiety inventory were administered at baseline and at the end of 8 weeks. RESULTS: Baseline assessment revealed a positive correlation between duration of yoga practice with SMAAS scores and negative correlation with MWQ and state anxiety scores. At the end of 8 weeks, both groups demonstrated enhanced psychological functions, but the experimental group receiving additional yoga breathing performed better than the group practicing yoga alone. CONCLUSION: An additional practice of yoga breathing with intermittent breath holding was found to enhance the psychological functions in young adult yoga practitioners.

Add-on Effect Of Hot Sand Fomentation To Yoga On Pain, Disability, And Quality Of Life In Chronic Neck Pain Patients.

BACKGROUND: Neck pain is one of the commonest complaints and an important public health problem across the globe. Yoga has reported to be useful for neck pain and hot sand has reported to be useful for chronic rheumatism. The present study was conducted to evaluate the add-on effect of hot sand fomentation (HSF) to yoga on pain, disability, quality of sleep (QOS) and quality of life (QOL) of the patients with non-specific neck pain. MATERIALS AND METHODS: A total of 60 subjects with non-specific or common neck pain were recruited and randomly divided into either study group or control group. Both the groups have received yoga and sesame seed oil (Sesamum Indicum L.) application. In addition to yoga and sesame seed oil, study group received HSF for 15 min per day for 5-days. Assessments were taken prior to and after the intervention. RESULTS: Results of the study showed a significant reduction in the scores of visual analogue scale for pain, neck disability index (NDI), The Pittsburgh Sleep Quality Index (PSQI), and a significant increase in physical function, physical health, emotional problem, pain, and general health both in study and control groups. However, reductions in pain and NDI along with improvement in social functions were better in the study group as compared with control group. CONCLUSION: Results of this study suggest that addition of HSF to yoga provides a better reduction in pain and disability along with improvement in the social functioning of the patients with non-specific neck pain than yoga alone.

Combination of Ayurveda and Yoga therapy reduces pain intensity and improves quality of life in patients with migraine headache.

OBJECTIVES: To Understand the efficacy of Ayurveda and Yoga in the management of Migraine Headache. METHODS: 30 subjects recruited to Ayurveda and Yoga (AY) group underwent traditional Panchakarma (Bio-purificatory process) using therapeutic Purgation followed by Yoga therapy, while 30 subjects of Control (CT) group continued on symptomatic treatment (NSAID's) for 90 days. Body constitution questionnaire was administered to both groups. The outcome measures included Symptom check list, Comprehensive Headache related Quality of Life Questionnaire and Visual Analogue Scale. RESULTS: Forty-six (76.6%) out of 60 subjects belonging to both groups had Pitta based body constitution. Following 90 days of intervention the AY group showed significant reduction in Migraine symptoms including pain intensity (p < .001) and improvement in Headache related Quality of Life (p < .001). The CT group showed no significant change (p > .05). CONCLUSION: Traditional Ayurveda along with Yoga therapy reduces symptoms, intensity of pain and improves Quality of life in Migraine patients.

Effect of mud pack to eyes on psychological variables in healthy volunteers: a pilot randomized controlled trial.

Background Mud pack is one of the fundamental therapeutic procedures used in naturopathy to treat various diseases. There is a lack of scientific evidence for the use of mud-pack application in psychological variables. The present study aims at evaluating the effect of mud pack to eyes on psychological variables in healthy volunteers. Materials and methods Sixty healthy individuals with the age varied from 18 to 21 years were recruited and randomly divided into either mud-pack group (n=30) or wet-pack group (n=30). Mud-pack group received mud pack to eyes and wet-pack group received wet pack to eyes for a duration of 30 min/session (a total of 15 sessions). Psychological assessments like Mindful Attention Awareness Scale (MAAS), Perservative Thinking Questionnaire (PTQ) and Positive and Negative Affect Scale (PANAS) were taken before and after the intervention. Statistical analysis was performed using statistical package for the social sciences, version 16. Results Result of this study showed a significant reduction in PTQ score and PANAS negative score in both mud-pack and wet-pack groups. But, a significant increase in MAAS score was observed only in the mud-pack group, unlike wet-pack group. However, there was no significant difference found in between group analysis. Conclusions Result suggests that though both mud pack and wet pack to eyes reduced the scores of PTQ and negative affects, only mud pack to eyes increased the state of mindfulness in healthy individuals.

Changes in MIDAS, Perceived Stress, Frontalis Muscle Activity and Non-Steroidal Anti-Inflammatory Drugs Usage in Patients with Migraine Headache without Aura following Ayurveda and Yoga Compared to Controls: An Open Labeled Non-Randomized Study.

BACKGROUND: There has been a significant increase in the use of complementary and integrative medicine to provide long-term healing solutions in migraine headache patients. Knowing the limitations of conventional medical approach, the present study evaluated the influence of two Indian traditional systems of medicine on migraine-related disability, autonomic variables, perceived stress, and muscle activity in patients with migraine headache without aura. METHODS: Thirty subjects recruited to the Ayurveda and Yoga (AY) group underwent traditional Panchakarma (Bio-purification) using therapeutic Purgation followed by yoga therapy, while 30 subjects of control (CT) group continued on symptomatic treatment (non-steroidal anti-inflammatory drugs [NSAID's]) for 90 days. Migraine disability assessment score, perceived stress, heart rate variability (HRV), and surface electromyography (EMG) of frontalis muscle were measured on day 1, day 30, and day 90 in both groups. RESULTS: Significant reduction in migraine disability and perceived stress scores were observed in the AY group. The low-frequency component of the HRV decreased significantly, the high-frequency component increased and their ratio showed improved sympathovagal balance. The EMG showed decreased activity of the frontalis muscle in the AY group compared to the control group. CONCLUSION: The integrative approach combining Ayurveda and Yoga therapy reduces migraine-related disability, perceived stress, sympathetic arousal, and muscle tension.

Cerebrovascular Hemodynamics During the Practice of Bhramari Pranayama, Kapalbhati and Bahir-Kumbhaka: An Exploratory Study.

Various pranayama techniques are known to produce different physiological effects. We evaluated the effect of three-different pranayama techniques on cerebrovascular hemodynamics. Eighteen healthy volunteers with the mean ± standard deviation age of 23.78 ± 2.96 years were performed three-different pranayama techniques: (1) Bhramari, (2) Kapalbhati and (3) Bahir-Kumbhaka in three-different orders. Continuous transcranial Doppler (TCD) monitoring was performed before, during and after the pranayama techniques. TCD parameters such as peak systolic velocity, end diastolic velocity (EDV), mean flow velocity (MFV) and pulsatility index (PI) of right middle cerebral artery were recorded. Practice of Kapalbhati showed significant reductions in EDV and MFV with significant increase in PI while, Bahir-Kumbhaka showed significant increase in EDV and MFV with significant reduction in PI. However, no such significant changes were observed in Bhramari pranayama. Various types of pranayama techniques produce different cerebrovascular hemodynamic changes in healthy volunteers.

Short-term effect of add on bell pepper (Capsicum annuum var. grossum) juice with integrated approach of yoga therapy on blood glucose levels and cardiovascular functions in patients with type 2 diabetes mellitus: A randomized controlled study.

BACKGROUND: Type 2 diabetes mellitus (T2DM) is a major global health problem. Though various studies have reported the beneficial effect of Yoga in patient with T2DM, there is a lack of study in combination with bell pepper and yoga. Hence, the present study aims at evaluating short-term effect of add on bell pepper juice with integrated approach of yoga therapy (IAYT) on blood glucose levels and cardiovascular variables in patients with T2DM. MATERIALS AND METHODS: Fifty T2DM subjects with the age varied from 34 to 69-years were recruited and randomly divided into either study group or control group. The study group received 100-ml of bell pepper juice (twice/day) along with IAYT while the control group received only IAYT for 4-consecutive days. Baseline and post-test assessments were taken before and after the intervention. Statistical analysis was performed using statistical package for the social sciences, version-16. RESULTS: Results of this study showed no significant difference in overall (fasting and post prandial) blood glucose level in the study group compared with control group. However, a significant reduction in Post prandial blood glucose (PPBG), systolic blood pressure (SBP), pulse pressure (PP), rate pressure product (RPP) and Double product (Do-P) was observed in the study group compared with control group. CONCLUSION: Results of this study suggest that though an addition of 100-ml of bell pepper juice (twice/day) along with IAYT is not more effective in reducing fasting blood glucose, it may be more effective in reducing PPBG, SBP, PP, RPP and Do-P than IAYT alone.

Effect of integrated approach of yoga therapy on autonomic functions in patients with type 2 diabetes.

BACKGROUND AND OBJECTIVES: Integrated approach of yoga therapy (IAYT) had shown beneficial effects in the management of type 2 diabetes mellitus (DM). Autonomic dysfunction is one of the major complications of type 2 DM. Research studies have demonstrated that yoga can modulate autonomic functions. Hence, the current study was designed to assess the effect of IAYT on autonomic functions in type 2 diabetics. MATERIALS AND METHODS: 15 patients of type 2 DM with ages ranging from 35 to 60 years were recruited for the study. They were diagnosed with type 2 diabetes from 1-year to 15 years. Assessments were made on day 1 (before yoga) and day 7 (after 1-week of yoga practice). Heart rate variability (HRV), blood pressure (BP) response to the isometric handgrip and heart rate response to deep breathing were assessed before and after 1-week of IAYT. RESULTS: There was a significant reduction in fasting plasma glucose from 154.67-130.27 mg/dL (Wilcoxon signed rank test, P = 0.029) following 1-week of IAYT. BP response to isometric hand grip improved significantly (Wilcoxon signed rank test, P = 0.01). There was no statistical significant change in HRV components and heart rate response to deep breathing test. However, there was a trend of increase in the low frequency power (41.07%), high frequency power (6.29%), total power (5.38%), and standard deviation of all NN intervals (SDNN) (6.29%). CONCLUSION: These findings suggest that, IAYT improved autonomic functions in type 2 diabetes patients.