Comparison of Yoga with exercise in ankylosing spondylitis on mobility and functional capacity

Abstract

Aim

To compare the effects of Yoga with traditional exercise on the mobility and functional capacity of individuals with ankylosing spondylitis (AS).

Methods

The participants of the study were recruited at the rheumatology department, adhering to the study's inclusion and exclusion criteria. Participants were randomized into two groups (Group A – Yoga, and Group B – exercise).The candidates participated in an 8‐week intervention consisting of 3 weekly sessions of either Yoga or Exercise intervention. Outcomes were collected at pre‐treatment, at 8 weeks, and at 12 weeks.

Results

The within‐group comparison showed an improvement in all outcome measures with p < .05 between post‐treatment and the follow‐up. In the yoga group, there was an improvement in the measures of BASMI (p = .001), BASFI (p = .005), PSQI (p = .021), CE (p = .053) and NPRS (p = .001). Similarly, in the exercise group, there was an improvement in BASMI (p = .002), BASFI (p = .003), PSQI (p = .010), CE (p = .004) and NPRS (p = .001). In the between group comparison at post‐treatment, there were no statistically significant differences in BASMI (yoga = 3.0 ± 1.50, exercise = 2.3 ± 1.38), PSQI (yoga = 5.3 ± 1.50, exercise = 4.9 ± 1.17) and NPRS (yoga = 1.3 ± 2.22, exercise = 0.4 ± 0.50) CE (yoga = 4.0 ± 1.18, exercise = 3.4 ± 0.96), BASFI (yoga = 1.8 ± 2.14, exercise = 2.1 ± 1.87).

Conclusion

The results demonstrated a statistically significant improvement in within‐group scores of mobility, functional capacity, sleep quality and pain in AS patients of both intervention programs but there were no significant differences between the groups.

1. INTRODUCTION

Ankylosing spondylitis (AS) is an autoimmune‐driven spondyloarthropathy primarily impacting the axial spine and soft tissues, notably prevalent in individuals carrying the human leukocyte antigen (HLA) B‐27 gene. ¹ The highest incidence is observed in North America, followed by Europe, Asia, Latin America, and Africa. ² Manifesting in the second and third decades of life, AS affects males more frequently (2:1 ratio). ³

The disease progression is marked by recurrent episodes of inflammation, potentially resulting in tissue scarring and eventual fusion of ligaments in and around the spine and other joints, with the hips and shoulders affected only one‐third of the time. ⁴ Prolonged inflammation contributes to a reduction in chest expansion. In the advanced stages of the disease, inflammation leads to ankylosis, causing the spinal column to fuse in a rigid position, thereby diminishing both mobility and flexibility. ⁵

The current multidisciplinary management approach for AS includes pharmacological and non‐pharmacological interventions. Pharmacologically, drugs such as Non‐Steroidal Anti‐Inflammatory Drugs (NSAIDs), analgesics, and, in cases of persistent high disease activity, anti‐TNF therapy are recommended. ⁶ However, patients can experience clinically meaningful advantages from NSAIDs when consistently taken regularly and at full anti‐inflammatory doses. ⁷ The prolonged use of drugs in individuals with ankylosing spondylitis is linked to numerous adverse effects, with gastrointestinal issues being frequently observed, among others, such as depression. ⁸

Non‐pharmacological strategies encompass patient education and physical activity. ⁹ Exercise tailored to the individual's abilities and preferences can help improve spinal mobility, reduce pain and increase overall physical function in patients with AS. It can also help maintain joint flexibility and prevent the progression of spinal stiffness. Therefore, exercise is considered an efficacious non‐pharmacological intervention for AS, and it is recommended as part of the management strategy for patients with ankylosing spondylitis. ⁷ A holistic approach involving strengthening, stretching, cardiopulmonary, and functional fitness forms the core of an optimal regime. ⁹

The term ‘Yoga’ originates from the Sanskrit word ‘Yuj’, signifying ‘to unite’ or ‘bind’, akin to the yoke of a chariot that binds the carriage to the horses. Drawing an analogy from the Katha Upanishad, where the body symbolizes the chariot, the senses and mind represent the horses, and the spirit embodies the charioteer. ¹⁰ Establishing its roots between 2500 and 5000 years ago, the earliest depictions of Yoga were discovered as soapstone seals in the Indus Valley archeological site of Mohenjo‐Daro (3rd millennium B.C.E.). ¹¹ Sage Patanjali's seminal work, the ‘Yoga Sutras’, presented the first unified and definitive system of Yoga, delineating eight limbs of Yoga known as ‘Astanga Yoga’. These limbs encompass Yama, Niyama, Asana, Pranayama, Pratyahara, Dharana, Dhyana and Samadhi. ¹²

The engagement in Yoga serves as a cost‐effective form of physical activity, presenting itself as a feasible, acceptable and notably safe intervention. ¹³ The proposition suggests that Yoga contributes to realigning the skeletal structure and easing stiff joints. These effects are posited to result from the postural geometry and muscle realignment, relieving stress and strain on the joints, thereby reinstating anatomical relationships. ¹⁴ Consistent practice has demonstrated reduced levels of C‐reactive protein and inflammatory cytokines while simultaneously maintaining heightened levels of leptin and adiponectin, effectively mitigating inflammation. ¹⁵ Furthermore, in a population free from diseases, Yoga enhances chest wall expansion and forced expiratory lung volumes, affirming its positive impact on respiratory capacity. ¹⁶ The incorporation of fundamental principles of body awareness in Yoga is particularly crucial in cases of joint diseases. ¹⁷

A systematic review, encompassing 17 studies involving 1626 participants, indicates Yoga as a dependable complementary strategy for arthritic conditions such as rheumatoid arthritis (RA) and osteoarthritis, showcasing clinically significant alterations in both pain levels and functional outcomes. ¹⁸

Despite these promising indications, the potential impact of Yoga on AS, characterized by chronic pain and stiffness, remains an underexplored area. This study seeks to address this gap by comparing the effects of Yoga with traditional exercise on the mobility and functional capacity of individuals with ankylosing spondylitis. Recognizing the unique attributes of Yoga, this research aims to contribute valuable insights to the management strategies for this specific population.

2. MATERIALS & METHODS

2.1. Type of RCT

An open randomized controlled trial (RCT) comparing yoga and exercise intervention was conducted at the physiotherapy department of Manipal Hospital, Bangalore. Collection of the data was done at baseline (T0), post‐intervention on week 8 (T1) and follow‐up at 12 weeks (T2). Randomization was performed by using computer‐generated block randomization (nine blocks of size 4 and 1 block of size 6), and the allocation sequence was placed in numbered, sealed, opaque envelopes.

2.2. Study groups

2.2.1. Yoga group

The Yoga group protocol includes Sukshma Vyama (warm‐up), Surya Namaskar, Asanas and Pranayama, which are in Table 1. Participants of this group will be taught the yoga program under a certified instructor and asked to perform at home 3 days a week for 8 weeks. The Asanas may be modified as suited to the subjects' abilities. Progression will be made by follow‐ups every 2 weeks, where they will be guided into progression for the 1st day of every 2 weeks.

TABLE 1.

Asanas performed by participants in yoga group.

Week 1–2	Week 3–4	Week 5–6	Week 7–8
(A) Sukshma Vyama	(A) Sukshma Vyama	(A) Sukshma Vyama	(A) Sukshma Vyama
(B) Surya namaskar	(B) Surya namaskar	(B) Surya namaskar	(B) Surya namaskar
(C) Asanas	(C) Asanas	(C) Asanas	(C) Asanas
(i) Standing	(i) Standing	(i) Standing	(i) Standing
Tadasana	Triyak Tadasana	Ardha Chakrasana	Veerbhadrasana
Triyak Tadasana	Vrikshasana	Dwikonasana	Trikonasana
(ii) Supine	(ii) Supine	(ii) Supine	(ii) Supine
Uttana Padasana	Uttana Padasana	Supta Baddha Konasana	Pavanamuktasana
Matsyasana	SuptaBaddha Konasana	Pavanamuktasana	Setubandhasana
(iii) Prone	(iii) Prone	(iii) Prone	(iii) Prone
Makarasana	Makarasana	Ardha Shalabhasana	Ardha Shalabhasana
Bhujangasana	Bhujangasana	Triyak Bhujangasana	Triyak Bhujangasana
(iv) Sitting	(iv) Sitting	(iv) Sitting	(iv) Sitting
Sukhasana	Vajarasana	Baddha Konasana	Bharadvajasana
Vajarasana	Adhomukha Swastiksasana	Bharadvajasana	Ardha Matsyendrasana
(D) Pranayama	(D) Pranayama	(D) Pranayama	(D) Pranayama
(i) Kapalbhathi	(i) Kapalbhathi	(i) Kapalbhathi	(i) Kapalbhathi
(ii) Nadi Shodhana	(ii) Nadi Shodhana	(ii) Nadi Shodhana	(ii) Nadi Shodhana
(iii) Bhramari	(iii) Bhramari	(iii) Bhramari	(iii) Bhramari

2.2.2. Exercise group

Participants were taught exercises curated to the condition that included warm‐up, breathing exercises, stretching, strengthening and walking (Table 2). Progression was made by follow‐ups every 2 weeks, where they were guided into progression for the 1st day of every 2 weeks.

TABLE 2.

Exercise protocol followed for participants in exercise group.

Warm up exercises: 15 min ‐ 10 reps two sets

Cervical – Lateral flexion, flexion‐extension, and rotation

Thoraco‐lumbar‐lateral flexion, flexion‐extension, rotation

Shoulder and upper limb‐abduction‐adduction, flexion‐extension, shoulder rotations

Lower limb‐abduction‐adduction, rotation, flexion‐extension

Respiratory exercises: 10 reps two sets

Deep breathing

Chest expansion exercise

Diaphragmatic breathing

Shoulder elevation with inspiration

Resistance exercises for inspiration (done by pressing hands against anterior chest wall as they breathe in.)

Stretching: two sets 30–40 s hold

Trunk, Upper limb and Lower limb stretches

Strengthening exercises: two sets 10 reps/10 s hold

Shoulder retraction exercise

Supine abdominal crunches

Single straight leg raises

Bridging exercise

Superman exercise ‐ progress to alternate raise

Endurance training: 10 min

Walking ‐ low speed

2.3. Patients

2.3.1. Participant recruitment and sample size

At a 5% level of significance with 80% power and an anticipated effect size of 0.40, the minimum sample size (per group) required for a two‐group repeated measures study design involving one primary outcome measured across three time‐points (correlation among repeated measures is 0.3), is 30 individuals i.e. 15 per group. Anticipating a 10% drop out, we have a requirement of 34 individuals, that is 17 per group.

2.3.2. Eligibility criteria

Inclusion criteria

Patients diagnosed with ankylosing spondylitis Based on Modified New York criteria between the ages of 20–40 years and having a functional score of I or II under Steinbrockers functional classification were included. ¹⁹

Exclusion criteria

Individuals were excluded if they have practiced Yoga in the past 2 months, have a history of drug or alcohol abuse in the past 6 months, are smokers and are individuals with post‐traumatic stiffness.

2.4. Outcome measures

Primary outcomes include the Bath ankylosing spondylitis Metrology Index (BASMI), which will be utilized to assess spinal mobility in the subjects. Secondary outcomes to measure functional capacity (Bath ankylosing spondylitis Functional Index, BASFI), sleep quality (Pittsburgh Sleep Quality Index, PSQI), pain symptom response to the intervention (Numerical Pain Rating scale, NPRS) and rib‐cage mobility (chest expansion, CE) have also been considered. ¹⁹ , ²⁰ , ²¹ , ²² , ²³ The therapist measured this at pre‐treatment, at 8 weeks (post‐treatment) and at 12 weeks, to assess further progression and persistence of the benefits of the intervention.

2.5. Procedure

The Institutional Research Committee and Institutional Ethical Committee approved the study following which the trial was registered under the Clinical Trials Registry‐India (CTRI/2021/03/032062). Upon clearance, patients diagnosed by a physician with ankylosing spondylitis were recruited. Written informed consent was taken from subjects fulfilling the eligibility criteria. Modified New York criteria were used in the diagnosis of ankylosing spondylitis. ²⁴ Steinbrocker Functional Classification was further used to determine the degree of physical disability on a four‐level scale system ranging from I to IV. ¹⁹ Participants were then randomly assigned by the tester into two groups using block randomization (nine blocks of size 4 and 1 block of size 6), namely: Group 1‐ Yoga Group, and Group 2‐ Exercise Group. Participants belonging to the Yoga group were taught the yoga program under a certified instructor and asked to perform the same at home for 3 days a week, for 8 weeks. Participants in the Exercise group were taught exercises and asked to perform them at home for 3 days a week, for 8 weeks. Progression was made to both groups by follow‐ups every 2 weeks where they were guided into progression for the 1st day of every 2 weeks. Patients were also asked to continue their medications recommended by their physician/rheumatologist to improve adherence to treatment programs. Outcome measures were assessed at the beginning of the treatment (T0) and compared to scores obtained on assessment following 8 weeks that is post‐treatment (T1). A follow‐up (T2) was done post 4 weeks to assess adherence and retention of the effects obtained from their respective programs.

2.6. Statistical analysis

Collected data were entered in Excel software and analyzed using R software version 4.0.2. Baseline demographic and clinical characteristics of dichotomous were compared using the Chi‐square test. The normal distribution of outcomes was assessed using the Shapiro–Wilk statistics (p < .05). The tests were two‐tailed, and the level of statistical significance was set at a p‐value of less than .05. A repeated measure ANOVA was implemented for changes across the three‐time points. The post hoc analysis determined pairwise comparisons of outcome measures between the time points. Intention‐to‐treat analysis was used to handle the missing values and the last value carried method was adopted.

3. RESULTS

The present study included 33 individuals, of which 13.3% were females. Out of the recruited individuals, seven dropped out, but they were included in the data analysis using the intention to treat RCT protocol. The mean age of the sample was 32.2 ± 5.72 and 31.6 ± 6.19 for the Yoga and Exercise groups, respectively. The mean disease duration was similar between the study groups which are 5.1 and 4.5 for the Yoga and Exercise groups, respectively. No statistically significant differences for gender (p = .579), age (p = .760) and length of the disease (p = .722) were seen between the two groups (Table 3). At baseline, there were no statistically significant differences between the two groups in BASMI, BASFI, PSQI, and CE measures. However, the outcome measures of NPRS at baseline were different (p = .035). It may therefore be presumed that they were not comparable in all characteristics at the beginning of the study.

TABLE 3.

Demographic data of participants.

Demographic data	Yoga group	Exercise group
Age (year), Mean + SD	32.2 ± 5.72	31.6 ± 6.19
Gender, M/F	13/2	17/1
Length of disease, Mean + SD	5.1 ± 4.77	4.5 ± 4.30

The mean scores of BASMI, BASFI, PQRS, CE and NPRS are summarized in Table 4. The within‐group comparison showed an improvement in all outcome measures with p < .05 between baseline and follow‐up in yoga and exercise. The within‐group differences between baseline and follow‐up assessments of the yoga group revealed increments in all mobility components of the BASMI index. On the other hand, the exercise group did not show statistically significant improvement in lumbar side flexion (p = .713) and modified Schober's (p = .106).

TABLE 4.

Comparison of outcome measures within and between groups.

Outcome measures	Yoga group (n = 15)				Exercises group (n = 18)				Between group change (Group × Time interaction)
	T0 Mean (SD)	T1 Mean (SD)	T2 Mean (SD)	p value	T0 Mean (SD)	T1 Mean (SD)	T2 Mean (SD)	p value	F	p value
BASMI	3.3 (1.4)	3.0 (1.50)	2.8 (1.49)	.001*	2.7 (1.50)	2.3 (1.38)	2.3 (1.41)	.002*	0.0047	.946
BASFI	2.1 (2.02)	1.8 (2.14)	1.6 (2.22)	.005*	2.7 (1.97)	2.1 (1.87)	1.7 (1.88)	.003*	0.604	.443
PSQI	6.5 (2.39)	5.3 (1.50)	4.8 (1.27)	.021*	5.7 (1.78)	4.9 (1.17)	4.9 (1.27)	.010*	0.172	.681
CE in cm	3.7 (1.37)	4.0 (1.18)	4.1 (1.16)	.053*	3.1 (1.04)	3.4 (0.96)	3.4 (0.93)	.004*	0.468	.499
NPRS	3.7 (2.63)	1.3 (2.22)	0.9 (1.73)	.001*	2.2 (1.34)	0.4 (0.50)	0.4 (0.94)	.001*	0.928	.343

Note: Baseline (T0) = 0 weeks, post treatment (T1) = 8 weeks, follow‐ up (T2) = 12 weeks.

Abbreviations: BASFI, Bath ankylosing spondylitis Functional Index; BASMI, Bath ankylosing spondylitis Metrology Index; CE, Chest expansion; NPRS, Numerical Pain Rating scale; PSQI, Pittsburgh Sleep Quality Index.

^*Statistically significant.

Repeated measures ANOVA did not show a significant group time effect on outcomes on analyzing between group changes (Table 5). Post hoc analysis revealed, significant improvement in both the groups in the primary outcomes BASMI (T0 vs. T1 p < .001; T0 vs. T2 p < .001), BASFI (T0 vs. T1 p < .001; T0 vs. T2 p < .001) and PSQI (T0 vs. T1 p < .001; T0 vs. T2 p = .002) on comparing from baseline to post‐training and baseline to follow‐up.

TABLE 5.

Comparison of outcomes between baseline, post training and follow‐up.

Outcome measures	Between groups comparison	Mean difference (SE)
BASMI	Baseline versus Post training	0.169 (0.03)*
	Baseline versus Follow‐up	0.253 (0.047)*
	Post training versus Follow‐up	0.084 (0.028)
BASFI	Baseline versus Post training	0.242 (0.044)*
	Baseline versus Follow‐up	0.458 (0.107) *
	Post training versus Follow‐up	0.216 (0.082)
PSQI	Baseline versus Post training	0.800 (0.189)*
	Baseline versus Follow‐up	0.973 (0.270)*
	Post training versus Follow‐up	0.173 (0.112)

Abbreviations: BASFI, Bath ankylosing spondylitis Functional Index; BASMI, Bath ankylosing spondylitis Metrology Index; PSQI, Pittsburgh Sleep Quality Index.

^* p < .05 statistical significance.

4. DISCUSSION

Our study aimed to compare the effect of Yoga with exercise on mobility and functional capacity in patients with ankylosing spondylitis. Overall, the results demonstrated a statistically significant improvement in within‐group scores of mobility, functional capacity, sleep quality and pain in AS patients of both intervention programs but there were no significant differences between the groups. No adverse effects were reported during our study.

The mobility of our study population was measured using BASMI. The within‐group differences of yoga group were 0.3 and 0.5 at post‐treatment and follow‐up, respectively. These values failed to reach SDC (Smallest Detectable Change) which is 0.82. The findings of BASMI in our study showed a small effect size of 0.3 which was smaller than the study conducted by Cetin et al. They achieved an effect size of 0.8 following 10 weeks of Tai‐Chi. ²⁵ The reason for limited improvement in the measures of BASMI in our study could be that the subjects once taught the yoga program, were then instructed to practice at home unsupervised. The within group difference findings of the exercise group were unable to achieve SDC, with mean changes of 0.4 at post‐treatment as well as at follow‐ up. The effect size of the exercise group was found to be 0.3 which is comparable to an earlier study (0.3) conducted by Sveaas et al. ²⁶ A reason for limited effect of exercise on mobility in our study could be that the dosage may not have been sufficient.

The functional capacity of the study population was measured using BASFI. The yoga group showed within group mean change of 0.3 and 0.5 at post‐treatment and follow‐up which failed to reach the MCID 0.8 (Minimal Clinical Important Difference). ²⁷ The effect size of our findings of BASFI in yoga group was smaller (0.2) than that of a study conducted by Cetin et al. They were able to achieve a large effect size of 0.8 following 12 weeks of Tai Chi intervention. ²⁵ Strong relations have been found between reduced occupational activity and functional limitation. The lack of restrictions to participation in work was more prominent during the pandemic. The functional capacity of the individuals in the exercise group showed a mean change of 0.7 at the post‐treatment and a clinically significant change of 1 at the follow‐up. The effect size of the exercise group was 0.5 which was comparable to a study done by Sveaas et al. Their study demonstrated a medium effect size of 0.7 in BASFI following 12 weeks of exercise and education. ²⁶ The rationale behind our positive findings could be the antiinflammatory effect of exercise along with improvement in perceived health, pain and physical fitness.

Sleep quality was assessed using PSQI. Improvement in sleep quality in the yoga group was demonstrated by a mean change 1.2 and 1.7 at post‐treatment and follow‐up which also failed to reach the MCID of PSQI which is 3. The PSQI score of our study showed a large effect size of 0.9. This was larger than the effect size achieved (0.6) in a study conducted by Maddali Bongi et al. ²⁸ on PSQI global score following 16 weeks of tai chi intervention for Fibromyalgia. Sleep medications and anti‐depressants have been hypothesized to have a negative effect on cortisol levels and hypothalamic–pituitary–adrenal (HPA) axis activity. This has also been observed in a study conducted by Sarubin et al. The members of the yoga group in their study showed an increased cortisol level in the 1st week and partial reduction after 5 weeks. ²⁹ The improvement in sleep quality in the exercise group was limited to a mean change of 0.8 at post‐treatment which did not improve further at follow up. PSQI scores showed a medium effect size of 0.5 non‐significant effect on sleep, it was larger than that obtained by Sveaas et al. ³⁰ who reported an insignificant effect size of 0.4 following 12 weeks of exercise. Factors such as disease status, psychosocial variables, pain, depression and anxiety are prevalent in ankylosing spondylitis population and could be the potential reason for limited improvement in sleep quality.

Since chest expansion (CE) is not considered in BASMI scale, we separately measured CE outcome to evaluate effects of our interventions on thoracic mobility. The Yoga group demonstrated a mean change of −0.3 and – 0.4 at post‐treatment and follow‐up which failed to exhibit the SDC of CE which is 2.4. ²⁷ Our finding indicated a small effect size of 0.3 which was comparable to a study conducted by Altan et al. ³¹ who obtained an effect size of 0.4 following 12 weeks of pilates. The exercise group demonstrated a limited change of −0.3 in chest expansion at post‐treatment without further improvement at follow‐up and failure to exhibit the SDC. Our findings showed a small effect size of 0.3 which was comparable to a study conducted by Altan et al. ³¹ who obtained an effect size of 0.4 following 12 weeks of pilates. The limited advancement in CE could be due to the longer disease duration by the end of which movements of the thoracic cage were diminished.

Our findings of pain showed clinical significance with mean changes of 2.4 (24%) and 2.8 (28%) at post treatment and follow‐up (MCID = 1; 2 = ‘much better’). ³² These changes are much larger than the findings of Badsha et al., ³³ who showed a 10% change in NPRS following 8 weeks of yoga intervention in patients with RA. The possible mechanism behind large improvements in pain score is the modulation of HPA axis and reduction of pain sensitivity. Another possible mechanism is the decrease in pain perception due to the release of endorphins. ³⁴ Findings of pain in the exercise group showed clinical significance with mean changes of 1.8 at post‐treatment with no further improvement at follow‐up (MCID = 1% or 15%; 2 = ‘much better’). These changes are much larger than the findings of Karahan et al., ³⁵ who showed a change of 1.3 in NPRS following 8 weeks of exergames intervention in patients with ankylosing spondylitis. Previous studies have recognized that exercise can result in analgesia also known as exercise‐induced hypoalgesia. Exercise also triggers the release of the endogenous opioid system by increasing heart rate and blood pressure, and inducing activation of arterial baroreceptors. ³⁶

Our study demonstrated no significant difference between the two interventions post‐treatment and follow‐up. The reason for similar findings in the between‐group analysis could be that both intervention protocols encompassed a range of techniques that tried to address most aspects of health in patients of ankylosing spondylitis.

The main limitation with the present study was the lack of blinding, which was not possible while comparing exercise with Yoga. We were unable to reach the estimated sample size mainly due to patients being unwilling to commit to the interventions, work commitments, travel and inconvenient timings. The covid pandemic prevalent during the duration of the study also put several restrictions on participation.

We recommend that future studies take a bigger sample size. Future studies should investigate longer duration of intervention for a better estimate of the efficacy of the interventions and include assessment of occupational history, duration till diagnosis, adherence to treatment and comorbidities.

5. CONCLUSION

The present study demonstrated a statistically significant improvement in within group scores of mobility, functional capacity, sleep quality and pain in AS patients of both intervention programs, thus showing the positive impact of both the treatments but there were no significant differences between the groups.

AUTHOR CONTRIBUTIONS

All authors gave substantial contributions to the conception and design of the work. The authors NA and VP were involved in the acquisition and analysis of the data, and drafting of the work. All authors were involved in interpretation of data, revision of the manuscript and final approval of the version to be published. All authors agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

CONFLICT OF INTEREST STATEMENT

The authors declare no conflicts of interest.

ETHICS STATEMENT

Approval from the institutional review board of Manipal College of Health Professions [MCHP], Manipal Academy of Higher Education [MAHE], Manipal to conduct this study. The procedures used in this study adhere to the tenets of the Declaration of Helsinki.

PATIENT CONSENT STATEMENT

Informed consent was obtained from all individual participants included in the study.

CLINICAL TRIAL REGISTRATION

Clinical Trials Registry‐India (CTRI/2021/03/032062).

DATA AVAILABILITY STATEMENT

Data available upon reasonable request from the corresponding author. Videos of the participants are not available due to ethical approval conditions.