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Study Protocol

Effect of Yogasana and Pranayama on cardiopulmonary functions on sawmill, sugar cane and bidi workers in the rural sector

[version 1; peer review: 1 approved with reservations, 1 not approved]
PUBLISHED 29 Dec 2023
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This article is included in the Datta Meghe Institute of Higher Education and Research collection.

Abstract

Background

The rural sector is an essential component of the country’s economy, and the economy is based on the large number of workers involved in various activities such as agriculture, forestry, and small and large-scale industries. People work in different industries like sawmills, sugarcane and Bidi factories for their livelihoods. These workers, among other factory workers, are frequently exposed to hazardous working conditions that can have a negative impact on their health. These workers are at high risk of developing respiratory and cardiovascular diseases due to prolonged exposure to dust, smoke and other harmful substances. This study aimed to evaluate the effect of yoga and pranayama on cardiopulmonary function in the sawmill, sugar cane and Bidi workers in the rural sectors.

Methods

348 workers will be randomly assigned to the Yogasana and Pranayama group or the control group. The intervention of the Yogasana and Pranayama group will be planned for a 20-week program, while the control group will be continuing their as-usual activities. Cardiopulmonary function will be assessed for baseline parameters, and after the intervention has been completed similar parameters will be recorded.

Conclusions

It could be concluded that the Yogasana and Pranayama may be effective for improving the cardiopulmonary function in sawmill, sugar cane, and Bidi workers in rural sectors.

Registration

CTRI/2023/07/055733.

Keywords

Bidi Workers; Cardiopulmonary Functions; Sawmill Workers; Sugar Cane ; Workers; Praṇayama; Yogasana.

Introduction

The likelihood of developing cardiopulmonary disease is increased due to high exposure to dust and pollution, which occurs with many people working in the industrial area.1 This high level of impact of exposure in the sawmill, sugar cane and Bidi workers leads to respiratory disorders. Yogasana and pranayama is an essential yogic practice that changes cardiopulmonary and autonomic variables.2 Yoga reduces stress and autonomic function, and the Yogic breathing practice was reported to benefit cardiovascular and autonomic variables.3 This cardiopulmonary risk is more associated with the people working in the industries.4 In India, in most markets, people work in many small- (sawmill, Bidi company) and large-scale industries (sugarcane). The majority of the people who work in these factories are from poor socio-economical backgrounds.5 While working, they are directly or indirectly exposed to dust and pollution in their workplace. In India, Maharashtra state is one of the major sugar, sawmills and Bidi producers. In the Wardha districts, Samudrapur Tehsil is where people’s primary income source is rolling the Bidi. Many of these workers are exposed to snuff powders while working for long durations. These people are regularly exposed to the risk of inhalation directly.

This study aims to investigate the effect of Yogasana and Pranayama on the cardiopulmonary functions of the workers in the rural sector who are engaged in sawmills, sugar cane, and Bidi industry work. These industries expose workers to high levels of air pollution, which can harm their health, mainly their cardiopulmonary function.68 This study seeks to determine whether the practice of Yogasana and Pranayama can mitigate the adverse effect of industrial air pollution on the workers’ cardiopulmonary function.9,10 The study is essential as it can provide insight into the potential of Yogasana and Pranayama as a preventive measure against the adverse health effects of exposure to industrial air pollution in the workplace.11

Sugar cane workers are highly exposed to wood dust (Bhusa) while working near the boiler to generate steam. This high exposure to dust and air pollution by sugar cane workers leads to cardiopulmonary diseases such as asthma, cardiovascular diseases, respiratory diseases and due to this leads to deaths were reported12 in a few studies over the last decade.13,14

Another study assessed the ventilator function of persons exposed to sawdust with rhinitis symptoms.15 A total of 500 sawmill workers in Ibadan were studied to evaluate occupation-induced lung damage due to exposure to sawdust. Occupational-related problems were measured through a structured questionnaire. The study was conducted on 500 workers at University College Hospital (UCH) Ibadan and served as age and sex-matched with control. Findings reported that respiratory symptoms are common in the sawmill workers and 4.1% workers suffered airway obstruction.16

In a study published on Bidi workers where raw tobacco dust is a known sensitizing agent,17 there was evidence of alveolitis in the manufacturing industry of tobacco. Some workers in tobacco manufacturing sectors were found to experience respiratory-related symptoms and lung fibrosis.18

Another study was conducted to determine the rice husk dust effect on pulmonary function in the rice mill workers. In this study the population was 150 male rice mill workers from 6 different rice mills with 50 as control of similar age, sex ethnic group, and agriculture work background. Out of which 28 rice mill workers suffered with obstructive diseases, whereas eight suffered from restrictive pulmonary impairment.19

The study conducted by Patil SN in 2008 conducted pulmonary function tests on sugar cane workers. The workers exposed to sugar cane dust were compared with normal healthy adults as a control group. In this study, they found dysfunction in high duct exposure in sugarcane workers in a specific region of Western Maharashtra, India.20

Rhinitis is one of the common clinical conditions found in occupational-related disorders. It affects the respiratory upper airway and also involves the lower respiratory tract along with considerable airflow limitation.21 Exposure of sawdust leads to symptoms related to rhinitis.22

Clip pipe workers are also exposed to high-concentration airborne mold spores. A few cases were reported in Finland, where they suffered from allergic alveolitis. In this study, they compared the immunological and clinical effects of continuous mould spore exposure, where eight non-smoking workers, six on-chip pipes, and two on-bark pipes were evaluated, and chronic bronchitis symptoms were reported due to exposure to wood dust.23,24

Exposure to this pollution is related to an enhanced risk of cardiopulmonary morbidity.25 Most of the studies on the subject are related to the urban population. This study will compare sawmills, sugar cane, and Bidi workers’ occupational hazards and incidences of respiratory symptoms. Recently, from 2001 there are no published studies on the comparison of these three groups regarding cardiopulmonary risks treated with the intervention of Yogasana in the Indian scenario. This paucity of data and the risk of cardiopulmonary problems observed in the factory workers can be resolved through the investigation of our study.

Rationale

Yogasana and Pranayama is an ancient traditional Yogic practice from Ayurveda for reducing stress and improve autonomic function. Yogasana (postural exercise) and Pranayama (breathing exercise) were reported to produce a positive effect on cardiovascular and autonomic function variables.26 Cardiopulmonary risk is more highly associated with people working in the industrial area.27 They are highly exposed to dust and air pollution in the environment where they work. Keeping this view in mind, the aim of the study is to evaluate the effect of Yogasana and Pranayama on cardiopulmonary function in sawmills, sugar cane, and Bidi workers in rural sectors.

Objectives

  • 1. To evaluate the effect of cardiopulmonary function in sawmill, sugar cane, and Bidi workers.

  • 2. To evaluate the effect of Yogasana and Pranayama on autonomic function test in sawmill, sugar cane, and Bidi workers.

  • 3. To compare the effect of Yogasana among the sawmill, sugar cane, and Bidi workers.

Methods

Trial design

This will be parallel group, single blind, randomized control trial.

Study setting and recruitment

The study will be conducted in the Department of Physiology, Jawaharlal Nehru Medical College Sawangi (M) Wardha and Mahatma Gandhi Ayurved College and Hospital and Research Centre Salod (H) Wardha.

Selection of the subjects will be done from outdoor patients (OPD) and indoor patients (IPD) of the Medicine Department, Jawaharlal Nehru Medical College Sawangi (M) Wardha and Department of Panchakarma, Mahatma Gandhi Ayurved College Hospital, and Research Centre Salod (H) Wardha. Also, subjects will be selected at their respective mills by organizing camps in the factory.

Participants

In this study, 348 subjects will be required according to the sample size calculation. The inclusion criteria will be: 1) sawmill, sugar cane, and Bidi workers aged between 25 and 40 years; 2) minimum exposure (i.e., employed in the industry) of 5 years and above; 3) those who have respiratory symptoms like breathlessness and cough. The exclusion criteria will be: 1) sawmill, sugar cane, and Bidi workers not exposed for more than 5 years; 2) Bidi workers who are BidiBidi smokers (confounder); 3) sawmill, sugar cane, and Bidi workers with hypertension (HTN), metabolic disorders, and congenital anomalies in cardio-respiration; 4) those who are addicted to alcohol. The allocation sequence was generated used computer-generated random numbers. The allocation concealment mechanism was a central telephone method.

Sample size

A sample of 348 has been calculated using Epi Info statistical software version 7.2.

To calculate the sample size for this study, several factors need to be considered, including the level of significance, power of the study, and effect size.

Assuming a level of significance of 0.05, a power of 0.80, and a moderate effect size of 0.5, the sample size can be calculated using the following formula:

n=/2+2SD2/d2

Where:

  • n = sample size

  • Zα/2 = the critical value of the standard normal distribution at 0.05 level of significance (1.96)

  • Zβ = the critical value of the standard normal distribution at 0.80 power (0.84)

  • SD = standard deviation of the population (assumed to be 10 based on previous studies)

  • d = effect size (0.5)

Plugging in these values, we get:

n=1.96+0.842102/0.52n=86.4
n=87GroupA=87GroupB=87GroupC=87and Control Group=87=348

Therefore, a sample size of at least 87 participants per group would be needed for this study. However, it is important to note that the sample size may need to be adjusted based on the specific population being studied and any potential confounding variables smoking history, family history of diabetic, hypertension.

Interventions

To improve adherence

We will motivate the participants by showing them videos of different exercises to build confidence among them for improvement. Every day we will send a reminder and motivational video on the WhatsApp group.

Concomitant care

If they are on bronchodilator or any other medication, subjects will not be included in this study, as this may change the results of the study.

Blinding (masking)

No unblinding is permitted in this study.

Data collection

The pulmonary function test (PFT) will be carried out through the Med Spiro PC based digital spirometer used for determining the peak expiratory flow rate, peak inspiratory flow rate, vital capacity, and maximum voluntary ventilation. Subjects will be given instruction on how to perform the pulmonary function test in this study, the intervention will be given as Yogasana and Pranayama with the help of a yoga teacher. The trained Yoga teacher will teach the experimental groups specific Asana like Halasana (plough), Akarna-dhanurasana (reverse bow posture), Ardh-matsyendrasana (half spine twist), Ushtrasana (camel), Bhujangasana (cobra), and Surya namaskar (sun salute) for their flexibility, physical strength and to improve their endurance. They will be required to do these exercises every day for 60 minutes after the 20-minute physical training or practicing different Yogasana. They will also be trained in the Pranayama for breathing exercise i.e., alternate nostril breathing, Kapalbhati, Bhastrika, and Bhramari Pranayama for improve their lung efficiency. This practice will be given to the subjects every day for up to 20 weeks under the supervision of a Yoga teacher. After the 20 weeks of training, their parameters will be assessed again. The study is expected to take 18-24 months.

Data management

After data collection, all data entry will be performed by a trained data operator, who will code the patients’ name, OPD and IPD number, and these will be safely stored with a password on the excel sheets.

Statistics

Analysis of the population and missing data

Data will be maintained with a hard copy on file. If data are missing, it will be optioned from hard copy. Dropout or follow up can be separately recorded in the entry registers.

Harms

In this study there are no drugs, hence no adverse effects are predicted. However, overstretching may cause muscle pain, and in osteoporosis patients fractures may happen. Some patients may also experience asthma attacks due to the exertion.

Data access

Data will be access via a separate excel sheet and it will be password-protected.

Trial registration

This trail is registered under the Clinical Trail Registry India and the registration number for this trail is CTRI/2023/07/055733.

Randomization

Participants who meet the eligibility criteria will be randomized into the internal group ABC and control group D. They will be randomly divided into four groups, Group A, Group B, and Group C, and the control group D. In each group, there will be 87 subjects included. All the baseline parameters will be recorded at the time of recruitment in the hospital. A lung function test will be carried out for determining the relatively affected cardiopulmonary status among the workers of the sawmill, sugar factory, and Bidi rolling workers.

Blinding of groups

Participants, research assistants and the clinicians will be unaware of which group the subjects will be assigned to in this study. The blinded group codes will be kept absolutely confidential during the trial to observe for any improvement in any specific group due to the intervention.

Screening investigation

Baseline parameters will be assessed in the participants: complete blood count (CBC), measuring the pulse with a pulse meter, blood pressure with digital sphygmomanometer, lipid profile, BMI, hip waist ratio, and computerized spirometer recoded force vital capacity (FVC), force expiratory volume for 1 second in percentages (FEV1 %), peak expiratory flow rate (PEFR), peak inspiratory flow rate (PIFR).

Post investigation

After 20 weeks of the intervention of Yogasana and Pranayama, the same parameters will be assessed again.

Criteria for discontinuing and modifying allocations

The subjects will be withdrawn from the study if they are not able to complete the training, if they start any bronchodilators or other medication than alters pulmonary function value, or if any problems emerge with them like asthma attack or, while performing Yogasana, severe pain. They will be noted along with their dropout criteria. They will be allowed to continue Yogasana and Pranayama if they feel comfortable.

Outcome of the study

We will observe for any significant changes in the groups after 20 weeks of the intervention.

PICO model

In this study, the PICO model will be incorporated. The population is sawmill, sugar cane, and Bidi workers; the intervention is Yogasana and Pranayama; the comparison will be among the different groups of sawmill, sugar cane, and Bidi workers with a control group; and the outcome of the study will be the benefits of Yogasana and Pranayama.

Participation timeline

The predicted timeline for this study is presented in Table 1.

Table 1. Participant timeline.

Study period
EnrolmentAllocationPre-allocationPost-allocationClosed outAnalysis
Time pointO day20 weeks
Enrolment
Eligibility screen
Informed consent
(List other procedures)
Allocation
Intervention
(Intervention A) (Intervention B)
Assessments
(List baseline variables)
(List outcome variables)
(List other data variables)

Discussion

We expect to find that practising Yogasana and Pranayama positively affects the cardiopulmonary function of the sawmill, sugar cane, and Bidi workers in the rural sector. We expect the workers will show significant improvement in lung capacity, oxygen saturation level, and heart rate variability after regular practice of Yogasana and Pranayama.

In this study, we expect to find that regular practice of Yogasana and Pranayama may lead to a positive effect on the cardiopulmonary function of sawmills, sugar cane, and Bidi workers in the rural sector. The workers who will be doing regular practice of Yogasana and Pranayama may improve their lung function, blood pressure, and decrease their heart rate compared to those who did not.

Pranayama is a form of breathing exercise that originated in ancient India and is now practised worldwide. It involves controlling the breath to improve physical, mental, and emotional health.28 A previous study suggests that some of the benefits of practising Pranayama for reduce stress and anxiety.29 The Pranayama may calm the mind and reduce stress and anxiety levels. It may also promote relaxation and a sense of well-being.30

We expect the study will suggest that deep breathing is used in Pranayama, which may be helps to increase the lung’s capacity and oxygen intake. This will have the potential to improve overall respiratory health. Pranayama may improve the movement of oxygen and blood throughout the body, which can strengthen the immune system and overall wellness. Pranayama can aid in the integration of the sympathetic and parasympathetic nervous systems, which can improve overall health and well-being. Pranayama can also help to improve digestive issues such as constipation, bloating, and indigestion.31 A few other studies suggest that Pranayama can help to improve mental clarity and focus, which can improve productivity and performance.3234

In this study, we will not consider the socio-economical background and lifestyle factors of the participants, which may influence the results. This study did not collect information on factors such as dust exposure, occasional consumption of alcohol, and diet, which may affect the cardiopulmonary function of the participants. Therefore, the study findings should be interpreted in the context of the limitations mentioned above.

In terms of generalizability, the study findings may apply to similar populations of sawmill, sugar cane, and Bidi workers in rural sectors. However, the findings cannot be generalizable to other populations such as urban workers or individuals with different occupational exposures, therefore, the study findings should be considered in the context of the specific population in rural sectors.

Dissemination

The work will be presented conferences and published in an indexed journal.

Study status

Not yet started, it will start in September 2023.

Ethical considerations

The study is approved by the Datta Meghe Institute of Medical Sciences Institutional Ethical Clearance Committee (protocol no: DMIMS (DU)/IEC/2021/664) after due consultation and gatekeepers’ consent and presentation. The I.E.C. letter was provided by ICE DMIMSU (DU) on 18.12.2021 Wardha, Maharashtra, India.

Re- regd no: ECR/440/Inst/MH/2013/RR-2019.

Consent

Informed written consent will be obtained for the purpose of the study from all the participants. Anonymity and confidentiality will be explained to them before the study begins, and they will voluntary sign the consent form. The informed consent agreement will include that the participants can withdraw his or her name from the study at any point if they no longer feel comfortable.

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Nisargandha MA, Parwe SD, Kuchewar VV and Saraf CA. Effect of Yogasana and Pranayama on cardiopulmonary functions on sawmill, sugar cane and bidi workers in the rural sector [version 1; peer review: 1 approved with reservations, 1 not approved]. F1000Research 2023, 12:1607 (https://doi.org/10.12688/f1000research.136645.1)
NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article.
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Key to Reviewer Statuses VIEW
ApprovedThe paper is scientifically sound in its current form and only minor, if any, improvements are suggested
Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit.
Not approvedFundamental flaws in the paper seriously undermine the findings and conclusions
Version 1
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PUBLISHED 29 Dec 2023
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Reviewer Report 05 Jun 2024
Maheshkumar Kuppusamy, Physiology, Government Yoga Medical college and Hospital, Chennai, Tamil Nadu, India 
Approved with Reservations
VIEWS 5
1. The introduction could provide more background information on the specific occupational hazards and exposures faced by sawmill, sugar cane, and Bidi workers, and their potential impact on respiratory and cardiovascular health.
 
2. Discuss the prevalence and ... Continue reading
CITE
CITE
HOW TO CITE THIS REPORT
Kuppusamy M. Reviewer Report For: Effect of Yogasana and Pranayama on cardiopulmonary functions on sawmill, sugar cane and bidi workers in the rural sector [version 1; peer review: 1 approved with reservations, 1 not approved]. F1000Research 2023, 12:1607 (https://doi.org/10.5256/f1000research.149789.r240553)
NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article.
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5
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Reviewer Report 21 May 2024
Gopal Nambi, Prince Sattam Bin Abdulaziz Universit, Al Kharj, Saudi Arabia 
Not Approved
VIEWS 5
The title of the study is not clear and self-explanatory.
Abstract:
  1. Please include background of the study.
  2. Mention the study design, study duration and study setting.
  3. Mention the character of the
... Continue reading
CITE
CITE
HOW TO CITE THIS REPORT
Nambi G. Reviewer Report For: Effect of Yogasana and Pranayama on cardiopulmonary functions on sawmill, sugar cane and bidi workers in the rural sector [version 1; peer review: 1 approved with reservations, 1 not approved]. F1000Research 2023, 12:1607 (https://doi.org/10.5256/f1000research.149789.r251343)
NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article.
  • Author Response 30 Dec 2024
    Shweta Parwe, Panchakarma, Mahatma Gandhi Ayurved College & Research Centre Wardha Datta Meghe Institute of Higher Education and Research, Wardha, India
    30 Dec 2024
    Author Response
    Dear sir/ madam, 
    This brings to your attention that this is a stduy protocol, not an original article. Your suggestion of the study is appreciated, as this is the study ... Continue reading
COMMENTS ON THIS REPORT
  • Author Response 30 Dec 2024
    Shweta Parwe, Panchakarma, Mahatma Gandhi Ayurved College & Research Centre Wardha Datta Meghe Institute of Higher Education and Research, Wardha, India
    30 Dec 2024
    Author Response
    Dear sir/ madam, 
    This brings to your attention that this is a stduy protocol, not an original article. Your suggestion of the study is appreciated, as this is the study ... Continue reading

Comments on this article Comments (0)

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Alongside their report, reviewers assign a status to the article:
Approved - the paper is scientifically sound in its current form and only minor, if any, improvements are suggested
Approved with reservations - A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit.
Not approved - fundamental flaws in the paper seriously undermine the findings and conclusions
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