1. What data in particular will be shared?
   Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
   


2. What additional supporting information will be shared?
   Response -  Study Protocol
   Response -  Statistical Analysis Plan
   Response - Clinical Study Report
   
   
3. Who will be able to view these files?
   Response - Anyone
   


4. For what types of analyses will this data be available?
   Response - Any purpose.
   


5. By what mechanism will data be made available?
   Response (Others) -  online


6. For how long will this data be available start date provided 01-09-2025 and end date provided 01-09-2026?
   Response - Immediately following publication. No end date.
   


7. Any URL or additional information regarding plan/policy for sharing IPD? 
   Additional Information - NA

Design and Development of a Wearable Metaboreflex Monitoring Device to Evaluate Physiological Alterations Induced by Arsenic Contaminated Water Among Young Athletes

Background and Purpose of trial

Arsenic toxicity from contaminated water or soil poses a global health threat, particularly in countries like India, Bangladesh, Taiwan, and Northern China. Punjab, a highly industrialized state in India, is experiencing increasing levels of arsenic contamination in its groundwater. Exposure to arsenic contaminated water can impair muscle physiology and disrupt cardiovascular regulation. Metaboreflex receptors located within muscles, are activated during exercise and help mediate autonomic responses. Adolescents aged 12 to18, who are typically involved in both academics and sports, represent a vulnerable population. With rising arsenic levels, it becomes imperative to understand the physiological impacts especially among young athletes who rely on optimal muscle and cardiovascular performance.

Review of Literature

Kianoush et al., 2022 reviewed arsenic contamination through water and food, identifying groundwater, fish, crops, and cereals as major sources of exposure in both developed and developing nations. However, the review lacked data on long-term effects across diverse populations and focused on limited dietary sources. Elliot Lam et al., 2019 studied muscle metaboreflex activation and its effect on heart rate during dynamic exercise. Using 13 healthy participants, the study demonstrated that post exercise circulatory occlusion increased ventilation and heart rate during exercise but not at rest. However, the study did not explore the effects of PECO across varying intensities, age groups, athletic populations, or clinical subjects indicating a gap in broader applicability.

Objectives of the Study
 To develop and evaluate the reliability of a wearable metaboreflex monitoring device.
 To establish normative values using the device.
 To examine physiological changes in metaboreflex responses due to arsenic exposure among young athletes.

Need for the Study

Chronic arsenic exposure disrupts physiological systems and may impair the metaboreflex response, a critical mechanism for regulating cardiovascular and muscular activity during physical exertion. Impaired metaboreflex activity can reduce athletic performance, lower self esteem, hinder training progress, increase the risk of injury, and adversely impact sports careers. Therefore, there is an urgent need for an accessible, athlete specific device capable of real time monitoring of metaboreflex and autonomic function. Early detection of arsenic induced impairments can facilitate personalized training protocols. This study bridges the fields of environmental health and sports science by developing such a monitoring device and assessing arsenic physiological impact on young athletes.

Methodology

Device Development

This phase involves transforming theoretical concepts into a practical, functional prototype. The device consists of two wearable straps integrated with real time monitoring software.
Strap 1 contains a heart rate sensor and is worn on the wrist.
Strap 2 incorporates NIRS, graphene based, and EMG sensors and is worn on the quadriceps or biceps.

Reliability Evaluation

19 male athletes of 12 to18 years will be selected through purposive sampling. Test retest and intra rater reliability will be assessed. Data will be analyzed using SPSS software, employing correlation and intraclass correlation coefficient tests.

Establishment of Normative Values

30 young athletes will be selected through purposive sampling and establish normative values for metaboreflex response. Data analysis will include calculations of mean, variance, and standard deviation.

Cross Sectional Study

Athletes from areas with arsenic contaminated water greater than 10 µg per L will form the case group, while athletes from non contaminated areas will serve as the control group. Arsenic levels will be confirmed using portable water testing kits. Both groups will perform isometric squats while wearing the device. Baseline and post exercise data will be analyzed using the Shapiro Wilk test for normality, followed by independent t tests or Mann Whitney U tests as appropriate.