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临床试验/CTRI/2024/10/075513
CTRI/2024/10/075513尚未招募不适用

Al-enabled pulse rate based biofeedback device to guide fitness enthusiasts in performing exercises correctly

School of Physiotherapy, RK University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年1月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
1. Harvard Step Test

研究概览

简要总结

Title: AI-ENABLED PULSE RATE-BASED BIOFEEDBACK DEVICE TO GUIDE FITNESS ENTHUSIASTS IN PERFORMING EXERCISES CORRECTLY

Background: Exercise is an integral part of health and wellness. For optimal health benefits and injury prevention, individuals must understand their individual exercise thresholds (such as anaerobic threshold) in relation to various exercise intensities, including walking, running on a treadmill, and weight lifting. Self-analysis and control of exercise intensity help achieve fitness goals while preventing excessive strain on the body. However, it is challenging for individuals to closely monitor their exertion levels and maintain them within safe limits. A Pulse Rate-based AI-enabled Biofeedback device can address this need by providing real-time monitoring and feedback, thus preventing critical challenges to the physiological system.

Need of the study:

  1. Monitoring Exertion Levels with Real-time Biofeedback.

  2. Understanding Exercise Thresholds and performing submaximal exercises.

  3. Identifying and understanding the progression of Exercises.

Research problem: The primary research problem addressed by this study is individuals’ difficulty in accurately monitoring their exertion levels and maintaining them within safe limits during exercise. Current fitness monitoring devices often lack real-time feedback and fail to provide personalized insights into exercise thresholds, resulting in submaximal workouts and increased injury risk. There is a need for an advanced, AI-enabled biofeedback device that offers real-time monitoring and feedback based on pulse rate, rhythm, and flow. This device will help users stay within their exercise thresholds, improve performance, reduce injury risk, and increase satisfaction compared to traditional self-monitoring methods.

Aim: This study aims to develop and validate an algorithm for  the rate, rhythm, and flow of the radial pulse which is taken by an AI-enabled pulse rate-based biofeedback device

Objectives:  

  1. Evaluate the accuracy of an AI-enabled biofeedback device in predicting and maintaining exercise intensity within the optimal threshold, as measured by pulse rate, rhythm, and flow, compared to the actual Rate of Perceived Exertion (RPE).

  2. Assess the impact of the AI-enabled biofeedback device on exercise efficiency and performance.

  3. Determine the effectiveness of the AI-enabled biofeedback device in reducing injury risk during exercise.

**Methods:**Efficacy Testing  of AI-enable pulse rate-based biofeedback device: - (Two stages) This phase has two stages,

Stage 1: Exercise Data Analysis and Algorithm Development: Thirty healthy individuals will perform the Harvard Step Test at moderate intensity (RPE 13), with their exercise intensity, pulse rate, and step-up count recorded to develop an algorithm. Blood samples will be taken at moderate intensity to validate anaerobic threshold biomarkers.

Stage 2: Algorithm Evaluation and Accuracy Testing: The developed algorithm will be tested on a new set of 30 individuals to reach moderate intensity (RPE 13). The actual RPE will be recorded and correlated with the algorithm-predicted RPE to evaluate accuracy.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Screening with SF-36 Health Questionnaire.

排除标准

  • Pregnancy
  • Recent Surgery or Injury in last 6 months
  • History of hospitalization in the last 6 months.

结局指标

主要结局

1. Harvard Step Test

时间窗: 1. Before the exercise performance | 2. During the exercise performance | 3. After the exercise performance

2. Rate of Perceived Exertion (RPE)

时间窗: 1. Before the exercise performance | 2. During the exercise performance | 3. After the exercise performance

3. Radial Pulse – Rate, rhythm and flow

时间窗: 1. Before the exercise performance | 2. During the exercise performance | 3. After the exercise performance

次要结局

  • Exercise efficiency & performance(Continuous monitoring while performing exercise)
  • Reduction in injury risk(History of injuries in last 6 months & upcoming 1 month, 3 months & 6 months)

研究者

发起方
School of Physiotherapy, RK University
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Rajvi Divyeshbhai Kamdar

School Of Physiotherapy, RK University

研究点 (1)

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