A study to assess accuracy and utility of a device to measure physical activity and change in heart rate in Indian children.

Completed

Conditions: This is a study on healthy volunteers with Good general and mental health.

Brief Summary: Objective quantification of physical activity is becoming anincreasingly important measure in health research. For example, the accuratemeasurement of daily movement is critical to understanding the relativecontribution of physical activity to weight management and metabolic health. Theaim of this study is to investigate the validity and repeatability of thistechnology for assessing overall daily activity and activity during controlledexercise, as well as HRV in Indian children aged from 9 to 11. This study willbe conducted in India and results may be used in subsequent interventionaltrials, for which resulting communications may be used about childrenâ€™s dailyphysical activity levels.

Recruitment & Eligibility

Inclusion Criteria

1 Demonstrates understanding of the study and willingness to participate.
Good general and mental health and no clinically significant and relevant abnormalities in medical history or upon physical examination.
Absence of any condition that would impact on the participantâ€™s safety or wellbeing 4.Participant and participantâ€™s parents/LAR understand and are willing, able and likely to comply with all study procedures and restrictions.
Able to read and comprehend one of the languages used for study visits and assessments.

Exclusion Criteria

1.A child cared for by foster parents or living in a care home or institution.
2.Concurrent Medication/ Medical History Use of concomitant medication that, in the opinion of the Principal Investigator, might interfere with the outcome of the study.
3.Allergy/ Intolerance Known or suspected intolerance or hypersensitivity to the study materials.
4.Participation in another clinical study within 30 days of the screening visit.
5.Previous participation in this study.
7.An employee of the sponsor or the study site or members of their immediate family/ OR Sibling of child already part of this study.
8.Current or relevant history of any serious, severe or unstable physical or psychiatric illness or any medical disorder that would make the participant unlikely to fully complete the study.

Primary Outcome Measures

Name	Time	Method
1. Movement/physical activity during structured exercise	1. Up to 72 hours \| 2. Up to 72 hours
2. Heart Rate Variability (HRV) during structured exercise	1. Up to 72 hours \| 2. Up to 72 hours

Secondary Outcome Measures

Name	Time	Method
1. Movement/physical activity and heart rate variability during spontaneous daily physical activity, including sleep	2. Heart rate variability during spontaneous daily physical activity, including sleep

Locations (1): Krumur Sports Academy
🇮🇳
Pune, MAHARASHTRA, India
Krumur Sports Academy
🇮🇳Pune, MAHARASHTRA, India
Dr S A Cruze
Principal investigator
9327570950
info@krumur.com