| CTRI Number |
CTRI/2018/01/011598 [Registered on: 30/01/2018] Trial Registered Retrospectively |
| Last Modified On: |
12/12/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to assess accuracy and utility of a device to measure physical activity and change in heart rate in Indian children. |
|
Scientific Title of Study
|
A pilot study to assess physical activity and heart rate
variability in Indian Children using the LifeInsightâ„¢
BioTelemetry Platform
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 205200 Version 3.0 dated 26Jul2016 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr S A Cruze |
| Designation |
Principal Investigator |
| Affiliation |
Krumur Sports Academy |
| Address |
Krumur Sports Academy, PMC yoga hall Gorpadi, pune -411001, Maharashtra India
JCDC
32, Sasoon Road,
Pune - 411001 Maharashtra,
India
Pune
MAHARASHTRA
411001
India |
| Phone |
9327570950 |
| Fax |
|
| Email |
info@krumur.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S A Cruze |
| Designation |
Principal Investigator |
| Affiliation |
Krumur Sports Academy |
| Address |
Krumur Sports Academy, PMC yoga hall Gorpadi, pune -411001, Maharashtra India
JCDC
32, Sasoon Road, Pune - 411001 Maharashtra,
India
Pune
MAHARASHTRA
411001
India |
| Phone |
9327570950 |
| Fax |
|
| Email |
info@krumur.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr S A Cruze |
| Designation |
Principal Investigator |
| Affiliation |
Krumur Sports Academy |
| Address |
Krumur Sports Academy, PMC yoga hall Gorpadi, pune -411001, Maharashtra India
JCDC,32, Sasoon Road, Pune - 411001 Maharashtra,
India
Pune
MAHARASHTRA
411001
India |
| Phone |
9327570950 |
| Fax |
|
| Email |
info@krumur.com |
|
|
Source of Monetary or Material Support
|
| GlaxoSmithKline Consumer Healthcare GSKCH,Sector 32, Plot no 62, Gurgaon Haryana |
|
|
Primary Sponsor
|
| Name |
GlaxoSmithKline Consumer Healthcare GSKCH |
| Address |
Plot Number 67, Sector 32, Gurgaon, Haryana, India |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Jehangir Clinical Development Centre Pvt Ltd |
Jehangir Hospital Premises, 32, Sassoon Road, Pune - 411001 Maharashtra,
India |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr S A Cruze |
Krumur Sports Academy |
PMC Yoga Hall, Behind Anand Talkies, Ghorpadi Pune- 411001
Pune
MAHARASHTRA |
9327570950
info@krumur.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee Jehangir Clinical Development Centre Pvt Ltd |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
This is a study on healthy volunteers with Good general and mental health. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Faros sensor and LifeInsight Hub, along with sufficient skin attachments |
1. Faros sensor- Data acquisition device
2. LifeInsight Hub - Wireless data transmission device
3. Chest strap + stingray adapter/2 wire electrode- Electrodes that connect to data acquisition device (Faros sensor) |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
9.00 Year(s) |
| Age To |
11.00 Year(s) |
| Gender |
Both |
| Details |
1 Demonstrates understanding of the study and willingness to participate.
2. Good general and mental health and no clinically significant and relevant abnormalities in medical history or upon physical examination.
3. Absence of any condition that would impact on the participant’s safety or wellbeing
4.Participant and participant’s parents/LAR understand and are willing, able and likely to comply with all study procedures and restrictions.
5. Able to read and comprehend one of the languages used for study visits and assessments.
|
|
| ExclusionCriteria |
| Details |
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.
6.Recent history (within the last one year) of alcohol or other substance abuse.
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. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Movement/physical activity during structured exercise
2. Heart Rate Variability (HRV) during structured exercise |
1. Up to 72 hours
2. Up to 72 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
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 |
1. Up to 72 hours
2. Up to 72 hours |
|
|
Target Sample Size
|
Total Sample Size="12"
Sample Size from India="12"
Final Enrollment numbers achieved (Total)= "12"
Final Enrollment numbers achieved (India)="12" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
13/06/2016 |
| Date of Study Completion (India) |
26/09/2016 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Objective quantification of physical activity is becoming an
increasingly important measure in health research. For example, the accurate
measurement of daily movement is critical to understanding the relative
contribution of physical activity to weight management and metabolic health. The
aim of this study is to investigate the validity and repeatability of this
technology for assessing overall daily activity and activity during controlled
exercise, as well as HRV in Indian children aged from 9 to 11. This study will
be conducted in India and results may be used in subsequent interventional
trials, for which resulting communications may be used about children’s daily
physical activity levels. |