Last updated: 11/03/2018 23:10:48
A pilot study to assess physical activity and heart rate variability in Indian Children using the LifeInsight BioTelemetry Platform.
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A pilot study to assess physical activity and heart rate variability in Indian Children using the LifeInsight BioTelemetry Platform.
Trial description: This study will evaluate a novel technology platform for measuring physical activity and heart rate variability in Indian children over two 72 hour periods during typical weekdays in the school year. Each period will include a session of structured exercise.
Primary purpose:
Other
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
N\A
Primary outcomes:
Movement/physical activity during structured exercise
Timeframe: Up to 72 hours
Heart Rate Variability (HRV) during structured exercise
Timeframe: Up to 72 hours
Secondary outcomes:
Movement/physical activity and heart rate variability during spontaneous daily physical activity, including sleep
Timeframe: Up to 72 hours
Heart rate variability during spontaneous daily physical activity, including sleep
Timeframe: Up to 72 hours
Interventions:
Enrollment:
12
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Sports Nutritional Sciences
Product
Not applicable
Collaborators
Not applicable
Study date(s)
June 2016 to September 2016
Type
Interventional
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
9 - 11 Year
Accepts healthy volunteers
yes
- Demonstrates understanding of the study and willingness to participate as evidenced by participant’s parents and/or LAR’s voluntary written informed consent as well as written assent by the participant and has received a signed and dated copy of the informed consent form as well as the assent form.
- Aged 9-11 years inclusive.
- A child who has been placed under the control or protect (CiCtion of an agency, organisation, institution or entity by the courts, the government or a government body, acting in accordance with powers conferred on them by law or regulation, the definition of a CiC can include a child cared for by foster parents or living in
- a care home or institution, provided that the arrangement falls within the definition above. The definition of a CiC does not include a child who is adopted or has an appointed legal guardian.
Inclusion and exclusion criteria
Inclusion criteria:
- Demonstrates understanding of the study and willingness to participate as evidenced by participant’s parents and/or LAR’s voluntary written informed consent as well as written assent by the participant and has received a signed and dated copy of the informed consent form as well as the assent form.
- Aged 9-11 years inclusive.
- Participant is male or female.
- Good general and mental health with, in the opinion of the Investigator or medically qualified designee no clinically significant and relevant abnormalities in medical history or upon physical examination and absence of any condition that would impact on the participant’s safety or wellbeing or affect the individual’s ability to understand and follow study procedures and requirements.
- Participant and participant’s parents/LAR (legally acceptable representative) understand and are willing, able and likely to comply with all study procedures and restrictions and able to read and comprehend one of the languages used for study visits and assessments.
Exclusion criteria:
- A child who has been placed under the control or protect (CiCtion of an agency, organisation, institution or entity by the courts, the government or a government body, acting in accordance with powers conferred on them by law or regulation, the definition of a CiC can include a child cared for by foster parents or living in a care home or institution, provided that the arrangement falls within the definition above. The definition of a CiC does not include a child who is adopted or has an appointed legal guardian.
- Use of concomitant medication that, in the opinion of the Principal Investigator, might interfere with the outcome of the study, known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients. Known hypersensitivity to medical-grade hypoallergenic adhesive.
- Participation in another clinical study (including cosmetic studies) or receipt of an investigational drug within 30 days of the screening visit and previous participation in this study.
- Recent history (within the last one year) of alcohol or other substance abuse.
- An employee of the sponsor or the study site or members of their immediate family and sibling of child already part of this study.
- 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 or any condition that presents undue risk from the study product or procedures in the opinion of the Principal Investigator/medical examiner.
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2016-26-09
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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