Effects of Kalaripayattu on Psychological Wellbeing and B... | NCT03610594

Studies
Effects of Kalaripayattu on Psychological Wellbeing and Behavior in Children

NCT03610594

Sponsor

NMP Medical Research Institute

Status

Unknown status

Last Update Posted

Oct 12, 2018Actual

Enrollment

70Estimated

Phase

Not Applicable

Conditions

Psychological
Behavior

Interventions

Kalaripayattu

Countries

India

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2018Actual

Primary Completion Date

Jun 30, 2019Estimated

Completion Date

Sep 1, 2019Estimated

First Submitted Date

Jul 26, 2018

First Submission Date that Met QC Criteria

Jul 26, 2018

First Posted Date

Aug 1, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 11, 2018

Last Update Posted Date

Oct 12, 2018Actual

Name	Class
Warwick Research Services	OTHER
Swamigal Trust for Vedic Science, India	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Kalaripayattu is an ancient martial art of India which has been practiced for centuries. It is mentioned in Vedic litrature of Ayurveda,Dhanurveda and Yoga. The main elements of Kalaripayattu include training in physical, combat, breathing exercises, higher form of meditation and specific class of medical treatments. The purpose of the experimental study is to determine the effect of kalaripayattu on psychological well-being and behaviour in children.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

70Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
kalaripayattu	Experimental	The experimental groups will treated with kalaripayattu exercises for the period of 12 weeks	Other: Kalaripayattu
Wait list control	No Intervention	Control group will not be given any intervention. After the treatment period is over, all the subjects will be given Kalaripayattu training.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Kalaripayattu	Other	Combination of Exercise, breathing, meditation, combat practices	kalaripayattu

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Psychological Well-being	Measured by MacArthur Health and Behavior Questionnaire	Change from baseline to 12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Behavior	Measured by Child Behavior Scale	Change from baseline to 12 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Children from 8 years to 12 years of age
Parents agreed to informed consent

Exclusion Criteria:

Physical disabilities
Diagnosed Mental or behavioural disorder
Practicing other exercise, physical trainings or yoga

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

8 Years

Maximum Age

12 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Neha sharma, PhD	Warwick Research Services	Study Director
Ravishankar Ramanathan, BA	Swamigal Trust for Vedic Studies	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
NMP Medical Reserach Institute		Jaipur	Rajasthan		India

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001519	Behavior

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided