NCT03610594

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 26, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 1, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

October 12, 2018

Status Verified

October 1, 2018

Enrollment Period

10 months

First QC Date

July 26, 2018

Last Update Submit

October 11, 2018

Conditions

PsychologicalBehavior

Outcome Measures

Primary Outcomes (1)

  • Psychological Well-being

    Measured by MacArthur Health and Behavior Questionnaire

    Change from baseline to 12 weeks

Secondary Outcomes (1)

  • Behavior

    Change from baseline to 12 weeks

Study Arms (2)

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

KalaripayattuOTHER

Combination of Exercise, breathing, meditation, combat practices

kalaripayattu

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NMP Medical Reserach Institute

Jaipur, Rajasthan, India

Location

MeSH Terms

Conditions

Behavior

Study Officials

  • Neha sharma, PhD

    Warwick Research Services

    STUDY DIRECTOR

  • Ravishankar Ramanathan, BA

    Swamigal Trust for Vedic Studies

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 26, 2018

First Posted

August 1, 2018

Study Start

September 1, 2018

Primary Completion

June 30, 2019

Study Completion

September 1, 2019

Last Updated

October 12, 2018

Record last verified: 2018-10

Locations

IN(1)