Manville Moves: an Exercise Intervention for Behavioral Regulation Among Children With Behavioral Health Challenges

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Brief Title

Manville Moves: an Exercise Intervention for Behavioral Regulation Among Children With Behavioral Health Challenges

Official Title

Can a Physical Activity Program Implemented at a Therapeutic School Promote Emotional Regulation and School Success in Socially and Emotionally Vulnerable Children?

Brief Summary

      The purpose of this study is to examine whether an exergaming, aerobic physical education
      (PE) curriculum is acceptable and elicits improvements in behavioral self-regulation and
      classroom functioning among children with behavioral health challenges attending a
      therapeutic day school. After following an approved consent/assent process, children
      attending the school were randomized by classroom to take part in either 7 weeks of the
      experimental PE curriculum, or 7 weeks of the standard PE curriculum; after a 10 week washout
      period, children then crossed over into the other arm.
    



Study Type

Interventional


Primary Outcome

Change in Minutes and Number of Disciplinary Time Out of Class Events (classroom functioning)


Condition

Autistic Disorder

Intervention

Aerobic Exergaming PE Curriculum

Study Arms / Comparison Groups

 Aerobic Exergaming PE
Description:  Progressive aerobic curriculum utilizing virtual reality exergaming stationary bicycles. Classes held 2 times per week for 30-40 minutes, aerobic exercise beginning at 10 minutes at moderate to vigorous intensity and building to 20 minutes plus.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Behavioral

Estimated Enrollment

103

Start Date

October 2014

Completion Date

April 2015

Primary Completion Date

April 2015

Eligibility Criteria

        Inclusion Criteria:

          -  Attending the Manville School at the time of study initiation

        Exclusion Criteria:

          -  Medical exemption from physical education classes

          -  Parental opt out from physical education classes
      

Gender

All

Ages

7 Years - 18 Years

Accepts Healthy Volunteers

No

Contacts

, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02766101

Organization ID

IRB14-2312


Responsible Party

Principal Investigator

Study Sponsor

Harvard School of Public Health (HSPH)

Collaborators

 Judge Baker Children's Center

Study Sponsor

, , 


Verification Date

May 2016