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

P

President and Fellows of Harvard College

Status

Completed

Conditions

Autistic Disorder
Attention Deficit and Disruptive Behavior Disorders
Oppositional Defiant Disorder
Conduct Disorder
Mood Disorders
Anxiety Disorders

Treatments

Behavioral: Standard PE
Behavioral: Aerobic Exergaming PE Curriculum

Study type

Interventional

Funder types

Other

Identifiers

NCT02766101
IRB14-2312

Details and patient eligibility

About

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.

Enrollment

103 patients

Sex

All

Ages

7 to 18 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

103 participants in 2 patient groups

Aerobic Exergaming PE
Experimental group
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.
Treatment:
Behavioral: Aerobic Exergaming PE Curriculum
Standard PE
Active Comparator group
Description:
Traditional PE focused on gross motor skill and sports skill acquisition, and team building. Typically non-aerobic.
Treatment:
Behavioral: Standard PE

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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