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

NCT ID: NCT02766101

Last Updated: 2016-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

103 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2015-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Aerobic Exergaming PE

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.

Group Type EXPERIMENTAL

Aerobic Exergaming PE Curriculum

Intervention Type BEHAVIORAL

Sustained aerobic exercise.

Standard PE

Traditional PE focused on gross motor skill and sports skill acquisition, and team building. Typically non-aerobic.

Group Type ACTIVE_COMPARATOR

Standard PE

Intervention Type BEHAVIORAL

Non-aerobic skill building.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Aerobic Exergaming PE Curriculum

Sustained aerobic exercise.

Intervention Type BEHAVIORAL

Standard PE

Non-aerobic skill building.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

7 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Judge Baker Children's Center

OTHER

Sponsor Role collaborator

Harvard School of Public Health (HSPH)

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Kirsten Davison

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Judge Baker Children's Center, Manville School

Boston, Massachusetts, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Davison K, Bowling A, Garcia J, Wood B, Hermesch R, Prince J, Hayes A, Kow R, Newlan S, Slavet J. A cybercycling intervention to improve behavioral regulation and classroom functioning among children with behavioral health disorders: Pragmatic randomized trial design for Manville Moves. Contemp Clin Trials. 2016 Jul;49:40-6. doi: 10.1016/j.cct.2016.05.008. Epub 2016 May 31.

Reference Type DERIVED
PMID: 27261171 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IRB14-2312

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Sustaining Quality Physical Education for Healthy Kids
NCT07227935 ENROLLING_BY_INVITATION NA