NCT02830022

Brief Summary

Autism Spectrum Disorders (ASD) is a neurodevelopmental disorder which involves social and behavioural impairments. Autonomic dysfunctions and disturbed sleep were often associated to ASD. The investigators proposed to explore the impact of physical activity on these disorders. In this context, it is necessary to characterize the cardiorespiratory capacities of ASD children in order to promote physical activity for this population. To examine potential differences between ASD and control children, some explorations were proposed: a maximal treadmill test, motor evaluation, and orthostatic test (for the evaluation of autonomic nervous system). An actimetry during one week (evaluation of physical activity and sleep) completed this study in order to specify sleep characteristic and established the possible link between physical activity sleep characteristics and physical fitness in ASD children.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

December 11, 2013

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

July 7, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 12, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 11, 2017

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 18, 2017

Completed
Last Updated

October 30, 2018

Status Verified

October 1, 2018

Enrollment Period

3.5 years

First QC Date

July 7, 2016

Last Update Submit

October 26, 2018

Conditions

Autonomic Nervous System DiseasesSleep

Keywords

autism spectrum disorder

Outcome Measures

Primary Outcomes (3)

  • cardiorespiratory evaluation

    a maximal treadmill test is proposed (evaluation of : VO² max, maximal heart rate)

    1 day

  • autonomic nervous system evaluation

    an orthostatic test is proposed in order to verify the ANS adaptation. A nocturnal recording is made during three nights in order to verify the possible link between the rest autonomic adaptations and a possible dysautonomia observed with the orthostatic test.

    1 day and 3 nights

  • sleep evaluation

    Sleep characteristics are obtained by an actimetry during 7 nights in order to observe sleep disorders. Sleep Questionnaires are also completed.

    7 nights

Secondary Outcomes (4)

  • physical activity

    7 days

  • Motor capacities

    1 day

  • Behavioural characteristics

    1 hour

  • biological parameters

    1 day

Study Arms (2)

Patients

EXPERIMENTAL

Children from 8 to 18 years with autism without without intellectual disabilities (IQ \> 70), verbals and responding to classification CIM 10-DSM IV.

Other: physiological explorations

Healthy volunteers

EXPERIMENTAL

Paired for age, gender, IQ and and the practice of a physical activity strictly within the school context.

Other: physiological explorations

Interventions

physiological explorationsOTHER
Healthy volunteersPatients

Eligibility Criteria

Age8 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • children physically active
  • children with an intellectual quotient \>70
  • for autism children a diagnosis of autism in accordance to DSMV

You may not qualify if:

  • history of cardio-vascular disease
  • history of asthma or respiratory disease
  • Behavior disorders.
  • medical treatment by neuroleptic or melatonin or antiepileptic

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Grenoble

Grenoble, 38100, France

Location

MeSH Terms

Conditions

Autonomic Nervous System DiseasesAutism Spectrum Disorder

Condition Hierarchy (Ancestors)

Nervous System DiseasesChild Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Véronique BRICOUT, PhD

    CHU Grenoble France

    PRINCIPAL INVESTIGATOR

  • Michel GUINOT, Dr

    CHU Grenoble France

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 7, 2016

First Posted

July 12, 2016

Study Start

December 11, 2013

Primary Completion

June 11, 2017

Study Completion

June 18, 2017

Last Updated

October 30, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)