Activity in Tourette Syndrome

Sponsor
Children's Hospital of Eastern Ontario (Other)
Overall Status
Completed
CT.gov ID
NCT02153463
Collaborator
(none)
14
1
2
7
2

Study Details

Study Description

Brief Summary

Tics are brief repetitive movements or vocalizations. Gilles de la Tourette's syndrome (TS) is a disorder characterized by recurrent motor and vocal tics. Tourette syndrome and tic disorders affect up to 8% of children. Peak severity of tic disorders occurs between the ages of 8 to 12 years, therefore during childhood and adolescence the most significant impacts are felt. The quality of life of young people with tics is lower than their peers' and tic severity predicts lower quality of life. Studies have also shown negative social perception toward children with tics.

Approximately 50% of patients with Tourette syndrome will have other diagnoses including attention deficit hyperactivity disorder (ADHD), obsessive compulsive disorder, anxiety and depression. Studies have shown improvements in ADHD with physical activity. ADHD and tic disorders are thought to involve the same areas of the brain; thus it is possible that tics might also improve with physical activity. However, no studies to date have examined this. The investigators predict that by implementing a motivational physical activity program, in conjunction with physical activity counseling, the investigators will be able to increase levels of physical activity in children with tics and Tourette syndrome, with a positive impact on tic severity.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Physical Activity Counselling
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
14 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Enhancing Physical Activity in Children With Tics and Tourette Syndrome: Impact on Tic Severity and Quality of Life
Study Start Date :
May 1, 2014
Actual Primary Completion Date :
Dec 1, 2014
Actual Study Completion Date :
Dec 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: Activity Counselling

Physical Activity Counselling weekly for 8 weeks

Behavioral: Physical Activity Counselling
Physical Activity Counselling weekly for 8 weeks

No Intervention: Standard Care

Standard care with no change in medications for 8 weeks

Outcome Measures

Primary Outcome Measures

  1. Decrease in Yale Global Tic Severity Scale. [8 weeks]

Secondary Outcome Measures

  1. Change in The Gilles de la Tourette Syndrome Quality of Life Scale for children and adolescents [8 weeks]

Other Outcome Measures

  1. Change in PedsQL 4.0 measure [8 weeks]

  2. Change in KidScreen-27 [8 weeks]

  3. Chang in The Children's Self-perceived Adequacy and Predilection for Physical Activity Questionnaire [8 Weeks]

  4. Change in step count via pedometer [8 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
8 Years to 16 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Participants are between 8-16 years of age.

  • Participants are required to have a diagnosis of either Tourette Syndrome or Persistent (Chronic) Motor of Vocal Tic Disorder as per the DSM V.

  • Participants must be ambulatory.

  • Participants and parents must understand English or French.

  • Participants must be able and willing to complete the questionnaires.

  • Participants cannot have any changes to their medication for tics, or any other psychotropic medications for 4 weeks prior to and for the entire duration of the study

Exclusion Criteria:
  • Participants who cannot ambulate independently.

  • Participants who are not permitted to participate in physical education class at school.

  • Participants or families who are not willing to be randomly assigned to a study group.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Children's Hospital of Eastern Ontario Ottawa Ontario Canada K1H 7G2

Sponsors and Collaborators

  • Children's Hospital of Eastern Ontario

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Asif Doja, Assistant Professor, Associate Investigator, Children's Hospital of Eastern Ontario
ClinicalTrials.gov Identifier:
NCT02153463
Other Study ID Numbers:
  • 14/72X
First Posted:
Jun 3, 2014
Last Update Posted:
Aug 6, 2015
Last Verified:
Aug 1, 2015
Keywords provided by Asif Doja, Assistant Professor, Associate Investigator, Children's Hospital of Eastern Ontario
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 6, 2015