Activity in Tourette Syndrome
Primary Purpose
Tourette Syndrome, Persistent Tic Disorder
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Physical Activity Counselling
Sponsored by
About this trial
This is an interventional treatment trial for Tourette Syndrome focused on measuring Tourette Syndrome, Persistent Tic Disorder, Physical Activity, Quality of Life
Eligibility Criteria
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.
Sites / Locations
- Children's Hospital of Eastern Ontario
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Activity Counselling
Standard Care
Arm Description
Physical Activity Counselling weekly for 8 weeks
Standard care with no change in medications for 8 weeks
Outcomes
Primary Outcome Measures
Decrease in Yale Global Tic Severity Scale.
Secondary Outcome Measures
Change in The Gilles de la Tourette Syndrome Quality of Life Scale for children and adolescents
Full Information
NCT ID
NCT02153463
First Posted
May 30, 2014
Last Updated
August 5, 2015
Sponsor
Children's Hospital of Eastern Ontario
1. Study Identification
Unique Protocol Identification Number
NCT02153463
Brief Title
Activity in Tourette Syndrome
Official Title
Enhancing Physical Activity in Children With Tics and Tourette Syndrome: Impact on Tic Severity and Quality of Life
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Children's Hospital of Eastern Ontario
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tourette Syndrome, Persistent Tic Disorder
Keywords
Tourette Syndrome, Persistent Tic Disorder, Physical Activity, Quality of Life
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Activity Counselling
Arm Type
Experimental
Arm Description
Physical Activity Counselling weekly for 8 weeks
Arm Title
Standard Care
Arm Type
No Intervention
Arm Description
Standard care with no change in medications for 8 weeks
Intervention Type
Behavioral
Intervention Name(s)
Physical Activity Counselling
Intervention Description
Physical Activity Counselling weekly for 8 weeks
Primary Outcome Measure Information:
Title
Decrease in Yale Global Tic Severity Scale.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Change in The Gilles de la Tourette Syndrome Quality of Life Scale for children and adolescents
Time Frame
8 weeks
Other Pre-specified Outcome Measures:
Title
Change in PedsQL 4.0 measure
Time Frame
8 weeks
Title
Change in KidScreen-27
Time Frame
8 weeks
Title
Chang in The Children's Self-perceived Adequacy and Predilection for Physical Activity Questionnaire
Time Frame
8 Weeks
Title
Change in step count via pedometer
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Children's Hospital of Eastern Ontario
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 7G2
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
30487937
Citation
Doja A, Bookwala A, Pohl D, Rossi-Ricci A, Barrowman N, Chan J, Longmuir PE. Relationship Between Physical Activity, Tic Severity and Quality of Life in Children with Tourette Syndrome. J Can Acad Child Adolesc Psychiatry. 2018 Nov;27(4):222-227. Epub 2018 Nov 1.
Results Reference
derived
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Activity in Tourette Syndrome
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