Activity in Tourette Syndrome

Tourette Syndrome Clinical Trial

Official title:

Enhancing Physical Activity in Children With Tics and Tourette Syndrome: Impact on Tic Severity and Quality of Life

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02153463
• Other study ID #: 14/72X
• Status: Completed
• Phase: N/A
• First received: May 30, 2014
• Last updated: August 5, 2015
• Start date: May 2014
• Est. completion date: December 2014

Study information

• Verified date: August 2015
• Source: Children's Hospital of Eastern Ontario
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 16 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Persistent Tic Disorder
• Syndrome
• Tic Disorders
• Tics
• Tourette Syndrome

Intervention

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

Locations

Country	Name	City	State
Canada	Children's Hospital of Eastern Ontario	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Eastern Ontario

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in PedsQL 4.0 measure		8 weeks	No
Other	Change in KidScreen-27		8 weeks	No
Other	Chang in The Children's Self-perceived Adequacy and Predilection for Physical Activity Questionnaire		8 Weeks	No
Other	Change in step count via pedometer		8 weeks	No
Primary	Decrease in Yale Global Tic Severity Scale.		8 weeks	No
Secondary	Change in The Gilles de la Tourette Syndrome Quality of Life Scale for children and adolescents		8 weeks	No