Clinical trial NCT03058640: Effects of Karate in Adolescents With Down Syndrome
Official title: The Effects of Participation in Karate on Health Outcomes in Adolescents With Down Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Down Syndrome
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Down Syndrome Association of Toledo
First posted: 2017-02-23
Enrollment: 16
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This randomized control study will investigate the health outcomes of adolescents with Down Syndrome who participate in a karate class as measured by ALPHA fitness testing and various PROMIS parent proxy questionnaires to assess participants mobility, physical activity, and overall affect.

Detailed description: Adolescents with Down syndrome suffer from a set of health problems including heart disease, sleep disturbances, and obesity. Their decreased cardiovascular fitness and exercise capacity limits their ability to perform activities of daily living. Exercise interventions in this population of children have been shown to improve muscle strength, balance, and cardiovascular fitness. Prior research has helped better define physical activity barriers in this population which include: requiring parental supervision, lack of accessible programs, seasonal activities and reduced physical skills of the child. Karate is an indoor activity that can be performed at different skill levels without parental involvement. The investigators hypothesize that adolescents with Down syndrome who participate in karate will show improved health outcomes compared to those who did not participate. Furthermore, the investigators hypothesize that the majority of participants will continue the activity outside of the research window. This randomized controlled trial will enroll 30 adolescents with Down syndrome. Participants will be randomly assigned to a 3 month karate program or the control group with no intervention. Measurements are taken at baseline, 3 months, and 6 months using validated ALPHA fitness testing and in addition parents will complete PROMIS questionnaires to assess overall participant's activity level, mobility, and generalized affect. An independent statistician will analyze the groups. This research will help physicians provide adolescents with Down syndrome appropriate recommendations for an individualized physical activity regimen that does not have similar limitations to other exercise programs.

Eligibility criteria: Inclusion Criteria:

* males \& females with a diagnosis of down syndrome
* Ability to participate in 2 hours of exercise per week
* No involvement in formal martial arts classes over the past 3 months

Exclusion Criteria:

* Behavior problems that would prevent them from participating in organized classes
* Health problems that preclude them from participating in moderate physical activity programs (e.g. uncontrolled seizures)
* No Co-existing diagnosis (e.g. ASD)

Primary outcomes:
measure: Balance
timeFrame: Measure difference between baseline and three months
measure: 20m shuttle run
timeFrame: Measure difference between baseline and three months
measure: standing long jump
timeFrame: Measure difference between baseline and three months
measure: handgrip strength
timeFrame: Measure difference between baseline and three months
measure: tricep skin fold test
timeFrame: Measure difference between baseline and three months
measure: waist circumference
timeFrame: Measure difference between baseline and three months
measure: BMI
timeFrame: Measure difference between baseline and three months
measure: PROMIS Parent Proxy Mobility SF v.2.0 -
timeFrame: Measure difference between baseline and three months
measure: PROMIS Parent Proxy Physical Activity SF v1.0
timeFrame: Measure difference between baseline and three months
measure: PROMIS Parent Proxy Positive Affect SF v1.0
timeFrame: Measure difference between baseline and three months
Secondary outcomes:
measure: Balance
timeFrame: Measure difference between baseline and 6 months
measure: 20m shuttle run
timeFrame: Measure difference between baseline and 6 months
measure: standing long jump
timeFrame: Measure difference between baseline and 6 months
measure: handgrip strength
timeFrame: Measure difference between baseline and 6 months
measure: tricep skin fold test
timeFrame: Measure difference between baseline and 6 months
measure: waist circumference
timeFrame: Measure difference between baseline and 6 months
measure: BMI
timeFrame: Measure difference between baseline and 6 months
measure: PROMIS Parent Proxy Mobility SF v.2.0 -
timeFrame: Measure difference between baseline and 6 months
measure: PROMIS Parent Proxy Physical Activity SF v1.0
timeFrame: Measure difference between baseline and 6 months
measure: PROMIS Parent Proxy Positive Affect SF v1.0
timeFrame: Measure difference between baseline and 6 months
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan PM&R
name: Joseph Hornyak, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan School of Kinesiology
name: Dale Ulrich, PhD
role: PRINCIPAL_INVESTIGATOR
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