Down Syndrome
Conditions
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.
Interventions
OTHERPKSA karate class
Participants will attend at least 20/24 PKSA karate classes over a 12 week period, completing standard karate training lessons. Participants will also be encouraged to practice on their own at home. • Participants must attend at LEAST 20/24 classes
Sponsors
Down Syndrome Association of Toledo
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 18 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PROMIS Parent Proxy Positive Affect SF v1.0 | Measure difference between baseline and three months | Parent completed questionnaire including eight questions that gauges parent's perception of how often their child felt happy, great, cheerful, joyful, in a good mood, refreshed, calm, peaceful |
| Balance | Measure difference between baseline and three months | Will measure the length of time that participant can stand on one foot (up to 30 seconds) |
| 20m shuttle run | Measure difference between baseline and three months | Participants are to run between 2 lines, 20 m apart in time with an audio signal. The speed of the signal is increased by 0.5 km/h/min. The test finishes when the participant fails to reach the end lines concurrent with audio signals on 2 consecutive occasions (or when participant stops because of fatigue) |
| standing long jump | Measure difference between baseline and three months | measure length of distance jumped from static position as part of Alpha Fitness Test |
| handgrip strength | Measure difference between baseline and three months | Squeeze hand dynamometer as hard as possible for seconds. This will be repeated with both hands twice |
| tricep skin fold test | Measure difference between baseline and three months | Width of skin fold test as measured with calipers as part of Alpha Fitness Test |
| waist circumference | Measure difference between baseline and three months | Simple measure of waist circumference as part of Alpha Fitness Test |
| BMI | Measure difference between baseline and three months | Calculation of body mass index by taking participants weight in kg divided by height in meters squared |
| PROMIS Parent Proxy Mobility SF v.2.0 - | Measure difference between baseline and three months | Parent completed questionnaire including eight questions that gauges parent confidence that their child could perform various mobility related tasks with no trouble, a little trouble, some trouble, a lot of trouble, or not able to do |
| PROMIS Parent Proxy Physical Activity SF v1.0 | Measure difference between baseline and three months | Parent completed questionnaire including eight questions that gauges parent's perception of how often their child was able to perform physical activity/exercise over the course of the seven days prior to completing the questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Balance | Measure difference between baseline and 6 months | Will measure the length of time that participant can stand on one foot (up to 30 seconds) |
| 20m shuttle run | Measure difference between baseline and 6 months | Participants are to run between 2 lines, 20 m apart in time with an audio signal. The speed of the signal is increased by 0.5 km/h/min. The test finishes when the participant fails to reach the end lines concurrent with audio signals on 2 consecutive occasions (or when participant stops because of fatigue) |
| standing long jump | Measure difference between baseline and 6 months | measure length of distance jumped from static position as part of Alpha Fitness Test |
| handgrip strength | Measure difference between baseline and 6 months | Squeeze hand dynamometer as hard as possible for seconds. This will be repeated with both hands twice |
| tricep skin fold test | Measure difference between baseline and 6 months | Width of skin fold test as measured with calipers as part of Alpha Fitness Test |
| waist circumference | Measure difference between baseline and 6 months | Simple measure of waist circumference as part of Alpha Fitness Test |
| BMI | Measure difference between baseline and 6 months | Calculation of body mass index by taking participants weight in kg divided by height in meters squared |
| PROMIS Parent Proxy Mobility SF v.2.0 - | Measure difference between baseline and 6 months | Parent completed questionnaire including eight questions that gauges parent confidence that their child could perform various mobility related tasks with no trouble, a little trouble, some trouble, a lot of trouble, or not able to do |
| PROMIS Parent Proxy Physical Activity SF v1.0 | Measure difference between baseline and 6 months | Parent completed questionnaire including eight questions that gauges parent's perception of how often their child was able to perform physical activity/exercise over the course of the seven days prior to completing the questionnaire |
| PROMIS Parent Proxy Positive Affect SF v1.0 | Measure difference between baseline and 6 months | Parent completed questionnaire including eight questions that gauges parent's perception of how often their child felt happy, great, cheerful, joyful, in a good mood, refreshed, calm, peaceful |
Countries
United States
Outcome results
None listed