Effects of Karate in Adolescents With Down Syndrome

Study Overview
=================
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.

Official Title
-----------------
The Effects of Participation in Karate on Health Outcomes in Adolescents With Down Syndrome

Conditions
-----------------
Down Syndrome

Intervention / Treatment
-----------------
* Other: PKSA karate class


Participation Criteria
=================
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)

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Karate Intervention<br>Participants will be enrolled into PKSA karate classes which includes at least two, standardized 1-hour classes per week for 12 weeks. Participants must attend at LEAST 20/24 classes. Attendance sheets will be signed by parents at each site. Practice at home will also be encouraged. Log sheets will be provided to participants to log their practice | Other: PKSA karate class<br>* 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<br>|
| No Intervention: Standard Care<br>Participants will have no initial intervention. Investigators will request that participants do not enroll in a structured martial arts class during the one-year period. Participants will, however, be given the option of receiving the structured karate program at 6 months, once measurements are completed | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Balance | Will measure the length of time that participant can stand on one foot (up to 30 seconds) | Measure difference between baseline and three months | 
| 20m shuttle run | 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) | Measure difference between baseline and three months | 
| standing long jump | measure length of distance jumped from static position as part of Alpha Fitness Test | Measure difference between baseline and three months | 
| handgrip strength | Squeeze hand dynamometer as hard as possible for seconds. This will be repeated with both hands twice | Measure difference between baseline and three months | 
| tricep skin fold test | Width of skin fold test as measured with calipers as part of Alpha Fitness Test | Measure difference between baseline and three months | 
| waist circumference | Simple measure of waist circumference as part of Alpha Fitness Test | Measure difference between baseline and three months | 
| BMI | Calculation of body mass index by taking participants weight in kg divided by height in meters squared | Measure difference between baseline and three months | 
| PROMIS Parent Proxy Mobility SF v.2.0 - | 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 | Measure difference between baseline and three months | 
| PROMIS Parent Proxy Physical Activity SF v1.0 | 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 | Measure difference between baseline and three months | 
| PROMIS Parent Proxy Positive Affect SF v1.0 | 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 | Measure difference between baseline and three months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Balance | Will measure the length of time that participant can stand on one foot (up to 30 seconds) | Measure difference between baseline and 6 months | 
| 20m shuttle run | 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) | Measure difference between baseline and 6 months | 
| standing long jump | measure length of distance jumped from static position as part of Alpha Fitness Test | Measure difference between baseline and 6 months | 
| handgrip strength | Squeeze hand dynamometer as hard as possible for seconds. This will be repeated with both hands twice | Measure difference between baseline and 6 months | 
| tricep skin fold test | Width of skin fold test as measured with calipers as part of Alpha Fitness Test | Measure difference between baseline and 6 months | 
| waist circumference | Simple measure of waist circumference as part of Alpha Fitness Test | Measure difference between baseline and 6 months | 
| BMI | Calculation of body mass index by taking participants weight in kg divided by height in meters squared | Measure difference between baseline and 6 months | 
| PROMIS Parent Proxy Mobility SF v.2.0 - | 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 | Measure difference between baseline and 6 months | 
| PROMIS Parent Proxy Physical Activity SF v1.0 | 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 | Measure difference between baseline and 6 months | 
| PROMIS Parent Proxy Positive Affect SF v1.0 | 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 | Measure difference between baseline and 6 months |