The Effects of Participation in Karate on Health Outcomes in Adolescents With Down Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- PROMIS Parent Proxy Mobility SF v.2.0 -
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
Karate Intervention
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
干预措施: PKSA karate class (Other)
Standard Care
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
结局指标
主要结局
PROMIS Parent Proxy Mobility SF v.2.0 -
时间窗: 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"
tricep skin fold test
时间窗: Measure difference between baseline and three months
Width of skin fold test as measured with calipers as part of Alpha Fitness Test
PROMIS Parent Proxy Physical Activity SF v1.0
时间窗: 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
handgrip strength
时间窗: Measure difference between baseline and three months
Squeeze hand dynamometer as hard as possible for seconds. This will be repeated with both hands twice
waist circumference
时间窗: Measure difference between baseline and three months
Simple measure of waist circumference as part of Alpha Fitness Test
Balance
时间窗: 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
时间窗: 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
时间窗: Measure difference between baseline and three months
measure length of distance jumped from static position as part of Alpha Fitness Test
BMI
时间窗: 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 Positive Affect SF v1.0
时间窗: 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
次要结局
- standing long jump(Measure difference between baseline and 6 months)
- tricep skin fold test(Measure difference between baseline and 6 months)
- Balance(Measure difference between baseline and 6 months)
- waist circumference(Measure difference between baseline and 6 months)
- 20m shuttle run(Measure difference between baseline and 6 months)
- handgrip strength(Measure difference between baseline and 6 months)
- BMI(Measure difference between baseline and 6 months)
- PROMIS Parent Proxy Mobility SF v.2.0 -(Measure difference between baseline and 6 months)
- PROMIS Parent Proxy Physical Activity SF v1.0(Measure difference between baseline and 6 months)
- PROMIS Parent Proxy Positive Affect SF v1.0(Measure difference between baseline and 6 months)
研究者
Dale A Ulrich
Professor of Physical Education and Movement Science
University of Michigan