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Completed

NCT Number: NCT03058640

Effects of Karate in Adolescents With Down Syndrome

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.

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Key information

Conditions

Down Syndrome Abnormalities, Multiple Chromosome Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Intellectual Disability Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48108, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

PKSA karate class

Other

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

Primary outcomes

  1. Balance

    Time frame: Measure difference between baseline and three months

    Will measure the length of time that participant can stand on one foot (up to 30 seconds)

  2. 20m shuttle run

    Time frame: 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)

  3. standing long jump

    Time frame: Measure difference between baseline and three months

    measure length of distance jumped from static position as part of Alpha Fitness Test

  4. handgrip strength

    Time frame: Measure difference between baseline and three months

    Squeeze hand dynamometer as hard as possible for seconds. This will be repeated with both hands twice

  5. tricep skin fold test

    Time frame: Measure difference between baseline and three months

    Width of skin fold test as measured with calipers as part of Alpha Fitness Test

  6. waist circumference

    Time frame: Measure difference between baseline and three months

    Simple measure of waist circumference as part of Alpha Fitness Test

  7. BMI

    Time frame: Measure difference between baseline and three months

    Calculation of body mass index by taking participants weight in kg divided by height in meters squared

  8. PROMIS Parent Proxy Mobility SF v.2.0 -

    Time frame: 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"

  9. PROMIS Parent Proxy Physical Activity SF v1.0

    Time frame: 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

  10. PROMIS Parent Proxy Positive Affect SF v1.0

    Time frame: 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

Secondary outcomes

  1. Balance

    Time frame: Measure difference between baseline and 6 months

    Will measure the length of time that participant can stand on one foot (up to 30 seconds)

  2. 20m shuttle run

    Time frame: 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)

  3. standing long jump

    Time frame: Measure difference between baseline and 6 months

    measure length of distance jumped from static position as part of Alpha Fitness Test

  4. handgrip strength

    Time frame: Measure difference between baseline and 6 months

    Squeeze hand dynamometer as hard as possible for seconds. This will be repeated with both hands twice

  5. tricep skin fold test

    Time frame: Measure difference between baseline and 6 months

    Width of skin fold test as measured with calipers as part of Alpha Fitness Test

  6. waist circumference

    Time frame: Measure difference between baseline and 6 months

    Simple measure of waist circumference as part of Alpha Fitness Test

  7. BMI

    Time frame: Measure difference between baseline and 6 months

    Calculation of body mass index by taking participants weight in kg divided by height in meters squared

  8. PROMIS Parent Proxy Mobility SF v.2.0 -

    Time frame: 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"

  9. PROMIS Parent Proxy Physical Activity SF v1.0

    Time frame: 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

  10. PROMIS Parent Proxy Positive Affect SF v1.0

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • Down Syndrome Association of Toledo

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Feb 23, 2017
Registry last updated
May 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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