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Trial record 2 of 42 for:    Recruiting, Not yet recruiting, Available Studies | "Down Syndrome"

Effects of Karate in Adolescents With Down Syndrome

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ClinicalTrials.gov Identifier: NCT03058640
Recruitment Status : Recruiting
First Posted : February 23, 2017
Last Update Posted : September 1, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Down Syndrome Other: PKSA karate class

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Effects of Participation in Karate on Health Outcomes in Adolescents With Down Syndrome
Actual Study Start Date : July 15, 2017
Estimated Primary Completion Date : January 31, 2018
Estimated Study Completion Date : August 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Down Syndrome
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 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
Other: PKSA 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

No Intervention: 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


Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03058640


Contacts
Contact: Cory W Wernimont, MD 734-330-8413 UMDSkarate@gmail.com
Contact: Christie McKinney, DO 734-552-9282 UMDSkarate@gmail.com

Locations
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48108
Contact: Cory W Wernimont, MD    734-330-8413    UMDSkarate@gmail.com   
Contact: Christie McKinney, DO    734-552-9282    UMDSkarate@gmail.com   
Sponsors and Collaborators
University of Michigan
Down Syndrome Association of Toledo
Investigators
Principal Investigator: Joseph Hornyak, MD University of Michigan PM&R
Principal Investigator: Dale Ulrich, PhD University of Michigan School of Kinesiology
More Information

Publications:

Responsible Party: Dale A Ulrich, Professor of Physical Education and Movement Science, University of Michigan
ClinicalTrials.gov Identifier: NCT03058640     History of Changes
Other Study ID Numbers: 00116460
First Posted: February 23, 2017    Key Record Dates
Last Update Posted: September 1, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Down Syndrome
Syndrome
Disease
Pathologic Processes
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn