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Effects of Karate in Adolescents With Down Syndrome

Primary Purpose

Down Syndrome

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PKSA karate class
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Down Syndrome

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • University of Michigan

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Karate Intervention

Standard Care

Arm Description

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

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

Outcomes

Primary Outcome Measures

Balance
Will measure the length of time that participant can stand on one foot (up to 30 seconds)
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)
standing long jump
measure length of distance jumped from static position as part of Alpha Fitness Test
handgrip strength
Squeeze hand dynamometer as hard as possible for seconds. This will be repeated with both hands twice
tricep skin fold test
Width of skin fold test as measured with calipers as part of Alpha Fitness Test
waist circumference
Simple measure of waist circumference as part of Alpha Fitness Test
BMI
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 -
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
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
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

Balance
Will measure the length of time that participant can stand on one foot (up to 30 seconds)
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)
standing long jump
measure length of distance jumped from static position as part of Alpha Fitness Test
handgrip strength
Squeeze hand dynamometer as hard as possible for seconds. This will be repeated with both hands twice
tricep skin fold test
Width of skin fold test as measured with calipers as part of Alpha Fitness Test
waist circumference
Simple measure of waist circumference as part of Alpha Fitness Test
BMI
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 -
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
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
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

Full Information

First Posted
February 16, 2017
Last Updated
May 17, 2019
Sponsor
University of Michigan
Collaborators
Down Syndrome Association of Toledo
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1. Study Identification

Unique Protocol Identification Number
NCT03058640
Brief Title
Effects of Karate in Adolescents With Down Syndrome
Official Title
The Effects of Participation in Karate on Health Outcomes in Adolescents With Down Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
July 15, 2017 (Actual)
Primary Completion Date
March 31, 2019 (Actual)
Study Completion Date
March 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
Down Syndrome Association of Toledo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Down Syndrome

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Karate Intervention
Arm Type
Experimental
Arm Description
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
Arm Title
Standard Care
Arm Type
No Intervention
Arm Description
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
Intervention Type
Other
Intervention Name(s)
PKSA karate class
Intervention Description
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 Outcome Measure Information:
Title
Balance
Description
Will measure the length of time that participant can stand on one foot (up to 30 seconds)
Time Frame
Measure difference between baseline and three months
Title
20m shuttle run
Description
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)
Time Frame
Measure difference between baseline and three months
Title
standing long jump
Description
measure length of distance jumped from static position as part of Alpha Fitness Test
Time Frame
Measure difference between baseline and three months
Title
handgrip strength
Description
Squeeze hand dynamometer as hard as possible for seconds. This will be repeated with both hands twice
Time Frame
Measure difference between baseline and three months
Title
tricep skin fold test
Description
Width of skin fold test as measured with calipers as part of Alpha Fitness Test
Time Frame
Measure difference between baseline and three months
Title
waist circumference
Description
Simple measure of waist circumference as part of Alpha Fitness Test
Time Frame
Measure difference between baseline and three months
Title
BMI
Description
Calculation of body mass index by taking participants weight in kg divided by height in meters squared
Time Frame
Measure difference between baseline and three months
Title
PROMIS Parent Proxy Mobility SF v.2.0 -
Description
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"
Time Frame
Measure difference between baseline and three months
Title
PROMIS Parent Proxy Physical Activity SF v1.0
Description
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
Time Frame
Measure difference between baseline and three months
Title
PROMIS Parent Proxy Positive Affect SF v1.0
Description
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
Time Frame
Measure difference between baseline and three months
Secondary Outcome Measure Information:
Title
Balance
Description
Will measure the length of time that participant can stand on one foot (up to 30 seconds)
Time Frame
Measure difference between baseline and 6 months
Title
20m shuttle run
Description
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)
Time Frame
Measure difference between baseline and 6 months
Title
standing long jump
Description
measure length of distance jumped from static position as part of Alpha Fitness Test
Time Frame
Measure difference between baseline and 6 months
Title
handgrip strength
Description
Squeeze hand dynamometer as hard as possible for seconds. This will be repeated with both hands twice
Time Frame
Measure difference between baseline and 6 months
Title
tricep skin fold test
Description
Width of skin fold test as measured with calipers as part of Alpha Fitness Test
Time Frame
Measure difference between baseline and 6 months
Title
waist circumference
Description
Simple measure of waist circumference as part of Alpha Fitness Test
Time Frame
Measure difference between baseline and 6 months
Title
BMI
Description
Calculation of body mass index by taking participants weight in kg divided by height in meters squared
Time Frame
Measure difference between baseline and 6 months
Title
PROMIS Parent Proxy Mobility SF v.2.0 -
Description
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"
Time Frame
Measure difference between baseline and 6 months
Title
PROMIS Parent Proxy Physical Activity SF v1.0
Description
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
Time Frame
Measure difference between baseline and 6 months
Title
PROMIS Parent Proxy Positive Affect SF v1.0
Description
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
Time Frame
Measure difference between baseline and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph Hornyak, MD
Organizational Affiliation
University of Michigan PM&R
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dale Ulrich, PhD
Organizational Affiliation
University of Michigan School of Kinesiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48108
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21554468
Citation
Barr M, Shields N. Identifying the barriers and facilitators to participation in physical activity for children with Down syndrome. J Intellect Disabil Res. 2011 Nov;55(11):1020-33. doi: 10.1111/j.1365-2788.2011.01425.x. Epub 2011 May 10.
Results Reference
background
PubMed Identifier
25171600
Citation
Chen CC, Ringenbach SD, Crews D, Kulinna PH, Amazeen EL. The association between a single bout of moderate physical activity and executive function in young adults with Down syndrome: a preliminary study. J Intellect Disabil Res. 2015 Jul;59(7):589-98. doi: 10.1111/jir.12163. Epub 2014 Aug 29.
Results Reference
background
PubMed Identifier
19927019
Citation
Cowley PM, Ploutz-Snyder LL, Baynard T, Heffernan K, Jae SY, Hsu S, Lee M, Pitetti KH, Reiman MP, Fernhall B. Physical fitness predicts functional tasks in individuals with Down syndrome. Med Sci Sports Exerc. 2010 Feb;42(2):388-93. doi: 10.1249/MSS.0b013e3181b07e7a.
Results Reference
background
PubMed Identifier
19893069
Citation
Shields N, Dodd KJ, Abblitt C. Do children with Down syndrome perform sufficient physical activity to maintain good health? A pilot study. Adapt Phys Activ Q. 2009 Oct;26(4):307-20. doi: 10.1123/apaq.26.4.307.
Results Reference
background
PubMed Identifier
20464738
Citation
Andriolo RB, El Dib RP, Ramos L, Atallah AN, da Silva EM. Aerobic exercise training programmes for improving physical and psychosocial health in adults with Down syndrome. Cochrane Database Syst Rev. 2010 May 12;(5):CD005176. doi: 10.1002/14651858.CD005176.pub4.
Results Reference
background
PubMed Identifier
22149772
Citation
Elmahgoub SS, Van de Velde A, Peersman W, Cambier D, Calders P. Reproducibility, validity and predictors of six-minute walk test in overweight and obese adolescents with intellectual disability. Disabil Rehabil. 2012;34(10):846-51. doi: 10.3109/09638288.2011.623757. Epub 2011 Dec 10.
Results Reference
background
PubMed Identifier
24374601
Citation
Izquierdo-Gomez R, Martinez-Gomez D, Acha A, Veiga OL, Villagra A, Diaz-Cueto M; UP&DOWN study group. Objective assessment of sedentary time and physical activity throughout the week in adolescents with Down syndrome. The UP&DOWN study. Res Dev Disabil. 2014 Feb;35(2):482-9. doi: 10.1016/j.ridd.2013.11.026. Epub 2013 Dec 25.
Results Reference
background
PubMed Identifier
17221138
Citation
Lotan M. Quality physical intervention activity for persons with Down syndrome. ScientificWorldJournal. 2007 Jan 10;7:7-19. doi: 10.1100/tsw.2007.20.
Results Reference
background
PubMed Identifier
23889635
Citation
Matute-Llorente A, Gonzalez-Aguero A, Gomez-Cabello A, Vicente-Rodriguez G, Casajus JA. Physical activity and cardiorespiratory fitness in adolescents with Down syndrome. Nutr Hosp. 2013 Jul-Aug;28(4):1151-5. doi: 10.3305/nh.2013.28.4.6509.
Results Reference
background
PubMed Identifier
21206759
Citation
Mendonca GV, Pereira FD, Fernhall B. Reduced exercise capacity in persons with Down syndrome: cause, effect, and management. Ther Clin Risk Manag. 2010 Dec 8;6:601-10. doi: 10.2147/TCRM.S10235.
Results Reference
background
PubMed Identifier
24818963
Citation
Pikora TJ, Bourke J, Bathgate K, Foley KR, Lennox N, Leonard H. Health conditions and their impact among adolescents and young adults with Down syndrome. PLoS One. 2014 May 12;9(5):e96868. doi: 10.1371/journal.pone.0096868. eCollection 2014.
Results Reference
background
PubMed Identifier
23442277
Citation
Tejero-Gonzalez CM, Martinez-Gomez D, Bayon-Serna J, Izquierdo-Gomez R, Castro-Pinero J, Veiga OL. Reliability of the ALPHA health-related fitness test battery in adolescents with Down syndrome. J Strength Cond Res. 2013 Nov;27(11):3221-4. doi: 10.1519/JSC.0b013e31828bed4e.
Results Reference
background
PubMed Identifier
21353712
Citation
Vis JC, de Bruin-Bon RH, Bouma BJ, Backx AP, Huisman SA, Imschoot L, Mulder BJ. 'The sedentary heart': physical inactivity is associated with cardiac atrophy in adults with an intellectual disability. Int J Cardiol. 2012 Jul 26;158(3):387-93. doi: 10.1016/j.ijcard.2011.01.064. Epub 2011 Feb 26.
Results Reference
background
PubMed Identifier
19651279
Citation
Vis JC, Thoonsen H, Duffels MG, de Bruin-Bon RA, Huisman SA, van Dijk AP, Hoendermis ES, Berger RM, Bouma BJ, Mulder BJ. Six-minute walk test in patients with Down syndrome: validity and reproducibility. Arch Phys Med Rehabil. 2009 Aug;90(8):1423-7. doi: 10.1016/j.apmr.2009.02.015.
Results Reference
background
PubMed Identifier
22575394
Citation
Casey AF, Wang X, Osterling K. Test-retest reliability of the 6-minute walk test in individuals with Down syndrome. Arch Phys Med Rehabil. 2012 Nov;93(11):2068-74. doi: 10.1016/j.apmr.2012.04.022. Epub 2012 May 7.
Results Reference
background

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Effects of Karate in Adolescents With Down Syndrome

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