Effects of Karate in Adolescents With Down Syndrome

The Effects of Participation in Karate on Health Outcomes 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.

Study Overview

• Status: Completed
• Conditions: Down Syndrome
• Intervention / Treatment: 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 Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48108
      • University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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

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

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: 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

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• Lotan M. Quality physical intervention activity for persons with Down syndrome. ScientificWorldJournal. 2007 Jan 10;7:7-19. doi: 10.1100/tsw.2007.20.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 15, 2017
• Primary Completion (ACTUAL): March 31, 2019
• Study Completion (ACTUAL): March 31, 2019

Study Registration Dates

• First Submitted: February 16, 2017
• First Submitted That Met QC Criteria: February 16, 2017
• First Posted (ACTUAL): February 23, 2017

Study Record Updates

• Last Update Posted (ACTUAL): May 20, 2019
• Last Update Submitted That Met QC Criteria: May 17, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Disease; Congenital Abnormalities; Genetic Diseases, Inborn; Intellectual Disability; Abnormalities, Multiple; Chromosome Disorders; Syndrome; Down Syndrome
• Other Study ID Numbers: 00116460

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No