Effects of Karate in Adolescents With Down Syndrome

NCT03058640 | Completed

• 1 other identifier: 00116460
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Down Syndrome

Outcome Measures

Primary Outcomes (10)

• 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 Outcomes (10)

• Balance

  Measure difference between baseline and 6 months

• 20m shuttle run

  Measure difference between baseline and 6 months

• standing long jump

  Measure difference between baseline and 6 months

• handgrip strength

  Measure difference between baseline and 6 months

• tricep skin fold test

  Measure difference between baseline and 6 months

Study Arms (2)

Karate Intervention

EXPERIMENTAL

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

Standard Care

NO INTERVENTION

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

Interventions

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

Karate Intervention

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Michigan: lead
• Down Syndrome Association of Toledo: collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48108, United States

Location

Related Publications (15)

• 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.

  PMID: 21554468 BACKGROUND

• 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.

  PMID: 25171600 BACKGROUND

• 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.

  PMID: 19927019 BACKGROUND

• 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.

  PMID: 19893069 BACKGROUND

• 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;2010(5):CD005176. doi: 10.1002/14651858.CD005176.pub4.

  PMID: 20464738 BACKGROUND

• 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.

  PMID: 22149772 BACKGROUND

• 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.

  PMID: 24374601 BACKGROUND

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

  PMID: 17221138 BACKGROUND

• 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.

  PMID: 23889635 BACKGROUND

• 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.

  PMID: 21206759 BACKGROUND

• 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.

  PMID: 24818963 BACKGROUND

• 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.

  PMID: 23442277 BACKGROUND

• 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.

  PMID: 21353712 BACKGROUND

• 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.

  PMID: 19651279 BACKGROUND

• 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.

  PMID: 22575394 BACKGROUND

MeSH Terms

Conditions

Down Syndrome

Condition Hierarchy (Ancestors)

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

Study Officials

• Joseph Hornyak, MD

  University of Michigan PM&R

  PRINCIPAL INVESTIGATOR

• Dale Ulrich, PhD

  University of Michigan School of Kinesiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Physical Education and Movement Science

Study Record Dates

• First Submitted: February 16, 2017
• First Posted: February 23, 2017
• Study Start: July 15, 2017
• Primary Completion: March 31, 2019
• Study Completion: March 31, 2019
• Last Updated: May 20, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)