Effects of Karate in Adolescents With Down Syndrome

Down Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03058640
• Other study ID #: 00116460
• Status: Completed
• Phase: N/A
• Start date: July 15, 2017
• Est. completion date: March 31, 2019

Study information

• Verified date: May 2019
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: March 31, 2019
• Est. primary completion date: March 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

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)

Related Conditions & MeSH terms

• Down Syndrome
• Syndrome

Intervention

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

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	Down Syndrome Association of Toledo

Country where clinical trial is conducted

United States, 

References & Publications (15)

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. Review. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Izquierdo-Gomez R, Martínez-Gómez 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. — View Citation

Lotan M. Quality physical intervention activity for persons with Down syndrome. ScientificWorldJournal. 2007 Jan 10;7:7-19. Review. — View Citation

Matute-Llorente A, González-Agüero A, Gómez-Cabello A, Vicente-Rodríguez G, Casajús 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. — View 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. — View 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. — View 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. — View Citation

Tejero-Gonzalez CM, Martinez-Gomez D, Bayon-Serna J, Izquierdo-Gomez R, Castro-Piñero 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. — View 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. — View 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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	standing long jump	measure length of distance jumped from static position as part of Alpha Fitness Test	Measure difference between baseline and three months
Primary	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
Primary	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
Primary	waist circumference	Simple measure of waist circumference as part of Alpha Fitness Test	Measure difference between baseline and three months
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	standing long jump	measure length of distance jumped from static position as part of Alpha Fitness Test	Measure difference between baseline and 6 months
Secondary	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
Secondary	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
Secondary	waist circumference	Simple measure of waist circumference as part of Alpha Fitness Test	Measure difference between baseline and 6 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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