Effects of Karate in Adolescents With Down Syndrome

NCT ID: NCT03058640

Last Updated: 2019-05-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-15
• Study Completion Date: 2019-03-31

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.

Conditions

Down Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

PKSA karate class

Intervention Type: 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

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: OTHER

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)

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Down Syndrome Association of Toledo

UNKNOWN

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Dale A Ulrich

Professor of Physical Education and Movement Science

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joseph Hornyak, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan PM&R

Dale Ulrich, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan School of Kinesiology

Locations

University of Michigan

Ann Arbor, Michigan, United States

Countries

United States

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Other Identifiers

00116460

Identifier Type: -

Identifier Source: org_study_id