The Impact of an 8-week Supported Exercise Program on Fitness and Symptoms in Adolescents With Down Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-15

Study Completion Date

2021-03-31

Brief Summary

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This study explores the effects of an eight-week exercise intervention for adolescents with Down syndrome on home exercise compliance. As well, to observe changes in fitness including muscular strength, endurance and aerobic capacity. Finally to observe any changes in mood, behavior and quality of life.

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Detailed Description

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Adolescents with Down syndrome will participate in an eight-week, center-based exercise intervention. Participants will undergo an hour of exercise intervention each week. During this time, participants will be working with a team consisting of a physician, physical therapy student volunteers, and clinical research coordinators. Exercises will focus on strength and endurance of all major muscle groups, while ensuring proper technique and form is used. They will also receive instruction on how to continue the exercise program at home.

Prior to starting, and at the end of eight sessions, all exercise participants will undergo testing procedures for anthropometric, strength and flexibility measurements. This data will be collected as part of clinically evaluating the impact of the program on each participant. In addition to the exercise program (and clinical assessments of fitness), DSFit participants will complete study measures of behavioral functioning as well as scales of depression and anxiety. Participants in the DSFit study will also complete a weekly exercise log during the intervention and for a follow-up period afterwards.

Conditions

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Down Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Exercise

These are participants who will be undergoing exercise intervention.

Group Type EXPERIMENTAL

Exercise

Intervention Type OTHER

Participants will undergo an exercise protocol once a week, for eight weeks. Exercise will be continuous for one hour.

Interventions

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Exercise

Participants will undergo an exercise protocol once a week, for eight weeks. Exercise will be continuous for one hour.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Males and females
* 10 to 17 years old (until 18th birthday)
* Diagnosed with Down syndrome by a physician
* Medically cleared to exercise

Exclusion Criteria

* Requires consistent one-on-one care
* History of behavioral issues (outbursts, aggressive/self-injurious, bolting)
* Pre-existing cardiovascular, respiratory or orthopedic conditions that could place participant at risk for injury or illness resulting from exercise. For example:
* Untreated significant atlantoaxial instability
* Severe pulmonary hypertension

Minimum Eligible Age

10 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No