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

Study Overview
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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.

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.

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

Conditions
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Down Syndrome

Intervention / Treatment
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* Other: Exercise


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise<br>These are participants who will be undergoing exercise intervention. | Other: Exercise<br>* Participants will undergo an exercise protocol once a week, for eight weeks. Exercise will be continuous for one hour.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Home Exercise Compliance | To establish if the participant is performing the same amount of exercise each week, for up to three months after the stopped visiting the group exercise sessions. | 2 months post completion of the exercise program | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscular strength & endurance | Participants will perform body-weight exercises that focus on upper body, lower body, core, and flexibility. | The test will be performed before the exercise intervention and then after 8 weeks of exercise intervention. | 
| Aerobic capacity | Participants will complete the 6 minute walk test, where the investigators will receive an estimate measure of maximum aerobic fitness. Investigators will also collect heart rate and blood pressure as pre and post measurements when possible. | The test will be preformed before the exercise intervention and then after 8 weeks of exercise intervention. | 
| Anxiety and Depression Symptoms | Patient-Reported Outcomes Measurement Information System (PROMIS) - Parent report questionnaires | The scale will be given the before the exercise intervention begins and then after 8 weeks of exercise intervention. | 
| Behavioral Symptoms | Vanderbilt Scale - parent report questionnaire | The scale will be given the before the exercise intervention begins and then after 8 weeks of exercise intervention. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exercise, Fitness, Overall wellbeing