Completed

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

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What is being tested

Exercise

Other
Who is being recruted

Congenital Abnormalities+9

+ Abnormalities, Multiple

+ Behavior

From 10 to 17 Years
+9 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Other Study

Interventional
Study Start: September 2018
See protocol details

Summary

Principal SponsorBoston Children's Hospital
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: September 15, 2018

Actual date on which the first participant was enrolled.

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 TitleThe Impact of an 8-week Supported Exercise Program on Fitness and Symptoms of Anxiety and Depression in Adolescents With Down Syndrome
NCT03192540
Principal SponsorBoston Children's Hospital
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

15 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Other Study

Some studies explore topics that don't fall into a specific category. These might include innovative research, new technologies, or emerging healthcare areas.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 10 to 17 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Congenital AbnormalitiesAbnormalities, MultipleBehaviorDown SyndromeIntellectual DisabilityMotor ActivityCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNervous System DiseasesNeurologic ManifestationsNeurobehavioral ManifestationsChromosome DisordersGenetic Diseases, Inborn

Criteria

4 inclusion criteria required to participate
Males and females

10 to 17 years old (until 18th birthday)

Diagnosed with Down syndrome by a physician

Medically cleared to exercise

5 exclusion criteria prevent from participating
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

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
These are participants who will be undergoing exercise intervention.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Boston Children's Hospital

Boston, United StatesOpen Boston Children's Hospital in Google Maps
CompletedOne Study Center