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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03192540
Acronym
DSFIT
Enrollment
15
Registered
2017-06-20
Start date
2018-09-15
Completion date
2021-03-31
Last updated
2022-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Down Syndrome

Keywords

Exercise, Fitness, Overall wellbeing

Brief summary

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

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.

Interventions

OTHERExercise

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

Sponsors

Boston Children's Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
10 Years to 17 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Home Exercise Compliance2 months post completion of the exercise programTo 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.

Secondary

MeasureTime frameDescription
Muscular strength & enduranceThe test will be performed before the exercise intervention and then after 8 weeks of exercise intervention.Participants will perform body-weight exercises that focus on upper body, lower body, core, and flexibility.
Aerobic capacityThe test will be preformed before the exercise intervention and then after 8 weeks of exercise intervention.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.
Anxiety and Depression SymptomsThe scale will be given the before the exercise intervention begins and then after 8 weeks of exercise intervention.Patient-Reported Outcomes Measurement Information System (PROMIS) - Parent report questionnaires
Behavioral SymptomsThe scale will be given the before the exercise intervention begins and then after 8 weeks of exercise intervention.Vanderbilt Scale - parent report questionnaire

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026