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

Boston Children's Hospital logo

Boston Children's Hospital

Status

Completed

Conditions

Down Syndrome

Treatments

Other: Exercise

Study type

Interventional

Funder types

Other

Identifiers

NCT03192540
P00023661

Details and patient eligibility

About

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.

Full 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.

Enrollment

15 patients

Sex

All

Ages

10 to 17 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

15 participants in 1 patient group

Exercise
Experimental group
Description:
These are participants who will be undergoing exercise intervention.
Treatment:
Other: Exercise

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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