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

Down Syndrome Clinical Trial

— DSFIT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03192540
• Other study ID #: P00023661
• Status: Completed
• Phase: N/A
• Start date: September 15, 2018
• Est. completion date: March 31, 2021

Study information

• Verified date: January 2022
• Source: Boston Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: March 31, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Down Syndrome
• Syndrome

Intervention

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

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.