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

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

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.

Study Overview

• Status: Completed
• Conditions: Down Syndrome
• Intervention / Treatment: Other: Exercise

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.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02446
      • Boston Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Boston Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2018
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): March 31, 2021

Study Registration Dates

• First Submitted: May 15, 2017
• First Submitted That Met QC Criteria: June 16, 2017
• First Posted (Actual): June 20, 2017

Study Record Updates

• Last Update Posted (Actual): January 26, 2022
• Last Update Submitted That Met QC Criteria: January 21, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Exercise; Fitness; Overall wellbeing
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Disease; Congenital Abnormalities; Genetic Diseases, Inborn; Intellectual Disability; Abnormalities, Multiple; Chromosome Disorders; Syndrome; Down Syndrome
• Other Study ID Numbers: P00023661

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No