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

Primary Purpose

Down Syndrome

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise
Sponsored by
Boston Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Down Syndrome focused on measuring Exercise, Fitness, Overall wellbeing

Eligibility Criteria

10 Years - 17 Years (Child)All SexesDoes not accept 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

Sites / Locations

  • Boston Children's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Exercise

Arm Description

These are participants who will be undergoing exercise intervention.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Muscular strength & endurance
Participants will perform body-weight exercises that focus on upper body, lower body, core, and flexibility.
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.
Anxiety and Depression Symptoms
Patient-Reported Outcomes Measurement Information System (PROMIS) - Parent report questionnaires
Behavioral Symptoms
Vanderbilt Scale - parent report questionnaire

Full Information

First Posted
May 15, 2017
Last Updated
January 21, 2022
Sponsor
Boston Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03192540
Brief Title
The Impact of an 8-week Supported Exercise Program on Fitness and Symptoms in Adolescents With Down Syndrome
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
September 15, 2018 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
March 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston Children's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Down Syndrome
Keywords
Exercise, Fitness, Overall wellbeing

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise
Arm Type
Experimental
Arm Description
These are participants who will be undergoing exercise intervention.
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
Participants will undergo an exercise protocol once a week, for eight weeks. Exercise will be continuous for one hour.
Primary Outcome Measure Information:
Title
Home Exercise Compliance
Description
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.
Time Frame
2 months post completion of the exercise program
Secondary Outcome Measure Information:
Title
Muscular strength & endurance
Description
Participants will perform body-weight exercises that focus on upper body, lower body, core, and flexibility.
Time Frame
The test will be performed before the exercise intervention and then after 8 weeks of exercise intervention.
Title
Aerobic capacity
Description
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.
Time Frame
The test will be preformed before the exercise intervention and then after 8 weeks of exercise intervention.
Title
Anxiety and Depression Symptoms
Description
Patient-Reported Outcomes Measurement Information System (PROMIS) - Parent report questionnaires
Time Frame
The scale will be given the before the exercise intervention begins and then after 8 weeks of exercise intervention.
Title
Behavioral Symptoms
Description
Vanderbilt Scale - parent report questionnaire
Time Frame
The scale will be given the before the exercise intervention begins and then after 8 weeks of exercise intervention.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02446
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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