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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03192540
Other study ID # P00023661
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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.
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