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Completed

NCT Number: NCT03192540

The Impact of an 8-week Supported Exercise Program on Fitness and Symptoms 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.

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Key information

Age range

10 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Boston Children's Hospital

Boston, Massachusetts, 02446, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise

Other

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

Primary outcomes

  1. Home Exercise Compliance

    Time frame: 2 months post completion of the exercise program

    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 outcomes

  1. Muscular strength & endurance

    Time frame: The test will be performed before the exercise intervention and then after 8 weeks of exercise intervention.

    Participants will perform body-weight exercises that focus on upper body, lower body, core, and flexibility.

  2. Aerobic capacity

    Time frame: The test will be preformed before the exercise intervention and then after 8 weeks of exercise intervention.

    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.

  3. Anxiety and Depression Symptoms

    Time frame: The scale will be given the before the exercise intervention begins and then after 8 weeks of exercise intervention.

    Patient-Reported Outcomes Measurement Information System (PROMIS) - Parent report questionnaires

  4. Behavioral Symptoms

    Time frame: The scale will be given the before the exercise intervention begins and then after 8 weeks of exercise intervention.

    Vanderbilt Scale - parent report questionnaire

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Registry information

Official study title

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

Acronym: DSFIT

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Jun 20, 2017
Registry last updated
Jan 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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