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Trial record 3 of 40 for:    Recruiting, Not yet recruiting, Available Studies | "Down Syndrome"

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

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ClinicalTrials.gov Identifier: NCT03192540
Recruitment Status : Recruiting
First Posted : June 20, 2017
Last Update Posted : January 31, 2018
Sponsor:
Information provided by (Responsible Party):
Emily Jean Davidson, MD, MPH, Boston Children's Hospital

Brief Summary:
This study explores the effects of an eight-week center-based 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.

Condition or disease Intervention/treatment Phase
Down Syndrome Other: Exercise Not Applicable

Detailed Description:
Adolescents with Down syndrome will attend 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 certified athletic trainer, exercise physiologist and physician. 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 visits, 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. In addition, participants in the DSFit study will complete a weekly exercise log during and for three months after the intervention.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 8 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: The Impact of an 8-week Supported Exercise Program on Fitness and Symptoms of Anxiety and Depression in Adolescents With Down Syndrome
Estimated Study Start Date : March 22, 2018
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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.



Primary Outcome Measures :
  1. Home Exercise Compliance [ Time Frame: 3 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 Outcome Measures :
  1. Muscular endurance [ Time Frame: The test will be preformed before the exercise intervention and then after 8 weeks of exercise intervention. ]
    Participants will preform an exercise called a bird dog, where the extend their opposite leg and arm, having to hold it for 10 seconds. Participants will be scored on if they can complete the tasks, and hold for the allotted time. Additionally, participants will do several overhead squats, where form will be judged using the NASM guidelines.

  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 VO2 peak. As well, investigators will be able to compare the distance walked pre and post exercise intervention, heart rate and blood pressure response changes.

  3. Muscular strength [ Time Frame: The test will be preformed before the exercise intervention and then after 8 weeks of exercise intervention. ]
    Quadriceps, hamstrings, biceps, and hand grip strength will be measured using a handheld dynamometer.

  4. Anxiety and Depression [ Time Frame: The scale will be given the before the exercise intervention begins and then after 8 weeks of exercise intervention. ]
    SPENCE

  5. Quality of life [ Time Frame: The scale will be given the before the exercise intervention begins and then after 8 weeks of exercise intervention. ]
    Peds QL 4.0

  6. Behavior [ Time Frame: The scale will be given the before the exercise intervention begins and then after 8 weeks of exercise intervention. ]
    ABC scale



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males and females
  • 12 to 17 years old (until 18th birthday)
  • Diagnosed with Down syndrome by a physician
  • Medically cleared by a study physician 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03192540


Contacts
Contact: Emily Davidson, MD 617-355-4658 emily.davidson@childrens.harvard.edu

Locations
United States, Massachusetts
Boston Children's Hospital Recruiting
Boston, Massachusetts, United States, 02446
Contact: Emily Davidson, MD       emily.davidson@childrens.harvard.edu   
Sponsors and Collaborators
Boston Children’s Hospital

Responsible Party: Emily Jean Davidson, MD, MPH, Doctor, Boston Children's Hospital
ClinicalTrials.gov Identifier: NCT03192540     History of Changes
Other Study ID Numbers: P00023661
First Posted: June 20, 2017    Key Record Dates
Last Update Posted: January 31, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Emily Jean Davidson, MD, MPH, Boston Children's Hospital:
Exercise

Additional relevant MeSH terms:
Down Syndrome
Syndrome
Disease
Pathologic Processes
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn