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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03192540
Recruitment Status : Active, not recruiting
First Posted : June 20, 2017
Last Update Posted : November 21, 2018
Sponsor:
Information provided by (Responsible Party):
Emily Jean Davidson, MD, MPH, Boston Children’s Hospital

Tracking Information
First Submitted Date  ICMJE May 15, 2017
First Posted Date  ICMJE June 20, 2017
Last Update Posted Date November 21, 2018
Actual Study Start Date  ICMJE September 15, 2018
Estimated Primary Completion Date January 12, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 16, 2017)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03192540 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 19, 2018)
  • 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.
  • 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.
  • 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.
  • 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
  • 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 - this tool provides a measure of quality of life
  • Behavior [ Time Frame: The scale will be given the before the exercise intervention begins and then after 8 weeks of exercise intervention. ]
    Aberrant Behavior Checklist
Original Secondary Outcome Measures  ICMJE
 (submitted: June 16, 2017)
  • 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.
  • 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.
  • 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.
  • 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
  • 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
  • Behavior [ Time Frame: The scale will be given the before the exercise intervention begins and then after 8 weeks of exercise intervention. ]
    ABC scale
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Impact of an 8-week Supported Exercise Program on Fitness and Symptoms in Adolescents With Down Syndrome
Official Title  ICMJE The Impact of an 8-week Supported Exercise Program on Fitness and Symptoms of Anxiety and Depression in Adolescents With Down Syndrome
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Down Syndrome
Intervention  ICMJE Other: Exercise
Participants will undergo an exercise protocol once a week, for eight weeks. Exercise will be continuous for one hour.
Study Arms  ICMJE Experimental: Exercise
These are participants who will be undergoing exercise intervention.
Intervention: Other: Exercise
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: June 16, 2017)
8
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 31, 2019
Estimated Primary Completion Date January 12, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03192540
Other Study ID Numbers  ICMJE P00023661
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Emily Jean Davidson, MD, MPH, Boston Children’s Hospital
Study Sponsor  ICMJE Boston Children’s Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Boston Children’s Hospital
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP