Clinical trial NCT03192540: The Impact of an 8-week Supported Exercise Program on Fitness and Symptoms in Adolescents With Down Syndrome
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
Overall status: COMPLETED
Phase: NA
Conditions: Down Syndrome
Keywords: Exercise
Fitness
Overall wellbeing
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2017-06-20
Enrollment: 15
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Home Exercise Compliance
timeFrame: 2 months post completion of the exercise program
Secondary outcomes:
measure: Muscular strength & endurance
timeFrame: The test will be performed before the exercise intervention and then after 8 weeks of exercise intervention.
measure: Aerobic capacity
timeFrame: The test will be preformed before the exercise intervention and then after 8 weeks of exercise intervention.
measure: Anxiety and Depression Symptoms
timeFrame: The scale will be given the before the exercise intervention begins and then after 8 weeks of exercise intervention.
measure: Behavioral Symptoms
timeFrame: The scale will be given the before the exercise intervention begins and then after 8 weeks of exercise intervention.
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
References: