The Impact of an 8-week Supported Exercise Program on Fitness and Symptoms in Adolescents With Down Syndrome
- Conditions
- Down Syndrome
- Interventions
- Other: Exercise
- Registration Number
- NCT03192540
- Lead Sponsor
- Boston Children's Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 15
- Males and females
- 10 to 17 years old (until 18th birthday)
- Diagnosed with Down syndrome by a physician
- Medically cleared to exercise
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Exercise Exercise These are participants who will be undergoing exercise intervention.
- Primary Outcome Measures
Name Time Method Home Exercise Compliance 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 Outcome Measures
Name Time Method Muscular strength & endurance 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.
Aerobic capacity 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.
Anxiety and Depression Symptoms 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
Behavioral Symptoms The scale will be given the before the exercise intervention begins and then after 8 weeks of exercise intervention. Vanderbilt Scale - parent report questionnaire
Trial Locations
- Locations (1)
Boston Children's Hospital
🇺🇸Boston, Massachusetts, United States