Down SyndromeDSFITNCT03192540
The Impact of an 8-week Supported Exercise Program on Fitness and Symptoms in Adolescents With Down Syndrome
A study testing Exercise in people with Down Syndrome, run by Boston Children's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Down Syndrome
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2018to 31 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Males and females
- 10 to 17 years old (until 18th birthday)
- Diagnosed with Down syndrome by a physician
- Medically cleared to exercise
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Children's Hospital
Boston, Massachusetts, 02446
About this study
Official title: The Impact of an 8-week Supported Exercise Program on Fitness and Symptoms of Anxiety and Depression 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.
Read the 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.
- Conditions
- Down Syndrome
- Being tested
- Exercise
- Keywords
- Exercise, Fitness, Overall wellbeing
- Medical subject headings
- Down Syndrome, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Participants will undergo an exercise protocol once a week, for eight weeks. Exercise will be continuous for one hour.
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | These are participants who will be undergoing exercise intervention. Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Home Exercise Compliance
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.
Measured: 2 months post completion of the exercise program
Secondary outcomes (4)
Muscular strength & endurance
Participants will perform body-weight exercises that focus on upper body, lower body, core, and flexibility.
Measured: The test will be performed before the exercise intervention and then after 8 weeks of exercise intervention.
Aerobic capacity
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.
Measured: The test will be preformed before the exercise intervention and then after 8 weeks of exercise intervention.
Anxiety and Depression Symptoms
Patient-Reported Outcomes Measurement Information System (PROMIS) - Parent report questionnaires
Measured: The scale will be given the before the exercise intervention begins and then after 8 weeks of exercise intervention.
Behavioral Symptoms
Vanderbilt Scale - parent report questionnaire
Measured: The scale will be given the before the exercise intervention begins and then after 8 weeks of exercise intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2017
- Study start15 Sep 2018
- Primary completion31 Dec 2020
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Down SyndromeStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emily Jean Davidson, MD, MPH, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03192540
- Sponsor's protocol ID
- P00023661
- Acronym
- DSFIT
- Status last verified
- Jan 2022
- First submitted
- 15 May 2017
- Last updated
- 26 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of an 8-week Supported Exercise Program on Fitness and Symptoms of Anxiety and Depression in Adolescents With Down Syndrome
- ClinicalTrials.gov ID
- NCT03192540
- Acronym / sponsor ID
- DSFIT / P00023661
- Conditions
- Down Syndrome
- Keywords
- Exercise, Fitness, Overall wellbeing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- 15 Sep 2018 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 20 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Other: ExerciseThese are participants who will be undergoing exercise intervention. |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Males and females
- 10 to 17 years old (until 18th birthday)
- Diagnosed with Down syndrome by a physician
- Medically cleared to exercise
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseParticipants will undergo an exercise protocol once a week, for eight weeks. Exercise will be continuous for one hour. | Other | Exercise |
Primary outcome
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.
4 secondary outcomes
Muscular strength & endurance
Time frame: The test will be performed before the exercise intervention and then after 8 weeks of exercise intervention.
Aerobic capacity
Time frame: The test will be preformed before the exercise intervention and then after 8 weeks of exercise intervention.
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.
Behavioral Symptoms
Time frame: The scale will be given the before the exercise intervention begins and then after 8 weeks of exercise intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Down Syndrome, run by Boston Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Home Exercise Compliance (time frame: 2 months post completion of the exercise program). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2022.