Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:38 PM
Ignite Modification Date:
2025-12-24 @ 2:38 PM
NCT ID:
NCT04048759
Eligibility Criteria:
Inclusion Criteria:
* age 18 and over.
* Diagnosis of DS as determined by a Community Service Provider operating in our recruitment area under the auspices of a Community Developmental Disability Organization (CDDO).
* Sufficient functional ability to understand directions, communicate preferences, wants and needs through spoken language.
* Living at home with a parent/guardian or in a supported living environment with a caregiver who agrees to serve as a study partner.
* No plans to relocate outside the study area over the next 12 mos.
* Internet access in the home.
Exclusion Criteria:
* Diagnosis of dementia as determine by the Cambridge Examination for Mental Disorders of Older People with Down Syndrome and others with intellectual disabilities.
* Unable to participate in MVPA.
* Pregnancy during the previous 6 mos., currently lactating or planned pregnancy in the following 12 mos.
* Serious medical risk, e.g., cancer, recent heart attack, stroke, angioplasty as determined by the PCP.
* Unwilling to be randomized.
* Participation in a regular exercise program, i.e. greater than or equal to 20 min/d greater than or equal to 3 d/wk.
* Contraindications for MRI, including metal implants or devices incompatible with MRI such as pacemakers, claustrophobia, and inability to lay in a supine position.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04048759
Study Brief:
Protocol Section:
NCT04048759