GameSquad for Adults With Down Syndrome

University of Kansas

Status: Not yet enrolling

Conditions: Physical Inactivity; Down Syndrome

Treatments: Behavioral: Ring-Fit Adventure Group

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT05473247

STUDY00148828

Details and patient eligibility

About

The investigators are assessing acceptability, appropriateness, and feasibility of the adapted GameSquad-DS intervention using validated scales alongside qualitative data among young adults with Down Syndrome. Specifically, the investigators will assess mins/wk of Ring-Fit Adventure played, attendance at 30 min. virtual health coaching sessions, semi-structured interviews, participant retention, and intervention safety measured as number of adverse events.

Full description

Adults with DS face unique barriers to participation in MVPA. Exergames, which integrate MVPA into video game play are an affordable, accessible, home-based exercise program which has shown effectiveness for increasing MVPA and improving both physical and cognitive function in typically developed populations. An exergaming intervention with individual health coaching called GameSquad has been shown to be effective in improving MVPA and cardiometabolic parameters in children with overweight/obesity and adolescents with neurodevelopmental and psychiatric diagnoses. The investigators propose a two phased project to adapt/evaluate the GameSquad intervention for use in adults with DS (GameSquad-DS). In Phase 1, the investigators will utilize a formative approach to develop GameSquad-DS, pilot test the intervention for 4 weeks in 10 young adults with DS and use feedback to refine the intervention for use in Phase 2. In Phase 2, the investigators will conduct a 12-wk. single arm pilot trial in 20 young adults with DS to assess the acceptability, appropriateness, and feasibility of the intervention and calculate effect sizes for change MVPA, physical function, muscular strength, physical activity enjoyment, and self-efficacy. Successful completion of this project represents an initial step in achieving the goal of developing effective interventions to increase MVPA and promote healthy aging in adults with DS.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 30 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Young adults (18-30 yrs.).
• Diagnosis of DS.
• 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 parent/caregiver who agrees to serve as a study partner.

Exclusion criteria

• Unable to participate in MVPA.
• Serious medical risk, e.g., cancer, recent heart attack, stroke, angioplasty as determined by their primary care provider (PCP).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Ring-Fit Adventure Group

Experimental group

Description:

In Phase 1, participants will be asked to play Ring-Fit Adventure for 60 minutes per week for 4 weeks. Participants will also be asked to attend a weekly, 90 minute health education session with a health educator on zoom. In Phase 2, participants will be asked to play Ring-Fit Adventure for 60 (wk 1), 90 (wk 2), 120 (wk 3), and 150 (wk 4-12) minutes per week. Participants will also be asked to attend a weekly, 90 minute health education session with a health educator on zoom.

Treatment:

Behavioral: Ring-Fit Adventure Group