Clinical trial NCT05473247: GameSquad for Adults With Down Syndrome
Official title: The Adaption of the GameSquad Exergaming Intervention for Young Adults With Down Syndrome: A Pilot Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Down Syndrome
Physical Inactivity
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: HRSA/Maternal and Child Health Bureau
First posted: 2022-07-25
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Minutes of Gameplay Per Week
timeFrame: 12-weeks
measure: Retention
timeFrame: 12-weeks
measure: Attendance
timeFrame: 12-weeks
Secondary outcomes:
measure: 6-minute Walk Test
timeFrame: 12-weeks
measure: Leg Strength
timeFrame: 12-weeks
measure: Hand Grip Strength
timeFrame: 12-weeks
measure: Timed Up and Go
timeFrame: 12-weeks
measure: Balance
timeFrame: 12-weeks
measure: Adverse Events
timeFrame: 12-weeks
measure: Qualitative Interview Data
timeFrame: 12-weeks
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Kirmayer Fitness Center
state: Kansas
Study officials:
References: