MedPath

GameSquad for Adults With Down Syndrome

Not Applicable
Completed
Conditions
Down Syndrome
Physical Inactivity
Interventions
Behavioral: Ring-Fit Adventure Group
Registration Number
NCT05473247
Lead Sponsor
University of Kansas Medical Center
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
20
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).

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Ring-Fit Adventure GroupRing-Fit Adventure GroupIn 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.
Primary Outcome Measures
NameTimeMethod
Minutes of Gameplay Per Week12-weeks

Minutes of Ring-Fit Adventure played per week will be collected from a self-reported sign in sheet.

Retention12-weeks

Participant retention will be collected.

Attendance12-weeks

Attendance at 30 min virtual health coaching sessions will be collected.

Secondary Outcome Measures
NameTimeMethod
6-minute Walk Test12-weeks

This test measures the distance that a participant can walk on a flat, hard surface in a period of 6 minutes. The research team will instruct them on how to prepare and conduct this test.

Leg Strength12-weeks

Leg strength will be measured on the leg press machine. Researchers will assess the maximum amount of weight the participant can press for 5 repetitions.

Hand Grip Strength12-weeks

The participant will be asked to squeeze a device as hard as they can to test their grip strength. This will be done on both hands.

Timed Up and Go12-weeks

During this test, the participant will be asked to sit down in a chair. Approximately 10 feet in front of the participant there will be a line on the floor. The research team will say "go" and the participant will get up from the chair, walk to the line at a normal pace, and then turnaround and walk back to the chair and sit down again. The research team will record how long it takes to do this.

Balance12-weeks

During this test, the investigators will ask the participant to balance on one leg and reach in three directions as far as they can with their other foot. They will then do the same on the other leg.

Adverse Events12-weeks

Adverse events will be collected.

Qualitative Interview Data12-weeks

Semi-Structured interviews will occur after the 12-week intervention to allow participants to make sense of their experience in the intervention.

Trial Locations

Locations (1)

Kirmayer Fitness Center

🇺🇸

Kansas City, Kansas, United States

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