Skip to main content
Clinical Trials/NCT05473247
NCT05473247
Completed
Not Applicable

The Adaption of the GameSquad Exergaming Intervention for Young Adults With Down Syndrome: A Pilot Feasibility Study

University of Kansas Medical Center1 site in 1 country20 target enrollmentJanuary 15, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Down Syndrome
Sponsor
University of Kansas Medical Center
Enrollment
20
Locations
1
Primary Endpoint
Minutes of Gameplay Per Week
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 15, 2023
End Date
August 30, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Kameron Suire

Postdoctoral Researcher

University of Kansas Medical Center

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).

Outcomes

Primary Outcomes

Minutes of Gameplay Per Week

Time Frame: 12-weeks

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

Retention

Time Frame: 12-weeks

Participant retention will be collected.

Attendance

Time Frame: 12-weeks

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

Secondary Outcomes

  • 6-minute Walk Test(12-weeks)
  • Leg Strength(12-weeks)
  • Hand Grip Strength(12-weeks)
  • Timed Up and Go(12-weeks)
  • Balance(12-weeks)
  • Adverse Events(12-weeks)
  • Qualitative Interview Data(12-weeks)

Study Sites (1)

Loading locations...

Similar Trials