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NCT Number: NCT05473247

GameSquad for Adults With Down Syndrome

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.

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Key information

Conditions

Down Syndrome Abnormalities, Multiple Behavior Chromosome Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Intellectual Disability Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Physical Inactivity Sedentary Behavior

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kirmayer Fitness Center

Kansas City, Kansas, 66103, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Ring-Fit Adventure Group

Behavioral

Participants will be asked to play the exergame software, Ring-Fit Adventure, and attend weekly virtual health coaching sessions.

Primary outcomes

  1. 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.

  2. Retention

    Time frame: 12-weeks

    Participant retention will be collected.

  3. Attendance

    Time frame: 12-weeks

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

Secondary outcomes

  1. 6-minute Walk Test

    Time frame: 12-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.

  2. Leg Strength

    Time frame: 12-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.

  3. Hand Grip Strength

    Time frame: 12-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.

  4. Timed Up and Go

    Time frame: 12-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.

  5. Balance

    Time frame: 12-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.

  6. Adverse Events

    Time frame: 12-weeks

    Adverse events will be collected.

  7. Qualitative Interview Data

    Time frame: 12-weeks

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

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Collaborators

  • HRSA/Maternal and Child Health Bureau

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jul 25, 2022
Registry last updated
Nov 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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