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GameSquad for Adults With Down Syndrome

Primary Purpose

Down Syndrome, Physical Inactivity

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ring-Fit Adventure Group
Sponsored by
University of Kansas Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Down Syndrome

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesAccepts 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).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Ring-Fit Adventure Group

    Arm 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.

    Outcomes

    Primary Outcome Measures

    Minutes of Gameplay per week
    Minutes of Ring-Fit Adventure played per week will be collected from a self-reported sign in sheet.
    Retention
    Participant retention will be collected.
    Attendance
    Attendance at 30 min virtual health coaching sessions will be collected.

    Secondary Outcome Measures

    6-minute walk test
    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 Strength
    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 Strength
    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 Go
    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.
    Balance
    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 Events
    Adverse events will be collected.
    Qualitative Interview Data
    Semi-Structured interviews will occur after the 12-week intervention to allow participants to make sense of their experience in the intervention.

    Full Information

    First Posted
    July 13, 2022
    Last Updated
    October 31, 2022
    Sponsor
    University of Kansas Medical Center
    Collaborators
    HRSA/Maternal and Child Health Bureau
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05473247
    Brief Title
    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

    2. Study Status

    Record Verification Date
    October 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 15, 2023 (Anticipated)
    Primary Completion Date
    June 30, 2023 (Anticipated)
    Study Completion Date
    August 30, 2030 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Kansas Medical Center
    Collaborators
    HRSA/Maternal and Child Health Bureau

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Down Syndrome, Physical Inactivity

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Ring-Fit Adventure Group
    Arm Type
    Experimental
    Arm 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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Ring-Fit Adventure Group
    Intervention Description
    Participants will be asked to play the exergame software, Ring-Fit Adventure, and attend weekly virtual health coaching sessions.
    Primary Outcome Measure Information:
    Title
    Minutes of Gameplay per week
    Description
    Minutes of Ring-Fit Adventure played per week will be collected from a self-reported sign in sheet.
    Time Frame
    12-weeks
    Title
    Retention
    Description
    Participant retention will be collected.
    Time Frame
    12-weeks
    Title
    Attendance
    Description
    Attendance at 30 min virtual health coaching sessions will be collected.
    Time Frame
    12-weeks
    Secondary Outcome Measure Information:
    Title
    6-minute walk test
    Description
    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.
    Time Frame
    12-weeks
    Title
    Leg Strength
    Description
    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.
    Time Frame
    12-weeks
    Title
    Hand Grip Strength
    Description
    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.
    Time Frame
    12-weeks
    Title
    Timed Up and Go
    Description
    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.
    Time Frame
    12-weeks
    Title
    Balance
    Description
    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.
    Time Frame
    12-weeks
    Title
    Adverse Events
    Description
    Adverse events will be collected.
    Time Frame
    12-weeks
    Title
    Qualitative Interview Data
    Description
    Semi-Structured interviews will occur after the 12-week intervention to allow participants to make sense of their experience in the intervention.
    Time Frame
    12-weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    30 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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).

    12. IPD Sharing Statement

    Learn more about this trial

    GameSquad for Adults With Down Syndrome

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