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
About this trial
This is an interventional treatment trial for Down Syndrome
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).
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
NCT ID
NCT05473247
First Posted
July 13, 2022
Last Updated
October 31, 2022
Sponsor
University of Kansas Medical Center
Collaborators
HRSA/Maternal and Child Health Bureau
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
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GameSquad for Adults With Down Syndrome
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