GameSquad for Adults With Down Syndrome

Physical Inactivity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05473247
• Other study ID #: STUDY00148828
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 15, 2023
• Est. completion date: August 30, 2030

Study information

• Verified date: October 2022
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: August 30, 2030
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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).

Related Conditions & MeSH terms

• Down Syndrome
• Physical Inactivity
• Syndrome

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Kansas Medical Center	HRSA/Maternal and Child Health Bureau

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Minutes of Gameplay per week	Minutes of Ring-Fit Adventure played per week will be collected from a self-reported sign in sheet.	12-weeks
Primary	Retention	Participant retention will be collected.	12-weeks
Primary	Attendance	Attendance at 30 min virtual health coaching sessions will be collected.	12-weeks
Secondary	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.	12-weeks
Secondary	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.	12-weeks
Secondary	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.	12-weeks
Secondary	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.	12-weeks
Secondary	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.	12-weeks
Secondary	Adverse Events	Adverse events will be collected.	12-weeks
Secondary	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.	12-weeks