GameSquad for Adults With Down Syndrome

NCT05473247 | Completed Results

• 1 other identifier: STUDY00148828
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Down Syndrome; Physical Inactivity

Outcome Measures

Primary Outcomes (3)

• 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

• Retention

  Participant retention will be collected.

  12-weeks

• Attendance

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

  12-weeks

Secondary Outcomes (7)

• 6-minute Walk Test

  12-weeks

• Leg Strength

  12-weeks

• Hand Grip Strength

  12-weeks

• Timed Up and Go

  12-weeks

• Balance

  12-weeks

Study Arms (1)

Ring-Fit Adventure Group

EXPERIMENTAL

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.

Behavioral: Ring-Fit Adventure Group

Interventions

Ring-Fit Adventure Group BEHAVIORAL

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

Ring-Fit Adventure Group

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Unable to participate in MVPA.
• Serious medical risk, e.g., cancer, recent heart attack, stroke, angioplasty as determined by their primary care provider (PCP).

Sponsors & Collaborators

• University of Kansas Medical Center: lead
• HRSA/Maternal and Child Health Bureau: collaborator

Study Sites (1)

Kirmayer Fitness Center

Kansas City, Kansas, 66103, United States

Location

MeSH Terms

Conditions

Down Syndrome; Sedentary Behavior

Condition Hierarchy (Ancestors)

Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn; Behavior

Results Point of Contact

• Title: Kameron Suire
• Organization: Berry College

ksuire@berry.edu

3373968980

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoctoral Researcher

Study Record Dates

• First Submitted: July 13, 2022
• First Posted: July 25, 2022
• Study Start: January 15, 2023
• Primary Completion: June 30, 2023
• Study Completion: August 30, 2023
• Last Updated: November 25, 2024
• Results First Posted: November 25, 2024

Record last verified: 2024-11

Locations

US (1)