跳至主要内容
临床试验/NCT05473247
NCT05473247已完成不适用

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

University of Kansas Medical Center1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年1月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
Retention

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 30 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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.

排除标准

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

研究组 & 干预措施

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.

干预措施: Ring-Fit Adventure Group (Behavioral)

结局指标

主要结局

Retention

时间窗: 12-weeks

Participant retention will be collected.

Minutes of Gameplay Per Week

时间窗: 12-weeks

Minutes of Ring-Fit Adventure played per week will be collected from a self-reported sign in sheet.

Attendance

时间窗: 12-weeks

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

次要结局

  • Hand Grip Strength(12-weeks)
  • 6-minute Walk Test(12-weeks)
  • Leg Strength(12-weeks)
  • Timed Up and Go(12-weeks)
  • Balance(12-weeks)
  • Adverse Events(12-weeks)
  • Qualitative Interview Data(12-weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kameron Suire

Postdoctoral Researcher

University of Kansas Medical Center

研究点 (1)

Loading locations...

相似试验