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临床试验/NCT04756245
NCT04756245招募中不适用

The Virtually Engaging Socially With Physical Activity (VESPA) Pilot Study

Wake Forest University2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年12月17日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
2
主要终点
The percentage of individuals attending all one-on-one and group calls

研究概览

简要总结

Physical activity has been described by the US federal government as a 'best buy' for public health. Unfortunately, most adults in the United States are not sufficiently active, and this worsens with age. Low levels of participation are driven by many challenging barriers, including lack of access, few opportunities for enjoyable activity, and few supportive social relationships, which is especially important given the central role of social connection for lasting behavior change.

A half-century of research in behavioral sciences has generated effective group-based physical activity programs, but these are inaccessible to most as they are often delivered in a few select research centers. Recent advances in telehealth have offered media for extending these interventions more broadly, but the experience of such programs is often hampered by technology that does not allow for a sense of physical and social presence. Fortunately, uptake of virtual reality (VR) is increasing rapidly, and the medium has a high level of potential for advancing the delivery of immersive evidence-based group interventions to those that most need it. Thus our specific aims are:

Specific aim 1: To test the feasibility and acceptability of a group-mediated physical activity intervention delivered fully via modern VR to older adults.

Specific aim 2: To examine the impact of this program on overall physical activity among older adults compared to the current standard-of-care for telehealth: the video conference meeting platform.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
45 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age of 45-80 years
  • Body mass index between 30-45 kg/m2
  • Low-active (30 or more minutes of moderate intensity physical activity on 2 or fewer days per week)
  • Have access to home Wi-Fi
  • Have regular access to a computer, tablet, or smartphone to receive teleconferencing calls
  • Have a clear "VR space" (7'x7' object-free space)
  • Have an "Activity buddy" (spouse, child, caregiver, etc.)
  • Modified Telephone Interview for Cognitive Status (TICS-M) score of 32 or greater
  • Consent from a physician for study participation
  • Proficient in the English language
  • Willingness to create or use existing personal Facebook account for virtual reality activities.

排除标准

  • Current involvement in other physical activity research studies
  • Hearing or sight impairments (significant visual or hearing impairment that cannot be corrected and results in the inability to use the telephone or hear normal conversation, colorblindness)
  • Dependence on a cane or walker
  • More than 1 fall in the past year
  • Contraindication to exercise
  • Current or recent history within the last 6 months of: symptomatic coronary heart disease, cancer, liver or renal disease, severe pulmonary disease, gross physical impairment, or uncontrolled hypertension; myocardial infarction or cardiovascular procedure within the last 3 months
  • History of or diagnosis of photosensitive epilepsy
  • Score of "severe" on any question in the Virtual Reality Sickness Questionnaire;
  • Unwillingness to use a head-mounted virtual reality system
  • Current severe or untreated depression

研究组 & 干预措施

Virtual Reality

Experimental

Participants engage in intervention procedures using virtual reality software.

干预措施: Virtual Reality (Behavioral)

Video Conference

Active Comparator

Participants engage in intervention procedures using video conference software.

干预措施: Video Conference (Behavioral)

结局指标

主要结局

The percentage of individuals attending all one-on-one and group calls

时间窗: Weeks 0 through 4

Feasibility will be assessed based on percentage of individuals attending all one-on-one and group calls

Acceptability

时间窗: Baseline

Percentage of individuals reporting no severe symptoms in response to virtual reality on the virtual reality sickness questionnaire

次要结局

  • Physical Activity(Baseline, Week 4)
  • Social Relatedness(Baseline, Week 4)

研究者

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

Jason Fanning

Assistant Professor

Wake Forest University

研究点 (2)

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