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临床试验/NCT05287529
NCT05287529已完成不适用

Telehealth Delivery of the Yoga for Seniors Program

University of Wisconsin, Madison2 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2021年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
52
试验地点
2
主要终点
Percentage of Classes Attended (?0

研究概览

简要总结

The overall purpose of this study is to adapt a 12-week, standardized in-home yoga program into an 8-week in-home program with a high degree of fidelity, participant adherence, and safety. The Yoga for Seniors program was previously implemented in five rural WI communities with five yoga teachers providing the in-class guidance and support for the standardized program. The investigators seek to convert the program to a telehealth-based approach and deliver the intervention with fidelity to the program, in a safe and effective manner to 120 participants.

详细描述

Participants will be randomly assigned to immediately begin an 8-week yoga class or complete an 8-week wait (wait-list control). Investigators will examine the measures of interest at pretest (wait-list only), baseline, and posttest to see what, if any, changes are observed after completion of the program. All assessment data collections sessions will be conducted on-line.

Phone screen: All interested participants will complete a phone screen to assess inclusion and exclusion factor for the study.

Testing Procedures: All participants who meet study requirements will complete approximately 60 to 90 minutes of on-line assessments and 60-90 minutes of mailed questionnaires at each testing timepoint (pretest, baseline, and posttest). The assessments will consist of demographic information including a health history form, a semi-structured interview, and a series of questionnaires. The following are the specific assessment components for each time point:

A. Intake and review of forms (Initial Visit (Baseline or Pretest ))

  1. Consent form
  2. Medical history

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
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • over 60 years of age
  • ability to independently ambulate for at least 10 minutes continuously (with or without an assistive device)
  • ability to attend the yoga class for all or most of the 8 weeks
  • a previous fall, near-fall or identified fear of falling
  • internet access
  • vision at or corrected to 20/40 or better

排除标准

  • known contraindication for exercise (i.e. a medical doctor has told you not to exercise)

结局指标

主要结局

Percentage of Classes Attended (?0

时间窗: up to 8 weeks

Participant adherence will be measured in part by class attendance. They will have twice weekly classes for 8 weeks, or 16 possible classes to attend. \[from the purpose: The overall purpose of this study is to adapt the 12-week, standardized in-home yoga program into an 8-week in-home program with a high degree of fidelity, participant adherence, and safety. Are fidelity/adherence/safety a primary outcomes?\]

次要结局

  • Change in Fall Frequency(baseline (or pretest for immediate group), 8 weeks (posttest for immediate group, pretest for waitlist group), 16 weeks (posttest for waitlist group))
  • Change in Activities-Specific Balance Confidence Scale (ABC)(baseline (or pretest for immediate group), 8 weeks (posttest for immediate group, pretest for waitlist group), 16 weeks (posttest for waitlist group))
  • Social Network Scale Score(baseline (or pretest for immediate group), 8 weeks (posttest for immediate group, pretest for waitlist group), 16 weeks (posttest for waitlist group))
  • Change in Mobility Scale Score(baseline (or pretest for immediate group), 8 weeks (posttest for immediate group, pretest for waitlist group), 16 weeks (posttest for waitlist group))
  • Change in the Canadian Occupational Performance Measures (COPM)(baseline (or pretest for immediate group), 8 weeks (posttest for immediate group, pretest for waitlist group), 16 weeks (posttest for waitlist group))
  • Change in Perceived Stress Scale Score(baseline (or pretest for immediate group), 8 weeks (posttest for immediate group, pretest for waitlist group), 16 weeks (posttest for waitlist group))
  • Change in Physical Activity Scale Score(baseline (or pretest for immediate group), 8 weeks (posttest for immediate group, pretest for waitlist group), 16 weeks (posttest for waitlist group))
  • Loneliness and Social Isolation Scale Score(baseline (or pretest for immediate group), 8 weeks (posttest for immediate group, pretest for waitlist group), 16 weeks (posttest for waitlist group))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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