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临床试验/NCT04240899
NCT04240899已完成不适用

Tele- Yoga for Adults With Anxiety: a Pilot Study

Rutgers, The State University of New Jersey2 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2020年3月9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
16
试验地点
2
主要终点
Parkinson's Anxiety Scale (PAS)

研究概览

简要总结

The purpose of this study is to investigate the effect of a telerehabilitation-yoga intervention delivered remotely via videoconferencing on adults with Parkinson's Disease and anxiety symptoms.

详细描述

A single group intervention study of adults (18-80 years-old) with Parkinson's Disease and anxiety symptoms undergoing a 6-week intervention of 30-minute yoga classes delivered remotely through videoconferencing 2-3 times per week. Subjects with symptoms of anxiety as indicated by their score on the Parkinson's Anxiety Scale will complete yoga classes delivered at-home with videoconferencing, receiving one-on-one yoga instruction including breathing, postures, and meditation/relaxation for two-three times a week. Data collection will occur remotely via videoconferencing at 0-weeks, 6-weeks after a waiting period, 12-weeks after the intervention, and 6-weeks after the last lab visit. Data collection will include demographics, mental health questionnaires, motor assessments, enjoyment, usability, and follow-up yoga status. Each yoga session will be video recorded to aide in recording adherence, adverse events, and challenges.

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • diagnosis of Parkinson's Disease
  • symptoms of anxiety as indicated by PAS (score ≥ 14)
  • 18-80 years old
  • ability to communicate verbally and follow directions
  • English-speaking
  • access to WiFi and applicable technological device (computer, laptop, tablet, smartphone etc.)
  • willing to be video recorded during the yoga session
  • willing to open Zoom on their technological device
  • demonstrates self-reported technological literacy.

排除标准

  • major depressive disorder (self-report medical history)
  • injury or condition that could prevent engagement in yoga poses
  • cognitive impairment or condition that would prevent the participant from understanding the tasks or communicating with the research team
  • past yoga experience exceeding 5 or more times within the last 2 months
  • pregnant women (self-report)

结局指标

主要结局

Parkinson's Anxiety Scale (PAS)

时间窗: follow-up (at 18 weeks)

The 12-item self-report PAS will be used to assess anxiety symptoms. It takes approximately 2-minutes to complete and is a 12-item scale with three sub-scales assessing 1. Persistent anxiety, episodic anxiety, and avoidance behavior. Participants answer questions on a scale from "not or never" (0) to "severe or almost always" (4) with a potential score range of 0-48. Higher score indicates greater symptoms of anxiety.

次要结局

  • Yoga Status at Follow-up(Follow-up (6-weeks after post-intervention))
  • Beck Depression Inventory-II (BDI-II)(Baseline (0 weeks), timepoint-2 (6-weeks), post-intervention (12-weeks) and at follow-up (6-weeks after post-intervention testing))
  • Five Times Sit to Stand Test (FTST)(Baseline (0 weeks), timepoint-2 (6-weeks), post-intervention (12-weeks) and at follow-up (6-weeks after post-intervention testing))
  • Technical Difficulties Encountered(Between week 6 to week 12)
  • Adherence will be assessed by calculating the total number of yoga sessions attended.(Between week 6 to week 12)
  • Adverse Events(Between week 6 to week 12)
  • Unified Parkinson's Disease Rating Scale (UPDRS)(Baseline (0 weeks), timepoint-2 (6-weeks), post-intervention (12-weeks) and at follow-up (6-weeks after post-intervention testing))
  • The Parkinson's Disease Questionnaire-39 (PDQ-39)(Baseline (0 weeks), timepoint-2 (6-weeks), post-intervention (12-weeks) and at follow-up (6-weeks after post-intervention testing))
  • Parkinson's Disease Sleep Scale-version 2 (PDSS-2)(Baseline (0 weeks), timepoint-2 (6-weeks), post-intervention (12-weeks) and at follow-up (6-weeks after post-intervention testing))
  • Enjoyment/Feedback(Post-intervention testing (at 12-weeks))
  • Usability(Post-intervention testing (at 12-weeks))

研究者

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

Jean-Francois Daneault, Ph.D.

Assistant Professor

Rutgers, The State University of New Jersey

研究点 (2)

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