跳至主要内容
临床试验/NCT03624868
NCT03624868终止不适用

A Randomized Pilot Trial of Tai Chi Compared to Wellness Education for Older Veterans

VA Boston Healthcare System2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2019年1月29日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
24
试验地点
2
主要终点
Senior Fitness Test

研究概览

简要总结

The primary purpose of this study is to examine physical fitness, PTSD, and satisfaction with a Tai Chi intervention for older (aged 60 and older), sedentary, trauma-exposed veterans, in comparison to a wellness education attention control. Secondary outcomes include physical activity, depression, well-being, late-onset stress, functional status, cognition, and exercise self-efficacy. Outcomes will be examined pre- to post-intervention and in comparison to the control condition.

详细描述

The proposed study will consist of a pilot trial of three 12-week, 24-session Tai Chi intervention groups compared with three 12-week, 24-session wellness education control groups. Participants will be randomly assigned in blocks of 14 to either the Tai Chi or the wellness education condition, half to each. Veterans who do not agree to randomization will be excluded. Baseline and post-intervention assessments will be completed, and it is anticipated that 42 individuals will complete baseline assessments. After the final sessions, participants will be asked to provide feedback to investigators via questionnaires, a focus group discussion, and individual interviews utilizing open-ended questions. Information collected from participants will be integrated and utilized for presentations/manuscript preparation, as well as to refine protocols for use in future research.

Potentially eligible veterans who have expressed interest in the study will be called and research staff will describe all aspects of the study. Research staff will answer any questions, and then obtain oral consent for screening for eligibility criteria in the medical record. Study staff will then go through the eligibility criteria over the telephone and schedule a baseline assessment as appropriate. Participants will be mailed information about the time and location for the initial baseline assessment and the class schedule and location to which they are assigned. They will also receive phone calls with this information. Information collected during the telephone screening (prior to completion of the Informed Consent Form) will be collected and retained with the prospective participant's verbal permission. This information will be kept separate from identifying information (names, addresses, and telephone numbers). Some information collected from the electronic medical record will be recorded in order to document inclusion and exclusion criteria.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

Pre- and Post-intervention assessments will be conducted by an assessor who is blind to study condition.

入排标准

年龄范围
60 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 60 or older
  • Have experienced a traumatic event (determined through telephone screening)
  • English-speaking
  • Considered to be sedentary
  • Not planning to relocate in the next three months
  • Reports ability to attend group sessions.

排除标准

  • Lacks the capacity to provide consent
  • Unable to stand for the duration of a 60-minute Tai Chi intervention
  • Has major medical, psychiatric, or neurological disorder or has a moderate or severe traumatic brain injury,
  • Change in psychotropic or pain medication during the past month
  • Regular current Tai Chi, formal mindfulness meditation program, or yoga practice
  • Unwillingness to be randomly assigned to group
  • Engagement in another treatment study that might impact findings

结局指标

主要结局

Senior Fitness Test

时间窗: at pre-intervention and at post-intervention, about 12 weeks

Physical fitness

Posttraumatic Stress Disorder Checklist (PCL-5)

时间窗: at pre-intervention and at post-intervention, about 12 weeks

PTSD checklist

次要结局

  • International Physical Activity Questionnaire(at pre-intervention and at post-intervention, about 12 weeks)

研究者

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

Anica Pless Kaiser

Clinical Research Psychologist

VA Boston Healthcare System

研究点 (2)

Loading locations...

相似试验