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临床试验/NCT06445413
NCT06445413招募中不适用

Tai Chi as a Novel Strategy to Increase Physical Activity Among Adults Pursuing Metabolic and Bariatric Surgery: A Feasibility and Acceptability Study

Hartford Hospital2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2024年1月22日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
24
试验地点
2
主要终点
Video view duration

研究概览

简要总结

The goal of this clinical trial is to evaluate the feasibility and acceptability of a 10-wk hybrid Tai Chi (TC) program with in-person classes and online TC videos among 24 physically inactive adults who are seeking metabolic and bariatric surgery (MBS) in a single-arm trial.

The aims are:

Aim 1: Feasibility: To evaluate whether TC is feasible, defined as a mean attendance rate of ≥70% in-person TC classes attended.

Aim 2: Acceptability: To evaluate whether TC is acceptable, defined as a mean rating of ≥4 across 4 acceptability questionnaire items measured on a 5-point Likert scale (e.g., rate "Tai Chi practice is appealing to me" on a scale from 1 [completely disagree] to 5 [completely agree]).

Participants will complete four individual in-person visits where they will complete study assessments and ten weekly group in-person Tai Chi classes where they will practice Tai Chi with up to 5 other study participants. Additionally, they will be asked to practice Tai Chi at home with the aid of instructional online videos and log their practice.

研究设计

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

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Seeking to undergo MBS at HHC.
  • Be able to give valid informed consent in English. Attending the live, in-person, group TC classes each week is the main component of the intervention. During the classes, the TC instructor will be giving instructions and communicating with the participants in English. It is not practical to having an interpreter during the live classes. Therefore, participation is limited to those who are English speakers.
  • Be 18-70 years of age.
  • Have BMI≥35 kg/m2
  • Absence of cognitive impairment since participants will need to learn and memorize the TC forms. Must score ≥24 Mini-Mental State Examination.
  • Be physically inactive defined as performing <150 min/wk of moderate to vigorous intensity PA based on self-report.
  • Be able to ambulate independently without use of an assistive device.
  • Be able to complete questionnaires and view TC instructional videos via REDCap.
  • Be able to commute to one of the HH Medical and Surgical Weight Loss Center clinics to participate in testing sessions and in-person TC classes.

排除标准

  • Having severe psychological or physical conditions that may impair their ability to adhere to the study protocol such as uncontrolled mental health issues, and severe arthritis.
  • Pregnant women.

结局指标

主要结局

Video view duration

时间窗: Measured once weekly (up to 10 weeks)

Number of minutes the weekly Tai Chi video was played

Home practice frequency

时间窗: Measured once weekly (up to 10 weeks)

Number of times participant practices Tai Chi at home

Home practice duration

时间窗: Measured once weekly (up to 10 weeks)

Number of minutes spent practicing Tai Chi at home

Attendance

时间窗: Attendance will be taken at each class (up to 10 weeks)

Percentage of Tai Chi classes attended over 10 week program

Video view frequency

时间窗: Measured once weekly for up to 10 weeks

Number of times the weekly Tai Chi video is viewed

Acceptability of Tai Chi

时间窗: Measured once at the end of Tai Chi class or when participant drops out

This is a validated tool to assess the acceptability of interventions with four 5-point Likert scale questions that will be rated from completely disagree to completely agree. Acceptability is defined as a mean rating of ≥4 across 4 acceptability questionnaire items measured on a 5-point Likert scale (e.g., rate "Tai Chi practice is appealing to me" on a scale from 1 \[completely disagree\] to 5 \[completely agree\]).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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