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临床试验/NCT05687240
NCT05687240已完成不适用

Effects of QiGong and Tai Chi (QTC) and Heart Rate Variability Biofeedback (HRVB) on Older Adults' Cardiometabolic Risk

Arizona State University2 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2020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
22
试验地点
2
主要终点
Vagal Tone

研究概览

简要总结

This study is designed as a two-group parallel randomized controlled trial (N=50) to test effects of 8-weeks of Qigong/Tai Chi (QTC) intervention compared to QTC plus HRVB on HRV parameters (primary), and cardiometabolic risk factors and sequelae (secondary) (e.g., BMI, waist circumference/percent body fat, sleep quality, stress, anxiety/depression, emotional regulation, eating behaviors, and cognitive performance).

详细描述

Heart rate variability biofeedback (HRVB) will be investigated as a target to optimize Qigong/Tai Chi (QTC) practices based on the expectation that learning to, and practicing changing heart rate variability (HRV) using HRVB, in addition to QTC, will result in higher levels of HRV and coherence than just the QTC alone. This study is designed as a two-group parallel randomized controlled trial to test effects of QTC compared to QTC plus HRVB on HRV parameters (primary), and cardiometabolic risk factors and sequelae (secondary). Fifty participants will be recruited and randomized to one of these groups and receive daily text prompts for 8 weeks to practice (using video links) Tai Chi Easy for 10-30 minutes (length of practice, the participants' choice). Half of the participants randomized to the HRVB enhancement will also be coached to practice HRVB to achieve coherence in their heart beat rhythms prior to practice (QTC plus HRVB group). Data collection at baseline and post intervention will assess body mass index (BMI, waist circumference/percent body fat, sleep quality, stress, eating behaviors, emotion regulation, mood (depression and anxiety), cognitive performance and changes in HRV parameters (high frequency power and coherence).

研究设计

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

入排标准

年龄范围
55 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 31.5 inch or above waist circumference women
  • 35.5 inch or above waist circumference men
  • Has a smartphone or tablet

排除标准

  • Those who are unable to stand for 10-minute segments (e.g., wheelchair or walker bound and too weak), and/or unable to walk
  • People who have been regularly practicing any form of meditative movement and or HRVB training regularly (i.e., 2 or more times per month for the past 6 months)
  • Individuals with diagnosed severe heart arrhythmias, heart transplant, or those with pacemakers would be excluded because either of those interferes with accurately assessing HRV parameters.

结局指标

主要结局

Vagal Tone

时间窗: 8 Weeks

Measured using resting Heart rate variability and computing parameters of high frequency power and coherence. Will be assessed with participants following a videoguide "to measure their heart rate" that helps them set up equipment and account, seated for 5 minutes of interbeat interval capture using the Inner Balance Bluetooth (HeartMath product) software and earlobe heart beat sensor.

次要结局

  • Waist circumference(8 Weeks)
  • Abdominal circumference(8 Weeks)
  • Weight(8 weeks)
  • Anxiety (Profile of Mood States subscale)(8 Weeks)
  • Eating Behaviors (Three Factor Eating Questionnaire)(8 Weeks)
  • Cognitive Performance (Weschler Adult Intelligence Scales -III, letter number sequencing and forward backward digit span tests)(8 Weeks)
  • Height(8 Weeks)
  • Perceived stress (Perceived Stress Scale-10)(8 Weeks)
  • Sleep (Insomnia Severity Index)(8 Weeks)
  • Depression (Profile of Mood States subscale)(8 Weeks)
  • Emotion regulation (Emotion Regulation Questionnaire)(8 Weeks)
  • Awareness (one subscale of the Mindful Eating Questionnaire)(8 Weeks)

研究者

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

Linda Larkey

Professor

Arizona State University

研究点 (2)

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