Changes in Cardiovascular and Sleep Quality Parameters Under Eurythmy Therapy and Tai Chi in Comparison to Standard Care - a Substudy of the Multi-centre, Parallel-group, Randomised Controlled Trial to Assess the Efficacy and Safety of Eurythmy Therapy and Tai Chi in Comparison to Standard Care in Chronically Ill Elderly Patients With Increased Risk of Falling - ENTAiER Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Change in RMSSD
研究概览
简要总结
ENTAiER study is a multicentre randomized controlled trial to assess the efficacy and safety of eurythmy therapy and Tai Chi in comparison to standard care in chronically ill elderly patients with increased risk of falling. Subjects will be randomized to eurythmy therapy or Tai Chi or standard care alone. To investigate the changes in cardiovascular and sleep quality parameters under Eurythmy Therapy and Tai Chi in comparison to Standard Care in this trial, a substudy will be conducted only at the ARCIM Institute. The substudy will recruit enrolled participants from the ENTAiER trial to record various cardiovascular and sleep quality parameters. The aim is to compare changes in cardiovascular and sleep quality parameters under eurythmy therapy, Tai Chi and standard care alone in chronically ill elderly patients with increased risk of falling.
详细描述
This is an optional substudy of a multi-centre, parallel-group, three-arm randomized controlled trial - ENTAiER trial - to compare the changes in cardiovascular and sleep quality parameters under Eurythmy Therapy and Tai Chi in comparison to Standard Care in chronically ill elderly patients with increased risk of falling (see DRKS-ID: DRKS00016609). Subjects who consent to enroll in ENTAiER will be asked to participate in this substudy. The main focus of this substudy is on assessing the effects of Tai Chi and Eurythmy on the vegetative nervous system by measuring various parameters of heart rate variability and pulse wave analysis. In addition, the effects on sleep quality will be assessed. Participants of the substudy will undergo a measurement of heart rate variability with a long-term-ECG (Bittium Faros 360 TM), a pulse wave analysis, recorded with a vital function monitor (VitaGuard® 3100 monitor, getemed, Germany), and a blood pressure measurement and they fill in a sleep quality questionnaire (Pittsburgh Sleep Quality Index, PSQI) at baseline and after 3, 6 and 12 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •To be eligible for this substudy, subjects must be enrolled in ENTAiER main study and provide separate written informed consent for EYT_12 Substudy. See DRKS-ID: DRKS00016609 for inclusion criteria into ENTAiER main study
- •Exclusion Criteria for Substudy:
- •Cardiac pacemaker
- •Atrial fibrillation (documented in medical reports)
- •To be eligible for this substudy, subjects must be enrolled in ENTAiER main study and provide separate written informed consent for EYT_12 Substudy. See DRKS-ID: DRKS00016609 for exclusion criteria into ENTAiER main study
排除标准
- 未提供
结局指标
主要结局
Change in RMSSD
时间窗: Continuous measurement (up to 15 minutes) at Baseline (pre-intervention) and 6 month (post-intervention)
Root Mean Square of Successive Differences (ms), assessed with 24h ECG recorder Bittium Faros 360™, continuous measurement (up to 15 minutes) during standardized rest period at Baseline (pre-intervention) and 6 month (post-intervention)
次要结局
- HRV analysis: Change in SDNN(Continuous 24-hours measurement at baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3))
- HRV analysis: Change in STRESSINDEX(Continuous 24-hours measurement at baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3))
- Pulse wave analysis: Change in Reflection Index(Continuous measurement (up to 15 minutes) during standardized rest period at baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3))
- Pulse wave analysis: Change in Pulse Transit Time(Continuous measurement (up to 15 minutes) during standardized rest period at baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3))
- HRV analysis: Change in pNN50(Continuous 24-hours measurement at baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3))
- HRV analysis: Change in HF(Continuous 24-hours measurement at baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3))
- HRV analysis: Change in HEART RATE / RESP. RATE RATIO(Continuous 24-hours measurement at baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3))
- Pulse wave analysis: Change in Stiffness Index(Continuous measurement (up to 15 minutes) during standardized rest period at baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3))
- Pulse wave analysis: Change in Perfusion Index(Continuous measurement (up to 15 minutes) during standardized rest period at baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3))
- Change in HRV analysis: Change in SD2/SD1 RATIO(Continuous measurement (up to 15 minutes) during standardized rest period at baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3))
- HRV analysis: Change in RESP. RATE(Continuous measurement (up to 15 minutes) during standardized rest period at baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3))
- Change in SBP(Baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3))
- Change in DBP(Baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3))
- HRV analysis: Change in RMSSD(Continuous 24-hours measurement at baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3))
- Change in PSQI(Baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3))
- HRV analysis: Change in LF(Continuous 24-hours measurement at baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3))
- HRV analysis: Change in LF/HF ratio(Continuous 24-hours measurement at baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3))
- HRV analysis: Change in VLF(Continuous 24-hours measurement at baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3))
- HRV analysis: Change in MEAN HR [1/MIN](Continuous 24-hours measurement at baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3))
- HRV analysis: Change in SD2/SD1 RATIO(Continuous 24-hours measurement at baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3))
- Change in HRV analysis: RESP. RATE(Continuous 24-hours measurement at baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3))
- 24h activity protocol: change in sleep quality(Baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3))