Clinical trial NCT04209738: Changes in Cardiovascular and Sleep Quality Parameters Under Eurythmy Therapy and Tai Chi in Comparison to Standard Care - A Substudy of the ENTAiER Trial
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fall Patients
Elderly Patients
Chronic Disease
Sleep Quality
Cardiovascular System
Tai Chi
Eurythmy Therapy
Keywords: Tai Chi; eurythmy; HRV; PWA; sleep quality; fall prevention
Lead sponsor: ARCIM Institute Academic Research in Complementary and Integrative Medicine
Sponsor class: OTHER
First posted: 2019-12-24
Enrollment: 54
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who have consented to participate and are enrolled in ENTAiER main study will be approached for participation in this substudy. Substudy will be conducted at the ARCIM Institute, Filderstadt.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Primary outcomes:
measure: Change in RMSSD
timeFrame: Continuous measurement (up to 15 minutes) at Baseline (pre-intervention) and 6 month (post-intervention)
Secondary outcomes:
measure: HRV analysis: Change in SDNN
timeFrame: Continuous measurement (up to 15 minutes) during standardized rest period at baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3)
measure: HRV analysis: Change in pNN50
timeFrame: Continuous measurement (up to 15 minutes) during standardized rest period at baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3)
measure: HRV analysis: Change in HF
timeFrame: Continuous measurement (up to 15 minutes) during standardized rest period at baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3)
measure: HRV analysis: Change in LF
timeFrame: Continuous measurement (up to 15 minutes) during standardized rest period at baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3)
measure: HRV analysis: Change in LF/HF ratio
timeFrame: Continuous measurement (up to 15 minutes) during standardized rest period at baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3)
measure: HRV analysis: Change in VLF
timeFrame: Continuous measurement (up to 15 minutes) during standardized rest period at baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3)
measure: HRV analysis: Change in MEAN HR [1/MIN]
timeFrame: Continuous measurement (up to 15 minutes) during standardized rest period at baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3)
measure: Change in HRV analysis: Change in SD2/SD1 RATIO
timeFrame: Continuous measurement (up to 15 minutes) during standardized rest period at baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3)
measure: HRV analysis: Change in STRESSINDEX
timeFrame: Continuous measurement (up to 15 minutes) during standardized rest period at baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3)
measure: HRV analysis: Change in RESP. RATE
timeFrame: Continuous measurement (up to 15 minutes) during standardized rest period at baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3)
measure: HRV analysis: Change in HEART RATE / RESP. RATE RATIO
timeFrame: Continuous measurement (up to 15 minutes) during standardized rest period at baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3)
measure: Pulse wave analysis: Change in Stiffness Index
timeFrame: Continuous measurement (up to 15 minutes) during standardized rest period at baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3)
measure: Pulse wave analysis: Change in Reflection Index
timeFrame: Continuous measurement (up to 15 minutes) during standardized rest period at baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3)
measure: Pulse wave analysis: Change in Perfusion Index
timeFrame: Continuous measurement (up to 15 minutes) during standardized rest period at baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3)
measure: Pulse wave analysis: Change in Pulse Transit Time
timeFrame: Continuous measurement (up to 15 minutes) during standardized rest period at baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3)
measure: HRV analysis: Change in RMSSD
timeFrame: Continuous 24-hours measurement at baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3)
measure: HRV analysis: Change in SDNN
timeFrame: Continuous 24-hours measurement at baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3)
measure: HRV analysis: Change in pNN50
timeFrame: Continuous 24-hours measurement at baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3)
measure: HRV analysis: Change in HF
timeFrame: Continuous 24-hours measurement at baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3)
measure: HRV analysis: Change in LF
timeFrame: Continuous 24-hours measurement at baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3)
measure: HRV analysis: Change in LF/HF ratio
timeFrame: Continuous 24-hours measurement at baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3)
measure: HRV analysis: Change in VLF
timeFrame: Continuous 24-hours measurement at baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3)
measure: HRV analysis: Change in MEAN HR [1/MIN]
timeFrame: Continuous 24-hours measurement at baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3)
measure: HRV analysis: Change in SD2/SD1 RATIO
timeFrame: Continuous 24-hours measurement at baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3)
measure: HRV analysis: Change in STRESSINDEX
timeFrame: Continuous 24-hours measurement at baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3)
measure: Change in HRV analysis: RESP. RATE
timeFrame: Continuous 24-hours measurement at baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3)
measure: HRV analysis: Change in HEART RATE / RESP. RATE RATIO
timeFrame: Continuous 24-hours measurement at baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3)
measure: Change in SBP
timeFrame: Baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3)
measure: Change in DBP
timeFrame: Baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3)
measure: 24h activity protocol: change in sleep quality
timeFrame: Baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3)
measure: Change in PSQI
timeFrame: Baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3)
Other outcomes:
Locations:
city: Filderstadt
country: Germany
facility: Arcim Institute
state: Baden-Württemberg
Study officials:
affiliation: ARCIM Institute Academic Research in Complementary and Integrative Medicine
name: Jan Vagedes, MD
role: STUDY_DIRECTOR
References: