Changes in Cardiovascular and Sleep Quality Parameters Under Eurythmy Therapy and Tai Chi in Comparison to Standard Care - A Substudy of the ENTAiER Trial

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Disease; Sleep Quality; Elderly Patients; Cardiovascular System; Fall Patients; Tai Chi; Eurythmy Therapy
• Intervention / Treatment: Other: This is an observational study being conducted as a substudy of another trial.

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.

• Study Type: Observational
• Enrollment (Actual): 54

Contacts and Locations

Study Locations

• Germany
  • Baden-Württemberg
    • Filderstadt, Baden-Württemberg, Germany, 70794
      • Arcim Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Eurythmy Therapy (performed as part of the ENTAiER main study); In group sessions á 5 patients with a qualified therapist: In the first 3 months 2 times a week, in the second 3 months once a week. Recommendation to practice at home at least 3 days a week (optimal to practice daily). They are supported by an eurythmy manual and an exercise video. This complements the regular care.	Other: This is an observational study being conducted as a substudy of another trial.; This is an observational study being conducted as a substudy of another trial. No intervention is planned for Substudy.
Tai Chi (performed as part of the ENTAiER main study); In group sessions á 5 patients with a qualified teacher: In the first 3 months 2 times a week, in the second 3 months once a week. Recommendation to practice at home at least 3 days a week (optimal to practice daily). They are supported by a Tai Chi manual and a practice video. This complements the regular care.	Other: This is an observational study being conducted as a substudy of another trial.; This is an observational study being conducted as a substudy of another trial. No intervention is planned for Substudy.
Standard Care; Brochure with detailed description of different evidence-based measures for fall prevention, created for the specific age group ("Gleichgewicht & Kraft - Trittsicher durchs Leben "https://www.trittsicher.org/files/trittsicher_bzga_sturzpraevention_2015-11-23.pdf") and recommendation to visit the family doctor and discuss fall prophylaxis with him.	Other: This is an observational study being conducted as a substudy of another trial.; This is an observational study being conducted as a substudy of another trial. No intervention is planned for Substudy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in RMSSD	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)	Continuous measurement (up to 15 minutes) at Baseline (pre-intervention) and 6 month (post-intervention)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HRV analysis: Change in SDNN	Standard deviation of normal to normal (NN) intervals (ms), assessed with 24h ECG Bittium Faros 360 TM, continuous measurement (up to 15 minutes) during standardized rest period at baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3)	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	Percentage of successive NN intervals that differ from each other by more than 50 ms (%), assessed with 24h ECG Bittium Faros 360 TM, continuous measurement (up to 15 minutes) during standardized rest period at baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3)	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 HF	High frequency power band (0.15-0.40 Hz) (ms2) from frequency domain analysis, assessed with 24h ECG Bittium Faros 360 TM, continuous measurement (up to 15 minutes) during standardized rest period at baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3)	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 LF	Low frequency power band (0.04-0.15 Hz) (ms2) from frequency domain analysis, assessed with 24h ECG Bittium Faros 360 TM, continuous measurement (up to 15 minutes) during standardized rest period at baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3)	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 LF/HF ratio	LF/HF ratio = ratio of the power in the LF band to the power in the HF band, assessed with 24h ECG Bittium Faros 360 TM, continuous measurement (up to 15 minutes) during standardized rest period at baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3)	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 VLF	Very low frequency power band (0.00-0.04 Hz) (ms2) from frequency domain analysis , assessed with 24h ECG Bittium Faros 360 TM, continuous measurement (up to 15 minutes) during standardized rest period at baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3)	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 MEAN HR [1/MIN]	Mean Heart Rate, assessed with 24h ECG Bittium Faros 360 TM, continuous measurement (up to 15 minutes) during standardized rest period at baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3)	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	Ratio of SD2 (standard deviation in long term of the RR interval) to SD1 (standard deviation of instantaneous beat-by beat variability), assessed with 24h ECG Bittium Faros 360 TM, continuous measurement (up to 15 minutes) during standardized rest period at baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3)	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 STRESSINDEX	Stress index (SI), assessed with 24h ECG Bittium Faros 360 TM, continuous measurement (up to 15 minutes) during standardized rest period at baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3)	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	Respiratory rate, assessed with 24h ECG Bittium Faros 360 TM, continuous measurement (up to 15 minutes) during standardized rest period at baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3)	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 HEART RATE / RESP. RATE RATIO	Ratio of Heart Rate to Respiratory rate, assessed with 24h ECG Bittium Faros 360 TM, continuous measurement (up to 15 minutes) during standardized rest period at baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3)	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 Stiffness Index	Stiffness Index, assessed with VitaGuard® 3100 monitor, getemed, Germany, continuous measurement (up to 15 minutes) during standardized rest period at baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3)	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 Reflection Index	Reflection Index (RI, %), assessed with VitaGuard® 3100 monitor, getemed, Germany, continuous measurement (up to 15 minutes) during standardized rest period at baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3)	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	Perfusion Index (PI, %), assessed with VitaGuard® 3100 monitor, getemed, Germany, continuous measurement (up to 15 minutes) during standardized rest period at baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3)	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	Pulse Transit Time (PTT-W1, ms), assessed with VitaGuard® 3100 monitor, getemed, Germany, continuous measurement (up to 15 minutes) during standardized rest period at baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3)	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 RMSSD	Root Mean Square of Successive Differences (ms), assessed with 24h ECG recorder Bittium Faros 360™, continuous 24-hour measurement for day and night phase at Baseline (pre-intervention) and 6 month (post-intervention)	Continuous 24-hours measurement at baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3)
HRV analysis: Change in SDNN	Standard deviation of normal to normal (NN) intervals (ms), assessed with 24h ECG recorder Bittium Faros 360™, continuous 24-hour measurement for day and night phase at Baseline (pre-intervention) and 6 month (post-intervention)	Continuous 24-hours measurement at baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3)
HRV analysis: Change in pNN50	Percentage of successive NN intervals that differ from each other by more than 50 ms (%), assessed with 24h ECG recorder Bittium Faros 360™ continuous 24-hour measurement measured for day and night phase at Baseline (pre-intervention) and 6 month (post-intervention)	Continuous 24-hours measurement at baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3)
HRV analysis: Change in HF	High frequency power band (0.15-0.40 Hz) (ms2) from frequency domain analysis, assessed with 24h ECG recorder Bittium Faros 360™, continuous 24-hour measurement measured for day and night phase at Baseline (pre-intervention) and 6 month (post-intervention)	Continuous 24-hours measurement at baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3)
HRV analysis: Change in LF	Low frequency power band (0.04-0.15 Hz) (ms2) from frequency domain analysis, assessed with 24h ECG recorder Bittium Faros 360™, continuous 24-hour measurement for day and night phase at Baseline (pre-intervention) and 6 month (post-intervention)	Continuous 24-hours measurement at baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3)
HRV analysis: Change in LF/HF ratio	LF/HF ratio = ratio of the power in the LF band to the power in the HF band, assessed with 24h ECG recorder Bittium Faros 360™, continuous 24-hour measurement for day and night phase at Baseline (pre-intervention) and 6 month (post-intervention)	Continuous 24-hours measurement at baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3)
HRV analysis: Change in VLF	Very low frequency power band (0.00-0.04 Hz) (ms2) from frequency domain analysis, assessed with 24h ECG recorder Bittium Faros 360™, continuous 24-hour measurement for day and night phase at Baseline (pre-intervention) and 6 month (post-intervention)	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]	Mean Heart Rate, assessed with 24h ECG recorder Bittium Faros 360™, continuous 24-hour measurement for day and night phase at Baseline (pre-intervention) and 6 month (post-intervention)	Continuous 24-hours measurement at baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3)
HRV analysis: Change in SD2/SD1 RATIO	Ratio of SD2 (standard deviation in long term of the RR interval) to SD1 (standard deviation of instantaneous beat-by beat variability), assessed with 24h ECG recorder Bittium Faros 360™, continuous 24-hour measurement for day and night phase at Baseline (pre-intervention) and 6 month (post-intervention)	Continuous 24-hours measurement at baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3)
HRV analysis: Change in STRESSINDEX	Stress index (SI), assessed with 24h ECG recorder Bittium Faros 360™, continuous 24-hour measurement for day and night phase at Baseline (pre-intervention) and 6 month (post-intervention)	Continuous 24-hours measurement at baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3)
Change in HRV analysis: RESP. RATE	Respiratory rate, assessed with 24h ECG recorder Bittium Faros 360™, continuous 24-hour measurement for day and night phase at Baseline (pre-intervention) and 6 month (post-intervention)	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	Ratio of Heart Rate to Respiratory rate, assessed with 24h ECG recorder Bittium Faros 360™, continuous 24-hour measurement for day and night phase at Baseline (pre-intervention) and 6 month (post-intervention)	Continuous 24-hours measurement at baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3)
Change in SBP	Systolic Blood Pressure	Baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3)
Change in DBP	Diastolic Blood Pressure	Baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3)
24h activity protocol: change in sleep quality	Self-reported sleep quality during the night after application of the long-term ECG, assessed with a 10-point scale (1=bad, 10=good)	Baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3)
Change in PSQI	Pittsburgh Sleep Quality Index (PSQI): Total Score. The PSQI is a validated self-rating instrument assessing aspects of sleep quality.Minimum score 0 (better); maximum score 21 (worse) < or = 5 associated with good sleep quality; > 5 associated with poor sleep quality	Baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3)

Collaborators and Investigators

• Sponsor: ARCIM Institute Academic Research in Complementary and Integrative Medicine
• Investigators: Study Director: Jan Vagedes, MD, ARCIM Institute Academic Research in Complementary and Integrative Medicine

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2020
• Primary Completion (Actual): September 29, 2023
• Study Completion (Actual): March 15, 2024

Study Registration Dates

• First Submitted: December 20, 2019
• First Submitted That Met QC Criteria: December 20, 2019
• First Posted (Actual): December 24, 2019

Study Record Updates

• Last Update Posted (Actual): March 26, 2024
• Last Update Submitted That Met QC Criteria: March 25, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Tai Chi; eurythmy; HRV; PWA; sleep quality; fall prevention
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Chronic Disease
• Other Study ID Numbers: EYT_12

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data will be made available, in addition to study protocol and informed consent form.
• IPD Sharing Time Frame: The data will be made available upon publication for a duration of three months.
• IPD Sharing Access Criteria: The data will be made available to researchers who provide a methodologically sound proposal for use in achieving the goals of the approved proposal.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No