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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Fall Patients, Elderly Patients, Chronic Disease, Sleep Quality, Cardiovascular System, Tai Chi, Eurythmy Therapy

Intervention / Treatment
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* Other: This is an observational study being conducted as a substudy of another trial.


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Eurythmy Therapy (performed as part of the ENTAiER main study)<br>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.<br>* This is an observational study being conducted as a substudy of another trial. No intervention is planned for Substudy.<br>|
| Tai Chi (performed as part of the ENTAiER main study)<br>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.<br>* This is an observational study being conducted as a substudy of another trial. No intervention is planned for Substudy.<br>|
| Standard Care<br>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.<br>* This is an observational study being conducted as a substudy of another trial. No intervention is planned for Substudy.<br>|

What is the study measuring?
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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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tai Chi; eurythmy; HRV; PWA; sleep quality; fall prevention