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NCT Number: 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

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.

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Key information

Conditions

Fall Patients Cardiovascular System Chronic Disease Disease Attributes Dyssomnias Elderly Patients Eurythmy Therapy Mental Disorders Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Quality Sleep Wake Disorders Tai Chi

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Arcim Institute

Filderstadt, Baden-Wurttemberg, 70794, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

This is an observational study being conducted as a substudy of another trial.

Other

This is an observational study being conducted as a substudy of another trial. No intervention is planned for Substudy.

Primary outcomes

  1. Change in RMSSD

    Time frame: 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)

Secondary outcomes

  1. HRV analysis: Change in SDNN

    Time frame: Continuous measurement (up to 15 minutes) during standardized rest period at baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3)

    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)

  2. HRV analysis: Change in pNN50

    Time frame: Continuous measurement (up to 15 minutes) during standardized rest period at baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3)

    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)

  3. HRV analysis: Change in HF

    Time frame: Continuous measurement (up to 15 minutes) during standardized rest period at baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3)

    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)

  4. HRV analysis: Change in LF

    Time frame: Continuous measurement (up to 15 minutes) during standardized rest period at baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3)

    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)

  5. HRV analysis: Change in LF/HF ratio

    Time frame: Continuous measurement (up to 15 minutes) during standardized rest period at baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3)

    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)

  6. HRV analysis: Change in VLF

    Time frame: Continuous measurement (up to 15 minutes) during standardized rest period at baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3)

    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)

  7. HRV analysis: Change in MEAN HR [1/MIN]

    Time frame: Continuous measurement (up to 15 minutes) during standardized rest period at baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3)

    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)

  8. Change in HRV analysis: Change in SD2/SD1 RATIO

    Time frame: Continuous measurement (up to 15 minutes) during standardized rest period at baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3)

    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)

  9. HRV analysis: Change in STRESSINDEX

    Time frame: Continuous measurement (up to 15 minutes) during standardized rest period at baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3)

    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)

  10. HRV analysis: Change in RESP. RATE

    Time frame: Continuous measurement (up to 15 minutes) during standardized rest period at baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3)

    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)

  11. HRV analysis: Change in HEART RATE / RESP. RATE RATIO

    Time frame: Continuous measurement (up to 15 minutes) during standardized rest period at baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3)

    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)

  12. Pulse wave analysis: Change in Stiffness Index

    Time frame: Continuous measurement (up to 15 minutes) during standardized rest period at baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3)

    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)

  13. Pulse wave analysis: Change in Reflection Index

    Time frame: Continuous measurement (up to 15 minutes) during standardized rest period at baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3)

    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)

  14. Pulse wave analysis: Change in Perfusion Index

    Time frame: Continuous measurement (up to 15 minutes) during standardized rest period at baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3)

    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)

  15. Pulse wave analysis: Change in Pulse Transit Time

    Time frame: Continuous measurement (up to 15 minutes) during standardized rest period at baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3)

    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)

  16. HRV analysis: Change in RMSSD

    Time frame: Continuous 24-hours measurement at baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3)

    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)

  17. HRV analysis: Change in SDNN

    Time frame: Continuous 24-hours measurement at baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3)

    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)

  18. HRV analysis: Change in pNN50

    Time frame: Continuous 24-hours measurement at baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3)

    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)

  19. HRV analysis: Change in HF

    Time frame: Continuous 24-hours measurement at baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3)

    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)

  20. HRV analysis: Change in LF

    Time frame: Continuous 24-hours measurement at baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3)

    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)

  21. HRV analysis: Change in LF/HF ratio

    Time frame: Continuous 24-hours measurement at baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3)

    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)

  22. HRV analysis: Change in VLF

    Time frame: Continuous 24-hours measurement at baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3)

    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)

  23. HRV analysis: Change in MEAN HR [1/MIN]

    Time frame: Continuous 24-hours measurement at baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3)

    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)

  24. HRV analysis: Change in SD2/SD1 RATIO

    Time frame: Continuous 24-hours measurement at baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3)

    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)

  25. HRV analysis: Change in STRESSINDEX

    Time frame: Continuous 24-hours measurement at baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3)

    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)

  26. Change in HRV analysis: RESP. RATE

    Time frame: Continuous 24-hours measurement at baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3)

    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)

  27. HRV analysis: Change in HEART RATE / RESP. RATE RATIO

    Time frame: Continuous 24-hours measurement at baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3)

    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)

  28. Change in SBP

    Time frame: Baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3)

    Systolic Blood Pressure

  29. Change in DBP

    Time frame: Baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3)

    Diastolic Blood Pressure

  30. 24h activity protocol: change in sleep quality

    Time frame: Baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3)

    Self-reported sleep quality during the night after application of the long-term ECG, assessed with a 10-point scale (1=bad, 10=good)

  31. Change in PSQI

    Time frame: Baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3)

    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

Sponsors and collaborators

Lead sponsor

ARCIM Institute Academic Research in Complementary and Integrative Medicine

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2023
Study completion
2024
First posted
Dec 24, 2019
Registry last updated
Mar 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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