Fall PatientsNCT04209738
Changes in Cardiovascular and Sleep Quality Parameters Under Eurythmy Therapy and Tai Chi in Comparison to Standard Care - A Substudy of the ENTAiER Trial
An observational study of Fall Patients and Elderly Patients, run by ARCIM Institute Academic Research in Complementary and Integrative Medicine at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Fall Patients, Elderly Patients, Chronic Disease
- What is being tested?
- This is an observational study being conducted as a substudy of another trial.
- How many people
- 54 participants
- Where
- 1 siteGermany
- Study dates
- 2 Mar 2020to 15 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Fall Patients, Elderly Patients, Chronic Disease, Sleep Quality, Cardiovascular System, Tai Chi
- Being tested
- This is an observational study being conducted as a substudy of another trial.
- Keywords
- Tai Chi; eurythmy; HRV; PWA; sleep quality; fall prevention
- Medical subject headings
- Chronic Disease, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: This is an observational study being conducted as a substudy of another trial. | |
| 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. Receives: Other: This is an observational study being conducted as a substudy of another trial. | |
| 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. Receives: Other: This is an observational study being conducted as a substudy of another trial. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Continuous measurement (up to 15 minutes) at Baseline (pre-intervention) and 6 month (post-intervention)
Secondary outcomes (31)
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Continuous 24-hours measurement at baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3)
Change in SBP
Systolic Blood Pressure
Measured: Baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3)
Change in DBP
Diastolic Blood Pressure
Measured: 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)
Measured: 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
Measured: Baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2019
- Study start2 Mar 2020
- Primary completion29 Sep 2023
- Study completion15 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fall PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- ARCIM Institute Academic Research in Complementary and Integrative Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jan Vagedes, MD, Study director, ARCIM Institute Academic Research in Complementary and Integrative Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04209738
- Sponsor's protocol ID
- EYT_12
- Status last verified
- Mar 2024
- First submitted
- 20 Dec 2019
- Last updated
- 26 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data will be made available, in addition to study protocol and informed consent form.
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04209738
- Acronym / sponsor ID
- EYT_12
- Conditions
- Fall Patients, Elderly Patients, Chronic Disease, Sleep Quality, Cardiovascular System, Tai Chi
- Keywords
- Tai Chi; eurythmy; HRV; PWA; sleep quality; fall prevention
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- ARCIM Institute Academic Research in Complementary and Integrative MedicineUniversity, hospital or other
- Study start
- 2 Mar 2020 (actual)
- Primary completion
- 29 Sep 2023 (actual)
- Study completion
- 15 Mar 2024 (actual)
- First posted
- 24 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Eurythmy Therapy (performed as part of the ENTAiER main study) | – | Other: This is an observational study being conducted as a substudy of another trial.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. |
| Tai Chi (performed as part of the ENTAiER main study) | – | Other: This is an observational study being conducted as a substudy of another trial.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. |
| Standard Care | – | Other: This is an observational study being conducted as a substudy of another trial.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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Eurythmy Therapy (performed as part of the ENTAiER main study), Standard Care, Tai Chi (performed as part of the ENTAiER main study) |
Primary outcome
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)
31 secondary outcomes
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
HRV analysis: Change in RMSSD
Time frame: Continuous 24-hours measurement at baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3)
HRV analysis: Change in SDNN
Time frame: Continuous 24-hours measurement at baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3)
HRV analysis: Change in pNN50
Time frame: Continuous 24-hours measurement at baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3)
HRV analysis: Change in HF
Time frame: Continuous 24-hours measurement at baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3)
HRV analysis: Change in LF
Time frame: Continuous 24-hours measurement at baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3)
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)
HRV analysis: Change in VLF
Time frame: 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]
Time frame: Continuous 24-hours measurement at baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3)
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)
HRV analysis: Change in STRESSINDEX
Time frame: Continuous 24-hours measurement at baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3)
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)
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)
Change in SBP
Time frame: Baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3)
Change in DBP
Time frame: Baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3)
24h activity protocol: change in sleep quality
Time frame: Baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3)
Change in PSQI
Time frame: Baseline (t0), 3 month (t1), 6 month (t2) and 12 month (t3)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2024.
- Individual participant dataSharing planned: Yes. De-identified individual participant data will be made available, in addition to study protocol and informed consent form.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Vagedes, MD study director
ARCIM Institute Academic Research in Complementary and Integrative Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fall Patients and Elderly Patients, run by ARCIM Institute Academic Research in Complementary and Integrative Medicine at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in RMSSD (time frame: Continuous measurement (up to 15 minutes) at Baseline (pre-intervention) and 6 month (post-intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2024.