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 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.
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.
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