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

ARCIM Institute Academic Research in Complementary and Integrative Medicine

Status: Completed

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

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

Study type: Observational

Funder types: Other

Identifiers

NCT04209738

EYT_12

Details and patient eligibility

About

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.

Full 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.

Enrollment: 54 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

54 participants in 3 patient groups

Eurythmy Therapy (performed as part of the ENTAiER main study)

Description:

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.

Treatment:

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

Tai Chi (performed as part of the ENTAiER main study)

Description:

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.

Treatment:

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

Standard Care

Description:

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.

Treatment:

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