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

NCT ID: NCT04209738

Last Updated: 2024-03-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 54 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-03-02
• Study Completion Date: 2024-03-15

Brief 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. 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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

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

Intervention Type: OTHER

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

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.

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

Intervention Type: OTHER

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

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.

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

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

Exclusion Criteria

• Cardiac pacemaker
• Atrial fibrillation (documented in medical reports)

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ARCIM Institute Academic Research in Complementary and Integrative Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jan Vagedes, MD

Role: STUDY_DIRECTOR

ARCIM Institute Academic Research in Complementary and Integrative Medicine

Locations

Arcim Institute

Filderstadt, Baden-Wurttemberg, Germany

Countries

Germany

Other Identifiers

EYT_12

Identifier Type: -

Identifier Source: org_study_id