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

NCT04209738 | Completed

• 1 other identifier: EYT_12
• Study Type: observational
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Tai Chi; eurythmy; HRV; PWA; sleep quality; fall prevention

Outcome Measures

Primary Outcomes (1)

• 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)

  Continuous measurement (up to 15 minutes) at Baseline (pre-intervention) and 6 month (post-intervention)

Secondary Outcomes (31)

• HRV analysis: Change in SDNN

  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

  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

  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

  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

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

Study Arms (3)

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.

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.

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.

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

Interventions

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.

Eurythmy Therapy (performed as part of the ENTAiER main study); Standard Care; Tai Chi (performed as part of the ENTAiER main study)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may not qualify if:

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

Sponsors & Collaborators

• ARCIM Institute Academic Research in Complementary and Integrative Medicine: lead

Study Sites (1)

Arcim Institute

Filderstadt, Baden-Wurttemberg, 70794, Germany

Location

MeSH Terms

Conditions

Chronic Disease; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Jan Vagedes, MD

  ARCIM Institute Academic Research in Complementary and Integrative Medicine

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2019
• First Posted: December 24, 2019
• Study Start: March 2, 2020
• Primary Completion: September 29, 2023
• Study Completion: March 15, 2024
• Last Updated: March 26, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: The data will be made available upon publication for a duration of three months.
• Access Criteria: The data will be made available to researchers who provide a methodologically sound proposal for use in achieving the goals of the approved proposal.

Locations

DE (1)