Sub-study of the Essen Study Centre for the ENTAiER Trial

Sub-study of the Essen Study Centre With Proteome and Telomer Analyses and Qualitative Parameters for the ENTAiER Trial

The present study is a sub-study of the ENTAiER study. The ENTAiER study is a multicenter, randomized, controlled study to evaluate the efficacy and safety of eurythmy therapy and Tai Chi in comparison to standard care in chronically ill older patients with an increased risk of falling.

In addition to the main questions of the ENTAiER study, three additional questions are being investigated at the Hospital Essen-Steele: Proteome and telomere analyses as well as qualitative parameters are recorded and examined. The aim is to compare the changes in proteomes, telomeres and qualitative factors under eurythmy therapy, Tai Chi and standard care in chronically ill older patients with an increased risk of falling.

Study Overview

• Status: Completed
• Conditions: Elderly Patients; Chronically Ill; Increased Risk of Falling
• Intervention / Treatment: Other: Eurythmy Therapy; Other: Tai Chi; Other: Standard Care

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Holger Cramer, PD Dr.; Phone Number: +4920117425015; Email: h.cramer@kem-med.com
• Study Contact Backup: Name: Anna K Koch, Dr.; Phone Number: +4920117425115; Email: a.koch@kem-med.com

Study Locations

• Germany
  • Essen, Germany, 45276
    • Kliniken Essen-Mitte

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 63 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• At least 65 years.
• Chronic disease (musculoskeletal, neurological, internal medicine).
• Increased risk of falling (Berg Balance Scale Score 49 or less).
• Medical history: feeling of balance disturbance in the past.
• Independent living at home or in an old people's or retirement home.
• Regular participation in a one-hour event is possible.
• Sufficiently mobile to leave the place of residence independently at least twice a week
• Written declaration of consent.

Exclusion Criteria:

• Disease that restricts participation (e.g. terminal disease, heart failure NYHA III-IV, unstable angina pectoris, uncontrolled seizure disorder, decompensated lung disease that already leads to shortness of breath during light activity, advanced cancer, chemo- or radiotherapy ongoing or during the last 3 months, amputation of one or both legs)
• Complete dependence on the rollator.
• Visual, hearing or speech problems that limit the understanding of the study documents and processes.
• Major cognitive impairment (MoCA score 18 or less).
• High risk of needing individual supervision during group sessions.
• Severe personality disorder or psychiatric illness, alcoholism or other substance dependence affecting the group sessions.
• Life expectancy under 1 year.
• Permanent bed-riddenness expected in less than one year.
• Regular participation in Tai Chi or EYT in the last 6 months.
• Participation in intensive sports activities in the last month (e.g. training in the fitness centre or in sports groups which lead to breathlessness and sweating; skiing, mountaineering in high mountains).
• Patients who cannot understand the nature, meaning and necessities of participating in a study.
• Participation in another clinical trial within 3 months prior to screening for the ENTAiER trial or concurrent participation in another trial that may interfere with this trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Eurythmy therapy exercises; As part of the ENTAiER trial: In group sessions á 5 patients with a qualified therapist: In the first 3 months twice a week, in the second 3 months once a week. Recommendation to practice at home on at least 3 days per week (optimal, practice daily). They are supported by an eurythmy manual and an exercise video. This supplements the regular care.	Other: Eurythmy Therapy; A mindfulness-oriented movement therapy
Experimental: Tai Chi exercises; As part of the ENTAiER trial:In group sessions of 5 patients each with a qualified teacher: In the first 3 months twice a week, in the second 3 months once a week. Recommendation to practice at home on at least 3 days per week (optimal, practice daily). They are supported by a Tai Chi Manual and an exercise video. This complements the regular care	Other: Tai Chi; A martial art developed in China, which in recent times is often regarded as a system of movement theory or gymnastics
Active Comparator: Standard Care Only; As part of the ENTAiER trial:Brochure with detailed description of various evidence-based measures for fall prevention, prepared for the specific age group (https://www.trittsicher.org/files/trittsicher_bzga_sturzpraevention_2015-11-23.pdf) - Recommendation to visit the family doctor and discuss fall prophylaxis with her	Other: Standard Care; Treatment process that a clinician should follow for a certain type of patient

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in proteomic analysis from baseline to after intervention	A maximum of 500 µL plasma is used for the proteomic studies. The proteins are digested tryptically, a concentration determination is performed by amino acid analysis and the peptide samples are then measured by different mass spectrometric methods (data dependent (DDA) and independent detection (DIA), proteome-wide prediction of peptide tandem mass spectra by deep learning (Prosit), etc.). The results obtained are then verified by Western blot, ELISA and/or a targeted mass spectrometric method (parallel reaction monitoring)	Before intervention (week 0) and after intervention (6 months)
Change in telomer analysis from baseline to after intervention	The telomere length is determined from blood samples using quantitative real-time PCR (TaqMan) from genomic DNA.	Before intervention (week 0) and after intervention (6 months)
Qualitative parameter	By means of semi-structured interviews of maximum 60 minutes per participant, the effects of the intervention are to be recorded qualitatively.	After intervention (6 months)

Collaborators and Investigators

• Sponsor: Universität Duisburg-Essen
• Collaborators: Software AG Stiftung; Universität Freiburg

Study record dates

Study Major Dates

• Study Start (Actual): July 27, 2021
• Primary Completion (Actual): December 7, 2022
• Study Completion (Actual): December 7, 2022

Study Registration Dates

• First Submitted: August 20, 2020
• First Submitted That Met QC Criteria: August 25, 2020
• First Posted (Actual): August 31, 2020

Study Record Updates

• Last Update Posted (Estimated): December 21, 2023
• Last Update Submitted That Met QC Criteria: December 15, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Chronic Disease
• Other Study ID Numbers: 20-9421-BO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No