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Completed

NCT Number: NCT04532073

Sub-study of the Essen Study Centre 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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kliniken Essen-Mitte

Essen, 45276, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Eurythmy Therapy

Other

A mindfulness-oriented movement therapy

Tai Chi

Other

A martial art developed in China, which in recent times is often regarded as a system of movement theory or gymnastics

Standard care

Other

Treatment process that a clinician should follow for a certain type of patient

Primary outcomes

  1. Change in proteomic analysis from baseline to after intervention

    Time frame: Before intervention (week 0) and after intervention (6 months)

    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)

  2. Change in telomer analysis from baseline to after intervention

    Time frame: Before intervention (week 0) and after intervention (6 months)

    The telomere length is determined from blood samples using quantitative real-time PCR (TaqMan) from genomic DNA.

  3. Qualitative parameter

    Time frame: After intervention (6 months)

    By means of semi-structured interviews of maximum 60 minutes per participant, the effects of the intervention are to be recorded qualitatively.

Sponsors and collaborators

Lead sponsor

Universität Duisburg-Essen

Other

Collaborators

  • Software AG Stiftung
  • Universität Freiburg

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 31, 2020
Registry last updated
Dec 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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