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

Primary Purpose

Elderly Patients, Chronically Ill, Increased Risk of Falling

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Eurythmy Therapy
Tai Chi
Standard Care
Sponsored by
Universität Duisburg-Essen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Elderly Patients

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Active Comparator

    Arm Label

    Eurythmy therapy exercises

    Tai Chi exercises

    Standard Care Only

    Arm Description

    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.

    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

    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

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Full Information

    First Posted
    August 20, 2020
    Last Updated
    November 30, 2020
    Sponsor
    Universität Duisburg-Essen
    Collaborators
    Software AG Stiftung, Universität Freiburg
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04532073
    Brief Title
    Sub-study of the Essen Study Centre for the ENTAiER Trial
    Official Title
    Sub-study of the Essen Study Centre With Proteome and Telomer Analyses and Qualitative Parameters for the ENTAiER Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 1, 2020 (Anticipated)
    Primary Completion Date
    August 31, 2021 (Anticipated)
    Study Completion Date
    August 31, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universität Duisburg-Essen
    Collaborators
    Software AG Stiftung, Universität Freiburg

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Elderly Patients, Chronically Ill, Increased Risk of Falling

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Eurythmy therapy exercises
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Tai Chi exercises
    Arm Type
    Experimental
    Arm Description
    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
    Arm Title
    Standard Care Only
    Arm Type
    Active Comparator
    Arm Description
    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
    Intervention Type
    Other
    Intervention Name(s)
    Eurythmy Therapy
    Intervention Description
    A mindfulness-oriented movement therapy
    Intervention Type
    Other
    Intervention Name(s)
    Tai Chi
    Intervention Description
    A martial art developed in China, which in recent times is often regarded as a system of movement theory or gymnastics
    Intervention Type
    Other
    Intervention Name(s)
    Standard Care
    Intervention Description
    Treatment process that a clinician should follow for a certain type of patient
    Primary Outcome Measure Information:
    Title
    Change in proteomic analysis from baseline to after intervention
    Description
    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)
    Time Frame
    Before intervention (week 0) and after intervention (6 months)
    Title
    Change in telomer analysis from baseline to after intervention
    Description
    The telomere length is determined from blood samples using quantitative real-time PCR (TaqMan) from genomic DNA.
    Time Frame
    Before intervention (week 0) and after intervention (6 months)
    Title
    Qualitative parameter
    Description
    By means of semi-structured interviews of maximum 60 minutes per participant, the effects of the intervention are to be recorded qualitatively.
    Time Frame
    After intervention (6 months)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Holger Cramer, PD Dr.
    Phone
    +4920117425015
    Email
    h.cramer@kem-med.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Anna K Koch, Dr.
    Phone
    +4920117425115
    Email
    a.koch@kem-med.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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