Clinical trial NCT04532073: 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
Overall status: COMPLETED
Phase: NA
Conditions: Elderly Patients
Chronically Ill
Increased Risk of Falling
Lead sponsor: Universität Duisburg-Essen
Sponsor class: OTHER
Collaborators: name: Software AG Stiftung
name: Universität Freiburg
First posted: 2020-08-31
Enrollment: 60
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change in proteomic analysis from baseline to after intervention
timeFrame: Before intervention (week 0) and after intervention (6 months)
measure: Change in telomer analysis from baseline to after intervention
timeFrame: Before intervention (week 0) and after intervention (6 months)
measure: Qualitative parameter
timeFrame: After intervention (6 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Essen
country: Germany
facility: Kliniken Essen-Mitte
Study officials:
References: