Sub-study of the Essen Study Centre for the ENTAiER Trial
NCT ID: NCT04532073
Last Updated: 2023-12-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
60 participants
INTERVENTIONAL
2021-07-27
2022-12-07
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
Eurythmy Therapy
A mindfulness-oriented movement therapy
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
Tai Chi
A martial art developed in China, which in recent times is often regarded as a system of movement theory or gymnastics
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
Standard Care
Treatment process that a clinician should follow for a certain type of patient
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Eurythmy Therapy
A mindfulness-oriented movement therapy
Tai Chi
A martial art developed in China, which in recent times is often regarded as a system of movement theory or gymnastics
Standard Care
Treatment process that a clinician should follow for a certain type of patient
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Software AG Stiftung
UNKNOWN
Universität Freiburg
UNKNOWN
Universität Duisburg-Essen
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Holger Cramer
Research Director
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Kliniken Essen-Mitte
Essen, , Germany
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
20-9421-BO
Identifier Type: -
Identifier Source: org_study_id