Elderly PatientsNCT04532073
Sub-study of the Essen Study Centre for the ENTAiER Trial
A study testing Eurythmy Therapy and Tai Chi in people with Elderly Patients and Chronically Ill, run by Universität Duisburg-Essen at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Elderly Patients, Chronically Ill, Increased Risk of Falling
- What is being tested?
- Eurythmy Therapy and Tai Chi
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- 27 Jul 2021to 7 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Elderly Patients, Chronically Ill, Increased Risk of Falling
- Being tested
- Eurythmy Therapy, Tai Chi, Standard Care
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eurythmy TherapyOther
A mindfulness-oriented movement therapy
Tai ChiOther
A martial art developed in China, which in recent times is often regarded as a system of movement theory or gymnastics
Standard CareOther
Treatment process that a clinician should follow for a certain type of patient
| Study group | Role | What they receive |
|---|---|---|
| Eurythmy therapy exercises | Experimental | 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. Receives: Other: Eurythmy Therapy |
| Tai Chi exercises | Experimental | 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 Receives: Other: Tai Chi |
| Standard Care Only | Active comparator | 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 Receives: Other: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: 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.
Measured: After intervention (6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2020
- Study start27 Jul 2021
- Primary completion7 Dec 2022
- Study completion7 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elderly PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universität Duisburg-Essen
- Sponsor type
- University, hospital or other
- Collaborators
- Software AG Stiftung, University of Freiburg
- Responsible party
- Principal investigator, Holger Cramer, Universität Duisburg-Essen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04532073
- Sponsor's protocol ID
- 20-9421-BO
- Status last verified
- Dec 2023
- First submitted
- 20 Aug 2020
- Last updated
- 21 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sub-study of the Essen Study Centre With Proteome and Telomer Analyses and Qualitative Parameters for the ENTAiER Trial
- ClinicalTrials.gov ID
- NCT04532073
- Acronym / sponsor ID
- 20-9421-BO
- Conditions
- Elderly Patients, Chronically Ill, Increased Risk of Falling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Universität Duisburg-EssenUniversity, hospital or other
- Collaborators
- Software AG Stiftung, University of Freiburg
- Study start
- 27 Jul 2021 (actual)
- Primary completion
- 7 Dec 2022 (actual)
- Study completion
- 7 Dec 2022 (actual)
- First posted
- 31 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Eurythmy therapy exercises | Experimental | Other: Eurythmy TherapyAs 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. |
| Tai Chi exercises | Experimental | Other: Tai ChiAs 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 |
| Standard Care Only | Active comparator | Other: Standard CareAs 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 |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eurythmy TherapyA mindfulness-oriented movement therapy | Other | Eurythmy therapy exercises |
| Tai ChiA martial art developed in China, which in recent times is often regarded as a system of movement theory or gymnastics | Other | Tai Chi exercises |
| Standard CareTreatment process that a clinician should follow for a certain type of patient | Other | Standard Care Only |
Primary outcome
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)
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2023.
- Main studyLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eurythmy Therapy and Tai Chi in people with Elderly Patients and Chronically Ill, run by Universität Duisburg-Essen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in proteomic analysis from baseline to after intervention (time frame: Before intervention (week 0) and after intervention (6 months)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2023.