Increased Risk of FallsNCT05547178
Changes in Everyday Life After a Tai Chi or Eurythmy Intervention in Elderly People at Risk of Falling: a Qualitative Exploration as a Sub-Study of the ENTAiER Study
An observational study of Increased Risk of Falls, run by ARCIM Institute Academic Research in Complementary and Integrative Medicine at 1 site in Germany.
Trial summary
The ENTAiER fall prevention study investigates the efficacy and safety of eurythmy therapy and tai chi in older people with chronic diseases and an increased risk of falls. In the course of the ENTAiER study, the participants observed changes in themselves and in their everyday life and described them in conversation… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Increased Risk of Falls
- What is being tested?
- Qualitative interview - eurythmy group and Qualitative interview - tai chi group
- How many people
- 16 participants
- Where
- 1 siteGermany
- Study dates
- 9 Nov 2022to 16 Oct 2023
- Phase
- Observational
- 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
Study population: Subjects who have consented to participate and are enrolled in the ENTAiER main study will be approached for participation in this sub-study. Sub-study will be conducted at the ARCIM Institute, Filderstadt.
Who may be able to join
- Enrolled and randomized participant of ENTAiER main study
- Written informed consent for participation in EYT_13 sub-study
- Participation in eurythmy or tai chi intervention for 24 weeks (-28d/+21d) (the standard care group will be time-equated to eurythmy and tai chi)
Who cannot join
- Early termination of the intervention (less than 20 weeks) (the standard care group will be time-equated to eurythmy and tai chi)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Self-perceived Changes in Everyday Life Among Participants of a Fall Prevention Study With Tai Chi or Eurythmy Intervention Versus Standard Care: a Qualitative Exploration as a Sub-Study of the ENTAiER Study
The ENTAiER fall prevention study investigates the efficacy and safety of eurythmy therapy and tai chi in older people with chronic diseases and an increased risk of falls. In the course of the ENTAiER study, the participants observed changes in themselves and in their everyday life and described them in conversation, which could not be recorded with the research methods used. A qualitative exploration of these subjectively experienced changes among participants of the ENTAiER study will be conducted as part of a sub-study. For this purpose, group interviews will be conducted.
- Conditions
- Increased Risk of Falls
- Being tested
- Qualitative interview - eurythmy group, Qualitative interview - tai chi group, Qualitative interview - standard care group
- Keywords
- Old age, Chronic disease, Risk of falls, Fear of falling, Fall prevention, Eurythmy, Tai Chi
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qualitative interview - eurythmy groupOther
Participants will be interviewed about self-perceived changes in everyday life during participation in the eurythmy intervention of the ENTAiER study.
Qualitative interview - tai chi groupOther
Participants will be interviewed about self-perceived changes in everyday life during participation in the tai chi intervention of the ENTAiER study.
Qualitative interview - standard care groupOther
Participants will be interviewed about self-perceived changes in everyday life during participation in the standard care group of the ENTAiER study.
| Study group | Role | What they receive |
|---|---|---|
| Eurythmy Therapy (performed as part of the ENTAiER main study) | Not described Receives: Other: Qualitative interview - eurythmy group | |
| Tai Chi (performed as part of the ENTAiER main study) | Not described Receives: Other: Qualitative interview - tai chi group | |
| Standard Care | Not described Receives: Other: Qualitative interview - standard care group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported changes in daily life through movement exercises
Semi-structured guided group interviews will be used
Measured: 90-minute interviews
Secondary outcomes (6)
Self-reported changes in the experience of movement in general
Semi-structured guided group interviews will be used
Measured: 90-minute interviews
Self-reported changes in movement security through movement exercises
Semi-structured guided group interviews will be used
Measured: 90-minute interviews
Self-reported changes in health through movement exercises
Semi-structured guided group interviews will be used
Measured: 90-minute interviews
Integration of movement exercises into everyday life
Semi-structured guided group interviews will be used
Measured: 90-minute interviews
Experiencing movement exercises
Semi-structured guided group interviews will be used
Measured: 90-minute interviews
Need for offers on movement exercises
Semi-structured guided group interviews will be used
Measured: 90-minute interviews
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2022
- Study start9 Nov 2022
- Primary completion16 Oct 2023
- Study completion16 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Increased Risk of FallsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- ARCIM Institute Academic Research in Complementary and Integrative Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jan Vagedes, Dr, Principal investigator, ARCIM Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05547178
- Sponsor's protocol ID
- EYT_13
- Status last verified
- Jan 2024
- First submitted
- 16 Sep 2022
- Last updated
- 19 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-perceived Changes in Everyday Life Among Participants of a Fall Prevention Study With Tai Chi or Eurythmy Intervention Versus Standard Care: a Qualitative Exploration as a Sub-Study of the ENTAiER Study
- ClinicalTrials.gov ID
- NCT05547178
- Acronym / sponsor ID
- EYT_13
- Conditions
- Increased Risk of Falls
- Keywords
- Old age, Chronic disease, Risk of falls, Fear of falling, Fall prevention, Eurythmy, Tai Chi
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- ARCIM Institute Academic Research in Complementary and Integrative MedicineUniversity, hospital or other
- Study start
- 9 Nov 2022 (actual)
- Primary completion
- 16 Oct 2023 (actual)
- Study completion
- 16 Oct 2023 (actual)
- First posted
- 21 Sep 2022 (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 ENTAiER fall prevention study investigates the efficacy and safety of eurythmy therapy and tai chi in older people with chronic diseases and an increased risk of falls. In the course of the ENTAiER study, the participants observed changes in themselves and in their everyday life and described them in conversation, which could not be recorded with the research methods used. A qualitative exploration of these subjectively experienced changes among participants of the ENTAiER study will be conducted as part of a sub-study. For this purpose, group interviews will be conducted.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Eurythmy Therapy (performed as part of the ENTAiER main study) | – | Other: Qualitative interview - eurythmy group |
| Tai Chi (performed as part of the ENTAiER main study) | – | Other: Qualitative interview - tai chi group |
| Standard Care | – | Other: Qualitative interview - standard care group |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Subjects who have consented to participate and are enrolled in the ENTAiER main study will be approached for participation in this sub-study. Sub-study will be conducted at the ARCIM Institute, Filderstadt.
Key inclusion criteria (3 listed)
- Enrolled and randomized participant of ENTAiER main study
- Written informed consent for participation in EYT_13 sub-study
- Participation in eurythmy or tai chi intervention for 24 weeks (-28d/+21d) (the standard care group will be time-equated to eurythmy and tai chi)
Key exclusion criteria (1 listed)
- Early termination of the intervention (less than 20 weeks) (the standard care group will be time-equated to eurythmy and tai chi)
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 |
|---|---|---|
| Qualitative interview - eurythmy groupParticipants will be interviewed about self-perceived changes in everyday life during participation in the eurythmy intervention of the ENTAiER study. | Other | Eurythmy Therapy (performed as part of the ENTAiER main study) |
| Qualitative interview - tai chi groupParticipants will be interviewed about self-perceived changes in everyday life during participation in the tai chi intervention of the ENTAiER study. | Other | Tai Chi (performed as part of the ENTAiER main study) |
| Qualitative interview - standard care groupParticipants will be interviewed about self-perceived changes in everyday life during participation in the standard care group of the ENTAiER study. | Other | Standard Care |
Primary outcome
Self-reported changes in daily life through movement exercises
Time frame: 90-minute interviews
Semi-structured guided group interviews will be used
6 secondary outcomes
Self-reported changes in the experience of movement in general
Time frame: 90-minute interviews
Self-reported changes in movement security through movement exercises
Time frame: 90-minute interviews
Self-reported changes in health through movement exercises
Time frame: 90-minute interviews
Integration of movement exercises into everyday life
Time frame: 90-minute interviews
Experiencing movement exercises
Time frame: 90-minute interviews
Need for offers on movement exercises
Time frame: 90-minute interviews
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 19 Jan 2024.
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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.
Jan Vagedes, Dr principal investigator
ARCIM Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Increased Risk of Falls, run by ARCIM Institute Academic Research in Complementary and Integrative Medicine 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 3 inclusion and 1 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 19 Jan 2024. 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?
Self-reported changes in daily life through movement exercises (time frame: 90-minute interviews). 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 19 Jan 2024.