NCT05547178

Brief 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, 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 16, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 21, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

November 9, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 16, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 16, 2023

Completed
Last Updated

January 19, 2024

Status Verified

January 1, 2024

Enrollment Period

11 months

First QC Date

September 16, 2022

Last Update Submit

January 18, 2024

Conditions

Increased Risk of Falls

Keywords

Old ageChronic diseaseRisk of fallsFear of fallingFall preventionEurythmyTai Chi

Outcome Measures

Primary Outcomes (1)

  • Self-reported changes in daily life through movement exercises

    Semi-structured guided group interviews will be used

    90-minute interviews

Secondary Outcomes (6)

  • Self-reported changes in the experience of movement in general

    90-minute interviews

  • Self-reported changes in movement security through movement exercises

    90-minute interviews

  • Self-reported changes in health through movement exercises

    90-minute interviews

  • Integration of movement exercises into everyday life

    90-minute interviews

  • Experiencing movement exercises

    90-minute interviews

  • +1 more secondary outcomes

Study Arms (3)

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

Interventions

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.

Eurythmy Therapy (performed as part of the ENTAiER main 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.

Tai Chi (performed as part of the ENTAiER main 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.

Standard Care

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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)

You may not qualify if:

  • Early termination of the intervention (less than 20 weeks) (the standard care group will be time-equated to eurythmy and tai chi)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arcim Institute

Filderstadt, Baden-Wurttemberg, 70794, Germany

Location

MeSH Terms

Conditions

Chronic Disease

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jan Vagedes, Dr

    ARCIM Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2022

First Posted

September 21, 2022

Study Start

November 9, 2022

Primary Completion

October 16, 2023

Study Completion

October 16, 2023

Last Updated

January 19, 2024

Record last verified: 2024-01

Locations

DE(1)