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

January 18, 2024 updated by: ARCIM Institute Academic Research in Complementary and Integrative Medicine

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

16

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Germany
    • Baden-Württemberg
      • Filderstadt, Baden-Württemberg, Germany, 70794
        • Arcim Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-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.

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Eurythmy Therapy (performed as part of the ENTAiER main study)
Other: Qualitative interview - eurythmy group
Participants will be interviewed about self-perceived changes in everyday life during participation in the eurythmy intervention of the ENTAiER study.
Tai Chi (performed as part of the ENTAiER main study)
Other: Qualitative interview - tai chi group
Participants will be interviewed about self-perceived changes in everyday life during participation in the tai chi intervention of the ENTAiER study.
Standard Care
Other: Qualitative interview - standard care group
Participants will be interviewed about self-perceived changes in everyday life during participation in the standard care group of the ENTAiER study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-reported changes in daily life through movement exercises
Time Frame: 90-minute interviews
Semi-structured guided group interviews will be used
90-minute interviews

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-reported changes in the experience of movement in general
Time Frame: 90-minute interviews
Semi-structured guided group interviews will be used
90-minute interviews
Self-reported changes in movement security through movement exercises
Time Frame: 90-minute interviews
Semi-structured guided group interviews will be used
90-minute interviews
Self-reported changes in health through movement exercises
Time Frame: 90-minute interviews
Semi-structured guided group interviews will be used
90-minute interviews
Integration of movement exercises into everyday life
Time Frame: 90-minute interviews
Semi-structured guided group interviews will be used
90-minute interviews
Experiencing movement exercises
Time Frame: 90-minute interviews
Semi-structured guided group interviews will be used
90-minute interviews
Need for offers on movement exercises
Time Frame: 90-minute interviews
Semi-structured guided group interviews will be used
90-minute interviews

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ARCIM Institute Academic Research in Complementary and Integrative Medicine

Investigators

  • Principal Investigator: Jan Vagedes, Dr, Arcim Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 9, 2022

Primary Completion (Actual)

October 16, 2023

Study Completion (Actual)

October 16, 2023

Study Registration Dates

First Submitted

September 16, 2022

First Submitted That Met QC Criteria

September 20, 2022

First Posted (Actual)

September 21, 2022

Study Record Updates

Last Update Posted (Estimated)

January 19, 2024

Last Update Submitted That Met QC Criteria

January 18, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • EYT_13

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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