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CompletedNCT05547178Updated Jan 19, 2024

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 in Increased Risk of Falls, sponsored by ARCIM Institute Academic Research in Complementary and Integrative Medicine. Completed at 1 site in Germany. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2024-01-19.

Sponsored by ARCIM Institute Academic Research in Complementary and Integrative Medicine · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
16
Ages
65 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Increased Risk of Falls

Keywords

  • Old age
  • Chronic disease
  • Risk of falls
  • Fear of falling
  • Fall prevention
  • Eurythmy
  • Tai Chi
03

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
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.

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

Exclusion Criteria:

  • Early termination of the intervention (less than 20 weeks) (the standard care group will be time-equated to eurythmy and tai chi)
04

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
16 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • OtherQualitative interview - eurythmy group

    Participants will be interviewed about self-perceived changes in everyday life during participation in the eurythmy intervention of the ENTAiER study.

  • OtherQualitative 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.

  • OtherQualitative 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.

05

What researchers measure

Primary outcomes

  1. Self-reported changes in daily life through movement exercises

    Semi-structured guided group interviews will be used

    Time frame: 90-minute interviews

Secondary outcomes

  1. Self-reported changes in the experience of movement in general

    Semi-structured guided group interviews will be used

    Time frame: 90-minute interviews

  2. Self-reported changes in movement security through movement exercises

    Semi-structured guided group interviews will be used

    Time frame: 90-minute interviews

  3. Self-reported changes in health through movement exercises

    Semi-structured guided group interviews will be used

    Time frame: 90-minute interviews

  4. Integration of movement exercises into everyday life

    Semi-structured guided group interviews will be used

    Time frame: 90-minute interviews

  5. Experiencing movement exercises

    Semi-structured guided group interviews will be used

    Time frame: 90-minute interviews

  6. Need for offers on movement exercises

    Semi-structured guided group interviews will be used

    Time frame: 90-minute interviews

06

Study locations

1 site
  • Arcim Institute
    Filderstadt, Baden-Württemberg 70794, Germany
07

Registry details

Key details

Study ID
NCT05547178
Lead sponsor
ARCIM Institute Academic Research in Complementary and Integrative Medicine
Responsible party
Sponsor
First posted
Sep 21, 2022
Start date
Nov 9, 2022
Primary completion
Oct 16, 2023
Completion
Oct 16, 2023
Last update
Jan 19, 2024

Study contacts

Jan Vagedes, Dr
principal investigator · ARCIM Institute

Oversight

FDA-regulated drug
No
FDA-regulated device
No
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