A multi-centre, parallel-group, randomised controlled trial to assess the efficacy and safety of eurythmy therapy and tai chi in comparison with standard care in chronically ill elderly patients with increased risk of falling (ENTAiER)

A multi-centre, parallel-group, randomised controlled trial to assess the efficacy and safety of eurythmy therapy and tai chi in comparison with standard care in chronically ill elderly patients with increased risk of falling(ENTAiER)
Abkürzung	ENTAiER
Studientyp	Multizentrische Studie, Randomisierte Studie, parallel-group trial
Status	Läuft (2021)
Personen	Gunver Kienle (Studienleitung) Paul Werthmann (Medizinische Studienkoordination)
Beginn	Die Patientenrekrutierung ist vom dritten Quartal 2019 bis zum zweiten Quartal 2021 geplant.
Ende	Ende des Follow-up ist geplant für das zweite Quartal 2022.
Publikation(en)	Studienprotokoll
Website	https://www.uniklinik-freiburg.de/entaier-studie
DRKS-ID	DRKS00016609
Population	Personen mit erhöhtem Sturzrisiko älter als 64 Jahre
Finanzierung	BMBF (Förderkennzeichen: 01GL1805)

ENTAiER ist eine Studie, um die Wirksamkeit von Heileurythmie und Tai Chi bei sturzgefährdeten Patient:innen zu untersuchen. Die Studie wird wesentlich vom IFAEMM betrieben. Sie wird gefördert durch das Bundesministerium für Bildung und Forschung (BMBF).

Abstract

Background

In elderly people, multimorbidity and polypharmacy increase while sensory, motor and cognitive functions decrease. Falls occur in 30% of people aged 65 years and older at least once per year, with injuries at 10–20%. Reducing falls and enhancing physical, emotional and cognitive capacities are essential for healthy aging despite chronic disease. Eurythmy therapy (EYT) and Tai Chi train balance, mobility and concentrative and sensory capacities.

Methods

In eight trial sites (academic or community hospitals), 550 outpatients aged 65 years and older with chronic disease and increased risk of falling (history of imbalance, Berg Balance Scale (BBS) score ≤ 49) will be randomly assigned (1:1:1) to receive either EYT or Tai Chi (each provided in one-hour group sessions, twice, later once per week plus practice at home, for over 24 weeks) added to standard care or standard care alone. Standard care includes a detailed written recommendation on fall prevention and the visit of a primary care doctor. Seniors living a reclusive life or economically disadvantaged elderly will be particularly addressed. A motivation and communication concept supports the trial participants’ compliance with trial procedures and practicing. Public and patient representatives are involved in the planning and conduction of the trial. Falls will be documented daily in a diary by the participants. These falls as well as injuries and complications will be ascertained during monthly phone visits. The falls efficacy scale, BBS, cognition (MoCA), Mood (GDS-15), quality of life (SF12), instrumental activities of daily living (IADL), use of medical and non-medical services (FIMA) and adherence will be assessed at months 3, 6, and 12 and inner correspondence with practices (ICPH) at month 6. The trial is funded by the Federal Ministry of Education and Research (BMBF 01GL1805).

Discussion

This study will determine whether EYT and Tai Chi reduce falls, injurious falls, fear of falling and healthcare utilisation and improve mobility, cognition, mood, quality of life and functional independence. A reduction of fall risk and fear of falling and an improvement of mobility, autonomy, quality of life, mood, and cognition are highly relevant for older people to cope with aging and diseases and to reduce healthcare costs.

Publikationen

• Liste von Publikationen: https://www.uniklinik-freiburg.de/entaier-studie/publikationen.html

Studienprotokoll

• GS Kienle, PG Werthmann, B Grotejohann, K Kaier, I Steinbrenner, S Voigt-Radloff, R Huber: A multi-centre, parallel-group, randomised controlled trial to assess the efficacy and safety of eurythmy therapy and tai chi in comparison with standard care in chronically ill elderly patients with increased risk of falling (ENTAiER): a trial protocol. In: BMC Geriatr. Band 20, Nr. 1, 17. März 2020, S. 108, doi:10.1186/s12877-020-1503-6, PMID 32183768, PMC 7076928 (freier Volltext).