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.

Author: Kienle GS1,2, Werthmann PG3,4, Grotejohann B5, Kaier K6, Steinbrenner I5, Voigt-Radloff S7,8, Huber R3
Author Information:
1Center for Complementary Medicine; Institute for Infection Prevention and Hospital Epidemiology, Medical Center, University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany. gunver.kienle@uniklinik-freiburg.de.
2IFAEMM at the University of Witten/Herdecke, Freiburg, Germany. gunver.kienle@uniklinik-freiburg.de.
3Center for Complementary Medicine; Institute for Infection Prevention and Hospital Epidemiology, Medical Center, University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.
4IFAEMM at the University of Witten/Herdecke, Freiburg, Germany.
5Clinical Trials Unit, Medical Center, University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.
6Institute of Medical Biometry and Statistics, Division Methods in Clinical Epidemiology, Medical Center, University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.
7Center for Geriatric Medicine and Gerontology Freiburg, Medical Center, University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.
8Institute for Evidence in Medicine (for Cochrane Germany Foundation), Medical Center, University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.
Conference/Journal: BMC Geriatr.
Date published: 2020 Mar 17
Other: Volume ID: 20 , Issue ID: 1 , Pages: 108 , Special Notes: doi: 10.1186/s12877-020-1503-6. , Word Count: 368


BACKGROUND: In elderly poeple, 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. TRAIL REGISTRATION: www.drks.de. DRKS00016609. Registered 30th July 2019.

KEYWORDS: Aged; Chronic disease; Eurythmy therapy; Exercise; Falls; Prevention; Tai chi

PMID: 32183768 DOI: 10.1186/s12877-020-1503-6

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