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A multi-centre, parallel-group, randomised controlled trial to assess the efficacy and safety of Eurythmy Therapy and Tai Chi in comparison to standard care in chronically ill elderly patients with increased risk of falling

A multi-centre, parallel-group, randomised controlled trial to assess the efficacy and safety of Eurythmy Therapy and Tai Chi in comparison to standard care in chronically ill elderly patients with increased risk of falling - ENTAiER

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
DRKS
Registry ID
DRKS00016609
Enrollment
550
Registered
2019-07-30
Start date
2019-08-16
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Increased risk for falling in elderly patients with chronic disease R29.6

Interventions

Group 1: Eurythmy Therapy (EYT): In group sessions á 5 patients instructed by a qualified teacher: During the first 3 months twice per week, during the second 3 months once per week. If group meeting

Sponsors

Universitätsklinikum Freiburg
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to No maximum

Inclusion criteria

Inclusion criteria: • Adults 65 years or older. • Chronic disease (musculoskeletal, neurologic, internistic) • Increased risk of falling (Berg Balance Scale (BBS) score 49 or less). • Self-reported history of imbalance (Anamnestic: Uncertainty when walking or standing) • Living in the community (at own home) or retirement or nursing home. • Ability to participate in 1-hour group-based sessions (medical assessment). • Able to leave home on their own at least twice per week (e.g. for doctors visit, shopping) • Patient's written informed consent has been obtained

Exclusion criteria

Exclusion criteria: • Medical conditions limiting participation (e.g., terminal illness, heart failure NYHA III-IV, unstable angina pectoris, uncontrolled seizure disorder, decompensated lung disease with less than ordinary activity leading to dyspnoea, cancer in advanced stage, chemo- or radiotherapy ongoing or during last three months, amputation of one or both legs). • Complete dependence on rollator (wheeled walker). • Visual, hearing or language problems affecting understanding of trial documents and procedures. • Major cognitive impairment (MoCA score 18 or less). • High risk for individual support during group session. • Urge incontinence affecting group sessions. • Severe personality disorder, psychiatric disease, alcohol use disorder or other substance use disorders affecting participation of group classes and regular practicing. • Life expectancy of less than 1 year. • Permanent confinement to bed to be expected in less than a year. • Participating in regular Tai Chi or EYT exercises within last 6 months. • Participating in vigorous sports for exercise within last month (e.g. training in fitness club or sport group inducing sweating and breathlessness or skiing and mountaineering in high mountains). • Patient without legal capacity who is unable to understand the nature, significance and consequences of the study. • Simultaneous participation in other studies which could interfere with this study. • Participation in a clinical study within the 3 months before the start of this study (screening).

Design outcomes

Primary

MeasureTime frame
Fall (yes/no) within 6 months recorded in diary (i.e. “fallers”)

Secondary

MeasureTime frame
Monthly: • Number of falls recorded in diary, • Number of injurious falls, • Safety: Complications. • Adherence to training recommendation (EYT and Tai Chi group). Month 0, 3, 6, 12: • Fear of falling (Short Falls Efficacy Scale-International, Short FES-I), • Mobility and Balance (Berg Balance Scale, BBS), • Cognition (Montreal Cognitive Assessment, MoCA), • Depression (Geriatric Depression Scale, GDS-15), • Health-related quality of life (SF-12), • Self-maintaining and instrumental activities of daily living (IADL), • Health Care Utilization: Physician contacts, medication, hospitalizations (FIMA). Month 6: • Inner Correspondence/Peaceful Harmony with Practices (ICPH), • use of recommendation of fall prevention brochure.

Countries

Germany

Contacts

Public ContactGunver Kienle

UNIVERSITÄTSKLINIKUM FREIBURG, Klinik für Innere Medizin II, Unizentrum Naturheilkunde

entaier@uniklinik-freiburg.de+49 761 270-82010

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 28, 2026