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

Phase 3

Conditions: Increased risk for falling in elderly patients with chronic disease
R29.6
Tendency to fall, not elsewhere classified

Registration Number: DRKS00016609

Lead Sponsor: niversitätsklinikum Freiburg

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 552

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

• 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).

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fall (yes/no) within 6 months recorded in diary (i.e. fallers”)

Secondary Outcome Measures

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