DRKS00016609已完成3 期
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
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 552
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 65 Years 至 one（—）
- 性别
- All
入选标准
- •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
排除标准
- •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).
研究者
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