Sub-study of the Essen Study Centre With Proteome and Telomer Analyses and Qualitative Parameters for the ENTAiER Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in telomer analysis from baseline to after intervention
研究概览
简要总结
The present study is a sub-study of the ENTAiER study. The ENTAiER study is a multicenter, randomized, controlled study to evaluate the efficacy and safety of eurythmy therapy and Tai Chi in comparison to standard care in chronically ill older patients with an increased risk of falling.
In addition to the main questions of the ENTAiER study, three additional questions are being investigated at the Hospital Essen-Steele: Proteome and telomere analyses as well as qualitative parameters are recorded and examined. The aim is to compare the changes in proteomes, telomeres and qualitative factors under eurythmy therapy, Tai Chi and standard care in chronically ill older patients with an increased risk of falling.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 65 years.
- •Chronic disease (musculoskeletal, neurological, internal medicine).
- •Increased risk of falling (Berg Balance Scale Score 49 or less).
- •Medical history: feeling of balance disturbance in the past.
- •Independent living at home or in an old people's or retirement home.
- •Regular participation in a one-hour event is possible.
- •Sufficiently mobile to leave the place of residence independently at least twice a week
- •Written declaration of consent.
排除标准
- •Disease that restricts participation (e.g. terminal disease, heart failure NYHA III-IV, unstable angina pectoris, uncontrolled seizure disorder, decompensated lung disease that already leads to shortness of breath during light activity, advanced cancer, chemo- or radiotherapy ongoing or during the last 3 months, amputation of one or both legs)
- •Complete dependence on the rollator.
- •Visual, hearing or speech problems that limit the understanding of the study documents and processes.
- •Major cognitive impairment (MoCA score 18 or less).
- •High risk of needing individual supervision during group sessions.
- •Severe personality disorder or psychiatric illness, alcoholism or other substance dependence affecting the group sessions.
- •Life expectancy under 1 year.
- •Permanent bed-riddenness expected in less than one year.
- •Regular participation in Tai Chi or EYT in the last 6 months.
- •Participation in intensive sports activities in the last month (e.g. training in the fitness centre or in sports groups which lead to breathlessness and sweating; skiing, mountaineering in high mountains).
- •Patients who cannot understand the nature, meaning and necessities of participating in a study.
- •Participation in another clinical trial within 3 months prior to screening for the ENTAiER trial or concurrent participation in another trial that may interfere with this trial.
结局指标
主要结局
Change in telomer analysis from baseline to after intervention
时间窗: Before intervention (week 0) and after intervention (6 months)
The telomere length is determined from blood samples using quantitative real-time PCR (TaqMan) from genomic DNA.
Qualitative parameter
时间窗: After intervention (6 months)
By means of semi-structured interviews of maximum 60 minutes per participant, the effects of the intervention are to be recorded qualitatively.
Change in proteomic analysis from baseline to after intervention
时间窗: Before intervention (week 0) and after intervention (6 months)
A maximum of 500 µL plasma is used for the proteomic studies. The proteins are digested tryptically, a concentration determination is performed by amino acid analysis and the peptide samples are then measured by different mass spectrometric methods (data dependent (DDA) and independent detection (DIA), proteome-wide prediction of peptide tandem mass spectra by deep learning (Prosit), etc.). The results obtained are then verified by Western blot, ELISA and/or a targeted mass spectrometric method (parallel reaction monitoring)
次要结局
未报告次要终点
研究者
Holger Cramer
Research Director
Universität Duisburg-Essen