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临床试验/NCT03110419
NCT03110419已完成不适用

Effects of a Multicomponent Training on Postural Control and Cardiovascular and Musculoskeletal Systems in Pre-frail Elderly

Universidade Federal de Sao Carlos2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2017年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
2
主要终点
Linear and nonlinear measurements of postural control

研究概览

简要总结

This study aim to evaluate the effects of 16 weeks of multicomponent training on postural control, cardiovascular and musculoskeletal systems in pre-frail elderly through nonlinear and linear measurements.

详细描述

Frailty syndrome is described as a clinical state of vulnerability to stress resulting from the decline of resilience and physiological reserves associated with aging. It is also characterized by a reduction of the interaction between systems and that would be reflected by a loss of physiological complexity. Physical exercise, especially the multi-component, is pointed out as a key element in the intervention of frail elderly individuals. However, it is still unclear whether the improvement in functional capacity observed with this type of training would be related to changes in the physiological complexity of these elderly individuals. The aim of this study is to evaluate the effect of multi-component training on the dynamics of the cardiovascular, motor, neuromuscular and physical activity levels of pre-frail elderly. Thirty-six pre-frail elderly individuals will be divided into intervention (IG, n = 18) and control (CG, n = 18) groups at three different moments (pre-intervention, post-intervention, 16 weeks, and follow-up of detraining of 6 Weeks). The complexity will be evaluated by calculating the entropy of the biological signals: a) heart rate, blood pressure (in supine and orthostatic conditions), b) oscillations of the pressure center (in open, closed eyes, after standing in a chair And under dual-task cognitive condition), c) torque oscillations of the knee extensor muscle group.

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
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • >= 65 years old;
  • conventional ECG without alterations in rest;
  • medical release for physical exercise;
  • understand the instructions and agree to participate.

排除标准

  • historical stroke which produces loss of strength and aphasia;
  • several impairment of motor skills;
  • Parkinson disease;
  • Diabetes Mellitus;
  • Peripheral Neuropathy;
  • Vestibular and visual disorders self-reported in anamnesis;
  • Severe cognitive impairment;
  • Cardiovascular disorders (atrial fibrillation, malignant ventricular arrhythmia; ventricular beats complexes ectopic, sinus tachycardia or supraventricular, second and third degree of atrioventricular block, use of pacemaker in the resting ECG);
  • Unstable angina;
  • Myocardial infarction;
  • Elderly end stage.

研究组 & 干预措施

Intervention

Experimental

The training group will perform a Physical Exercise as multicomponent training.

干预措施: Physical Exercise (Other)

Control

No Intervention

The control group will only be evaluated, without any intervention.

结局指标

主要结局

Linear and nonlinear measurements of postural control

时间窗: Change from baseline sample entropy and approximate entropy at 16 weeks of multicomponent training and after 6 weeks of detraining

Sample Entropy; Approximate Entropy

Linear and nonlinear measurements of cardiovascular system

时间窗: Change from baseline heart rate variability and conditional entropy at 16 weeks of multicomponent training and after 6 weeks of detraining

Heart Rate Variability; Conditional Entropy

Linear and nonlinear measurements of musculoskeletal systems

时间窗: Change from baseline knee extensor torque complexity at 16 weeks of multicomponent training and after 6 weeks of detraining

Knee extensor torque complexity

Cognition Measures

时间窗: Change from baseline addenbrooke's cognitive examination at 16 weeks of multicomponent training and after 6 weeks of detraining

Addenbrooke's Cognitive Examination

次要结局

  • Functional Measures(Change from baseline short physical performance battery at 16 weeks of multicomponent training and after 6 weeks of detraining)

研究者

发起方
Universidade Federal de Sao Carlos
申办方类型
Other
责任方
Principal Investigator
主要研究者

Anielle C M Takahashi

PhD, Adjunt Professor

Universidade Federal de Sao Carlos

研究点 (2)

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