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临床试验/NCT05286723
NCT05286723Unknown不适用

Effectiveness Multicomponent Exercise Programme in Older Subjects. A Pilot Study.

Universitat Internacional de Catalunya2 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2022年4月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
13
试验地点
2
主要终点
Functionality (Running speed in 4 metres. Seconds)

研究概览

简要总结

Sarcopenia can occur or increase due to sedentary lifestyles, physical inactivity or chronic endocrine and inflammatory disorders, this pathology is much more frequent in older people due to the added risk factors and the fact that the physiological ageing process generates a pro-inflammatory situation and an alteration in the synthesis of hormones and myokines, it has been observed that the loss of strength causes functional deterioration and a significant increase in the person's dependence, reduces their functional status and quality of life, and may increase the risk of falls, thereby increasing mortality.

The hipotesis of this study is that multicomponent training 3 times a week for 6 weeks, produces improvements in the functional capacity of elderly patients.

This study has the objective is whether multicomponent training 3 times a week for 6 weeks produces improvements in the functional capacity of elderly patients.

The methodology is a pilot clinical trial. The study population is people over 65 years of age, sedentary, with functional independence and with a state of health that allows them to carry out physical activity. The study is planned as a pilot study and will consist of 13 subjects in the experimental group (multicomponent training).

The variables to be measured are anthropometric variables and variables of neuromuscular function an functionality.

The intervention will be a training will be 3 times a week during 6 weeks, with a warm-up, a main block with aerobic work, strength work and training and coordination work, and finally a return to calm.

详细描述

Sarcopenia can occur or increase due to sedentary lifestyles, physical inactivity or chronic endocrine and inflammatory disorders, this pathology is much more frequent in older people due to the added risk factors and the fact that the physiological ageing process generates a pro-inflammatory situation and an alteration in the synthesis of hormones and myokines, it has been observed that the loss of strength causes functional deterioration and a significant increase in the person's dependence, reduces their functional status and quality of life, and may increase the risk of falls, thereby increasing mortality.

The hipotesis of this study is that multicomponent training 3 times a week for 6 weeks, produces improvements in the functional capacity of elderly patients.

This study has the objective is whether multicomponent training 3 times a week for 6 weeks produces improvements in the functional capacity of elderly patients.

The methodology is a pilot clinical trial. The study population is people over 65 years of age, sedentary, with functional independence and with a state of health that allows them to carry out physical activity. The study is planned as a pilot study and will consist of 13 subjects in the experimental group (multicomponent training).

The variables to be measured are anthropometric variables and variables of neuromuscular function an functionality.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
65 Years 至 95 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Sedentary persons between 65 and 95 years of age.
  • Have a walking speed ≤0.8 metres per second as this is characteristic of patients with or with onset of sarcopenia.
  • Have a grip strength <30 kg for men and <20 kg for women as being characteristic of patients with or with onset of sarcopenia.

排除标准

  • Severe untreated osteoporosis.
  • Having suffered a bone fracture in the last year.
  • Having had juvenile osteoporosis during adolescence or young adulthood.
  • Active chronic pathology
  • Uncontrolled arterial hypertension.
  • Uncontrolled orthostatic hypotension.
  • Severe acute respiratory failure.
  • Diabetes mellitus with acute decompensation or uncontrolled hypoglycaemia.
  • Endocrine, haematological and other associated rheumatic diseases.
  • Mental health problems (schizophrenia, dementia, depression, etc.) or not being in full mental capacity.
  • Patients with pharmacological treatments of glucocorticoids, anticoagulants and/or diuretics.
  • Patients with coagulation problems or previous cardiac pathology.
  • People with a body mass index (BMI) of 30 or more.
  • Subjects with a systemic disease or any other pathology in which therapeutic exercise may be contraindicated.

结局指标

主要结局

Functionality (Running speed in 4 metres. Seconds)

时间窗: Change between baseline and 6 weeks

The participant's speed in covering 4 metres at their usual walking speed is assessed. The shorter the time, the faster the walking speed and therefore the better the functionality.

Functionality (Timed get up and go. Seconds)

时间窗: Change between baseline and 6 weeks

The time it takes the participant to get up from a chair, walk 3 metres, turn around an obstacle (a cone) and sit back down in the chair is assessed. The less time the participant takes to perform the test, the better the functionality.

次要结局

  • Functionality (Short Physical Performance Battery. 0-12 points)(Change between baseline and 6 weeks)
  • Neuromuscular Function, Handgrip (Kg)(Change between baseline and 6 weeks)
  • Neuromuscular Function, Myotonometry (Stiffness)(Change between baseline and 6 weeks)
  • Neuromuscular Function,Tensiomyography (Radial displacement (Dm)).(Change between baseline and 6 weeks)
  • Neuromuscular Function,Tensiomyography (Shrinkage time (Tc))(Change between baseline and 6 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jacobo Rodríguez Sanz

Principal Investigator

Universitat Internacional de Catalunya

研究点 (2)

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