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临床试验/NCT06627881
NCT06627881招募中不适用

Effect of Three Training Programs on the Cardiovascular Condition of Individuals with Spinal Cord Injury, a Model of Autonomic Nervous System Dysfunction.

Instituto Nacional de Rehabilitacion2 个研究点 分布在 1 个国家目标入组 63 人开始时间: 2023年1月25日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
63
试验地点
2
主要终点
Measured metabolic equivalents

研究概览

简要总结

Objective: Describe the effect of different aerobic training programs on the autonomic nervous system (ANS), cardiovascular condition, body composition, metabolic profile, movement and functional independence in patients with spinal cord injury (SCI).

Design: Randomized clinical trial Participants: Individuals in the chronic phase of SCI. Interventions: Three training programs: continuous aerobic in kayak, aerobic resistance circuit, and high-intensity interval with rope. The main measures to be explored will be the potential effects of training on heart rate variability as an indicator of autonomic function; measurement of oxygen consumption (VO2max) and resting metabolic unit (METs) for cardiovascular fitness; bone density examination (DXA) for body composition, metabolic profile, functional independence and life satisfaction in individuals with SCI.

Results: The 8-week training program will increase METs and VO2max, improve heart rate variability and anthropometric variables, body composition, and metabolic profile

详细描述

Background The increased overall cardiovascular risk could have some causes, such as dyslipidemia, diabetes mellitus, hypertension (HTN), higher BMI, higher waist-to-hip ratio, or deterioration in physical fitness. Obesity and diabetes have been shown to be comparatively higher among people with SCI. An additional factor that contributes to the high cardiovascular morbidity and mortality in SCI is sedentary lifestyle and reduced physical function associated with the loss of motor function, and the interruption of normal autonomic cardiovascular control mechanisms.

It is increasingly recognized that inflammation plays an important role in the development of cardiovascular disease (CVD); elevated reactive C protein (RCP) levels are independently associated with increased all-cause mortality, cardiovascular death, and cardiovascular events. In turn, the higher degree of dyslipidemia found in the population with SCI contributes significantly to this risk. Abnormal lipids are generally modifiable with changes in physical activity and diet along with the use of statins. Numerous studies in people with diabetes have unequivocally shown that hyperglycemia is a potent risk marker for CVD; altered carbohydrate metabolism is more common in people with SCI, and is believed to appear at an earlier age than in people without disabilities.

High adiposity and visceral fat accumulation are related to insulin resistance, gluco-metabolic disorders and a higher risk of developing DM (diabetes mellitus) and CVD. Sophisticated and high-precision radiological techniques, such as DXA and CT, are considered the gold standards for accurate measurement of the ratio of lean to fat mass, it is proposed that the increase in body fat mass and the decrease in Lean tissue mass are valuable markers of CVD.

Exercise has been shown to have good results, mainly in the early stages of BF. In particular, it has been described that aerobic exercise training improves baroreflex sensitivity and that the magnitude of the improvement is related to the intensity of the exercise performed and is proportional to the gains in aerobic capacity (through VO2max). However, in advanced stages of CVD, the response to exercise may be affected due to ANS dysfunction. Indeed, autonomic dysfunction plays a primary role in the pathophysiology of coronary ischemic disease. The presence of a high HRV is a sign of good adaptability and implies that the individual has autonomic control mechanisms that function adequately, that is, the activity of this system plays a substantial role in the physiological adaptations of circulation to changes in brain activity. human being. Therefore, the study of pathologies that affect the ANS can help understand this lack of response and search for effective strategies to improve cardiovascular function.

To date, there are few studies that have evaluated the effect of different exercise modalities on the cardiovascular condition of people with SCI, who will have a different response from that of healthy people or at the beginning of chronic diseases, but similar to that of people in advanced stages of cardiovascular disease. Therefore, exercise can exert cardioprotective effects and benefit the cardiovascular risk profile.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

Those in charge of evaluating results and the person in charge of statistical analysis will be blinded and will not know the assignment of the intervention. The person in charge of carrying out the assigned exercise and the participant will know the assignment of the intervention.

入排标准

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

入选标准

  • Clinical diagnosis of spinal cord injury with any American Spinal Injury Association Impairment Scale (AIS) classification
  • Neurologic level below C8
  • Time since injury greater than 6 months
  • Any etiology
  • Any type (complete and incomplete)
  • Adequate trunk control (trunk control scale >13 points)

排除标准

  • Another neurologic diagnosis
  • Sense organ alteration
  • Orthopedic problem that interferes with training
  • Alteration in superior mental function
  • Cardiovascular or metabolic disease that interferes with training

结局指标

主要结局

Measured metabolic equivalents

时间窗: Before training and 8 weeks

Metabolic unit of measurement that indicates the ml of oxygen consumed per kg/min

Oxygen consumption (VO2máx)

时间窗: Before training and 8 weeks

It is the largest amount of oxygen that the body can absorb, transport and consume in a given time.

Low-high frequency ratio (LF/HF)

时间窗: Before training and 8 weeks

Heart rate variability domain measurement

次要结局

  • Satisfaction with life(Before training and 8 weeks)
  • Spinal Cord Injury Independence Measure III(Before training and 8 weeks)
  • Plasma glucose concentration.(Before training and 8 weeks)
  • Plasma triglyceride concentration(Before training and 8 weeks)
  • High-density lipoprotein cholesterol (HDL-C)(Before training and 8 weeks)
  • Low-density lipoprotein cholesterol(Before training and 8 weeks)
  • Serum insulin(Before training and 8 weeks)
  • Ultrasensitive CRP(Before training and 8 weeks)
  • Appendicular lean mass to height ratio (ALM/Height2)(Before training and 8 weeks)
  • Body mass index(Before training and 8 weeks)
  • Trunk control Test(Before training and 8 weeks)

研究者

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

Marlene Alejandra Rodríguez Barragán

MD, MSc

Instituto Nacional de Rehabilitacion

研究点 (2)

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