跳至主要内容
临床试验/NCT03521401
NCT03521401已完成不适用

Effects of Exercise on Young Adult Women With ACEs: an Integrative Pilot Study

Oklahoma State University2 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2018年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
64
试验地点
2
主要终点
Interleukin-1 receptor agonist

研究概览

简要总结

The process by which the body responds to stressors to maintain homeostasis is called allostasis and is dependent on the integrated function of the nervous, endocrine, and immune systems. ACEs adversely affect these system, cause allostatic load, and can modify development of allostatic systems. However, the central hypothesis is that exercise can reduce allostatic load by positively augmenting function of each of these three systems. No previous studies have examined the effects of structured exercise interventions in individuals with ACEs. The investigators are studying the effects of 8-weeks of structured resistance and aerobic exercise on biomarkers related to nervous, endocrine, immune, and metabolic function and several clinical outcomes in young adult women with ACEs. The specific aims will test several hypotheses, and are as follows: SPECIFIC AIM 1: Conduct a feasibility study to explore whether progressive, structured exercise can help mitigate the adverse physiological effects of stress and trauma early in life. SPECIFIC AIM 2: Determine whether progressive, structured exercise can help improve health-related quality of life, anxiety, and traits like hope, self-efficacy, or self-control, resilience. SPECIFIC AIM 3: Determine whether the type and timing of exposure to ACEs has a significant influence on the severity of psychopathology and long-term physiological response to ACEs.

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
18 Years 至 29 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • provide written and dated informed consent to participate in the study;
  • be willing and able to comply with the protocol;
  • be between the ages of 18 and 29, inclusive;
  • be free from chronic cardiovascular, pulmonary, or musculoskeletal disease as determined by a health history questionnaire;
  • not currently prescribed or taking anti-inflammatory or lipid-lowering medications;
  • have either an ACE score of 0 or 4 or higher;
  • have a BMI between 18.5 and 40.0, inclusive;
  • not enrolled in another clinical trial within thirty days prior to enrollment; and
  • answer no to all questions on the PAR-Q for people aged 15 to 69, which assesses a person's eligibility to engage in exercise without contraindications.

排除标准

  • 未提供

结局指标

主要结局

Interleukin-1 receptor agonist

时间窗: 8-weeks

Interleukin-1 receptor agonist concentrations (pg/mL) will be examined from blood samples taken before- and after- the 8-week training or control period.

C-reactive protein

时间窗: 8-weeks

C-reactive protein concentrations (mg/L) will be examined from blood samples taken before- and after- the 8-week training or control period.

Brain-Derived Neurotrophic Factor

时间窗: 8-weeks

Plasma concentrations of brain-derived neurotrophic factor (BDNF; pg/mL), a biomarker of neurogenesis, will be examined from blood samples taken before- and after- the 8-week training or control period.

Skeletal muscle strength

时间窗: 8-weeks

Skeletal muscle strength (Newton meters \[Nm\]) will be determined before- and after- the 8-week training or control period.

Skeletal muscle size

时间窗: 8-weeks

Ultrasound based assessments of skeletal muscle size (cm\^2) will be obtained before- and after- the 8-week training or control period.

Skeletal muscle function

时间窗: 8-weeks

Motor unit behavior will be assessed utilizing surface electromyographic signal decomposition, which will be collected while participants perform submaximal isometric (i.e., static) muscle actions. These signals will be collected before- and after- the 8-week training or control period. To examine motor unit behavior, the relationship between motor unit recruitment threshold versus firing rate will be determined for all detected motor units for an individual subject.

TNF-alpha

时间窗: 8-weeks

TNF-alpha concentrations (pg/mL) will be examined from blood samples taken before- and after- the 8-week training or control period. TNF-alpha is a cytokine involved in systemic inflammation.

Cortisol

时间窗: 8-weeks

Concentrations of salivary cortisol (µg/dL), a stress hormone, will be obtained twice in one day (8 h between samples) before- and after- the 8-week training or control period.

次要结局

  • Health-related quality of life(8-weeks)
  • Resiliency(8-weeks)
  • Monocyte Heterogeneity(8-weeks)
  • Hope(8-weeks)
  • Anxiety(8-weeks)
  • Depression(8-weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验