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临床试验/NCT03056417
NCT03056417已完成不适用

Impact of Lifestyle Changes Via the Complete Health Improvement Program on Telomerase Activity and Telomere Length in Patients With Chronic Pain

Ohio University2 个研究点 分布在 1 个国家目标入组 67 人开始时间: 2017年1月10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
67
试验地点
2
主要终点
Telomerase activity changes as a result of lifestyle change

研究概览

简要总结

The current project will use the Complete Health Improvement Program (CHIP) as an intervention for patients with chronic pain. CHIP is a nationally recognized program that encourages a diet of whole plant-based foods, moderate exercise, stress reduction, and social support. Patients with chronic pain who enroll in CHIP classes will be monitored and compared to patients with chronic pain who are not enrolled in CHIP classes. It is hypothesized that patients who complete CHIP will have increased telomerase activity and longer relative telomere length at follow-up when compared to those who do not enroll in the program. Chromosomes consist of DNA that contains the genetic makeup of an individual; and telomeres are the caps on these chromosomes that protect them from damage. Telomere shortening occurs normally with aging and once they are too short to replicate cellular death occurs. Telomerase is a ribonucleic protein that counterbalances this shortening by extending the ends of chromosomes. Research has shown that patients with chronic pain may have shorter telomeres relative to others of the same age. This study will investigate this association further.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
40 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 40-70 years old
  • Physician confirmed chronic pain diagnosis for at least 6 months

排除标准

  • Pregnancy
  • Physical or mental condition that limits ability to provide consent or answer questionnaires

结局指标

主要结局

Telomerase activity changes as a result of lifestyle change

时间窗: Change from baseline telomerase at 3 months

Assessed via peripheral blood mononuclear cells

Subjective pain ratings as a function of positive lifestyle modifications

时间窗: Change from baseline subjective pain at 3 months

Assessed via the Brief Pain Inventory - Short Form. Measures pain intensity from 0 to 10, 10 being pain as bad as you can imagine. Also measures the extent to which pain interferes with daily functioning (0 - 10 possible, with 10 indicating completely interferes).

次要结局

  • C-reactive protein changes as a result of lifestyle change(change from baseline C-reactive protein at 3 months)
  • Fasting lipid profile (i.e., HDL, LDL, triglycerides) modification as a result of lifestyle change(change from baseline fasting lipids at 3 months)
  • Overall well-being changes as a result of lifestyle change(change from baseline overall well-being at 3 months)
  • Depressive symptom changes as a result of lifestyle change(change from baseline depressed mood at 3 months)
  • Relative telomere length changes as a result of lifestyle change(Change from baseline telomere length at 3 months)
  • Fasting glucose changes as a result of lifestyle change at 1-year follow-up(Change from 3 month follow-up data of fasting glucose at 1-year)
  • Fasting lipid profile (i.e., HDL, LDL, triglycerides) modification as a result of lifestyle change at 1-year follow-up(Change from 3 month follow-up data of fasting lipids at 1-year)
  • Perceived Stress changes as a result of lifestyle change(change from baseline perceived stress at 3 months)
  • Perceived Stress changes as a result of lifestyle change at 1-year follow-up(Change from 3 month follow-up data of perceived stress at 1-year)
  • Depressive symptom changes as a result of lifestyle change at 1-year follow-up(Change from 3 month follow-up data of depressed mood at 1-year)
  • Perceived social support modification as a result of lifestyle change at 1-year follow-up(Change from 3 month follow-up data of perceived social support at 1-year)
  • Health-Promoting behavior change as a result of lifestyle modification(change from baseline health promoting behavior at 3 months)
  • Telomerase activity changes as a result of lifestyle change at 1-year follow-up(Change from 3 month follow-up data of telomerase activity at 1-year)
  • Relative telomere length changes as a result of lifestyle change at 1-year follow-up(Change from 3 month follow-up data of telomere length at 1-year)
  • C-reactive protein changes as a result of lifestyle change at 1-year follow-up(Change from 3 month follow-up data of C-reactive protein at 1-year)
  • Overall well-being changes as a result of lifestyle change at 1-year follow-up(Change from 3 month follow-up data of overall well-being at 1-year)
  • Fasting glucose changes as a result of lifestyle change(Change from baseline fasting glucose at 3 months)
  • Perceived social support modification as a result of lifestyle change(change from baseline perceived social support at 3 months)
  • Health-Promoting behavior change as a result of lifestyle modification at 1-year follow-up(Change from 3 month follow-up data of health promoting behavior at 1-year)
  • Subjective pain ratings as a function of positive lifestyle modifications at 1-year follow-up(Change from 3 month follow-up data of subjective pain at 1-year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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