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Clinical Trials/NCT03056417
NCT03056417
Completed
Not Applicable

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

Ohio University1 site in 1 country67 target enrollmentJanuary 10, 2017
ConditionsChronic Pain

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Pain
Sponsor
Ohio University
Enrollment
67
Locations
1
Primary Endpoint
Telomerase activity changes as a result of lifestyle change
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
January 10, 2017
End Date
May 2019
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Telomerase activity changes as a result of lifestyle change

Time Frame: Change from baseline telomerase at 3 months

Assessed via peripheral blood mononuclear cells

Subjective pain ratings as a function of positive lifestyle modifications

Time Frame: 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).

Secondary Outcomes

  • 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)

Study Sites (1)

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