Clinical trial NCT03056417: Impact of Lifestyle Changes on Telomeric Activity in Patients With Chronic Pain
Official title: Impact of Lifestyle Changes Via the Complete Health Improvement Program on Telomerase Activity and Telomere Length in Patients With Chronic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Keywords: chronic pain
telomere
telomerase
life style
Lead sponsor: Ohio University
Sponsor class: OTHER
First posted: 2017-02-17
Enrollment: 67
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


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

Primary outcomes:
measure: Telomerase activity changes as a result of lifestyle change
timeFrame: Change from baseline telomerase at 3 months
measure: Subjective pain ratings as a function of positive lifestyle modifications
timeFrame: Change from baseline subjective pain at 3 months
Secondary outcomes:
measure: Relative telomere length changes as a result of lifestyle change
timeFrame: Change from baseline telomere length at 3 months
measure: Relative telomere length changes as a result of lifestyle change at 1-year follow-up
timeFrame: Change from 3 month follow-up data of telomere length at 1-year
measure: Fasting glucose changes as a result of lifestyle change
timeFrame: Change from baseline fasting glucose at 3 months
measure: Fasting glucose changes as a result of lifestyle change at 1-year follow-up
timeFrame: Change from 3 month follow-up data of fasting glucose at 1-year
measure: Fasting lipid profile (i.e., HDL, LDL, triglycerides) modification as a result of lifestyle change
timeFrame: change from baseline fasting lipids at 3 months
measure: Fasting lipid profile (i.e., HDL, LDL, triglycerides) modification as a result of lifestyle change at 1-year follow-up
timeFrame: Change from 3 month follow-up data of fasting lipids at 1-year
measure: C-reactive protein changes as a result of lifestyle change
timeFrame: change from baseline C-reactive protein at 3 months
measure: C-reactive protein changes as a result of lifestyle change at 1-year follow-up
timeFrame: Change from 3 month follow-up data of C-reactive protein at 1-year
measure: Overall well-being changes as a result of lifestyle change
timeFrame: change from baseline overall well-being at 3 months
measure: Overall well-being changes as a result of lifestyle change at 1-year follow-up
timeFrame: Change from 3 month follow-up data of overall well-being at 1-year
measure: Perceived Stress changes as a result of lifestyle change
timeFrame: change from baseline perceived stress at 3 months
measure: Perceived Stress changes as a result of lifestyle change at 1-year follow-up
timeFrame: Change from 3 month follow-up data of perceived stress at 1-year
measure: Depressive symptom changes as a result of lifestyle change
timeFrame: change from baseline depressed mood at 3 months
measure: Depressive symptom changes as a result of lifestyle change at 1-year follow-up
timeFrame: Change from 3 month follow-up data of depressed mood at 1-year
measure: Perceived social support modification as a result of lifestyle change
timeFrame: change from baseline perceived social support at 3 months
measure: Perceived social support modification as a result of lifestyle change at 1-year follow-up
timeFrame: Change from 3 month follow-up data of perceived social support at 1-year
measure: Health-Promoting behavior change as a result of lifestyle modification
timeFrame: change from baseline health promoting behavior at 3 months
measure: Health-Promoting behavior change as a result of lifestyle modification at 1-year follow-up
timeFrame: Change from 3 month follow-up data of health promoting behavior at 1-year
measure: Telomerase activity changes as a result of lifestyle change at 1-year follow-up
timeFrame: Change from 3 month follow-up data of telomerase activity at 1-year
measure: Subjective pain ratings as a function of positive lifestyle modifications at 1-year follow-up
timeFrame: Change from 3 month follow-up data of subjective pain at 1-year
Other outcomes:
Locations:
city: Athens
country: United States
facility: Ohio University
state: Ohio
Study officials:
affiliation: Ohio University
name: Katrina Hamilton, M.S.
role: PRINCIPAL_INVESTIGATOR
affiliation: Ohio University
name: David Drozek, D.O.
role: STUDY_DIRECTOR
affiliation: Ohio University
name: Peggy Zoccola, Ph.D.
role: STUDY_CHAIR
References:
citation: Shcherbakova DM, Zvereva ME, Shpanchenko OV, Dontsova OA. [Telomerase: structure and properties of the enzyme, characteristics of the yeast telomerase]. Mol Biol (Mosk). 2006 Jul-Aug;40(4):580-94. Russian.
citation: Li B, Comai L. Requirements for the nucleolytic processing of DNA ends by the Werner syndrome protein-Ku70/80 complex. J Biol Chem. 2001 Mar 30;276(13):9896-902. doi: 10.1074/jbc.M008575200. Epub 2001 Jan 4.
citation: Drozek D, Diehl H, Nakazawa M, Kostohryz T, Morton D, Shubrook JH. Short-term effectiveness of a lifestyle intervention program for reducing selected chronic disease risk factors in individuals living in rural appalachia: a pilot cohort study. Adv Prev Med. 2014;2014:798184. doi: 10.1155/2014/798184. Epub 2014 Jan 16.
citation: Hassett AL, Epel E, Clauw DJ, Harris RE, Harte SE, Kairys A, Buyske S, Williams DA. Pain is associated with short leukocyte telomere length in women with fibromyalgia. J Pain. 2012 Oct;13(10):959-69. doi: 10.1016/j.jpain.2012.07.003.