Impact of Lifestyle Changes on Telomeric Activity in Patients With Chronic Pain

NCT03056417 | Completed

• 1 other identifier: 14X145
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain

Keywords

chronic pain; telomere; telomerase; life style

Outcome Measures

Primary Outcomes (2)

• Telomerase activity changes as a result of lifestyle change

  Assessed via peripheral blood mononuclear cells

  Change from baseline telomerase at 3 months

• Subjective pain ratings as a function of positive lifestyle modifications

  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).

  Change from baseline subjective pain at 3 months

Secondary Outcomes (20)

• Relative telomere length changes as a result of lifestyle change

  Change from baseline telomere length at 3 months

• 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

• Fasting glucose changes as a result of lifestyle change

  Change from baseline fasting glucose 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

  change from baseline fasting lipids at 3 months

Study Arms (2)

Intervention

EXPERIMENTAL

Participants in the Complete Health Improvement Program.

Behavioral: The Complete Health Improvement Program

No Change to Treatment

NO INTERVENTION

Participants who choose not to participate in the Complete Health Improvement Program.

Interventions

The Complete Health Improvement Program BEHAVIORAL

The Complete Health Improvement Program is a nationally recognized program that encourages a diet of whole plant based foods, moderate exercise, stress reduction, and social support.

Intervention

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ohio University: lead

Study Sites (1)

Ohio University

Athens, Ohio, 45701, United States

Location

Related Publications (4)

• 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.

  PMID: 16913218 BACKGROUND

• 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.

  PMID: 11152456 BACKGROUND

• 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.

  PMID: 24527219 BACKGROUND

• 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.

  PMID: 23031395 BACKGROUND

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Katrina Hamilton, M.S.

  Ohio University

  PRINCIPAL INVESTIGATOR

• David Drozek, D.O.

  Ohio University

  STUDY DIRECTOR

• Peggy Zoccola, Ph.D.

  Ohio University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2017
• First Posted: February 17, 2017
• Study Start: January 10, 2017
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: October 30, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)