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

NCT ID: NCT03056417

Last Updated: 2020-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-10

Study Completion Date

2019-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Pain

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Intervention

Participants in the Complete Health Improvement Program.

Group Type EXPERIMENTAL

The Complete Health Improvement Program

Intervention Type 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.

No Change to Treatment

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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The Complete Health Improvement Program

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 Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ohio University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Katrina Hamilton, M.S.

Role: PRINCIPAL_INVESTIGATOR

Ohio University

David Drozek, D.O.

Role: STUDY_DIRECTOR

Ohio University

Peggy Zoccola, Ph.D.

Role: STUDY_CHAIR

Ohio University

Locations

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Ohio University

Athens, Ohio, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 16913218 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11152456 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24527219 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23031395 (View on PubMed)

Other Identifiers

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14X145

Identifier Type: -

Identifier Source: org_study_id