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

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03056417
• Other study ID #: 14X145
• Status: Completed
• Phase: N/A
• Start date: January 10, 2017
• Est. completion date: May 2019

Study information

• Verified date: September 2020
• Source: Ohio University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: May 2019
• Est. primary completion date: May 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Ohio University	Athens	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio University

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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. — View 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. Epub 2001 Jan 4. — View 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. Review. Russian. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Telomerase activity changes as a result of lifestyle change	Assessed via peripheral blood mononuclear cells	Change from baseline telomerase at 3 months
Primary	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	Relative telomere length changes as a result of lifestyle change	Assessed via whole blood samples	Change from baseline telomere length at 3 months
Secondary	Relative telomere length changes as a result of lifestyle change at 1-year follow-up	Assessed via whole blood samples	Change from 3 month follow-up data of telomere length at 1-year
Secondary	Fasting glucose changes as a result of lifestyle change	Assessed via whole blood samples	Change from baseline fasting glucose at 3 months
Secondary	Fasting glucose changes as a result of lifestyle change at 1-year follow-up	Assessed via whole blood samples	Change from 3 month follow-up data of fasting glucose at 1-year
Secondary	Fasting lipid profile (i.e., HDL, LDL, triglycerides) modification as a result of lifestyle change	Assessed via whole blood	change from baseline fasting lipids at 3 months
Secondary	Fasting lipid profile (i.e., HDL, LDL, triglycerides) modification as a result of lifestyle change at 1-year follow-up	Assessed via whole blood	Change from 3 month follow-up data of fasting lipids at 1-year
Secondary	C-reactive protein changes as a result of lifestyle change	Assessed via plasma	change from baseline C-reactive protein at 3 months
Secondary	C-reactive protein changes as a result of lifestyle change at 1-year follow-up	Assessed via plasma	Change from 3 month follow-up data of C-reactive protein at 1-year
Secondary	Overall well-being changes as a result of lifestyle change	The RAND-36 item short form survey. High score indicates more favorable health state. Minimum score 0 Maximum score 100.	change from baseline overall well-being at 3 months
Secondary	Overall well-being changes as a result of lifestyle change at 1-year follow-up	The RAND-36 item short form survey. High score indicates more favorable health state. Minimum score 0 Maximum score 100.	Change from 3 month follow-up data of overall well-being at 1-year
Secondary	Perceived Stress changes as a result of lifestyle change	The 14-item Perceived Stress Scale. Minimum score 0 Maximum score 40. Higher scores indicate greater perceived stress.	change from baseline perceived stress at 3 months
Secondary	Perceived Stress changes as a result of lifestyle change at 1-year follow-up	The 14-item Perceived Stress Scale. Minimum score 0 Maximum score 40. Higher scores indicate greater perceived stress.	Change from 3 month follow-up data of perceived stress at 1-year
Secondary	Depressive symptom changes as a result of lifestyle change	Center for Epidemiological Studies Depression Scale. Higher score indicates greater depressed mood. Minimum score 0 Maximum score 60.	change from baseline depressed mood at 3 months
Secondary	Depressive symptom changes as a result of lifestyle change at 1-year follow-up	Center for Epidemiological Studies Depression Scale. Higher score indicates greater depressed mood. Minimum score 0 Maximum score 60.	Change from 3 month follow-up data of depressed mood at 1-year
Secondary	Perceived social support modification as a result of lifestyle change	Multidimensional Scale of Perceived Social Support. Higher score indicates greater perceived social support. Minimum score 1 Maximum score 7.	change from baseline perceived social support at 3 months
Secondary	Perceived social support modification as a result of lifestyle change at 1-year follow-up	Multidimensional Scale of Perceived Social Support. Higher score indicates greater perceived social support. Minimum score 1 Maximum score 7.	Change from 3 month follow-up data of perceived social support at 1-year
Secondary	Health-Promoting behavior change as a result of lifestyle modification	Health-Promoting Lifestyle Profile II questionnaire. Higher score indicate greater health promotion. Minimum score 1 Maximum score 4.	change from baseline health promoting behavior at 3 months
Secondary	Health-Promoting behavior change as a result of lifestyle modification at 1-year follow-up	Health-Promoting Lifestyle Profile II questionnaire. Higher score indicate greater health promotion. Minimum score 1 Maximum score 4.	Change from 3 month follow-up data of health promoting behavior at 1-year
Secondary	Telomerase activity changes as a result of lifestyle change at 1-year follow-up	Assessed via peripheral blood mononuclear cells	Change from 3 month follow-up data of telomerase activity at 1-year
Secondary	Subjective pain ratings as a function of positive lifestyle modifications at 1-year follow-up	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 3 month follow-up data of subjective pain at 1-year