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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03056417
Enrollment
67
Registered
2017-02-17
Start date
2017-01-10
Completion date
2019-05-31
Last updated
2020-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pain

Keywords

chronic pain, telomere, telomerase, life style

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.

Interventions

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.

Sponsors

Ohio University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Telomerase activity changes as a result of lifestyle changeChange from baseline telomerase at 3 monthsAssessed via peripheral blood mononuclear cells
Subjective pain ratings as a function of positive lifestyle modificationsChange from baseline subjective pain at 3 monthsAssessed 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

MeasureTime frameDescription
Fasting glucose changes as a result of lifestyle changeChange from baseline fasting glucose at 3 monthsAssessed via whole blood samples
Fasting glucose changes as a result of lifestyle change at 1-year follow-upChange from 3 month follow-up data of fasting glucose at 1-yearAssessed via whole blood samples
Fasting lipid profile (i.e., HDL, LDL, triglycerides) modification as a result of lifestyle changechange from baseline fasting lipids at 3 monthsAssessed via whole blood
Fasting lipid profile (i.e., HDL, LDL, triglycerides) modification as a result of lifestyle change at 1-year follow-upChange from 3 month follow-up data of fasting lipids at 1-yearAssessed via whole blood
C-reactive protein changes as a result of lifestyle changechange from baseline C-reactive protein at 3 monthsAssessed via plasma
C-reactive protein changes as a result of lifestyle change at 1-year follow-upChange from 3 month follow-up data of C-reactive protein at 1-yearAssessed via plasma
Overall well-being changes as a result of lifestyle changechange from baseline overall well-being at 3 monthsThe RAND-36 item short form survey. High score indicates more favorable health state. Minimum score 0 Maximum score 100.
Overall well-being changes as a result of lifestyle change at 1-year follow-upChange from 3 month follow-up data of overall well-being at 1-yearThe RAND-36 item short form survey. High score indicates more favorable health state. Minimum score 0 Maximum score 100.
Perceived Stress changes as a result of lifestyle changechange from baseline perceived stress at 3 monthsThe 14-item Perceived Stress Scale. Minimum score 0 Maximum score 40. Higher scores indicate greater perceived stress.
Relative telomere length changes as a result of lifestyle changeChange from baseline telomere length at 3 monthsAssessed via whole blood samples
Depressive symptom changes as a result of lifestyle changechange from baseline depressed mood at 3 monthsCenter for Epidemiological Studies Depression Scale. Higher score indicates greater depressed mood. Minimum score 0 Maximum score 60.
Depressive symptom changes as a result of lifestyle change at 1-year follow-upChange from 3 month follow-up data of depressed mood at 1-yearCenter for Epidemiological Studies Depression Scale. Higher score indicates greater depressed mood. Minimum score 0 Maximum score 60.
Perceived social support modification as a result of lifestyle changechange from baseline perceived social support at 3 monthsMultidimensional Scale of Perceived Social Support. Higher score indicates greater perceived social support. Minimum score 1 Maximum score 7.
Perceived social support modification as a result of lifestyle change at 1-year follow-upChange from 3 month follow-up data of perceived social support at 1-yearMultidimensional Scale of Perceived Social Support. Higher score indicates greater perceived social support. Minimum score 1 Maximum score 7.
Health-Promoting behavior change as a result of lifestyle modificationchange from baseline health promoting behavior at 3 monthsHealth-Promoting Lifestyle Profile II questionnaire. Higher score indicate greater health promotion. Minimum score 1 Maximum score 4.
Health-Promoting behavior change as a result of lifestyle modification at 1-year follow-upChange from 3 month follow-up data of health promoting behavior at 1-yearHealth-Promoting Lifestyle Profile II questionnaire. Higher score indicate greater health promotion. Minimum score 1 Maximum score 4.
Telomerase activity changes as a result of lifestyle change at 1-year follow-upChange from 3 month follow-up data of telomerase activity at 1-yearAssessed via peripheral blood mononuclear cells
Subjective pain ratings as a function of positive lifestyle modifications at 1-year follow-upChange from 3 month follow-up data of subjective pain at 1-yearAssessed 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).
Perceived Stress changes as a result of lifestyle change at 1-year follow-upChange from 3 month follow-up data of perceived stress at 1-yearThe 14-item Perceived Stress Scale. Minimum score 0 Maximum score 40. Higher scores indicate greater perceived stress.
Relative telomere length changes as a result of lifestyle change at 1-year follow-upChange from 3 month follow-up data of telomere length at 1-yearAssessed via whole blood samples

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026