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

Primary Purpose

Chronic Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
The Complete Health Improvement Program
Sponsored by
Ohio University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Chronic Pain focused on measuring chronic pain, telomere, telomerase, life style

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ohio University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

No Change to Treatment

Arm Description

Participants in the Complete Health Improvement Program.

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

Outcomes

Primary Outcome Measures

Telomerase activity changes as a result of lifestyle change
Assessed via peripheral blood mononuclear cells
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).

Secondary Outcome Measures

Relative telomere length changes as a result of lifestyle change
Assessed via whole blood samples
Relative telomere length changes as a result of lifestyle change at 1-year follow-up
Assessed via whole blood samples
Fasting glucose changes as a result of lifestyle change
Assessed via whole blood samples
Fasting glucose changes as a result of lifestyle change at 1-year follow-up
Assessed via whole blood samples
Fasting lipid profile (i.e., HDL, LDL, triglycerides) modification as a result of lifestyle change
Assessed via whole blood
Fasting lipid profile (i.e., HDL, LDL, triglycerides) modification as a result of lifestyle change at 1-year follow-up
Assessed via whole blood
C-reactive protein changes as a result of lifestyle change
Assessed via plasma
C-reactive protein changes as a result of lifestyle change at 1-year follow-up
Assessed via plasma
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Telomerase activity changes as a result of lifestyle change at 1-year follow-up
Assessed via peripheral blood mononuclear cells
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).

Full Information

First Posted
February 13, 2017
Last Updated
October 27, 2020
Sponsor
Ohio University
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1. Study Identification

Unique Protocol Identification Number
NCT03056417
Brief Title
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

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
January 10, 2017 (Actual)
Primary Completion Date
May 2019 (Actual)
Study Completion Date
May 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ohio University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
chronic pain, telomere, telomerase, life style

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
67 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Participants in the Complete Health Improvement Program.
Arm Title
No Change to Treatment
Arm Type
No Intervention
Arm Description
Participants who choose not to participate in the Complete Health Improvement Program.
Intervention Type
Behavioral
Intervention Name(s)
The Complete Health Improvement Program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Telomerase activity changes as a result of lifestyle change
Description
Assessed via peripheral blood mononuclear cells
Time Frame
Change from baseline telomerase at 3 months
Title
Subjective pain ratings as a function of positive lifestyle modifications
Description
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).
Time Frame
Change from baseline subjective pain at 3 months
Secondary Outcome Measure Information:
Title
Relative telomere length changes as a result of lifestyle change
Description
Assessed via whole blood samples
Time Frame
Change from baseline telomere length at 3 months
Title
Relative telomere length changes as a result of lifestyle change at 1-year follow-up
Description
Assessed via whole blood samples
Time Frame
Change from 3 month follow-up data of telomere length at 1-year
Title
Fasting glucose changes as a result of lifestyle change
Description
Assessed via whole blood samples
Time Frame
Change from baseline fasting glucose at 3 months
Title
Fasting glucose changes as a result of lifestyle change at 1-year follow-up
Description
Assessed via whole blood samples
Time Frame
Change from 3 month follow-up data of fasting glucose at 1-year
Title
Fasting lipid profile (i.e., HDL, LDL, triglycerides) modification as a result of lifestyle change
Description
Assessed via whole blood
Time Frame
change from baseline fasting lipids at 3 months
Title
Fasting lipid profile (i.e., HDL, LDL, triglycerides) modification as a result of lifestyle change at 1-year follow-up
Description
Assessed via whole blood
Time Frame
Change from 3 month follow-up data of fasting lipids at 1-year
Title
C-reactive protein changes as a result of lifestyle change
Description
Assessed via plasma
Time Frame
change from baseline C-reactive protein at 3 months
Title
C-reactive protein changes as a result of lifestyle change at 1-year follow-up
Description
Assessed via plasma
Time Frame
Change from 3 month follow-up data of C-reactive protein at 1-year
Title
Overall well-being changes as a result of lifestyle change
Description
The RAND-36 item short form survey. High score indicates more favorable health state. Minimum score 0 Maximum score 100.
Time Frame
change from baseline overall well-being at 3 months
Title
Overall well-being changes as a result of lifestyle change at 1-year follow-up
Description
The RAND-36 item short form survey. High score indicates more favorable health state. Minimum score 0 Maximum score 100.
Time Frame
Change from 3 month follow-up data of overall well-being at 1-year
Title
Perceived Stress changes as a result of lifestyle change
Description
The 14-item Perceived Stress Scale. Minimum score 0 Maximum score 40. Higher scores indicate greater perceived stress.
Time Frame
change from baseline perceived stress at 3 months
Title
Perceived Stress changes as a result of lifestyle change at 1-year follow-up
Description
The 14-item Perceived Stress Scale. Minimum score 0 Maximum score 40. Higher scores indicate greater perceived stress.
Time Frame
Change from 3 month follow-up data of perceived stress at 1-year
Title
Depressive symptom changes as a result of lifestyle change
Description
Center for Epidemiological Studies Depression Scale. Higher score indicates greater depressed mood. Minimum score 0 Maximum score 60.
Time Frame
change from baseline depressed mood at 3 months
Title
Depressive symptom changes as a result of lifestyle change at 1-year follow-up
Description
Center for Epidemiological Studies Depression Scale. Higher score indicates greater depressed mood. Minimum score 0 Maximum score 60.
Time Frame
Change from 3 month follow-up data of depressed mood at 1-year
Title
Perceived social support modification as a result of lifestyle change
Description
Multidimensional Scale of Perceived Social Support. Higher score indicates greater perceived social support. Minimum score 1 Maximum score 7.
Time Frame
change from baseline perceived social support at 3 months
Title
Perceived social support modification as a result of lifestyle change at 1-year follow-up
Description
Multidimensional Scale of Perceived Social Support. Higher score indicates greater perceived social support. Minimum score 1 Maximum score 7.
Time Frame
Change from 3 month follow-up data of perceived social support at 1-year
Title
Health-Promoting behavior change as a result of lifestyle modification
Description
Health-Promoting Lifestyle Profile II questionnaire. Higher score indicate greater health promotion. Minimum score 1 Maximum score 4.
Time Frame
change from baseline health promoting behavior at 3 months
Title
Health-Promoting behavior change as a result of lifestyle modification at 1-year follow-up
Description
Health-Promoting Lifestyle Profile II questionnaire. Higher score indicate greater health promotion. Minimum score 1 Maximum score 4.
Time Frame
Change from 3 month follow-up data of health promoting behavior at 1-year
Title
Telomerase activity changes as a result of lifestyle change at 1-year follow-up
Description
Assessed via peripheral blood mononuclear cells
Time Frame
Change from 3 month follow-up data of telomerase activity at 1-year
Title
Subjective pain ratings as a function of positive lifestyle modifications at 1-year follow-up
Description
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).
Time Frame
Change from 3 month follow-up data of subjective pain at 1-year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katrina Hamilton, M.S.
Organizational Affiliation
Ohio University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David Drozek, D.O.
Organizational Affiliation
Ohio University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Peggy Zoccola, Ph.D.
Organizational Affiliation
Ohio University
Official's Role
Study Chair
Facility Information:
Facility Name
Ohio University
City
Athens
State/Province
Ohio
ZIP/Postal Code
45701
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
16913218
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.
Results Reference
background
PubMed Identifier
11152456
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.
Results Reference
background
PubMed Identifier
24527219
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.
Results Reference
background
PubMed Identifier
23031395
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.
Results Reference
background

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

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