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

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ClinicalTrials.gov Identifier: NCT03056417
Recruitment Status : Enrolling by invitation
First Posted : February 17, 2017
Last Update Posted : February 17, 2017
Sponsor:
Information provided by (Responsible Party):
Ohio University

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.

Condition or disease Intervention/treatment Phase
Chronic Pain Behavioral: The Complete Health Improvement Program Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Impact of Lifestyle Changes Via the Complete Health Improvement Program on Telomerase Activity and Telomere Length in Patients With Chronic Pain
Actual Study Start Date : January 10, 2017
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arm Intervention/treatment
Experimental: Intervention
Participants in the Complete Health Improvement Program.
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.

No Intervention: Control
Participants who choose not to participate in the Complete Health Improvement Program.



Primary Outcome Measures :
  1. Telomerase activity as a result of lifestyle change [ Time Frame: 3 months ]
    Assessed via peripheral blood mononuclear cells

  2. Subjective pain ratings as a function of positive lifestyle modifications [ Time Frame: 3 months ]
    Assessed via the Brief Pain Inventory - Short Form


Secondary Outcome Measures :
  1. Telomere length as a result of lifestyle change [ Time Frame: 3 months ]
    Assessed via whole blood samples

  2. Fasting glucose [ Time Frame: 3 months ]
    Assessed via whole blood samples

  3. Fasting lipid profile [ Time Frame: 3 months ]
    Assessed via whole blood

  4. C-reactive protein [ Time Frame: baseline and 3 months ]
    Assessed via plasma

  5. Overall well-being [ Time Frame: 3 months ]
    RAND-36

  6. Perceived Stress [ Time Frame: 3 months ]
    Perceived Stress Scale

  7. Depressive symptoms [ Time Frame: 3 months ]
    Center for Epidemiological Studies Depression Scale

  8. Perceived social support [ Time Frame: 3 months ]
    Multidimensional Scale of Perceived Social Support

  9. Health-Promoting Lifestyle Profile II questionnaire [ Time Frame: 3 months ]
    This questionnaire is a self-report of health-promoting lifestyle habits. Subscales include Self-Actualization, Health Responsibility, Physical activity, Nutrition, Interpersonal Support, and Stress Management.habits. Subscales include Self-Actualization, Health Responsibility, Physical activity, Nutrition, Interpersonal Support, and Stress Management.



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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03056417


Locations
United States, Ohio
Ohio University
Athens, Ohio, United States, 45701
Sponsors and Collaborators
Ohio University
Investigators
Principal Investigator: Katrina Hamilton, B.A. Ohio University
Study Director: David Drozek, D.O. Ohio University
Study Chair: Peggy Zoccola, Ph.D. Ohio University

Publications:
Responsible Party: Ohio University
ClinicalTrials.gov Identifier: NCT03056417     History of Changes
Other Study ID Numbers: 14X145
First Posted: February 17, 2017    Key Record Dates
Last Update Posted: February 17, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ohio University:
chronic pain
telomere
telomerase
life style

Additional relevant MeSH terms:
Chronic Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms