Effects of Aerobic Exercise Within a Behavioral Treatment Program for Chronic Headaches

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Donald Penzien, University of Mississippi Medical Center
ClinicalTrials.gov Identifier:
NCT01525303
First received: January 30, 2012
Last updated: January 14, 2013
Last verified: January 2013
  Purpose

This proposed study seeks to examine whether adding an aerobic exercise prescription to a behavioral treatment program for chronic headaches will improve headache frequency and intensity, headache-related disability, and mood. It is hypothesized that participants who receive the exercise prescription at the start of treatment will show greater gains than those who receive the prescription halfway through treatment. It is also predicted that participants who begin the exercise component halfway through treatment will demonstrate greater improvement in the second half of treatment compared to the first half.


Condition Intervention
Chronic Headaches
Behavioral: Behavioral Treatment for Chronic Headache- Exercise Version

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Additive Effects of Aerobic Exercise to a Standard Behavioral Self-Management Program for Chronic Headaches

Resource links provided by NLM:


Further study details as provided by University of Mississippi Medical Center:

Primary Outcome Measures:
  • Patient-reported headache-free days per week [ Time Frame: 2 weeks prior to treatment through 2 weeks post-treatment ] [ Designated as safety issue: No ]
    Patients are asked to report the number of days per week they do no experience headaches


Secondary Outcome Measures:
  • Headache Disability Index (HDI) [ Time Frame: baseline, 8 weeks, 10 weeks ] [ Designated as safety issue: No ]
    HDI is a 25-item questionnaire that assesses headache-related functional and emotional disability in chronic headache sufferers. Participants respond to items using a 3-point scale: "yes," "sometimes," or "no."

  • Highest weekly headache intensity [ Time Frame: 2 weeks prior to treatment through 2 weeks post-treatment ] [ Designated as safety issue: No ]
    Patients are asked to report the the intensity of their worst headache during the past week, using a 0 (pain-free) to 10 (extremely intense pain) scale.

  • Composite Depression/Anxiety Screening Scale (PHQ-4) [ Time Frame: 2 weeks prior to treatment through 2 weeks follow-up ] [ Designated as safety issue: No ]
    This is a 4-item measure assessing symptoms of anxiety and depression in the past two weeks. Participants respond on a 4 point scale: 0=Not at all; 1=Several days; 2=More than half of the days; 3=Nearly every day. When this measure is administered during the course of treatment (weekly) participants will be asked to respond based on their experiences in the past week.


Enrollment: 5
Study Start Date: December 2011
Study Completion Date: August 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Exercise-Start (ES)
The ES group will receive standard behavioral treatment in the Self-Management Training Program for Chronic Headaches. In addition to this material, participants in this group will receive an exercise prescription for 20 minutes of moderate-intensity aerobic activity at the beginning of Week 1. The exercise prescription will increase to 25 minutes in Week 2, and 30 minutes in Week 3. They are asked to maintain 30 minutes per day of exercise through Week 8. Participants choose the type of exercise, and have the option to break it up into 10-minute increments throughout the day.
Behavioral: Behavioral Treatment for Chronic Headache- Exercise Version
This behavioral treatment program consists of behavioral approaches to headache management: progressive muscle relaxation, stress-management training, and biofeedback. Skills for these techniques are presented during the clinic sessions, and supplemented with workbooks and audio CDs. In addition, all participants will receive a graduated exercise prescription of 20-30 minutes of moderate-intensity exercise, five days per week. They will be instructed to assess the intensity of their exercise using the Borg perceived exertion scale. Client contact sessions are as follows: Clinic Session (CS)1; Phone Session (PS) 1 (end of week1), CS 2 (end of week 4); PS 2 (end of week 6); CS 3 (end of week 8).
Experimental: Exercise-Middle (EM)
The EM group will receive standard behavioral treatment in the Self-Management Training Program for Chronic Headaches.In addition to this material, participants in this group will receive an exercise prescription for 20 minutes of moderate-intensity aerobic activity at the beginning of Week 5. The exercise prescription will increase to 25 minutes in Week 6, and 30 minutes in Week 7. They are asked to maintain 30 minutes per day of exercise through Week 8. Participants choose the type of exercise, and have the option to break it up into 10-minute increments throughout the day.
Behavioral: Behavioral Treatment for Chronic Headache- Exercise Version
This behavioral treatment program consists of behavioral approaches to headache management: progressive muscle relaxation, stress-management training, and biofeedback. Skills for these techniques are presented during the clinic sessions, and supplemented with workbooks and audio CDs. In addition, all participants will receive a graduated exercise prescription of 20-30 minutes of moderate-intensity exercise, five days per week. They will be instructed to assess the intensity of their exercise using the Borg perceived exertion scale. Client contact sessions are as follows: Clinic Session (CS)1; Phone Session (PS) 1 (end of week1), CS 2 (end of week 4); PS 2 (end of week 6); CS 3 (end of week 8).

Detailed Description:

Aerobic exercise has long been discussed as a potential treatment for chronic headaches, though research in this area has been somewhat limited. It is warranted to consider the effectiveness of aerobic exercise as part of a larger headache management intervention. Early research in this area suggests that including an exercise component in conjunction with other effective forms of headache management, such as progressive muscle relaxation, biofeedback, and stress management, is associated with improvement in number of days with a headache, headache pain intensity and mood. None of these studies have specifically analyzed the effectiveness of the aerobic exercise component, though Lemestra et al. (2002) noted that participants who continued with their exercise regimen had better overall outcomes three months after the intervention ended.

Given the high rates of obesity and the fact that many people do not meet the minimum daily requirement for exercise, it is worthwhile to investigate the additive effect of exercise to behavioral headache interventions.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of chronic headache (according to International Headache Association (IHA) guidelines) by research personnel
  • Interested in receiving behavioral treatment for chronic headaches
  • Engaged in less than 60 minutes/week of physical activity in the past 3 months
  • Physically capable of engaging in a regular exercise routine
  • Interested in in taking part in a regular exercise routine
  • Regular internet access (at least once a week)

Exclusion Criteria:

  • Males
  • Unable to access internet at least once a week
  • Currently engaging in regular exercise
  • Not interested in participating in regular exercise
  • Not capable of safely exercising
  • Pregnant, nursing, or planning on becoming pregnant during the course of the study
  • Does not meet IHA diagnostic criteria for chronic headache
  • Not interested in behavioral headache treatment
  • Diagnosis of Medication Overuse Headache, or headaches related to a physical or neurological disorder
  • Cognitive or other forms of impairment that would decrease ability to fully engage in treatment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01525303

Locations
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
Sponsors and Collaborators
University of Mississippi Medical Center
Investigators
Principal Investigator: Donald Penzien, Ph.D. University of Mississippi Medical Center
  More Information

No publications provided

Responsible Party: Donald Penzien, Professor, University of Mississippi Medical Center
ClinicalTrials.gov Identifier: NCT01525303     History of Changes
Other Study ID Numbers: 2011-0044
Study First Received: January 30, 2012
Last Updated: January 14, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Mississippi Medical Center:
headaches
behavioral treatment
physical activity

Additional relevant MeSH terms:
Headache
Headache Disorders
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Brain Diseases
Central Nervous System Diseases

ClinicalTrials.gov processed this record on September 29, 2014