Back to resultsEffects of Aerobic Exercise Within a Behavioral Treatment Program for Chronic Headaches
Primary Purpose
Chronic Headaches
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Behavioral Treatment for Chronic Headache- Exercise Version
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Headaches focused on measuring headaches, behavioral treatment, physical activity
Eligibility 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
Sites / Locations
- University of Mississippi Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Exercise-Start (ES)
Exercise-Middle (EM)
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Patient-reported headache-free days per week
Patients are asked to report the number of days per week they do no experience headaches
Secondary Outcome Measures
Headache Disability Index (HDI)
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
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)
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.
Full Information
NCT ID
NCT01525303
First Posted
January 30, 2012
Last Updated
January 14, 2013
Sponsor
University of Mississippi Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01525303
Brief Title
Effects of Aerobic Exercise Within a Behavioral Treatment Program for Chronic Headaches
Official Title
Additive Effects of Aerobic Exercise to a Standard Behavioral Self-Management Program for Chronic Headaches
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
August 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Mississippi Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Headaches
Keywords
headaches, behavioral treatment, physical activity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exercise-Start (ES)
Arm Type
Experimental
Arm Description
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.
Arm Title
Exercise-Middle (EM)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Behavioral Treatment for Chronic Headache- Exercise Version
Intervention Description
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).
Primary Outcome Measure Information:
Title
Patient-reported headache-free days per week
Description
Patients are asked to report the number of days per week they do no experience headaches
Time Frame
2 weeks prior to treatment through 2 weeks post-treatment
Secondary Outcome Measure Information:
Title
Headache Disability Index (HDI)
Description
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."
Time Frame
baseline, 8 weeks, 10 weeks
Title
Highest weekly headache intensity
Description
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.
Time Frame
2 weeks prior to treatment through 2 weeks post-treatment
Title
Composite Depression/Anxiety Screening Scale (PHQ-4)
Description
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.
Time Frame
2 weeks prior to treatment through 2 weeks follow-up
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donald Penzien, Ph.D.
Organizational Affiliation
University of Mississippi Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
12. IPD Sharing Statement
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Effects of Aerobic Exercise Within a Behavioral Treatment Program for Chronic Headaches
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