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

Not Applicable

Completed

• Conditions: Chronic Headaches

• Registration Number: NCT01525303
• Lead Sponsor: University of Mississippi Medical Center

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.

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2012-01-30
• Study First Submitted QC: 2012-01-30
• Study First Posted: 2012-02-02
• Primary Completion: 2012-06
• Study Completion: 2012-08
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-14
• Last Update Posted: 2013-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Patient-reported headache-free days per week	2 weeks prior to treatment through 2 weeks post-treatment	Patients are asked to report the number of days per week they do no experience headaches

Secondary Outcome Measures

Name	Time	Method
Highest weekly headache intensity	2 weeks prior to treatment through 2 weeks post-treatment	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)	2 weeks prior to treatment through 2 weeks follow-up	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.
Headache Disability Index (HDI)	baseline, 8 weeks, 10 weeks	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."

Trial Locations

Locations (1)

University of Mississippi Medical Center; 🇺🇸 Jackson, Mississippi, United States