Clinical trial NCT01525303: 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
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Headaches
Keywords: headaches
behavioral treatment
physical activity
Lead sponsor: University of Mississippi Medical Center
Sponsor class: OTHER
First posted: 2012-02-02
Enrollment: 5
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Patient-reported headache-free days per week
timeFrame: 2 weeks prior to treatment through 2 weeks post-treatment
Secondary outcomes:
measure: Headache Disability Index (HDI)
timeFrame: baseline, 8 weeks, 10 weeks
measure: Highest weekly headache intensity
timeFrame: 2 weeks prior to treatment through 2 weeks post-treatment
measure: Composite Depression/Anxiety Screening Scale (PHQ-4)
timeFrame: 2 weeks prior to treatment through 2 weeks follow-up
Other outcomes:
Locations:
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
Study officials:
affiliation: University of Mississippi Medical Center
name: Donald Penzien, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: