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

Chronic Headaches Clinical Trial

Official title:

Additive Effects of Aerobic Exercise to a Standard Behavioral Self-Management Program for Chronic Headaches

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01525303
• Other study ID #: 2011-0044
• Status: Completed
• Phase: N/A
• First received: January 30, 2012
• Last updated: January 14, 2013
• Start date: December 2011
• Est. completion date: August 2012

Study information

• Verified date: January 2013
• Source: University of Mississippi Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: August 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 64 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Headaches
• Headache
• Headache Disorders

Intervention

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).

Locations

Country	Name	City	State
United States	University of Mississippi Medical Center	Jackson	Mississippi

Sponsors (1)

Lead Sponsor	Collaborator
University of Mississippi Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient-reported headache-free days per week	Patients are asked to report the number of days per week they do no experience headaches	2 weeks prior to treatment through 2 weeks post-treatment	No
Secondary	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."	baseline, 8 weeks, 10 weeks	No
Secondary	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.	2 weeks prior to treatment through 2 weeks post-treatment	No
Secondary	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.	2 weeks prior to treatment through 2 weeks follow-up	No