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NCT Number: NCT01525303

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

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.

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Key information

Conditions

Chronic Headaches Behavior Brain Diseases Central Nervous System Diseases Headache Headache Disorders Motor Activity Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–64 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Behavioral Treatment for Chronic Headache- Exercise Version

Behavioral

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 outcomes

  1. Patient-reported headache-free days per week

    Time frame: 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 outcomes

  1. Headache Disability Index (HDI)

    Time frame: 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."

  2. Highest weekly headache intensity

    Time frame: 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.

  3. Composite Depression/Anxiety Screening Scale (PHQ-4)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Mississippi Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Feb 2, 2012
Registry last updated
Jan 16, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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