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

NCT01525303 | Completed

• 1 other identifier: 2011-0044
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Headaches

Keywords

headaches; behavioral treatment; physical activity

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Headache Disability Index (HDI)

  baseline, 8 weeks, 10 weeks

• Highest weekly headache intensity

  2 weeks prior to treatment through 2 weeks post-treatment

• Composite Depression/Anxiety Screening Scale (PHQ-4)

  2 weeks prior to treatment through 2 weeks follow-up

Study Arms (2)

Exercise-Start (ES)

EXPERIMENTAL

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.

Behavioral: Behavioral Treatment for Chronic Headache- Exercise Version

Exercise-Middle (EM)

EXPERIMENTAL

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.

Behavioral: Behavioral Treatment for Chronic Headache- Exercise Version

Interventions

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).

Exercise-Middle (EM); Exercise-Start (ES)

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Mississippi Medical Center: lead

Study Sites (1)

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

MeSH Terms

Conditions

Headache Disorders; Headache; Motor Activity

Interventions

Behavior Therapy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Donald Penzien, Ph.D.

  University of Mississippi Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 30, 2012
• First Posted: February 2, 2012
• Study Start: December 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: August 1, 2012
• Last Updated: January 16, 2013

Record last verified: 2013-01

Locations

US (1)