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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01525303
Enrollment
5
Registered
2012-02-02
Start date
2011-12-31
Completion date
2012-08-31
Last updated
2013-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Headaches

Keywords

headaches, behavioral treatment, physical activity

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.

Interventions

BEHAVIORALBehavioral 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).

Sponsors

University of Mississippi Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 64 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Patient-reported headache-free days per week2 weeks prior to treatment through 2 weeks post-treatmentPatients are asked to report the number of days per week they do no experience headaches

Secondary

MeasureTime frameDescription
Headache Disability Index (HDI)baseline, 8 weeks, 10 weeksHDI 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.
Highest weekly headache intensity2 weeks prior to treatment through 2 weeks post-treatmentPatients 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-upThis 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026