Chronic HeadachesNCT01525303
Effects of Aerobic Exercise Within a Behavioral Treatment Program for Chronic Headaches
A study testing Behavioral Treatment for Chronic Headache- Exercise Version in people with Chronic Headaches, run by University of Mississippi Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 64 years, women only
- Conditions the study is for
- Chronic Headaches
- What is being tested?
- Behavioral Treatment for Chronic Headache- Exercise Version
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2011to Aug 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Mississippi Medical Center
Jackson, Mississippi, 39216
About this study
Official title: Additive Effects of Aerobic Exercise to a Standard Behavioral Self-Management 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.
Read the 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.
- Conditions
- Chronic Headaches
- Being tested
- Behavioral Treatment for Chronic Headache- Exercise Version
- Keywords
- headaches, behavioral treatment, physical activity
- Medical subject headings
- Headache Disorders, Headache, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral Treatment for Chronic Headache- Exercise VersionBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Behavioral Treatment for Chronic Headache- Exercise Version |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-reported headache-free days per week
Patients are asked to report the number of days per week they do no experience headaches
Measured: 2 weeks prior to treatment through 2 weeks post-treatment
Secondary outcomes (3)
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."
Measured: baseline, 8 weeks, 10 weeks
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.
Measured: 2 weeks prior to treatment through 2 weeks post-treatment
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.
Measured: 2 weeks prior to treatment through 2 weeks follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2012 (estimated)
- Study startDec 2011
- Primary completionJun 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic HeadachesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Mississippi Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Donald Penzien, University of Mississippi Medical Center
- Investigators
- Donald Penzien, Ph.D., Principal investigator, University of Mississippi Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01525303
- Sponsor's protocol ID
- 2011-0044
- Status last verified
- Jan 2013
- First submitted
- 30 Jan 2012
- Last updated
- 16 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Additive Effects of Aerobic Exercise to a Standard Behavioral Self-Management Program for Chronic Headaches
- ClinicalTrials.gov ID
- NCT01525303
- Acronym / sponsor ID
- 2011-0044
- Conditions
- Chronic Headaches
- Keywords
- headaches, behavioral treatment, physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of Mississippi Medical CenterUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 2 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise-Start (ES) | Experimental | Behavioral: Behavioral Treatment for Chronic Headache- Exercise VersionThe 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. |
| Exercise-Middle (EM) | Experimental | Behavioral: Behavioral Treatment for Chronic Headache- Exercise VersionThe 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. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral Treatment for Chronic Headache- Exercise VersionThis 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). | Behavioural | Exercise-Middle (EM), Exercise-Start (ES) |
Primary outcome
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
3 secondary outcomes
Headache Disability Index (HDI)
Time frame: baseline, 8 weeks, 10 weeks
Highest weekly headache intensity
Time frame: 2 weeks prior to treatment through 2 weeks post-treatment
Composite Depression/Anxiety Screening Scale (PHQ-4)
Time frame: 2 weeks prior to treatment through 2 weeks follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Donald Penzien, Ph.D. principal investigator
University of Mississippi Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Treatment for Chronic Headache- Exercise Version in people with Chronic Headaches, run by University of Mississippi Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-reported headache-free days per week (time frame: 2 weeks prior to treatment through 2 weeks post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2013.