Healthy Living Partnerships for Veterans With Migraine

Launched by WAKE FOREST UNIVERSITY HEALTH SCIENCES · Apr 29, 2020

Keywords

ClinConnect Summary

The "Healthy Living Partnerships for Veterans With Migraine" trial is a study designed to help veterans who suffer from chronic migraines. This trial aims to explore how changes in lifestyle, like diet and physical activity, can affect migraine frequency and severity. It takes inspiration from a previous program that successfully helped veterans at risk for diabetes. By adding education about migraines to this lifestyle program, the researchers hope to find effective ways to reduce migraine symptoms and improve the quality of life for participants.

To participate in this study, veterans aged 21 and older who have been diagnosed with chronic migraines (having headaches 15 or more days a month) may be eligible. Participants should not currently be engaging in regular physical activity and must be open to being assigned to either a lifestyle intervention or a comparison group. Throughout the trial, participants will learn about managing their migraines and will be asked to stick with the program to see how well it works. It's important to note that individuals with certain medical conditions or unstable headache treatments may not be eligible for this study. This trial is currently not recruiting participants, but it aims to gather valuable information that could lead to future, larger studies on migraine management.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Demographics: Community dwelling men and women Veterans (21 years of age and older) of all races/ethnicities seen as patients at the Kernersville Health Care Center.
• • Headache Diagnosis, frequency, and chronicity: All participants will be required to have a diagnosis of chronic migraine as per ICHD-IIIβ criteria24. Those with headache frequency ≥ 15 headache days per month for more than three months will be eligible to participate.
• • Willingness to Accept Randomization: Prospective participants must be willing to accept randomization to either the intensive lifestyle intervention or the comparison intervention condition.
• • Baseline Physician Activity Level: At the time of enrollment, prospective participants must not be participating in a regular physical activity or exercise regimen, and should meet the criteria for "sedentary" (i.e., does not report current engagement in vigorous or moderate activity) on the International Physical Activity Questionnaire Short form (IPAQ-SF).
• Exclusion Criteria:
• • Other painful conditions: A diagnosis of headache disorder other than chronic migraine (eg, cluster headache or medication overuse headache as per ICHD-IIIβ criteria24) or characterizes a pain disorder other than migraine as their primary presenting problem.
• • Non-stable headache treatment regimen: Reports a change in physician prescribed preventive or acute headache pharmacotherapy within three weeks prior to enrollment or anticipates a change in preventive headache pharmacotherapy during the study period.
• • Recent history of cardiovascular disease: Clinical history of cardiovascular disease (CVD) occurring within the past 6 months, including myocardial infarction, angina, coronary revascularization, stroke, TIA, carotid revascularization, peripheral arterial disease, and congestive heart failure. All persons with recent CVD should be participating in cardiac rehabilitation (with appropriate supervision as indicated) to reduce their risk of recurrence; hence, randomization might raise ethical concerns.
• • Hypertension: Uncontrolled high blood pressure: BP \> 160/100 mmHg. Potential participants can be re-screened after controlled.
• • Pregnancy, planning pregnancy and breast feeding (self-report) during screening: Pregnancy, breast feeding, or planning pregnancy within the next year.
• • Physical preparedness for exercise: Those screening positive on the Physical Activity Readiness Questionnaire (PAR-Q)25 those must obtain physician clearance prior to participation, and will be excluded unless the clearance is obtained and documented.
• • Other Medical and Psychiatric Conditions: Candidates will be screened for other co-morbid conditions that could make physical activity unsafe or limit participation. This includes other chronic disease likely to limit lifespan to less than 2-3 years (eg, any cancer requiring treatment in past 5 years except non-melanoma skin cancer), elevated depressive symptoms and/or suicidal ideation (Patient Health Questionnaire (PHQ-9)28,29), anxiety levels that could interfere with participation in this trial (PROMIS-29 Anxiety Subscale30-32, and evidence of opioid use disorder (Current Opioid Misuse Measure (COMM)33).
• • Other: Conditions/criteria likely to interfere with participation and acceptance of randomized assignment, including the following: inability/unwillingness to give informed consent, another household member already randomized to HELP-VM, evidence of major psychiatric or cognitive problems (schizophrenia, dementia, self-reported active illegal substance or alcohol abuse), participation in another research study that would interfere with HELP-VM.