Comprehensive Approach to Lifestyle Modification in Chronic Migraine

Investigation of the Effectiveness of a Lifestyle-Based Intervention on Migraine-Related Clinical Outcomes, Neuroinflammatory Biomarkers, Health-Related Lifestyle Behaviors, Body Composition, Autonomic Nervous System Function, Cognitive Function, Self-Efficacy, and Quality of Life in Patients With Chronic Migraine

Migraine is a highly prevalent neurological disorder and one of the leading causes of disability worldwide, substantially affecting quality of life and individuals during their most productive years. Chronic migraine, defined as headache occurring on ≥15 days per month for more than three months, is a particularly disabling form of the disease. Physical inactivity, unhealthy dietary behaviors, stress, sleep disturbances, risky substance use, and inadequate social support may contribute to the burden and chronification of migraine. The CALM-Migraine trial aims to investigate the effects of a comprehensive lifestyle-based intervention in individuals with chronic migraine. Participants will be randomly assigned to either a lifestyle intervention group or a wait-list control group. Participants allocated to the lifestyle intervention group will receive an 8-week comprehensive lifestyle intervention alongside their usual pharmacological treatment. The intervention will consist of supervised exercise training, structured patient education, and peer support sessions delivered under the supervision of a physiotherapist. It will address the six pillars of lifestyle medicine: physical activity, diet, mental health and stress management, sleep, risky substance use, and social connections. The study will evaluate the intervention's effects on migraine-related clinical outcomes, neuroinflammatory biomarkers, health-related lifestyle behaviors, body composition, autonomic nervous system function, cognitive function, self-efficacy, and quality of life. Participants will be followed after the intervention to assess whether the effects are maintained over time.

Inclusion Criteria:

• Having been diagnosed with chronic migraine according to the ICHD-3 diagnostic criteria after a neurological examination by a Neurology Specialist
• Not having a regular medication habit other than for migraine pain
• No changes in current medication management during the study period
• Being between 18-55 years of age

Exclusion Criteria:

• Having headache types other than chronic migraine
• Having rheumatological diseases characterized by chronic widespread pain, such as fibromyalgia
• Having neurological, orthopedic, or cardiovascular conditions that may prevent the individual from participating in exercise
• Comorbid conditions other than migraine that are known to adversely affect cognitive functioning (e.g., traumatic brain injury, personality disorders, post-traumatic stress disorder, bipolar affective disorder, etc.)
• Use of medications that may affect autonomic function
• Receiving hormone replacement therapy
• Receiving antihypertensive treatment
• Having undergone botulinum toxin application within the last six months
• Having undergone invasive procedures such as dry needling/injection within the last six months
• Pregnancy
• For female patients, being postmenopausal