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Comprehensive Approach to Lifestyle Modification in Chronic Migraine

Study acronym: CALM-Migraine
StatusNot Yet Recruiting
PhaseNot applicable
Started2026-09
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463 trials monitored
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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.
Trial Details
NCT Number NCT07802860
Lead Sponsor Hacettepe University
Conditions Chronic Migraine, Headache
Enrollment 30 participants
Start Date 2026-09
Primary Completion 2028-02-01 (estimated)
Study Completion 2028-02-01 (estimated)
Updated on ClinicalTrials.gov 2026-09-03