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Comprehensive Approach to Lifestyle Modification in Chronic Migraine
Sponsor: Hacettepe University
Summary
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 55 Years
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2026-09
Completion Date
2028-02-01
Last Updated
2026-09-03
Healthy Volunteers
No
Conditions
Interventions
Comprehensive Lifestyle Intervention
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 24 individual, face-to-face sessions delivered three times per week under a physiotherapist's supervision. The intervention will address the six pillars of lifestyle medicine: physical activity, diet, mental health and stress management, sleep, risky substance use, and social connections. It will include three main components: supervised exercise training, structured patient education, and peer support sessions.
Locations (1)
Hacettepe University Faculty of Physical Therapy and Rehabilitation
Ankara, Turkey (Türkiye)