Comprehensive Approach to Lifestyle Modification in Chronic Migraine
ConditionChronic Migraine, Headache
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-55
SponsorHacettepe University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.)
Trial design
Design model
Parallel
Treatments tested in this trial
Comprehensive Lifestyle Intervention
BehavioralParticipants 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.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Lifestyle Intervention GroupExperimental treatment 1 intervention
Group B: Wait-list control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Migraine severity
Migraine severity will be assessed using the Visual Analog Scale (VAS). For each migraine attack, participants will indicate pain intensity on a 10-cm horizontal line anchored from "no pain" to "worst imaginable pain." The distance from the left endpoint to the participant's mark will be measured in centimeters, with higher values indicating greater migraine severity. Participants will prospectively record migraine severity for each attack in a migraine diary throughout the study.
Time frame
Baseline (T0), post-intervention at 8 weeks (T1), 3 months after baseline (T2), and 6 months after baseline (T3)2
Average Attack Duration
Average migraine attack duration will be determined using prospectively recorded migraine diary data. Participants will record each migraine attack duration in hours, and the average attack duration will be calculated for the relevant assessment period.
Time frame
Baseline (T0), post-intervention at 8 weeks (T1), 3 months after baseline (T2), and 6 months after baseline (T3)3
Total Number of Attacks
Participants will prospectively record each migraine attack using a migraine diary throughout the study. The diary records will determine the total number of migraine attacks for each relevant assessment period.
Time frame
Baseline (T0), post-intervention at 8 weeks (T1), 3 months after baseline (T2), and 6 months after baseline (T3)4
Migraine Disability Assessment (MIDAS)
Migraine-related disability will be assessed using the Migraine Disability Assessment (MIDAS) questionnaire. The MIDAS total score is calculated by summing the first five items, which assess the number of days with missed or reduced productivity at work or school, in household activities, and in social or leisure activities during the previous 3 months. Higher total scores indicate greater migraine-related disability.
Time frame
Baseline (T0), post-intervention at 8 weeks (T1), 3 months after baseline (T2), and 6 months after baseline (T3)Secondary outcomes
1
High Mobility Group Box 1 (HMGB1) Level
Time frame
Baseline (T0), post-intervention at 8 weeks (T1), 3 months after baseline (T2), and 6 months after baseline (T3)2
NOD-Like Receptor Family Pyrin Domain Containing 3 (NLRP3) Level
Time frame
Baseline (T0), post-intervention at 8 weeks (T1), 3 months after baseline (T2), and 6 months after baseline (T3)3
Objective Physical Activity Measurement (ActiGraph LEAP™ Activity Monitor)
Physical activity outcomes will include step count, sedentary time (ST), light physical activity (LPA), and moderate-to-vigorous physical activity (MVPA).
Time frame
Baseline (T0), post-intervention at 8 weeks (T1), 3 months after baseline (T2), and 6 months after baseline (T3)4
Consumption of Migraine-Triggering Foods and Associated Headache Severity
Time frame
Baseline (T0), post-intervention at 8 weeks (T1), 3 months after baseline (T2), and 6 months after baseline (T3)Sponsors and contacts
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Source ClinicalTrials.gov
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