Chronic Migraine, Headache
Conditions
Keywords
Lifestyle, Physical Activity, Exercise, Nutrition, Stress Management, Sleep, Social Support, Cognitive Function, Heart Rate Variability, Neuroinflammation, Quality of Life, Patient Education, Peer Support, Relaxation Training
Brief 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.
Interventions
BEHAVIORALComprehensive 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.
Sponsors
Hacettepe University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
A physiotherapist will perform outcome assessments and be blinded to group allocation.
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Number of Attacks | Baseline (T0), post-intervention at 8 weeks (T1), 3 months after baseline (T2), and 6 months after baseline (T3) | 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. |
| Migraine severity | Baseline (T0), post-intervention at 8 weeks (T1), 3 months after baseline (T2), and 6 months after baseline (T3) | 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. |
| Average Attack Duration | Baseline (T0), post-intervention at 8 weeks (T1), 3 months after baseline (T2), and 6 months after baseline (T3) | 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. |
| Migraine Disability Assessment (MIDAS) | Baseline (T0), post-intervention at 8 weeks (T1), 3 months after baseline (T2), and 6 months after baseline (T3) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| High Mobility Group Box 1 (HMGB1) Level | Baseline (T0), post-intervention at 8 weeks (T1), 3 months after baseline (T2), and 6 months after baseline (T3) | — |
| NOD-Like Receptor Family Pyrin Domain Containing 3 (NLRP3) Level | Baseline (T0), post-intervention at 8 weeks (T1), 3 months after baseline (T2), and 6 months after baseline (T3) | — |
| Objective Physical Activity Measurement (ActiGraph LEAP™ Activity Monitor) | Baseline (T0), post-intervention at 8 weeks (T1), 3 months after baseline (T2), and 6 months after baseline (T3) | Physical activity outcomes will include step count, sedentary time (ST), light physical activity (LPA), and moderate-to-vigorous physical activity (MVPA). |
| Consumption of Migraine-Triggering Foods and Associated Headache Severity | Baseline (T0), post-intervention at 8 weeks (T1), 3 months after baseline (T2), and 6 months after baseline (T3) | — |
| Healthy Eating Index-2020 (HEI-2020) | Baseline (T0), post-intervention at 8 weeks (T1), 3 months after baseline (T2), and 6 months after baseline (T3) | — |
| 10-item Perceived Stress Scale (PSS-10) | Baseline (T0), post-intervention at 8 weeks (T1), 3 months after baseline (T2), and 6 months after baseline (T3) | — |
| Hospital Anxiety and Depression Scale (HADS) | Baseline (T0), post-intervention at 8 weeks (T1), 3 months after baseline (T2), and 6 months after baseline (T3) | — |
| Objective Sleep Measurement (ActiGraph LEAP™ Activity Monitor) | Baseline (T0), post-intervention at 8 weeks (T1), 3 months after baseline (T2), and 6 months after baseline (T3) | Objective sleep outcomes will include total sleep time, sleep latency, and sleep efficiency. |
| Pittsburgh Sleep Quality Index (PSQI) | Baseline (T0), post-intervention at 8 weeks (T1), 3 months after baseline (T2), and 6 months after baseline (T3) | — |
| Epworth Sleepiness Scale (ESS) | Baseline (T0), post-intervention at 8 weeks (T1), 3 months after baseline (T2), and 6 months after baseline (T3) | — |
| Risky Substance Use | Baseline (T0), post-intervention at 8 weeks (T1), 3 months after baseline (T2), and 6 months after baseline (T3) | Risky substance use will be assessed based on smoking exposure (pack-years) and alcohol consumption (drinks/week). |
| Multidimensional Scale of Perceived Social Support (MSPSS) | Baseline (T0), post-intervention at 8 weeks (T1), 3 months after baseline (T2), and 6 months after baseline (T3) | — |
| Body Composition (Tanita MC-780-MA Body Composition Analyzer) | Baseline (T0), post-intervention at 8 weeks (T1), 3 months after baseline (T2), and 6 months after baseline (T3) | Body composition outcomes will include body weight, body fat percentage, fat mass, fat-free mass, and skeletal muscle mass. |
| Heart Rate Variability (HRV) | Baseline (T0), post-intervention at 8 weeks (T1), 3 months after baseline (T2), and 6 months after baseline (T3) | HRV outcomes will include mean RR interval, SDNN, RMSSD, pNN50, low-frequency (LF) power, high-frequency (HF) power, and the LF/HF ratio. |
| Montreal Cognitive Assessment (MoCA) | Baseline (T0), post-intervention at 8 weeks (T1), 3 months after baseline (T2), and 6 months after baseline (T3) | — |
| Task-Specific Cognitive Assessment | Baseline (T0), post-intervention at 8 weeks (T1), 3 months after baseline (T2), and 6 months after baseline (T3) | Computerized Stroop and N-Back Tasks |
| Chronic Headache Self-Efficacy Scale (CHASE) | Baseline (T0), post-intervention at 8 weeks (T1), 3 months after baseline (T2), and 6 months after baseline (T3) | — |
| Migraine Specific Quality of Life Questionaire version 2.1 (MSQ v2.1) | Baseline (T0), post-intervention at 8 weeks (T1), 3 months after baseline (T2), and 6 months after baseline (T3) | — |
Countries
Turkey (Türkiye)
Contacts
CONTACTOzlem Ulger, PhD
CONTACTSinan Buran, MSc
PRINCIPAL_INVESTIGATOROzlem Ulger
Hacettepe University
Outcome results
None listed